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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 2011
Printed in U.S.A.
Avedro, Inc.
KXL System
Revision B
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 B Copyright 2011 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 C...
  • Page 4 Chapter: Chapter: Chapter: Chapter: KXL System Operator’s Manual, Rev B...
  • Page 5 Table of Figures KXL System Operator’s Manual, Rev B...
  • Page 6 This page is left blank intentionally. KXL System Operator’s Manual, Rev B...
  • Page 7 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 B...
  • Page 8 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 B...
  • Page 9 Chapter 1: Forward 1.7 Patient Safety KXL System Operator’s Manual, Rev B...
  • Page 10 Chapter 1: Forward 1.8 Additional Safety Considerations 1.9 FCC Compliance Notice KXL System Operator’s Manual, Rev B...
  • Page 11 2 Introduction 2.1 System Overview KXL System Operator’s Manual, Rev B...
  • Page 12 Chapter 2: Introduction 2.1.1 Major Components Figure 2.1: Overview Illustration of System KXL System Operator’s Manual, Rev B...
  • Page 13 Chapter 2: Introduction Figure 2-1. System Illustrations with Callouts Figure 2-2. Wireless Remote KXL System Operator’s Manual, Rev B...
  • Page 14 Chapter 2: Introduction Figure 2-3: KXL Label Figure 2-4: UV emitting Label Figure 2-5: Laser Classification Label KXL System Operator’s Manual, Rev B...
  • Page 15 3 Treatment Guidelines 3.1 Keratoconus / Post Lasik Ectasia Avedro recommends the following KXL settings: 3.2 LASIK Xtra KXL System Operator’s Manual, Rev B...
  • Page 16 Chapter3:Treatment Guidelines KXL System Operator’s Manual, Rev B...
  • Page 17 Power Off button Turns OFF electric power to (Initial screen) the personal computer. Start New Treatment Directs the system to repeat button (Initial screen) the entire clinical treatment protocol so the physician can treat another patient. KXL System Operator’s Manual, Rev B...
  • Page 18 Return to Treatment Cancels the Cancel Session button command and returns to the (Confirm Cancel Treatment screen. Session screen) Return button Returns to the Device (various Device Settings menu. Settings screen) KXL System Operator’s Manual, Rev B...
  • Page 19 Chapter 4: System Operation 4.3 UV Dose 4.4 Preparing the System 4.5 Important Steps before Turning on the System 4.6 Powering Up the System KXL System Operator’s Manual, Rev B...
  • Page 20 Chapter 4: System Operation Figure 4-1. Startup Screen 4.7 Setting Treatment Settings Figure 4-2. Induction Period Screen KXL System Operator’s Manual, Rev B...
  • Page 21 Chapter 4: System Operation Figure 4-3 Enter Treatment Parameters Screen Figure 4-4 Populated Treatment Parameters Screen KXL System Operator’s Manual, Rev B...
  • Page 22 Chapter 4: System Operation Figure 4-5 Confirm Treatment Parameters Screenn KXL System Operator’s Manual, Rev B...
  • Page 23 Chapter 4: System Operation 4.8 Starting Treatment Figure 4-6 Scan Disposables Scree Figure 4-7 System Setup Status KXL System Operator’s Manual, Rev B...
  • Page 24 Chapter 4: System Operation 4.9 Preparing the Patient KXL System Operator’s Manual, Rev B...
  • Page 25 Chapter 4: System Operation Figure 4-8 Prepare Patient Screen KXL System Operator’s Manual, Rev B...
  • Page 26 Chapter 4: System Operation Figure 4-9 Align Crosshairs during induction 4.10 Initiating Treatment Figure 4-10 Induction Complete KXL System Operator’s Manual, Rev B 4-10...
  • Page 27 Chapter 4: System Operation Figure 4-11 Treatment Screen 4.11 Monitoring Treatment 4.12 Stopping a Treatment Figure 4-12. Treatment Paused Screen KXL System Operator’s Manual, Rev B 4-11...
  • Page 28 Chapter 4: System Operation 4.13 Treatment Complete Figure 4-13. Treatment Complete Screen KXL System Operator’s Manual, Rev B 4-12...
  • Page 29 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 KXL System Operator’s Manual, Rev B 4-13...
  • Page 30 Chapter 4: System Operation Figure 4-16. Partial Treatment Information KXL System Operator’s Manual, Rev B 4-14...
  • Page 31 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 Access KXL System Operator’s Manual, Rev B 4-15...
  • Page 32 Chapter 4: System Operation 4.15.2 Country Code Figure 4-19 Advanced Settings: Country Code 4.15.3 Editing System Volume Figure 4-20. Device Settings Edit Volume KXL System Operator’s Manual, Rev B 4-16...
  • Page 33 Chapter 4: System Operation 4.15.4 Copying Treatment Data to USB Figure 4-21. Device Settings Transfer to USB KXL System Operator’s Manual, Rev B 4-17...
  • Page 34 Chapter 4: System Operation KXL System Operator’s Manual, Rev B 4-18...
  • Page 35 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 KXL System Operator’s Manual, Rev B...
  • Page 36 Chapter 5: Maintenance/Service 5.6 Trouble Shooting Figure 5-1 Remote Lost Sync KXL System Operator’s Manual, Rev B...
  • Page 37 Chapter 5: Maintenance/Service 5.7 Directions for Sterilization or Disinfection 5.8 Cleaning the System 5.9 Cleaning the Aperture 5.10 Articulating Arm Adjustment KXL System Operator’s Manual, Rev B...
  • Page 38 Chapter 5: Maintenance/Service 5.11 Performing Periodic Maintenance Interval Specific Task Annual Calibration by Avedro trained personnel. 5.12 Moving the System 5.13 Storing the System 5.14 Software 5.15 Identifying Risks Associated with Disposing of Waste Products 5.16 Performing a Visible Check KXL System Operator’s Manual,...
  • Page 39 6 Equipment Classification        KXL System Operator’s Manual, Rev B...
  • Page 40 Chapter 6: Equipment Classification KXL System Operator’s Manual, Rev B...
  • Page 41 10. ! in a Triangle Caution specific warning in operators manual Weight Net Weight (kgs) Gross Weight (kgs) 12. Umbrella with raindrops Keep Dry: Store protected from moisture. (symbol is with or without rain drops) KXL System Operator’s Manual, Rev B...
  • Page 42 14. Two up arrows Keep arrows on carton pointing 15. Water drop in a box Humidity limits (percentages below symbol are the acceptable range for humidity) 16. Temperature limits Temperature shipment limits. KXL System Operator’s Manual, Rev B...
  • Page 43 Transport and Storage Conditions The instrument withstands the following transport and storage conditions without damage or performance deterioration. Ambient temperature -15 to +70 ºC Relative humidity 10% to 100% including condensation Atmospheric pressure 500 to 1060 mbar KXL System Operator’s Manual, Rev B...