Avedro, Inc.
KXL System
Operator’s Manual

ML-00002

Revision B

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 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:

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Chapter:

Chapter:
Chapter:
Chapter:

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Table of Figures

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This page is left blank intentionally.

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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

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Chapter 1: Forward

1.6 Contraindications, Warnings and Cautions
1.6.1 Contraindications

1.6.2 Warnings

1.6.3 Electrical Safety Warnings

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Chapter 1: Forward

1.7 Patient Safety

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Chapter 1: Forward

1.8 Additional Safety Considerations

1.9 FCC Compliance Notice

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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

Figure 2-1. System Illustrations with Callouts

Figure 2-2. Wireless Remote

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Chapter 2: Introduction

Figure 2-3: KXL Label

Figure 2-4: UV emitting Label

Figure 2-5: Laser Classification LabelKXL System Operator’s Manual,
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3 Treatment Guidelines
3.1 Keratoconus / Post Lasik Ectasia
Avedro recommends the following KXL settings:

3.2 LASIK Xtra

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Chapter3:Treatment Guidelines

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4 System Operation
4.1 Charging the KXL Batteryooo

4.2 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 physiciancan treat another patient.

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Chapter 4: 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 Cancel
Session screen)

Cancels the Cancel Sessioncommand and returns to theTreatment screen.

Return button(various DeviceSettings screen)

Returns to the Device
Settings menu.

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Chapter 4: System Operation

4.3 UV Dose

4.4 Preparing the System

4.5 Important Steps before Turning on the Systemoo

4.6 Powering Up the System

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Chapter 4: System Operation

Figure 4-1. Startup Screen

4.7 Setting Treatment Settings

Figure 4-2. Induction Period Screen

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Chapter 4: System Operation

Figure 4-3 Enter Treatment Parameters Screen

ooFigure 4-4 Populated Treatment Parameters Screen

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Chapter 4: System Operation

Figure 4-5 Confirm Treatment Parameters ScreennKXL System Operator’s Manual,
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Chapter 4: System Operation

4.8 Starting Treatment

Figure 4-6 Scan Disposables Scree

Figure 4-7 System Setup Status

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Chapter 4: System Operation

4.9 Preparing the Patient

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Chapter 4: System Operation

Figure 4-8 Prepare Patient Screen

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Chapter 4: System Operation

Figure 4-9 Align Crosshairs during induction

4.10 Initiating Treatment

Figure 4-10 Induction Complete

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Chapter 4: System Operation

Figure 4-11 Treatment Screen

4.11 Monitoring Treatment

4.12 Stopping a Treatment

Figure 4-12. Treatment Paused Screen

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Chapter 4: System Operation

4.13 Treatment Complete

Figure 4-13. Treatment Complete Screen

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Chapter 4: System Operation

4.14 Pausing or Canceling a Treatment

Figure 4-14. Initial Confirm Cancel Session Screen

Figure 4-15. Confirm Cancel Partial Treatment

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Chapter 4: System Operation

Figure 4-16. Partial Treatment Information

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Chapter 4: System Operation

4.15 Using the Device Settings Menu

Figure 4-17. Device Settings Menu

4.15.1 Advanced Settings

Figure 4-18 Advanced Setting AccessKXL System Operator’s Manual,
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Chapter 4: System Operation

4.15.2 Country Code

Figure 4-19 Advanced Settings: Country Code4.15.3 Editing System Volume

Figure 4-20. Device Settings Edit Volume

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Chapter 4: System Operation

4.15.4 Copying Treatment Data to USB

Figure 4-21. Device Settings Transfer to USB

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Chapter 4: System Operation

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5 Maintenance / Service
5.1 Installation Policy

5.2 Customer Maintenance

5.3 Warranty Information
5.4 Service Contract Information

5.5 Per Patient Disposables

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Chapter 5: Maintenance/Service

5.6 Trouble Shooting

Figure 5-1 Remote Lost Syncoooo

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Chapter 5: Maintenance/Serviceo

5.7 Directions for Sterilization or Disinfection

5.8 Cleaning the System

5.9 Cleaning the Aperture

5.10 Articulating Arm Adjustment

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Chapter 5: Maintenance/Service

5.11 Performing Periodic MaintenanceInterval

Specific TaskAnnual

Calibration by Avedro trained personnel.

5.12 Moving the System5.13 Storing the System

5.14 Software

5.15 Identifying Risks Associated with Disposingof Waste Products
5.16 Performing a Visible CheckKXL System Operator’s Manual,
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6 Equipment Classification
o
o
o

o
o

o


oooo

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Chapter 6: Equipment Classification

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7 Symbol Library
Text Symbol

Symbol Illustration

Definition

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 SwitchON

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)

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Chapter 7: 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 (percentagesbelow symbol are theacceptable range for humidity)

16. Temperature limits

Temperature shipment limits.

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Chapter 12: Parts List

8 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/cm2
365 nmExternal 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

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