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Avedro KXL System Operator's Manual
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Avedro KXL System Operator's Manual

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Operator's Manual
ML-00002
Copyright 2010
Printed in U.S.A.
Avedro, Inc.
KXL System
Revision A
All Rights Reserved

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Summary of Contents for Avedro KXL System

  • Page 1 Avedro, Inc. KXL System Operator’s Manual ML-00002 Revision A Copyright 2010 All Rights Reserved Printed in U.S.A.
  • Page 2 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.
  • Page 3 Table of Contents Chapter: Chapter: Chapter: Chapter: KXL System Operator’s Manual, Rev A...
  • Page 4 Chapter: Chapter: Chapter: Chapter: Chapter: KXL System Operator’s Manual, Rev A...
  • Page 5 Chapter 1: Foreword List of Figures KXL System Operator’s Manual, Rev A...
  • Page 6 KXL System Operator’s Manual, Rev A...
  • Page 7 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 KXL System Operator’s Manual, Rev A...
  • Page 8 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 KXL System Operator’s Manual, Rev A...
  • Page 9 Chapter 1: Foreword 1.6.4 Grounding 1.6.5 Safety Instructions KXL System Operator’s Manual, Rev A...
  • Page 10 Chapter 1: Foreword 1.7 Eye Protection 1.8 Patient Safety KXL System Operator’s Manual, Rev A...
  • Page 11 Chapter 1: Foreword 1.9 Use Restrictions 1.10 Safety Design KXL System Operator’s Manual, Rev A...
  • Page 12 Chapter 1: Foreword 1.11 Additional Safety Considerations 1.12 FCC Compliance Notice KXL System Operator’s Manual, Rev A...
  • Page 13 Chapter 1: Foreword 1.13 Use in Presence of Flammable Mixtures KXL System Operator’s Manual, Rev A...
  • Page 14 Chapter 1: Foreword KXL System Operator’s Manual, Rev A...
  • Page 15 2 Introduction 2.1 System Overview KXL System Operator’s Manual, Rev A...
  • Page 16 Chapter 2: Introduction 2.1.1 Major Components Figure 2-1. Overview Illustration of System KXL System Operator’s Manual, Rev A...
  • Page 17 Chapter 2: Introduction Articulating Arm UV Indicator User Interface/ RFID reader Handle UV Output Remote holster Charging Cord Figure 2-2. System Illustrations with Callouts Figure 2-3. Wireless Remote KXL System Operator’s Manual, Rev A...
  • Page 18 Chapter 2: Introduction Figure 2-4: KXL Label Figure 2-5: UV emitting Label Figure 2-6: Laser Classification Label KXL System Operator’s Manual, Rev A...
  • Page 19 3 Procedure Guidelines 3.1 UV Dose 3.2 Preparing the System 3.3 Select the Induction Period KXL System Operator’s Manual, Rev A...
  • Page 20 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 KXL System Operator’s Manual, Rev A...
  • Page 21 3.8 Alignment of Light Source 3.9 Monitoring Treatment KXL System Operator’s Manual, Rev A...
  • Page 22 Chapter 3: Procedure Guidelines 3.10 Stopping a Treatment 3.11 Resuming a Treatment 3.12 Canceling Treatment 3.13 Treatment Complete KXL System Operator’s Manual, Rev A...
  • Page 23 4 Treatment Guidelines 4.1 Keratoconus / Post Lasik Ectasia Avedro recommends the following KXL settings: 4.2 LASIK Xtra KXL System Operator’s Manual, Rev A...
  • Page 24 Chapter 3: Procedure Guidelines KXL System Operator’s Manual, Rev A...
  • Page 25 UP arrow Increases the value of the (various Clinical current field Protocol screens) DOWN arrow Decreases the value of the (various Clinical current field Protocol screens) KXL System Operator’s Manual, Rev A...
  • Page 26 Cancels the Cancel Session button command and returns to the (Confirm Cancel Treatment screen. Session screen) Return button Returns you to the Device (various Device Settings menu. Settings screen) 5.3 Important Steps before Turning on the System KXL System Operator’s Manual, Rev A...
  • Page 27 Chapter 5: Operation 5.4 Software User Interface: Powering Up the System Figure 5-1 Startup Test Screen KXL System Operator’s Manual, Rev A...
  • Page 28 Chapter 5: Operation Figure 5-2. Welcome Screen 5.5 Software User Interface: Setting Treatment Settings Figure 5-3. Induction Period Screen KXL System Operator’s Manual, Rev A...
  • Page 29 Chapter 5: Operation Figure 5-4 Enter Treatment Parameters Screen Figure 5-5 Populated Treatment Parameters Screen KXL System Operator’s Manual, Rev A...
  • Page 30 Chapter 5: Operation Figure 5-6 Select UV Beam Diameter Screen KXL System Operator’s Manual, Rev A...
  • Page 31 Chapter 5: Operation Figure 5-7 Confirm Treatment Parameters Screen 5.6 Software User Interface: Starting Treatment Figure 5-8 Scan Disposables Screen KXL System Operator’s Manual, Rev A...
  • Page 32 Chapter 5: Operation Figure 5-9 System Setup Status Figure 5-10 Prepare Patient Screen KXL System Operator’s Manual, Rev A...
  • Page 33 Chapter 5: Operation Figure 5-11 Figure 5-12 Induction Complete KXL System Operator’s Manual, Rev A...
  • Page 34 Chapter 5: Operation Figure 5-13 Treatment Screen Figure 5-14. Treatment Paused Screen KXL System Operator’s Manual, Rev A 5-10...
  • Page 35 Chapter 5: Operation Figure 5-15. Treatment Complete Screen KXL System Operator’s Manual, Rev A 5-11...
  • Page 36 Chapter 5: Operation 5.7 Software User Interface: Canceling a Treatment Figure 5-16. Initial Confirm Cancel Session Screen Figure 5-17. Confirm Cancel Partial Treatment KXL System Operator’s Manual, Rev A 5-12...
  • Page 37 Chapter 5: Operation Figure 5-18. Partial Treatment Information KXL System Operator’s Manual, Rev A 5-13...
  • Page 38 Chapter 5: Operation 5.8 Software User Interface: Using the Device Settings Menu Figure 5-19. Device Settings Menu 5.8.1 Advanced Settings Figure 5-20 Advanced Setting Access KXL System Operator’s Manual, Rev A 5-14...
  • Page 39 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 KXL System Operator’s Manual, Rev A 5-15...
  • Page 40 Chapter 5: Operation 5.8.4 Copying Treatment Data to USB Figure 5-23. Device Settings Transfer to USB KXL System Operator’s Manual, Rev A 5-16...
  • Page 41 6 Maintenance 6.1 Customer Maintenance 6.2 Service and Diagnostic Requirements 6.3 Directions for Sterilization or Disinfection 6.4 Cleaning the System KXL System Operator’s Manual, Rev A...
  • Page 42 Chapter 6: Maintenance 6.5 Cleaning the Aperture 6.6 Performing Periodic Maintenance Interval Specific Task Annual Calibration by Avedro trained personnel. 6.7 Moving the System 6.8 Storing the System 6.9 Updating Software 6.10 Identifying Risks Associated with Disposing of Waste Products KXL System Operator’s Manual,...
  • Page 43 Chapter 6: Maintenance 6.11 Performing a Visible Check KXL System Operator’s Manual, Rev A...
  • Page 44 Chapter 6: Maintenance KXL System Operator’s Manual, Rev A...
  • Page 45 7 Customer Service Information 7.1 Before Calling your local Avedro Representative for Help calling your for 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 KXL System Operator’s Manual,...
  • Page 46 Chapter 7: Customer Service Information KXL System Operator’s Manual, Rev A...
  • Page 47 6. Ground symbol in circle Protected earth (ground) 7. “I” on Power Switch 8. “0” on Power Switch 9. Fuse symbol Fuse 10. Lightning bolt in triangle Dangerous Voltage 14. CE Mark Conformity mark 14. CE Mark Standby KXL System Operator’s Manual, Rev A...
  • Page 48 Chapter 8: Symbol Library KXL System Operator’s Manual, Rev A...
  • Page 49 Device Classification per MDD Class IIa 93/42/EEC Physical Dimensions No larger than 60 x 60 x 150 cm (Length x Width x Height) Weight (crated system) At least 120 Kg Battery Life 16 hours (normal operating conditions) KXL System Operator’s Manual, Rev A...