Avedro KXL System Operator'S Manual Download Page 29

 

 

Chapter 3: System Operation 

KXL System Operator’s Manual, 

Rev G 

3-15

 

The screen displays 

Partial Treatment Information

 

 

Figure 3-19. Partial Treatment Information 

Summary of Contents for KXL System

Page 1: ...Avedro Inc KXL System Operator s Manual ML 00002 Revision G Copyright 2012 All Rights Reserved Printed in U S A...

Page 2: ...rights All rights reserved 2012 Microsoft and Windows are registered trademarks and trademarks respectively of Microsoft Corporation Any other trademarks or service marks contained within this manual...

Page 3: ...Charging the KXL Battery 3 1 3 2 Touchpad Keyboard Use 3 1 3 3 UV Dose 3 3 3 4 Preparing the System 3 3 3 5 Important Steps before Turning on the System 3 3 3 6 Powering Up the System 3 3 3 7 Setting...

Page 4: ...ections for Sterilization or Disinfection 4 3 4 8 Cleaning the System 4 3 4 9 Cleaning the Aperture 4 3 4 10 Articulating Arm Adjustment 4 3 4 11 Performing Periodic Maintenance 4 4 4 12 Moving the Sy...

Page 5: ...maining 3 8 Figure 3 10 System Setup Status 3 9 Figure 3 11 Prepare Patient Screen 3 10 Figure 3 12 Align Crosshairs during induction 3 11 Figure 3 13 Induction Complete 3 11 Figure 3 14 Treatment Scr...

Page 6: ...KXL System Operator s Manual Rev G vi This page is left blank intentionally...

Page 7: ...the right to change product design at any time without notice which may subsequently affect the contents of this manual Avedro assumes no responsibility for any errors that may appear in this manual A...

Page 8: ...ent corneal erosion corneal dystrophy Epithelial healing disorders 1 6 3 Electrical Safety Warnings For Equipment Classifications please refer to chapter 5 0 Equipment Classifications WARNING To avoid...

Page 9: ...to the USB during treatment WARNING Do not operate the KXL System in the presence of flammable mixtures or anesthetics WARNING Never look directly into the UV light beam Never direct the beam towards...

Page 10: ...erates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications However there is no gu...

Page 11: ...oximate diameter of 9 mm Alignment lasers are used to aid the user in focusing the beam on the patient s cornea Fine alignment of the UV beam through observation of the alignment lasers is controlled...

Page 12: ...he major components of the KXL System include the following Optics Head with UV source KXL console with user interface Wireless remote control with replaceable batteries KXL Accelerated Crosslinking T...

Page 13: ...Chapter 2 Introduction KXL System Operator s Manual Rev G 2 3 Figure 2 2 System Illustrations with Callouts Figure 2 3 Wireless Remote...

Page 14: ...Chapter 2 Introduction KXL System Operator s Manual Rev G 2 4 Figure 2 4 KXL Label Figure 2 5 UV emitting Label Figure 2 6 Laser Classification Label...

Page 15: ...dro Service Representative NOTE the battery pack on the system should last for 16 hours during normal operation The software system will notify the user when the battery needs to be charged The KXL is...

Page 16: ...k button various Clinical Protocol screens and Device Settings screen Directs the system to accept the current screen entries and to proceed to the next step Cancel Session button various Clinical Pro...

Page 17: ...ers to secure the device s position Make sure the system is turned ON Check glass window of beam aperture for dust and dirt See sections 4 8 and 4 9 for cleaning instructions 3 5 Important Steps befor...

Page 18: ...rvice immediately 3 7 Setting Treatment Settings To begin patient treatment press the Start New Treatment button Specify the desired induction period 1 30 min for the patient When finished entering pa...

Page 19: ...3 45 mW cm2 NOTE Total Energy will be displayed in the lower orange box The maximum permissible total Energy density is 10 J cm2 When finished entering treatment parameters press the Checkmark button...

Page 20: ...stem Operator s Manual Rev G 3 6 3 8 Starting Treatment Place the disposable kit which is unique for each patient or an activation card on the RFID reader and hold in place until the system emits a be...

Page 21: ...disposables Figure 3 6 Reading Tag Screen Hold until read is complete and discard tag or activation card 3 8 2 Multi use disposables Once a multi use activation card has been scanned the display will...

Page 22: ...Chapter 3 System Operation KXL System Operator s Manual Rev G 3 8 Figure 3 8 Final Treatment Figure 3 9 No Treatments Remaining...

Page 23: ...within the 15 second window displayed on the screen This is required for every procedure NOTE If the light on the remote is flashing two times per second the remote s batteries need to be changed If...

Page 24: ...ent without head movement Apply a lid speculum and optional drapes using standard clinical technique Apply Riboflavin to the area of treatment in accordance with the Riboflavin Instructions for Use IF...

Page 25: ...alignment as needed using the wireless remote 3 10 Initiating Treatment When the Induction Time is complete the Begin UV Treatment button will appear Press the Begin UV Treatment button to initiate tr...

Page 26: ...nt has to fixate on the center of the light beam aperture throughout the treatment Patients should remain still during the treatment 3 12 Stopping a Treatment The treatment stops automatically after t...

Page 27: ...16 Treatment Complete Screen To exit treatment and or start a new treatment press Start New Treatment If treatments are complete Power OFF the system using the Power Off button on the Main Screen Car...

Page 28: ...sion is canceled screen displays with Confirm Cancel Session Figure 3 17 Initial Confirm Cancel Session Screen To cancel session press Cancel Session If the session is Paused the screen displays Confi...

Page 29: ...Chapter 3 System Operation KXL System Operator s Manual Rev G 3 15 The screen displays Partial Treatment Information Figure 3 19 Partial Treatment Information...

Page 30: ...m Operator s Manual Rev G 3 16 3 15 Powering Down the System It is recommended that the KXL System be plugged into an electrical outlet when not in use or when stored Press the Power Off on the touch...

Page 31: ...peration KXL System Operator s Manual Rev G 3 17 Turn the system power switch to the Off position Plug the KXL System in to an electrical outlet until next use Figure 3 21 Power Off Position Figure 3...

Page 32: ...alization screen New Patient Start displayed press and hold the KXL on the touch screen Figure 3 23 Device Settings Menu 3 16 1 Advanced Settings Advanced Settings are only available to Avedro and Ser...

Page 33: ...of the alignment crosshairs Select the Edit Alignment Crosshairs Intensity button on the Device Settings menu Figure 3 24 Edit Alignment Crosshairs Intensity 3 16 3 Editing System Volume The Edit Vol...

Page 34: ...atment Select the Copy Treatment Data to USB button on the Device Settings menu Figure 3 26 Device Settings Transfer to USB Insert a USB device to a USB port and then press the Copy treatment data to...

Page 35: ...Editing Default Treatment Parameters Screen The Edit Default Treatment Parameters option allows a user to set the default treatment parameters that are displayed on entry to the Set Induction Time an...

Page 36: ...Chapter 3 System Operation KXL System Operator s Manual Rev G 3 22 This page is left blank intentionally...

Page 37: ...ormal operation should be performed by or with the guidance of an Avedro authorized distributor 4 2 Customer Maintenance In general there is no customer maintenance required for The KXL System All tec...

Page 38: ...e o If light on the remote is flashing two times per second the remote s batteries need to be changed If the light on the remote is flashing once per second then it is not synchronized o If the remote...

Page 39: ...0 alcohol or 10 chlorine bleach solution can also be used if necessary DO NOT submerse the system in liquid or pour liquid onto the system CAUTION Remove the power supply cord from the main outlet and...

Page 40: ...l the components and the main power supply as well Disconnect the power cord physically from its electrical outlet Remove the batteries from the wireless remote Cover the touch screen LCD display and...

Page 41: ...Common Devices IP20 No protection against ingress of water o Method of sterilization or disinfection Disinfect able device o Degree of protection for use in the presence of a flammable as aesthetic m...

Page 42: ...Chapter 5 Equipment Classification KXL System Operator s Manual Rev G 5 2 This page is left intentionally blank...

Page 43: ...ttention Consult ACCOMPANYING DOCUMENTS 4 Ground symbol in circle Protected earth ground 5 Power Switch ON 6 Power Switch OFF 7 Fuse symbol Fuse 8 CE Mark Conformity mark 9 Manufacturer Name and addre...

Page 44: ...tion Definition 13 Wine glass with crack on it or Contents are fragile handle with care 14 Two up arrows Keep arrows on carton pointing up 15 Water drop in a box Humidity limits percentages below symb...

Page 45: ...60 x 60 x 150 cm3 Length x Width x Height Weight crated system NW 45 Kg GW 120 Kg Battery Life normal operating conditions 16 hours Environmental Operating Conditions The system operates under the fo...

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