Avedro, Inc.
KXL System
Operator’s Manual

ML-00002

Revision E

Copyright 2011

All Rights Reserved

Printed in U.S.A.

Patents, Trademarks, Copyrights
The KXL System may be covered by one or more patent applications issued orpending in the United States and worldwide.
“KXL” and the Avedro logo design are registered trademarks or trademarks ofAvedro, Inc. All software and documentation is subject to Avedro, Inc. copyrights.
All rights reserved 2011.
Microsoft and Windows are registered trademarks and trademarks, respectively,of Microsoft Corporation. Any other trademarks or service marks contained
within this manual are the property of their respective owners.

For more information, contact:Your Local Avedro-authorized distributor
Avedro, Inc.
230 Third Avenue
Waltham, MA 02451
Authorized Representative
EMERGO EUROPE
Molenstraat 152513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299

0470

Table of Contents
Chapter:

Chapter:

Chapter:

Chapter:
KXL System Operator’s Manual,
Rev Eiii

Chapter:
Chapter:
Chapter:

KXL System Operator’s Manual,
Rev Eiv

Table of Figures
Figure 2.1: Overview Illustration of System.................................................................... 2-2
Figure 2-1. System Illustrations with Callouts ................................................................ 2-3
Figure 2-2. Wireless Remote ........................................................................................... 2-3
Figure 2-3: KXL Label .................................................................................................... 2-4
Figure 2-4: UV emitting Label ........................................................................................ 2-4
Figure 2-5: Laser Classification Label ............................................................................. 2-4
Figure 3-1. Startup Screen ............................................................................................... 3-4Figure 3-2. Induction Period Screen ................................................................................ 3-4
Figure 3-3 Enter Treatment Parameters Screen ............................................................... 3-5
Figure 3-4 Populated Treatment Parameters Screen ........................................................ 3-5
Figure 3-5 Confirm Treatment Parameters Screenn ........................................................ 3-6
Figure 3-6 Reading Disposables ...................................................................................... 3-7Figure 3-7 Reading Tag Screen ....................................................................................... 3-8Figure 3-8 System Setup Status ....................................................................................... 3-8Figure 3-9 Prepare Patient Screen.................................................................................... 3-9Figure 3-10 Align Crosshairs during induction ............................................................. 3-10Figure 3-11 Induction Complete .................................................................................... 3-10Figure 3-12 Treatment Screen ....................................................................................... 3-11Figure 3-13. Treatment Paused Screen .......................................................................... 3-11Figure 3-14. Treatment Complete Screen ...................................................................... 3-12Figure 3-15. Initial Confirm Cancel Session Screen ..................................................... 3-13Figure 3-16. Confirm Cancel Partial Treatment ............................................................ 3-13Figure 3-17. Partial Treatment Information ................................................................... 3-14
Figure 3-18. Device Settings Menu ............................................................................... 3-15
Figure 3-19. Edit Alignment Crosshairs Intensity ......................................................... 3-16
Figure 3-20. Device Settings Edit Volume .................................................................... 3-16
Figure 3-21. Device Settings Transfer to USB .............................................................. 3-17
Figure 4-1. Remote Lost Sync ......................................................................................... 4-2

KXL System Operator’s Manual,
Rev Ev

This page is left blank intentionally.

KXL System Operator’s Manual,
Rev Evi

1 Forward
1.1 Intended Use of Manual

1.2 Intended Use

1.3 Design Change Disclaimer


1.4 Reproduction Disclaimer

1.5 User Operation Assistance Statement

KXL System Operator’s Manual,
Rev E
1-1

Chapter 1: Forward

1.6 Contraindications, Warnings and Cautions
1.6.1 Contraindications






1.6.2 Warnings

1.6.3 Electrical Safety Warnings


KXL System Operator’s Manual,
Rev E
1-2

Chapter 1: Forward








1.7 Patient Safety

KXL System Operator’s Manual,
Rev E
1-3

Chapter 1: Forward

1.8 Additional Safety Considerations

1.9 FCC Compliance Notice

KXL System Operator’s Manual,
Rev E
1-4

2 Introduction
2.1 System Overview

KXL System Operator’s Manual,
Rev E2-1

Chapter 2: Introduction

2.1.1 Major ComponentsFigure 2.1: Overview Illustration of System

KXL System Operator’s Manual,
Rev E
2-2

Chapter 2: Introduction

Figure 2-1. System Illustrations with Callouts

Figure 2-2. Wireless Remote

KXL System Operator’s Manual,
Rev E
2-3

Chapter 2: Introduction

Figure 2-3: KXL Label

Figure 2-4: UV emitting Label

Figure 2-5: Laser Classification LabelKXL System Operator’s Manual,
Rev E
2-4

KXL System Operator’s Manual,
Rev E2-1

3 System Operation
3.1 Charging the KXL Batteryooo

3.2 Touchpad/Keyboard Use
Touchpad Key

Icon

Description/Function

Power Off button(Initial screen)

Turns OFF electric power tothe personal computer.

Start New Treatment
button (Initial screen)

Directs the system to repeat
the entire clinical treatment
protocol so the physician
can treat another patient.

KXL System Operator’s Manual,
Rev E
3-1

Chapter 3: System Operation

Touchpad Key

Icon

Description/Function

UP arrow(various ClinicalProtocol screens)

Increases the value of thecurrent field

DOWN arrow(various ClinicalProtocol screens)

Decreases the value of thecurrent field

X button(various DeviceSettings screens)

Cancels all the entries on aparticular screen andreturns to the previousscreen.

Checkmark button(various ClinicalProtocol screens andDevice Settingsscreen)

Directs the system to accept
the current screen entries
and to proceed to the nextstep.

Cancel Session
button(various ClinicalProtocol screens)

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

Return to Treatment
button(Confirm CancelSession screen)

Cancels the Cancel Sessioncommand and returns to theTreatment screen.

Return button(various DeviceSettings screen)

Returns to the Device
Settings menu.

KXL System Operator’s Manual,
Rev E3-2

Chapter 3: System Operation

3.3 UV Dose

3.4 Preparing the System

3.5 Important Steps before Turning on the Systemoo

3.6 Powering Up the System

KXL System Operator’s Manual,
Rev E
3-3

Chapter 3: System Operation

Figure 3-1. Startup Screen

3.7 Setting Treatment Settings
Figure 3-2. Induction Period Screen

KXL System Operator’s Manual,
Rev E3-4

Chapter 3: System Operation

Figure 3-3 Enter Treatment Parameters Screen
ooFigure 3-4 Populated Treatment Parameters Screen

KXL System Operator’s Manual,
Rev E
3-5

Chapter 3: System Operation

Figure 3-5 Confirm Treatment Parameters Screen
KXL System Operator’s Manual,
Rev E
3-6

Chapter 3: System Operation

3.8 Starting Treatment
Figure 3-6 Reading Disposables

KXL System Operator’s Manual,
Rev E
3-7

Chapter 3: System Operation

Figure 3-7 Reading Tag ScreenFigure 3-8 System Setup Status

KXL System Operator’s Manual,
Rev E
3-8

Chapter 3: System Operation

3.9 Preparing the PatientOnce the Riboflavin is aaplied to the eye, Start the induction by pressing
the “Riboflavin Applied: Start Timer” button. Figure 3-9 Prepare PatientScreen

KXL System Operator’s Manual,
Rev E
3-9

Chapter 3: System Operation

Figure 3-10 Align Crosshairs during induction

3.10 Initiating Treatment

Figure 3-11 Induction Complete
KXL System Operator’s Manual,
Rev E
3-10

Chapter 3: System Operation

Figure 3-12 Treatment Screen

3.11 Monitoring Treatment

3.12 Stopping a Treatment
Figure 3-13. Treatment Paused Screen
KXL System Operator’s Manual,
Rev E3-11Chapter 3: System Operation

3.13 Treatment Complete

Figure 3-14. Treatment Complete Screen






KXL System Operator’s Manual,
Rev E
3-12

Chapter 3: System Operation

3.14 Pausing or Canceling a Treatment

Figure 3-15. Initial Confirm Cancel Session ScreenFigure 3-16. Confirm Cancel Partial Treatment
KXL System Operator’s Manual,
Rev E
3-13

Chapter 3: System Operation

Figure 3-17. Partial Treatment Information

KXL System Operator’s Manual,
Rev E
3-14

Chapter 3: System Operation

3.15 Using the Device Settings Menu


Figure 3-18. Device Settings Menu

3.15.1 Advanced Settings
KXL System Operator’s Manual,
Rev E
3-15

Chapter 3: System Operation

3.15.2 Editing Alignment Crosshairs IntensityFigure 3-19. Edit Alignment Crosshairs Intensity

3.15.3 Editing System Volume

Figure 3-20. Device Settings Edit Volume

KXL System Operator’s Manual,
Rev E
3-16

Chapter 3: System Operation

3.15.4 Copying Treatment Data to USBFigure 3-21. Device Settings Transfer to USB
KXL System Operator’s Manual,
Rev E
3-17

Chapter 3: System Operation

KXL System Operator’s Manual,
Rev E
3-18

4 Maintenance / Service
4.1 Installation Policy

4.2 Customer Maintenance

4.3 Warranty Information


4.4 Service Contract Information


4.5 Per Patient Disposables

KXL System Operator’s Manual,
Rev E4-1

Chapter 5: Maintenance/Service

4.6 Trouble Shooting

Figure 4-1. Remote Lost Syncoooo

KXL System Operator’s Manual,
Rev E
4-2

Chapter 5: Maintenance/Serviceo

4.7 Directions for Sterilization or Disinfection


4.8 Cleaning the System






4.9 Cleaning the Aperture

4.10 Articulating Arm Adjustment

KXL System Operator’s Manual,
Rev E4-3

Chapter 5: Maintenance/Service4.11 Performing Periodic MaintenanceInterval

Specific Task

AnnualCalibration by Avedro trained personnel.

4.12 Moving the System

4.13 Storing the System

4.14 Software

4.15 Identifying Risks Associated with Disposingof Waste Products

4.16 Performing a Visible Check

KXL System Operator’s Manual,
Rev E
4-4

5 Equipment Classificationo

o

o
o
o

o


oooo

KXL System Operator’s Manual,
Rev E
5-1

Chapter 5: Equipment Classification

KXL System Operator’s Manual,
Rev E
5-2

6 Symbol Library
Text Symbol

Symbol IllustrationDefinition

1. No AP symbol in presenceof flammable anesthetics

Danger, Risk of Explosion. Notfor use.

2. AC symbol

Alternating current

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

4. Ground symbol in circle

Protected earth (ground)

5. Power Switch

ON

6. Power Switch

OFF

7. Fuse symbol

Fuse

8. CE Mark

Conformity mark9. Manufacturer

Name and address of themanufacturer

10. ! in a Triangle

Caution specific warning inoperators manual

11.

Weight

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

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

KXL System Operator’s Manual,
Rev E
6-1

Chapter 6: Symbol Library

Text Symbol

Symbol Illustration

13. Wine glass with crack on
itDefinition
Contents are fragile, handlewith care.

or
14. Two up arrows

Keep arrows on carton pointingup

15. Water drop in a box

Humidity limits (percentages
below symbol are theacceptable range for humidity)

16. Temperature limits

Temperature shipment limits.

KXL System Operator’s Manual,
Rev E
6-2

Chapter 12: Parts List

7 Specifications
Specification

Description

Software Version

System 1.0

ElectricalBattery Powered: 12V 35 Ah SLALine voltages 100-240 volts AC, ± 10%
Current 2A
Single Phase
RMS, 50/60 Hz, ± 5%
Remote 2x AAA batteries

User accessible Fuses

250 V~ F2AL

Energy Delivery

UV Radiation
3-30 mW/cm2365 nm

External Interfaces
Physical Dimensions
Weight (crated system)
Battery Life
(normal operating conditions)
Environmental Operating Conditions
Ambient temperature
Relative humidity
Atmospheric pressure
Transport and Storage Conditions

Ambient temperature
Relative humidity
Atmospheric pressure

USB 2.0
No larger than 60 x 60 x 150 cm3 (Lengthx Width x Height)
NW 45 Kg
GW 120 Kg
16 hours
The system operates under the following
atmospheric conditions (no condensation).
+10 to +40 ºC
30% to 75%
900 to 1060 mbar
The instrument withstands the following
transport and storage conditions without
damage or performance deterioration.
-15 to +70 ºC
10% to 100% including condensation
500 to 1060 mbar

KXL System Operator’s Manual,
Rev E
7-1