Avedro, Inc.

KXL System
Service Manual

SM-00002 Revision E

Copyright 2010 All Rights Reserved

Printed in U.S.A.
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 2010.

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: Avedro, Inc.

230 Third Avenue
Waltham, MA 02451
Tel: (781) 768-3400
Fax: (781) 768-3401
Email: [email protected]

Authorized Representative

EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299
 Chapter 1: Foreword

Table of Contents

Chapter: 1 Foreword .................................................................................. 1-1

1.1 Intended Use of Manual ................................................................................. 1-1
1.2 Intended Use .................................................................................................. 1-1
1.3 Design Change Disclaimer ............................................................................ 1-1
1.4 Reproduction Disclaimer ............................................................................... 1-1
1.5 User Operation Assistance Statement ............................................................ 1-1
Chapter: 2 Installation and Set Up ........................................................... 2-1
2.1 Uncrating the system...................................................................................... 2-1
2.1.1 Removing Front Panel ........................................................................ 2-1
2.1.2 Inspect for damage ............................................................................. 2-2
2.1.3 Install Ramp and remove KXL Console from the crate ..................... 2-3
2.1.4 KXL Console with Power Source ...................................................... 2-5
2.2 Attach Optics Head ........................................................................................ 2-6
2.2.1 Attach Optics head to the articulating Arm (New Style) ................... 2-6
2.2.2 Attach Optics head to the articulating Arm (Old Style) ..................... 2-7
2.2.3 Connect Power and Communication cables ....................................... 2-8
2.3 Attach Monitor to the KXL System ............................................................... 2-9
2.3.1 Attach the User Interface to the KXL Module (Newer Models)........ 2-9
2.3.2 Mount the PC to the bracket that is mounted to the neck. ............... 2-10
2.3.3 Secure PC assembly to Mount Bracket ............................................ 2-11
2.4 Verify Arm Tension is adequate .................................................................. 2-12
2.4.1 Fully extend the Arm and monitor. The arm should remain motionless
and not rise or fall ........................................................................................ 2-12
2.4.2 Adjust Arm Tension if Required ...................................................... 2-12
2.5 Adjust system volume if desired .................................................................. 2-13
2.5.1 Access the “System Volume” adjustment screen ............................. 2-13
2.6 Edit Red Cross Hair Intensity if desired ...................................................... 2-14
2.6.1 Access the “Alignment Crosshairs Intensity” adjustment screen .... 2-14
2.7 Wireless Remote .......................................................................................... 2-16
Chapter: 3 System Verification ................................................................. 3-1
3.1 Verify alignment lasers and range of motion ................................................. 3-1
3.1.1 Accessing Device Settings Menu ....................................................... 3-1
3.1.2 Accessing Advanced Settings Menu .................................................. 3-1
3.1.3 Accessing System Diagnostics ........................................................... 3-2
3.1.4 Service Card Access .......................................................................... 3-2
3.1.5 System Diagnostics (Newer Models) ................................................. 3-3
3.2 Verify UV Spot Size ...................................................................................... 3-5
3.3 Perform Calibration Verification ................................................................... 3-7
3.3.1 Enter the Advanced Settings Menu .................................................... 3-7
3.3.2 Access the calibration screen ............................................................. 3-8
3.3.3 Select the button labeled “Check Calibration Without Meter” .......... 3-8

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 3.3.4 Calibration check pass ........................................................................ 3-9
3.4 Fill out Avedro KXL Installation Form ......................................................... 3-9
3.4.1 To obtain a copy of the Installation Form: ......................................... 3-9
3.4.2 To submit a completed Installation Form: ......................................... 3-9
Chapter: 4 Service Maintenance ............................................................... 4-1
4.1 Customer Maintenance .................................................................................. 4-1
4.2 Service and Diagnostic Requirements ........................................................... 4-1
4.3 Cleaning the Aperture .................................................................................... 4-1
4.4 Performing Periodic Maintenance ................................................................. 4-1
4.5 Updating Software ......................................................................................... 4-1
4.5.1 Remove the existing User Interface Software .................................... 4-1
4.6 Flashing Firmware (New Style) ..................................................................... 4-3
4.6.1 This procedure describes how to update the firmware for KXL devices
that are equipped with a Boot Loader. ........................................................... 4-3
4.7 Flashing Firmware (Old Style) ...................................................................... 4-5
4.7.1 This procedure describes how to update the firmware for KXL devices
that are not equipped with a Boot Loader. ..................................................... 4-5
4.8 Replacing the KXL Battery ......................................................................... 4-10
4.9 Specialized Tools ......................................................................................... 4-12
4.9.1 KXL Head Spindle Tool .................................................................. 4-12
4.9.2 Service Access Card ......................................................................... 4-12
4.9.3 KXL Aperture Range and Test Sheet ............................................... 4-13
4.9.4 UV Power Meter .............................................................................. 4-13
4.9.5 Close up of 5mm Aperture ............................................................... 4-14
4.9.6 Firmware Programming Device ....................................................... 4-15
4.10 System Calibration ....................................................................................... 4-16
4.10.1 Enter the Advanced Settings Menu ................................................ 4-16
4.10.2 Access the calibration screen ......................................................... 4-16
4.10.3 Align Red and Green lasers on the Power Sensor.......................... 4-17
4.10.4 Start Calibration ............................................................................. 4-17
4.10.5 Calibration Complete ..................................................................... 4-18
4.10.6 Accessing Device Settings Menu to Save Calibration Data .......... 4-18
4.10.7 Accessing Advanced Settings Menu .............................................. 4-19
4.11 System Errors Codes .................................................................................... 4-20
4.12 System Block Diagram ................................................................................ 4-21
4.13 Firmware / Software Compatibility Matrix ................................................. 4-22
Chapter: 5 Customer Service Information .............................................. 5-1
5.1 Before Calling Avedro for Help .................................................................... 5-1
5.2 Customer Service Policy ................................................................................ 5-1
5.3 Installation Policy .......................................................................................... 5-2
5.4 Warranty Information .................................................................................... 5-2
5.5 RMA Policy ................................................................................................... 5-2
5.6 Service Contract Information ......................................................................... 5-2
5.7 Per Patient Disposables .................................................................................. 5-2
Chapter: 6 Symbol Library ....................................................................... 6-1
 Chapter 1: Foreword

Chapter: 7 Specifications ........................................................................... 7-1

List of Figures
Figure 2-1. Shipping Crate, Front View ....................................................................................... 2-1
Figure 2-2. Crated system view .................................................................................................... 2-2
Figure 2-3. Set up of shipping ramp ............................................................................................. 2-3
Figure 2-4. Locking casters .......................................................................................................... 2-3
Figure 2-5. Overview Illustration of System ................................................................................ 2-4
Figure 2-6. KXL Console with skins removed ............................................................................. 2-5
Figure 2-7. Optical Head Assembly ............................................................................................. 2-6
Figure 2-7. Spindle Engagement .................................................................................................. 2-6
Figure 2-8. Attach Optics Head to Articulating Arm ................................................................... 2-7
Figure 2-9. Optics Head with cables ............................................................................................ 2-7
Figure 2-10. Optics Head attached to Arm ................................................................................... 2-8
Figure 2-11. Optics Head Cables connected ................................................................................ 2-8
Figure 2-12. Monitor Cables Figure 2-13. Attaching VGA Cable .......................... 2-9
Figure 2-14. Attaching VGA Cable ...................................................................................... 2-9
Figure 2-15. PC Mount Bracket Figure 2-16.System Mount Bracket .... 2-10
Figure 2-17. PC Mount Bracket, back view ..................................................................... 2-11
Figure 2-18. PC Mount Final Side View ............................................................................ 2-11
Figure 2-19. Full Arm Extension................................................................................................ 2-12
Figure 2-20. Tension adjustment Figure 2-21. Allen Key Adjust ...................... 2-12
Figure 2-22. Access the Device Settings Screen ........................................................................ 2-13
Figure 2-23. Access the Device Settings Screen ........................................................................ 2-13
Figure 2-24. Access the Edit Volume screen ............................................................................. 2-14
Figure 2-25. Access the Device Settings Screen ........................................................................ 2-14
Figure 2-26. Access the Device Settings Screen ........................................................................ 2-15
Figure 2-27. Access the Crosshairs Intensity Adjustment .......................................................... 2-15
Figure 2-28. Wireless Remote .................................................................................................... 2-16
Figure 3-1: System Start Screen ................................................................................................... 3-1
Figure 3-2: Device Settings Menu................................................................................................ 3-1
Figure 3-3: Advanced Settings Menu ........................................................................................... 3-2
Figure 3-4: Scanning for Access Card.......................................................................................... 3-2
Figure 3-5: Service Access Card .................................................................................................. 3-3
Figure 3-6: System Diagnostic (Old Style) Figure 3-7: System Diagnostic (New Style) 3-
3
Figure 3-8: Avedro Set Up Tool (TOOL 029) ............................................................................. 3-4
Figure 3-9: Verify Range of Motion ............................................................................................ 3-4
Figure 3-10: System Diagnostic Tests Screen .............................................................................. 3-5
Figure 3-11: System Diagnostics Screen ...................................................................................... 3-6
Figure 3-12: Sample UV Beam test (9MM) ................................................................................. 3-6
Figure 3-13: Advanced Settings Menu ......................................................................................... 3-7

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Figure 3-14: System Calibration Screen....................................................................................... 3-8
Figure 3-15: Calibration Check Passed ........................................................................................ 3-8
Figure 4-1. Program Files Folder ................................................................................................. 4-2
Figure 4-2: KXL Boot Loader root folder .................................................................................... 4-3
Figure 4-3: Boot Loader Application Launched Figure 4-4: Disconnect Power to the Head 4-4
Figure 4-5: Gain access to Optics Head Board............................................................................. 4-5
Figure 4-6: Firmware Programming Port ..................................................................................... 4-6
Figure 4-7. Connected Programmer ............................................................................................. 4-6
Figure 4-8. Select Target Device .................................................................................................. 4-7
Figure 4-9. Programmer Selection ............................................................................................... 4-7
Figure 4-10. Software communication verification...................................................................... 4-8
Figure 4-11. Program Device ....................................................................................................... 4-9
Figure 4-12. Base Cover Clamps................................................................................................ 4-10
Figure 4-13. Base Plate Exposed ................................................................................................ 4-10
Figure 4-14. Battery Compartment Exposed .............................................................................. 4-11
Figure 4-15: Service Access Card .............................................................................................. 4-12
Figure 4-16: UV Power Meter and Sensor ................................................................................. 4-13
Figure 4-17: 5mm Aperture in place .......................................................................................... 4-14
Figure 4-18: 5mm Aperture Removed ....................................................................................... 4-14
Figure 4-19: ICD3 Programming Puck ...................................................................................... 4-15
Figure 4-20: Advanced Settings Menu ....................................................................................... 4-16
Figure 4-21: System Calibration Screen..................................................................................... 4-16
Figure 4-22: Example of proper alignment ................................................................................ 4-17
Figure 4-23: Start Calibration..................................................................................................... 4-17
Figure 4-24: System Start Screen ............................................................................................... 4-18
Figure 4-25: Device Settings Menu ............................................................................................ 4-19
Figure 4-26: KXL Error Code List ............................................................................................. 4-20
Figure 4-27: KXL System Block Diagram ................................................................................. 4-21
Figure 4-28: Software / Firmware Compatibility Matrix ........................................................... 4-22
Chapter 1: Foreword

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 Chapter 6: Maintenance

1 Foreword
1.1 Intended Use of Manual
This manual is designed to serve as reference for Avedro trained Field Service Technicians 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
the operator’s responsibility to ensure that all safety instructions in this manual are applied
strictly.

1.2 Intended Use

The KXL System delivers a uniform, metered dose of UVA light to a targeted treatment area for
the intended use of illuminating the cornea during corneal crosslinking procedures.

1.3 Design Change Disclaimer

• Due to design changes and product improvements, information in 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
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
permission or without permission.

1.4 Reproduction Disclaimer

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

1.5 User Operation Assistance Statement

Should you experience any difficulty in running your KXL System, please contact your Avedro
representative. The troubleshooting chapter in this manual (Chapter 7) includes a list of error
messages and possible solutions. The information given here is general. Some applications may
require additional procedure or equipment modification. Feel free to contact the Technical
Support department of Avedro at 781-768-3406. Hours are 8:00 a.m. – 5:00 p.m. (Eastern Time),
Monday through Friday.

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2 Installation and Set Up
2.1 Uncrating the system

2.1.1 Removing Front Panel

Remove the front panel of the shipping crate. There will be six clasps that hold the front panel in
place. The positions of the clasps are circled in red.

Figure 2-1. Shipping Crate, Front View

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2.1.2 Inspect for damage

With the front panel of the crate removed, inspect the KXL cart for signs of visible damage.

If damage is suspected, report to your local distributor immediately.

The three components of the KXL system will be visible as shown

KXL Console with Power Source

KXL User Interface

KXL Optics Head

KXL User
Interface

Ramp
KXL Optics
Head

KXL Console with

Power Source

Figure 2-2. Crated system view

 Chapter 2: Installation and Set Up

2.1.3 Install Ramp and remove KXL Console from the crate
The shipping crate has a ramp on the inside wall to help remove the console from the crate. Place
this ramp on the front edge of the shipping crate as shown.

Figure 2-3. Set up of shipping ramp

Unlock the casters to roll the console out of the crate

Figure 2-4. Locking casters

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Chapter 2: Installation and Set Up

The KXL System is shipped in three major subcomponents. The crated System includes the
following:
• Optics Head with UV source
• KXL user interface
• KXL Console with Power Source

Figure 2-5. Overview Illustration of System

 Chapter 2: Installation and Set Up

2.1.4 KXL Console with Power Source

To gain access to the internal components of the KXL, simply remove the two covers on the Main
column. These covers are secured using ‘Snap Clamps” and are easily removed by hand.

NOTE: It is NOT necessary to gain access to the KXL internal components to set up the system

Figure 2-6. KXL Console with skins removed

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 Chapter 2: Installation and Set Up

2.2 Attach Optics Head

2.2.1 Attach Optics head to the articulating Arm (New Style)

Wire Bushing

Head Spindle Nut

Thrust Washer

Articulating Arm

KXL Optical Head

Figure 2-7. Optical Head Assembly

NOTE: It is critical that the thrust washer is in the correct position in order for the
assembly to fully engage.

UNLOCKED LOCKED

Figure 2-8. Spindle Engagement

NOTE: Assembly aid tool 390-00113 KXL Head Spindle Tool shown above
 Chapter 2: Installation and Set Up

2.2.2 Attach Optics head to the articulating Arm (Old Style)

NOTE: The snap ring and washer are shipped with the Optical Head, attached to the mounting
post. The cables (shown in figure 2-8) will fit through the center of the snap ring and
washer.

Snap Ring

Washer

Wavy Washer

Articluating Arm
Optical Head

Figure 2-9. Attach Optics Head to Articulating Arm

Figure 2-10. Optics Head with cables

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2.2.3 Connect Power and Communication cables

Once the Optics Head is secured to the Articulating Arm, attach both the Power and
Communication Cables in the Arm.

Figure 2-11. Optics Head attached to Arm

Figure 2-12. Optics Head Cables connected

 Chapter 2: Installation and Set Up

2.3 Attach Monitor to the KXL System

2.3.1 Attach the User Interface to the KXL Module (Newer Models)
NOTE: The newer KXL systems have a VGA cable added. This cable gives the KXL the feature
of powering down the system entirely using the monitor only

RFID Cable

VGA Cable

Power Cable

Comm Cable

Figure 2-13. Monitor Cables Figure 2-14. Attaching VGA Cable

NOTE: The VGA cable is attached using a 3/32” Ball Driver that is located in the upper arm of
the device (Avdero P/N 390-01971)

Power Cable

Comm Cable

RFID Cable

Figure 2-15. Attaching VGA Cable

NOTE: VGA Cable not shown in above picture

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Chapter 2: Installation and Set Up

2.3.2 Mount the PC to the bracket that is mounted to the neck.

NOTE: There are two tabs on the PC that need to be slotted into the two holes on the mounting
bracket. Once these are in place, The PC can be attached with the two screws provided.

Figure 2-16. PC Mount Bracket Figure 2-17.System Mount Bracket

NOTE: The two tabs on the PC mount bracket are circled in Red. Likewise, the two
corresponding slots on the System mount bracket are also circled in red
 Chapter 2: Installation and Set Up

2.3.3 Secure PC assembly to Mount Bracket

NOTE: Once the cables are connected and the tabs & slots are aligned, secure the PC assembly to
the mount bracket using the two screws provided. The two holes cirlced should be aligned with
the corresponding pem nuts on the PC assembly.

Figure 2-18. PC Mount Bracket, back view

Figure 2-19. PC Mount Final Side View

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2.4 Verify Arm Tension is adequate

NOTE: The system was designed so that the arm would remain still in any position it is placed
while performing a procedure. The arm tension is factory set to remain motionless with
the Optical Head Attached

2.4.1 Fully extend the Arm and monitor. The arm should remain
motionless and not rise or fall

Figure 2-20. Full Arm Extension

2.4.2 Adjust Arm Tension if Required

The Arm Tension can be adjusted using a 7/32 Allen Key (Supplied) The adjustment port
is located directly behind the monitor at the base of the Arm as shown

Counterclockwise tightens the tension

Clockwise loosens the tension

Figure 2-21. Tension adjustment Figure 2-22. Allen Key Adjust

 Chapter 2: Installation and Set Up

2.5 Adjust system volume if desired

The KXL is shipped with the system volume set at mid-range. This is an adequate volume for
reasonable use. However, the system volume may be adjusted if desired.

2.5.1 Access the “System Volume” adjustment screen

The “Edit Volume” screen can be accessed by the user

Figure 2-23. Access the Device Settings Screen

Figure 2-24. Access the Device Settings Screen

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Chapter 2: Installation and Set Up

Figure 2-25. Access the Edit Volume screen

Once in this screen simply edit the volume to a level that is satisfactory. Once the desired level is
achieved, press the GREEN CHECK box.

2.6 Edit Red Cross Hair Intensity if

desired
2.6.1 Access the “Alignment Crosshairs Intensity” adjustment
screen
The “Edit Crosshairs Intensity” screen can be accessed by the user

Figure 2-26. Access the Device Settings Screen

 Chapter 2: Installation and Set Up

Figure 2-27. Access the Device Settings Screen

Figure 2-28. Access the Crosshairs Intensity Adjustment

Once in this screen simply edit the intensity to a level that is satisfactory. Once the desired level
is achieved, press the GREEN CHECK box.

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2.7 Wireless Remote

Horizontal
Control
Vertical
Control

Synchronization
Button (S)

Figure 2-29. Wireless Remote

NOTE: Use the Blue button on the left to pair the remote with the device.

NOTE: The wireless remote will display a flashing blue light (left side of remote) for two distinct
reasons

The remote is disconnecting (un-pairing) with the device. This happens at the conclusion of
UV at the end of a treatment
The remote batteries are low and need to be replaced

• In the case of the remote disconnecting with the device, the light will blink once per
second for a period of ten seconds
• In the case of low battery power, the light will blink more rapidly (twice per second) and
it will constantly blink until the batteries are replaced

It is important to replace the remote batteries as soon as indicated. If the batteries die during a
procedure, the Optical Head may return to an unknown state and compromise the procedure
`
 Chapter 2: Installation and Set Up

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3 System Verification
3.1 Verify alignment lasers and range of
motion
3.1.1 Accessing Device Settings Menu
Pressing the Touch Screen right on the KXL Logo will allow access to the Device Settings Menu

Figure 3-1: System Start Screen

3.1.2 Accessing Advanced Settings Menu

The “Advanced Settings” button allows access to the Advanced Settings Menu

Figure 3-2: Device Settings Menu

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Chapter 3: System Verification

Note: You will need your Avedro Service Card to enter the Advanced Settings Menu

3.1.3 Accessing System Diagnostics

Figure 3-3: Advanced Settings Menu

3.1.4 Service Card Access

Figure 3-4: Scanning for Access Card

Place Avedro Service Access Card over the RFID tag on the monitor to access the Advanced
Settings Menu
 Chapter 3: System Verification

Figure 3-5: Service Access Card

3.1.5 System Diagnostics (Newer Models)

Using the “Motion Control Subsystem” section on the “System Diagnostic Tests” screen activates
the following functions:

1. Pair Dongle – This may have to be pressed twice to pair the remote hand piece

2. Red (X, Y) On – Activates Red Crosshairs for X & Y alignment

3. Green (Z) On – Activates Green laser for Z alignment

4. Home – Puts the Lasers and Diode in the “Home” or centered position

Figure 3-6: System Diagnostic (Old Style) Figure 3-7: System Diagnostic (New Style)

NOTE: In the older style systems, the red crosshair aligns the X, Y axis and the green dot aligns
the Z axis.

In Newer style systems, both the X, Y laser AND the Z laser are red crosshairs

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With the X,Z and Z lasers activated and the system on its “Home” position, adjust the height of
the Optical Head until the Z laser is close to the intersection of the X,Y crosshairs. Use the
Remote for fine alignment of Z laser. Use Avedro Set Up tool 029 for range of motion and UV
spot size checks.

Figure 3-8: Avedro Set Up Tool (TOOL 029)

After roughly aligning the X,Y and Z lasers to the center of the 16mm grid, use the remote to
move the lasers to all four corners of the grid. This will successfully complete verification of
the lasers and range of motion

Figure 3-9: Verify Range of Motion

NOTE: Notify Avedro Service if the X, Y range of motion test is NOT able to reach all 4 corners
of the 16mm Grid.
 Chapter 3: System Verification

3.2 Verify UV Spot Size

With the lasers and range of motion validated, return to the “System Diagnostic Tests” screen and
press the “HOME” button in the Motion Control Subsystem field. Leave the Red and Green lasers
on for this next step

Figure 3-10: System Diagnostic Tests Screen

1. Verify that X,Y,Z reads:

X = 3200

Y = 3200

Z = 4000

2. Advance to the UV Diagnostics page by selecting the “UV Diag” Button

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Chapter 3: System Verification

Position the alignment lasers over the 9MM aperture test circle and select the button marked
“Low UV” Check for two things:

1. Check that the edges of the UV light are crisp, indicating that the UV is at the proper
focal point

2. Check that the UV beam is the correct size using the hash marks for min/max size.

Figure 3-11: System Diagnostics Screen

NOTE: Below is an example of a 9mm Beam.

Figure 3-12: Sample UV Beam test (9MM)

 Chapter 3: System Verification

3.3 Perform Calibration Verification

NOTE: The KXL System is shipped calibrated from the factory. Initial verification is
performed to ensure that the system calibration has not been compromised during
shipment.

3.3.1 Enter the Advanced Settings Menu

Note: You will need your Avedro Service Card to enter the Advanced Settings Menu

Figure 3-13: Advanced Settings Menu

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3.3.2 Access the calibration screen

Figure 3-14: System Calibration Screen

3.3.3 Select the button labeled “Check Calibration Without

Meter”
Note: The box in the upper right will provide status updates as
• The dialog box (Large white box) will display the status of the calibration

Figure 3-15: Calibration Check Passed

NOTE: DO NOT select the box marked “Start Calibration” as this will initiate a new calibration.
This is not necessary at this time.
 Chapter 3: System Verification

NOTE: The KXL System will take approximately 2 minutes to perform the calibration check.

3.3.4 Calibration check pass

Once the KXL passes its calibration check, the dialog box in the upper right corner will indicate
that the test has passed successfully.

NOTE: If the test fails to pass successfully, a new calibration will be required. Refer to the
Service Maintenance section for instructions to perform a full calibration.

3.4 Fill out Avedro KXL Installation Form

Once system set up and validation is completed, complete the KXL Installation Form that is
provided and provide to Avedro Service to validate the installation.

3.4.1 To obtain a copy of the Installation Form:

• Call Avedro Service at +1781-768-3406

• E-mail Avedro service at [email protected]

3.4.2 To submit a completed Installation Form:

• Fax it to Avedro Service at +1 781-768-3401

• E-mail a scanned copy of the form to [email protected]

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4 Service Maintenance
By definition “Service Maintenance” is to be performed only by an Avedro trained service person

4.1 Customer Maintenance

• In general, the only maintenance required on the KXL System is annual recalibration of
the Optical Head.

4.2 Service and Diagnostic

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

4.3 Cleaning the Aperture

Check the beam aperture routinely prior to treatment.

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

4.4 Performing Periodic Maintenance

Interval Specific Task

Annual Calibration by Avedro trained personnel.

4.5 Updating Software

It may be necessary to update the user interface on the KXL System as updates become available.
The following steps will guide you through the procedure to update this Software

4.5.1 Remove the existing User Interface Software

• Access the computer C:\ drive through “Advanced Settings / Exit to Desktop”
• From the Start Menu select “My Computer”
• From “My Computer” select the C:\ drive
• In the C:\Programs folder you will find a folder named “Avedro”
• Delete the contents of this folder

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Figure 4-1. Program Files Folder

• Replace the files that were just deleted from the “Avedro” folder with the new folder
contents that has been provided to you by Avedro
• Close Explorer and power down the Touch computer

NOTE: The standard Windows “Shutdown” option has been disabled on this machine. To power
down the Panel PC you must press “CTRL/ALT/DELETE” then “LOGOFF” then
“SHUT DOWN”

1. Shut off Console at main power switch

2. Reinitialize console with main power switch
3. Fill out KXL Installation Form (FORM 7-00047) whenever updating software or firmware.
 Chapter 4: Service Maintenance

4.6 Flashing Firmware (New Style)

New style KXL systems are shipped with a Boot Loader flashed onto the Optical Head PCB. This
allows the Service Tech to flash firmware through the USB port. This eliminates the need to gain
access to the inside of the Optical Head.

4.6.1 This procedure describes how to update the firmware for

KXL devices that are equipped with a Boot Loader.
Begin this process by gaining access to the Monitor Desktop through the Advanced Settings
screen

To initiate the Boot Loader, install the USB stick that has been provided to you into the USB port
located on the KXL monitor. On this you will find the following folder.

Figure 4-2: KXL Boot Loader root folder

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Click on the executable file “KXLBoot – TOOL-00121” to launch the Boot Loader application.

Figure 4-3: Boot Loader Application Launched Figure 4-4: Disconnect Power to the Head

Now follow 6 simple steps to flash firmware onto the PCB

1. Press the program button on the Boot Loader

2. Reconnect power to the head (You only have 10 seconds to do this)

3. Once power has been established, the boot loader will flash the firmware

4. Confirm that the Boot Loader displays “Programming Done”

5. Power down the KXL and restart

6. Confirm correct firmware has been loaded through the system diagnostics page.
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4.7 Flashing Firmware (Old Style)

4.7.1 This procedure describes how to update the firmware for

KXL devices that are not equipped with a Boot Loader.
The main circuit board is located in the optics head. This board can be accessed by
removing the 3 screws that hold the bottom portion of the head in place.

NOTE: Take care to avoid scratching the optics lens when removing the lower portion of
the head. Lay it carefully on its side when flashing firmware

Figure 4-5: Gain access to Optics Head Board

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Figure 4-6: Firmware Programming Port

Attach the Microchip MPLAB ICD3 programming puck to the Optics Head main circuit board
using the programming cable as shown in diagram below.

Figure 4-7. Connected Programmer

At drafting of this document, the following software and hardware are used.
Microhip MPLAB ICD3 Programming Puck (P/N DV164035)
MPLAB IDE SOFTWARE V8.56
KXL BOARD FIRMWARE (KXL.HEX)
1. Launch the MPLAB IDE v8.56 Software from laptop or PC
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2. Using the “CONFIGURE” drop down menu, select the “SELECT DEVICE” tab and
identify target device to program to as shown in photo below.
NOTE: Unless otherwise specified, select PIC24FJ256GA110 as your target device.

Figure 4-8. Select Target Device

1. Using the “PROGRAMMER” drop down tab click on “SELECT PROGRAMMER” and
then click on “MPLAB ICD3” as shown on diagram below
2. You have now allowed the software to identify both the programming device and the
target device for programming

Figure 4-9. Programmer Selection

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3. Make sure that the software is communicating with programming puck before
proceeding (See below)

Figure 4-10. Software communication verification

4. Using the “FILE” dropdown menu select the “IMPORT” tab to Import the firmware
you wish to program to the device.
5. Once the appropriate firmware is loaded, press the “PROGRAM DEVICE” button to
begin programming. (See diagram)
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The “PROGRAM TARGET DEVICE” button is not labeled.

Hovering over the button will cause the identification dialogue box
to appear as shown. The button is on the far left in this diagram

Figure 4-11. Program Device

6. The dialog box will indicate that programming has successfully completed.
7. Fill out KXL Installation Form (FORM 7-00047) whenever updating software or
firmware.

Attach the Microchip MPLAB ICD3 programming puck to the Optics Head main circuit board
using the programming cable as shown in diagram below.
8. Use the USB cable provided with the MPLAB ICD3 programming puck to connect to
laptop or PC

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4.8 Replacing the KXL Battery

The KXL System utilizes a 12V DC battery to power the system during patient treatments where
the power cord is not used. In the occasion this battery needs to be replaced, follow this section.

WARNING: Always remove the Optical Head prior to accessing the battery enclosure. With the
chassis separated from its base, tipping of the unit could damage the optical head.

To gain access to the battery, first remove the Blue base cover. Two clamps hold the base cover
in place.

Base Cover Clamps

Figure 4-12. Base Cover Clamps

Disconnect the cables from the charger and remove the 8 M6 SCHD screws as shown

Figure 4-13. Base Plate Exposed

Carefully set the Chassis aside. Take care to avoid tipping.

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With the battery compartment exposed, carefully remove old battery and replace with new
battery. When installing the new battery, repeat the orientation shown in the picture below.

Use a 10mm Socket wrench to remove bracket and terminals

Figure 4-14. Battery Compartment Exposed

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4.9 Specialized Tools

In general there few specialized tools required for Servicing the KXL System. A Service Access
Card and specially equipped Power Meter are all that are required.

4.9.1 KXL Head Spindle Tool

The KXL Head Spindle tool is an assembly aid for the newer style KXL Optical heads.

4.9.2 Service Access Card

The Service Access Card allows the Avedro Trained Service Technician access to the Advanced
Settings menu.

Ordering Information: Part Number 390-00011

Figure 4-15: Service Access Card

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4.9.3 KXL Aperture Range and Test Sheet

Ordering Information: 390-00029 KXL Aperture Range and test sheet

4.9.4 UV Power Meter

The Avedro supplied UV Power Meter has been specially retrofitted with a 5mm aperture in the
Power Sensor. This Aperture is required for all diagnostic and calibration activities

Ordering Information:

390-00026 Nova II Universal Sensor Display

390-00027 Photodiode Sensor 10pW-3W

390-00028 Nova II Universal Sensor Power Supply (US connection)

390-00029 KXL Aperture Range and test card

390-00030 5mm Aperture for Photdiode Sensor

USB Communication Cable and Stand both included (pictured below

Figure 4-16: UV Power Meter and Sensor

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4.9.5 Close up of 5mm Aperture

The 5mm Aperture is not visible while the filter is attached. This aperture is required for all
calibration activities.

NOTE: If the Aperture is removed, the calibration or calibration checks will not be carried out
correctly, resulting in the systems inability to carry out its own checks and therefore be
rendered inoperable.

Figure 4-17: 5mm Aperture in place

Figure 4-18: 5mm Aperture Removed

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4.9.6 Firmware Programming Device

It will be periodically required to Flash Firmware onto the Circuit Board located in the Optics
Head. The Avedro supplied programming puck will be required to perform these upgrades.

Ordering Information:

390-000008 ICD3 Programming Puck

Figure 4-19: ICD3 Programming Puck

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4.10 System Calibration

4.10.1 Enter the Advanced Settings Menu
Note: You will need your Avedro Service Card to enter the Advanced Settings Menu

Figure 4-20: Advanced Settings Menu

4.10.2 Access the calibration screen

NOTE: You will be prompted to connect the KXL System to the Power Meter.
• Connect Power Meter to KXL via USB connection located on the bottom of the Monitor
• Press the button marked “Connect to Power Meter”
• The system will now initialize the Power Meter

Figure 4-21: System Calibration Screen

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4.10.3 Align Red and Green lasers on the Power Sensor

Note: The command box in the upper right corner will prompt you to align the UV beam before
Calibrating or checking Calibration. This ensures that the UV beam will be focused on the
power sensor
• Position the Optical Head and the sensor so as to align the Red Crosshairs onto the Power
Sensor so each corner of the sensor has a Crosshair populating it
• Using the fine Z Axis adjustment on the wireless remote, position the Green Laser in the
center of the Red Crosshairs.
• The KXL is now aligned properly to start calibration

Figure 4-22: Example of proper alignment

4.10.4 Start Calibration

• With the Red and Green lasers properly aligned, select the box marked “Start
Calibration”

NOTE: DO NOT select the box marked “Check Calibration” as this will simply recheck current
calibration.

Figure 4-23: Start Calibration

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NOTE: The KXL System will take approximately 3 minutes to perform the calibration. During
this time it will occasionally pause to allow the LED to cool. This is normal.

4.10.5 Calibration Complete

Once the KXL successfully calibrates the system, the dialog box in the upper right corner will
indicate that calibration is successfully completed

4.10.6 Accessing Device Settings Menu to Save Calibration

Data
Pressing the Touch Screen right on the KXL Logo will allow access to the Device Settings Menu

Figure 4-24: System Start Screen

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4.10.7 Accessing Advanced Settings Menu

The “Device Settings” Menu allows access to the “Copy Data to USB” button.

Figure 4-25: Device Settings Menu

Selecting the “Copy Data to USB” button will download the KXL system’s new or existing
calibration data through the USB port located on the bottom of the monitor. The download will
creat a file with the KXL system serial number, Date and Time as the folder name

NOTE: Please send this new data to Avedro Service so it may be stored with the Device History
File.

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4.11 System Errors Codes

When errors occur on the KXL system the user will be shown an error code. The table below will
help you determine the root cause for each of the error codes you may see. It is important to write
down error codes as you see them. These will be helpful when trouble shooting with Avedro
Service.

Root Cause Error Code

ERROR_SYSTEM_FATAL =0

ERROR_UART_FRAME_ERROR, =1

ERROR_UART_HW_OVERFLOW, =2

ERROR_COMM, =3

ERROR_UVMON_PD1_H = 10,

ERROR_UVMON_PD1_L, = 11

ERROR_UVMON_I_H, = 12

ERROR_UVMON_I_L, = 13

ERROR_UVMON_TRMT_TIME_H, = 14

ERROR_UVMON_TRMT_TIME_L, = 15

ERROR_UVMON_OVERTEMP, = 16

ERROR_UVMON_DAC_RB, = 17

ERROR_XYZ_FAILED_HOMING = 20,

ERROR_APERTURE_MOVE_FAILED = 30,

ERROR_APERTURE_MOTOR_I2C, = 31

ERROR_APERTURE_ENCODER_READ, = 32

Figure 4-26: KXL Error Code List

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4.12 System Block Diagram

Figure 4-27: KXL System Block Diagram

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4.13 Firmware / Software

Compatibility Matrix
NOTE: It is functionally critical that the system User Interface software and system Firmware
are compatible. The following chart should be referenced when upgrading User
Interface software to insure the proper revision of Firmware is present. Contact
Avedro Service if there are compatibility concerns.

The User Interface version as well as the Firmware version can be found in the “System
Diagnostic Tests” screen in the upper right corner

UI = User Interface

PRI = Firmware version

User Interface (UI) Firmware (PRI)

1.5.1 1.1.3
2.1.0 2.0.0
3.0.0 3.0.0
4.0.0 4.0.0 (New Style Heads)
4.0.0 2.1.0 (Old Style Heads)
Figure 4-28: Software / Firmware Compatibility Matrix
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Information
5.1 Before Calling Avedro for Help
Whenever you experience difficulty using the KXL System, before calling Avedro for help, first
follow the information contained in this chapter.

1. Write down the time and date that the problem occurred, or when you first noticed the
problem. Also, note what the system was doing when the problem occurred or was first
noticed. Note all other relevant information.

2. Attempt to isolate the problem.

5.2 Customer Service Policy

Avedro has developed a Customer Service department to meet the varied service needs of its
customers. Examples of department functions include:

• Telephone troubleshooting with technical experts

• On-site repair of all equipment malfunctions by qualified service representatives

• Technical assistance to solve specific application questions

Avedro's Customer Service department can help customers expedite shipments, contact the
proper personnel, or help with special customer requests. To contact Avedro's Customer Service
department, call 781-768-3406. A Customer Service Representative is available from 8:00 a.m. to
5:00 p.m. (Eastern Time) to:

• place an order

• check on installation

• request technical assistance

• request field repair service

• request product and procedure training

• report a problem

• return products

• issue a complaint

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5.3 Installation Policy

For each new KXL System customer, an Avedro trained Service Technician 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.

This manual includes specific instructions relating to installation or set-up of the system. Per your
service agreement, any further hardware adjustment, other than what is specified for normal
operation, should be performed by, or with the guidance of, an Avedro representative.

5.4 Warranty Information

A Warranty is supplied separately with the purchasing information.

5.5 RMA Policy

“RMA” stands for Returned Merchandise Authorization. If it ever proves necessary to return
hardware to Avedro, you MUST follow this procedure.

1. A warranty claim must be made promptly and must be received during the applicable
warranty period by Avedro upon receipt of the RMA form.

2. If it becomes necessary to return a product for repair or replacement, prior authorization

from Avedro must be obtained. Instructions as to how and where these products should
be shipped will be provided by Avedro.

3. Any product or component returned for examination and/or warranty repair shall be sent
to Avedro in Waltham, Massachusetts. All items must be returned at the customer’s cost
(freight prepaid), quoting a return authorization number which is available from the
Customer Service Department. All products or components repaired or replaced under
warranty will be returned to the customer at Avedro’s cost using UPS (United Parcel
Service) or an equivalent service.

4. In all cases, Avedro has sole responsibility for determining the cause and nature of
failure, and Avedro’s determination with regard thereto shall be final.

5. All parts that are returned under warranty will become the property of Avedro.

5.6 Service Contract Information

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

5.7 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 unauthorized materials.
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6 Symbol Library
Text Symbol Symbol Illustration Definition
1. Man in a box Type BF “Body Floating”
applied part

2. No AP symbol in presence Danger, Risk of Explosion. Not

of flammable anesthetics for use.

3. AC symbol Alternating current

4. ! in triangle Attention: Consult

ACCOMPANYING
DOCUMENTS
6. Ground symbol in circle Protected earth (ground)

7. “I” on Power Switch ON

8. “0” on Power Switch OFF

9. Fuse symbol Fuse

10. Lightning bolt in triangle Dangerous Voltage

14. CE Mark Conformity mark

14. CE Mark Standby

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7 Specifications
Specification Description
Software Version System 2.0.0
Electrical Battery Powered: 12V 35 Ah
Charging:
Line voltages 100, 115, 22, 240 volts AC,
± 10% RMS, 50/60 Hz, ± 5%
Energy Delivery UV Radiation
External Interfaces USB 2.0
Environmental Operating Conditions The system operates under the following
atmospheric conditions (no condensation).
Ambient temperature +15 to +40 ºC
Relative humidity 30% to 75%
Atmospheric pressure 900 to 1060 mbar
Transport and Storage Conditions The instrument withstands the following
transport and storage conditions without
damage or performance deterioration.
Ambient temperature +15 to +70 ºC
Relative humidity 10% to 100% including condensation
Atmospheric pressure 500 to 1060 mbar
Device Classification per MDD Class IIa
93/42/EEC
Physical Dimensions No larger than 60 x 60 x 150 cm3 (Length
x Width x Height)
Weight (crated system) At least 120 Kg
Battery Life 16 hours
(normal operating conditions)

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