Avedro KXL System User manual

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 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: Your Local Avedro-authorized distributor
Avedro, Inc.
230 Third Avenue
Waltham, MA 02451
Authorized Representative
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: [phone]
Fax: [phone]
0470

KXL System Operator’s Manual,
Rev A
iii
Table of Contents
Chapter:
Chapter:
Chapter:
Chapter:

KXL System Operator’s Manual,
Rev A
iv
Chapter:
Chapter:
Chapter:
Chapter:
Chapter:

Chapter 1: Foreword
KXL System Operator’s Manual,
Rev A
v
List of Figures

KXL System Operator’s Manual,
Rev A
vi

Chapter 6: Maintenance
KXL System Operator’s Manual,
Rev A
1-1
1Foreword
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

Chapter 1: Foreword
KXL System Operator’s Manual,
Rev A
1-2
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

Chapter 1: Foreword
KXL System Operator’s Manual,
Rev A
1-3
1.6.4 Grounding
1.6.5 Safety Instructions

Chapter 1: Foreword
KXL System Operator’s Manual,
Rev A
1-4
1.7 Eye Protection
1.8 Patient Safety

Chapter 1: Foreword
KXL System Operator’s Manual,
Rev A
1-5
1.9 Use Restrictions
1.10 Safety Design

Chapter 1: Foreword
KXL System Operator’s Manual,
Rev A
1-6
1.11 Additional Safety Considerations
1.12 FCC Compliance Notice

Chapter 1: Foreword
KXL System Operator’s Manual,
Rev A
1-7
1.13 Use in Presence of Flammable Mixtures

Chapter 1: Foreword
KXL System Operator’s Manual,
Rev A
1-8

KXL System Operator’s Manual,
Rev A
2-1
2Introduction
2.1 System Overview

Chapter 2: Introduction
KXL System Operator’s Manual,
Rev A
2-2
2.1.1 Major Components
Figure 2-1. Overview Illustration of System

Chapter 2: Introduction
KXL System Operator’s Manual,
Rev A
2-3
Charging Cord
Handle
Remote holster
UV Output
UV Indicator
Articulating Arm
User Interface/
RFID reader
Figure 2-2. System Illustrations with Callouts
Figure 2-3. Wireless Remote

Chapter 2: Introduction
KXL System Operator’s Manual,
Rev A
2-4
Figure 2-4: KXL Label
Figure 2-5: UV emitting Label
Figure 2-6: Laser Classification Label

KXL System Operator’s Manual,
Rev A
3-1
3Procedure Guidelines
3.1 UV Dose
3.2 Preparing the System
3.3 Select the Induction Period

Chapter 3: Procedure Guidelines
KXL System Operator’s Manual,
Rev A
3-2
3.4 Select the UV Treatment Parameters
3.5 Select and Prepare Accessories
3.6 Preparing the Patient
3.7 Starting Treatment