Avedro, Inc.
KXL System
Operator’s Manual

ML-00002

Revision A

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 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 2010.
Microsoft and Windows are registered trademarks and trademarks, respectively,of Microsoft Corporation.

Any other trademarks or service marks contained within this manual are theproperty 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,
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Chapter:

Chapter:

Chapter:

Chapter:
Chapter:

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Chapter 1: Foreword

List of Figures

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KXL System Operator’s Manual,
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Chapter 6: Maintenance

1 Foreword
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

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Chapter 1: Foreword

1.6 Contraindications, Warnings and Cautions
1.6.1 Contraindications

Prior corneal surgery
Corneal melting disorders
Aphakic patients
Pseudophakic patients without UV blocking lens implanted

1.6.2 Warnings
Herpes simplex, herpes zoster keratitis, recurrent corneal erosion, corneal dystrophy

1.6.3 Electrical Safety Warnings

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Chapter 1: Foreword

1.6.4 Grounding

1.6.5 Safety Instructions

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Chapter 1: Foreword

1.7 Eye Protection

1.8 Patient Safety

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Chapter 1: Foreword

1.9 Use Restrictions

1.10 Safety Design

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Chapter 1: Foreword

1.11 Additional Safety Considerations

1.12 FCC Compliance Notice

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Chapter 1: Foreword1.13 Use in Presence of Flammable MixturesKXL System Operator’s Manual,
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Chapter 1: Foreword

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2 Introduction
2.1 System Overview

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Chapter 2: Introduction

2.1.1 Major Components

Figure 2-1. Overview Illustration of System

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Chapter 2: Introduction

Articulating Arm

UV Indicator

User Interface/
RFID reader

HandleUV Output

Remote holster

Charging CordFigure 2-2. System Illustrations with Callouts

Figure 2-3. Wireless Remote

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Chapter 2: Introduction

Figure 2-4: KXL Label

Figure 2-5: UV emitting Label

Figure 2-6: Laser Classification LabelKXL System Operator’s Manual,
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3 Procedure Guidelines
3.1 UV Dose

3.2 Preparing the System

3.3 Select the Induction Period

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Chapter 3: Procedure Guidelines

3.4 Select the UV Treatment Parameters

3.5 Select and Prepare Accessories

3.6 Preparing the Patient

3.7 Starting Treatment

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3.8 Alignment of Light Source

3.9 Monitoring Treatment

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Chapter 3: Procedure Guidelines

3.10 Stopping a Treatment

3.11 Resuming a Treatment

3.12 Canceling Treatment

3.13 Treatment Complete

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4 Treatment Guidelines
4.1 Keratoconus / Post Lasik Ectasia
Avedro recommends the following KXL settings:

4.2 LASIK Xtra

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Chapter 3: Procedure Guidelines

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5 Operation
5.1 Charging the KXL Battery

5.2 Software User Interface: Touchpad/Keyboard
Use
Touchpad KeyIconDescription/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.

UP arrow(various ClinicalProtocol screens)

Increases the value of thecurrent field

DOWN arrow(various ClinicalProtocol screens)

Decreases the value of thecurrent fieldKXL System Operator’s Manual,
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Chapter 5: Operation

Touchpad KeyIcon

Description/Function

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 next
step.

Cancel Session
button(various ClinicalProtocol screens)

Cancels a treatment session
for a particular patient. A
prompt displays to confirm
your decision.

Return to Treatment
button(Confirm Cancel
Session screen)

Cancels the Cancel Sessioncommand and returns to theTreatment screen.

Return button(various DeviceSettings screen)

Returns you to the Device
Settings menu.

5.3 Important Steps before Turning on the System

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Chapter 5: Operation

5.4 Software User Interface: Powering Up theSystem

Figure 5-1 Startup Test Screen

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Chapter 5: Operation

Figure 5-2. Welcome Screen

5.5 Software User Interface: Setting Treatment
Settings

Figure 5-3. Induction Period Screen

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Chapter 5: Operation

Figure 5-4 Enter Treatment Parameters Screen

Figure 5-5 Populated Treatment Parameters Screen

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Chapter 5: Operation

Figure 5-6 Select UV Beam Diameter Screen

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Chapter 5: Operation

Figure 5-7 Confirm Treatment Parameters Screen

5.6 Software User Interface: Starting Treatment

Figure 5-8 Scan Disposables Screen

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Chapter 5: Operation

Figure 5-9 System Setup Status

Figure 5-10 Prepare Patient Screen

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Chapter 5: Operation

Figure 5-11

Figure 5-12 Induction Complete

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Chapter 5: Operation

Figure 5-13 Treatment Screen

Figure 5-14. Treatment Paused Screen

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Chapter 5: Operation

Figure 5-15. Treatment Complete Screen

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Chapter 5: Operation

5.7 Software User Interface: Canceling aTreatment
Figure 5-16. Initial Confirm Cancel Session Screen

Figure 5-17. Confirm Cancel Partial Treatment

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Chapter 5: Operation

Figure 5-18. Partial Treatment Information

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Chapter 5: Operation

5.8 Software User Interface: Using the Device
Settings MenuFigure 5-19. Device Settings Menu

5.8.1 Advanced Settings

Figure 5-20 Advanced Setting AccessKXL System Operator’s Manual,
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Chapter 5: Operation

5.8.2 Country Code

Figure 5-21 Advanced Settings: Country Code

5.8.3 Editing System Volume

Figure 5-22. Device Settings Edit Volume
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Chapter 5: Operation

5.8.4 Copying Treatment Data to USB

Figure 5-23. Device Settings Transfer to USB

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6 Maintenance
6.1 Customer Maintenance

6.2 Service and Diagnostic Requirements

6.3 Directions for Sterilization or Disinfection

6.4 Cleaning the System

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Chapter 6: Maintenance

6.5 Cleaning the Aperture

6.6 Performing Periodic MaintenanceInterval

Specific Task

AnnualCalibration by Avedro trained personnel.

6.7 Moving the System

6.8 Storing the System

6.9 Updating Software

6.10 Identifying Risks Associated with Disposingof Waste Products
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Chapter 6: Maintenance6.11 Performing a Visible CheckKXL System Operator’s Manual,
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Chapter 6: MaintenanceKXL System Operator’s Manual,
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6-47 Customer ServiceInformation
7.1 Before Calling your local Avedro
Representative for Helpcalling yourfor help, first follow the information contained in this chapter.

7.2 Installation Policy

7.3 Warranty Information
7.4 Service Contract Information

7.5 Per Patient Disposables

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Chapter 7: Customer Service Information

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8 Symbol Library
Text Symbol

Symbol Illustration

Definition

1. Man in a box

Type BF “Body Floating”
applied part

2. No AP symbol in presenceof flammable anesthetics

Danger, Risk of Explosion. Notfor 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 SwitchON

8. “0” on Power Switch

OFF

9. Fuse symbol

Fuse

10. Lightning bolt in triangle

Dangerous Voltage

14. CE Mark

Conformity mark14. CE MarkStandbyKXL System Operator’s Manual,
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Chapter 8: Symbol Library

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Chapter 12: Parts List

9 Specifications
Specification

Description

Software Version

System 1.0ElectricalBattery Powered: 12V 35 AhCharging:Line voltages 100, 115, 22, 240 volts AC,± 10% RMS, 50/60 Hz, ± 5%

Energy Delivery

UV Radiation

External Interfaces
Environmental Operating Conditions

USB 2.0
The system operates under the following
atmospheric conditions (no condensation).
+15 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
Class IIa

Ambient temperature
Relative humidity
Atmospheric pressure
Transport and Storage Conditions

Ambient temperature
Relative humidity
Atmospheric pressure
Device Classification per MDD
93/42/EEC
Physical Dimensions
Weight (crated system)
Battery Life
(normal operating conditions)

No larger than 60 x 60 x 150 cm3 (Lengthx Width x Height)
At least 120 Kg
16 hours

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