Avedro KXL System Operator's Manual
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Summary of Contents for Avedro KXL System
- Page 1 Avedro, Inc. KXL System Operator’s Manual Copyright 2017 All Rights Reserved Printed in U.S.A. KXL Operator’s Manual Rev A ML-00040 Page 1 of 74...
- 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.
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Page 3: Table Of Contents
Table of Contents Foreword ......................7 1.1 Intended Use of Manual ................7 1.2 Intended Use / Indications for Use ............7 1.3 Design Change Disclaimer ................7 Reproduction Disclaimer ...................7 User Operation Assistance Statement ..............7 Contraindications, Warnings and Cautions............8 1.6.1 Contraindications ...................8 1.6.2 Warnings ....................8 1.6.3 Electrical Safety Warnings ..............8 Radiation Safety Warnings ................10 Patient Safety ....................11... - Page 4 3.11 Preparing the Patient ..................35 3.11.1 Applying Riboflavin ................36 3.12 Initiating Treatment ..................38 3.13 Monitoring Treatment ..................39 3.14 Pausing a Treatment ..................40 3.15 Cancelling Mid Treatment ................41 3.16 Capturing Images .....................43 3.17 Treatment Complete..................44 3.18 Reviewing Images ....................45 3.19 Deleting Photos ....................45 3.20 Patient Treatment Report .................48 3.20.1 Adding Notes to a Patient Treatment Report ........49...
- Page 5 Table of Figures Figure 2-1 Overview Illustration of System .................... 14 Figure 2-2 System Illustrations with Callouts..................15 Figure 2-3 Wireless Remote ........................15 Figure 3-1 Power Switch......................... 20 Figure 3-2 Patient Database ........................21 Figure 3-3 Enter Patient Information...................... 22 Figure 3-4 Create New Treatment Plan ....................
- Page 6 Figure 3-44 Treatment report exported ....................53 Figure 3-45 Page 1 of 3: Treatment Details ..................... 54 Figure 3-46 Page 2 of 3: Comments ......................55 Figure 3-47 Page 3 of 3: Photos ......................56 Figure 3-48 Power Off ..........................57 Figure 3-49 Power Off ..........................
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Page 7: Foreword
1 Foreword 1.1 Intended Use of Manual This manual is designed to serve the operators of the Avedro, Inc. KXL System. All operating instructions, product illustrations, screen graphics, troubleshooting/error messages, and other relevant information are contained in this manual. It is the operator’s responsibility to ensure that all safety instructions in this manual are applied strictly. -
Page 8: Contraindications, Warnings And Cautions
(EMC). Installation and use should be carried out according to the EMC information provided in this manual. • Portable and mobile RF communications equipment can affect medical electrical equipment such as the Avedro KXL System. For Equipment Classifications please refer to chapter 5.0 Equipment Classifications KXL Operator’s Manual Rev A... - Page 9 WARNING: Do not use the instrument near water and be careful not to spill liquids on any part of it. 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 a person except for therapeutic purposes.
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Page 10: Radiation Safety Warnings
WARNING: The remote contains replaceable batteries; if system is not going to be used for an extended period of time remove the batteries. WARNING: No modification of this equipment is allowed. WARNING: Use of not included accessories results in non-compliance of the device WARNING: System may be interfered with by other equipment even if that equipment complies with CISPR Emissions requirements. -
Page 11: Patient Safety
CAUTION: The KXL System is a medical device. It may be operated, therefore, only in health care facilities or medical areas under the supervision of medically trained personnel. - Page 12 • Properly shielded and grounded cables and connectors must be used in order to meet FCC emission limits. Proper cables and connectors are available from Avedro. Avedro is not responsible for any radio or television interference caused by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the user's authority to operate the equipment.
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Page 13: Introduction
(Riboflavin Induction Period, Total UV Energy, UV Power and UV Pulse Cycle Times) are selected through the user interface touch screen computer. The KXL System is used in conjunction with a Riboflavin solution and an RFID card. KXL Operator’s Manual Rev A... -
Page 14: Major Components
2.1.1 Major Components The major components of the KXL System include the following: • Optics Head with UV source and Camera • KXL console with user interface • Wireless remote control (with replaceable batteries) • KXL Accelerated Crosslinking Treatment Kit (disposable supplied separately) •... -
Page 15: Figure 2-2 System Illustrations With Callouts
User Interface/Console /RFID reader Figure 2-2 System Illustrations with Callouts Figure 2-3 Wireless Remote KXL Operator’s Manual Rev A ML-00040 Page 15 of 74... -
Page 16: System Operation
3 System Operation 3.1 Touchpad/Keyboard Use The table below identifies and describes important touchpad keys and icons unique to KXL System operation. Chapter 2 identifies and describes the system’s major components. Touchpad Key Icon Description/Function Power Off button Turns OFF electric power (Initial screen) to the console. - Page 17 Touchpad Key Icon Description/Function 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) X button Cancels all the entries on a (various Device screen and returns to the Settings screens) previous screen.
- Page 18 (various Device Settings menu. Settings screen) Restore to factory Presets restored to normal presets (manage parameters clinic preset plans) CAUTION: Only qualified and experienced personnel shall operate the KXL System. KXL Operator’s Manual Rev A ML-00040 Page 18 of 74...
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Page 19: Uv Energy (Dose)
*Please reference Riboflavin Instructions for Use (IFU) for formulation information. 3.3 Preparing the System • Position the KXL System adjacent to the treatment table or chair. Lock the casters to secure the device’s position. • Make sure the system is turned ON. -
Page 20: Important Steps Before Turning On The System
3.5 Powering Up the System • Turn ON the master power switch on the base of the KXL system, adjacent to the power cord plug. This switch provides AC mains power to the KXL system. • Please see section 3.21 for Power Down sequence instructions. -
Page 21: Existing Patient Data
Figure 3-2 Patient Database o The Patient database stores: Previously treated patients Untreated patients with saved treatment plans New patients with no assigned treatment plans 3.6 Existing Patient Data • To search database for an existing patient, tap in the “search patients” box and a keyboard will generate. -
Page 22: Create New Treatment Plan
Figure 3-3 Enter Patient Information 3.8 Create New Treatment Plan • Select patient to treat from patient database • Press “Create new treatment plan” to begin • Treatment plans can be made and saved prior to patients arrival Figure 3-4 Create New Treatment Plan KXL Operator’s Manual Rev A ML-00040 Page 22 of 74... -
Page 23: Select Eye To Treat
3.8.1 Select Eye to Treat • Choose the eye you wish to treat: OD or OS • When eye is selected, the field will be outlined in blue Figure 3-5 Select Eye 3.8.2 Select Treatment Type • The system is pre-programmed with five preset treatment plans: o Epi-On Accelerated CXL o Epi-Off Accelerated CXL o Conventional CXL... -
Page 24: Adjusting Treatment Parameters
• Once a pre-set treatment plan is chosen or a customizable treatment plan is saved, select “Next” to proceed. Figure 3-6 Select Treatment Type 3.8.3 Adjusting Treatment Parameters • Review and confirm all treatment parameters within selected treatment plan. To edit individual parameters, press within the specific parameter and use the arrows to increase or decrease the desired field. -
Page 25: Figure 3-7 Adjusting Parameters
Figure 3-7 Adjusting Parameters • When finished editing parameters, select “Save for later treatment” for future use, or “Save and perform treatment” for immediate use. • If parameters were adjusted within any of the four presets, “Modified” will be displayed next to chosen treatment plan. KXL Operator’s Manual Rev A ML-00040 Page 25 of 74... -
Page 26: Select Treatment Mode
Figure 3-8 Adjusted Treatment Plan 3.9 Select Treatment Mode There are two UV treatment modes available, Continuous and Pulsed. • Continuous Mode: The UV output is constant for the duration of the UV treatment. • Pulsed Mode: The UV output turns ON and OFF at user selected intervals. 3.9.1 Continuous UV Mode To select Continuous treatment mode, select “Continuous”... -
Page 27: Figure 3-9 Select Continuous Treatment Mode
Figure 3-9 Select Continuous Treatment Mode • Enter the desired UV treatment parameters: o Total Energy* o UV Power (3 – 45 mW/cm NOTE: UV irradiation time is automatically calculated and displayed. * The user may select UV Energy in 0.1 J/cm increments. -
Page 28: Pulsed Uv Mode
Figure 3-10 Modifying Continuous Treatment Parameters 3.9.2 Pulsed UV Mode • To select Pulsed treatment mode, select “Pulsed” from the drop down menu to the right of “UV Delivery”. 3.10 Starting a Treatment o Choose patient from patient database. o If a treatment plan was just created, select “Perform treatment”. 3.10.1 Insert Treatment / RFID Activation Card •... -
Page 29: Single-Use Activation Cards
Figure 3-11 Insert Activation Card 3.10.2 Single-use Activation Cards • Keep card in place until read is complete. • The “OK” button will illuminate when it is OK to remove the card. KXL Operator’s Manual Rev A ML-00040 Page 29 of 74... -
Page 30: Multi-Use Activation Cards
Figure 3-12 Reading Tag 3.10.3 Multi-use Activation Cards • Once a multi-use activation card has been inserted, the display will show the number of treatments remaining on the card. • Activation card can either be removed or remain in the RFID slot and stored for next use. -
Page 31: Figure 3-14 Card Balance: 1 Treatment Remaining
Figure 3-14 Card Balance: 1 Treatment Remaining • If no treatments remain on the card, the system alerts the user to insert a different card or to save the treatment for later. Figure 3-15 No Treatments Left KXL Operator’s Manual Rev A ML-00040 Page 31 of 74... -
Page 32: Rfid Card Controlled Limits
3.10.4 RFID card controlled limits • If the user has programmed a UV Energy range that is outside the allowable value(s) controlled by the RFID card the following message will appear after “perform treatment” has been selected. Figure 3-16 Invalid Treatment Parameters •... -
Page 33: Sync Alignment Remote
Figure 3-17 Invalid Treatment Parameters 3.10.5 Sync Alignment Remote Figure 3-18 Sync Remote KXL Operator’s Manual Rev A ML-00040 Page 33 of 74... -
Page 34: Figure 3-19 Sync Process Timed Out
The Sync alignment remote message will be visible on the screen for 15 seconds When the timer gets to three seconds, it will beep for the remaining seconds If the sync button is not pressed within the timeframe, a message stating the sync process has timed out. -
Page 35: Preparing The Patient
• Press the “S” button on the remote to synchronize the remote within the 15 second window displayed on the screen. This is required for every procedure. NOTE: The KXL system performs an internal self-test prior to each treatment to verify proper UVA calibration. The internal self-test uses a redundant set of optical sensors to ensure that accurate levels of UVA will be delivered for each treatment. -
Page 36: Applying Riboflavin
• When lasers turn on, align the crosshairs over eye to be treated. Figure 3-21 Prepare Treatment: Apply Riboflavin CAUTION: Riboflavin (vitamin B2) is not a part of the KXL System described in this manual. For details , please refer to the Riboflavin’s Directions for Use. -
Page 37: Figure 3-22 Align Crosshairs During Induction
Crosshairs may differ in appearance. They may appear thicker, thinner, longer or shorter. Note: For correct alignment when using the Remote, the Avedro logo on optics head should face the user. • Manually move the Optics head back and forth and left and right until the X/Y axes’... -
Page 38: Initiating Treatment
Figure 3-23 Remote Functions Figure 3-24. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment 3.12 Initiating Treatment • When the Induction Time is complete, Select the “Start UV Treatment” button to initiate treatment. KXL Operator’s Manual Rev A ML-00040 Page 38 of 74... -
Page 39: Monitoring Treatment
Figure 3-25 Start UV Treatment WARNING: Start treatments only after the photosensitizer is applied. CAUTION: UV light is emitted when the Avedro logo on the optical head flashes color from blue to green. WARNING: Make sure that the KXL System and the patient’s table or chair are secured and not moved after alignment and during treatment. -
Page 40: Pausing A Treatment
Figure 3-26 Treatment in Progress Screen NOTE: When using Pulsed Treatment mode, UVA light will not be visible during the OFF periods. The User Interface will not change to “UV is OFF” during these cycles. • The patient should fixate on the red X & Y alignment crosshair throughout the treatment. -
Page 41: Cancelling Mid Treatment
Figure 3-27 Treatment Paused Screen • To cancel or resume treatment select “Cancel Treatment” or “Resume UV treatment” respectively. See section 3.14 if canceling a session. 3.15 Cancelling Mid Treatment • If treatment is cancelled mid treatment, screen displays with Confirm cancelling treatment before it is complete •... -
Page 42: Figure 3-28 Confirm Cancel Partial Treatment
Figure 3-28 Confirm Cancel Partial Treatment • If cancelling treatment was confirmed, the screen displays confirmation Figure 3-29 Treatment Cancelled Confirmation • Once cancelled, the screen displays Partial Treatment Information. KXL Operator’s Manual Rev A ML-00040 Page 42 of 74... -
Page 43: Capturing Images
Figure 3-30 Partial Treatment Not Completed 3.16 Capturing Images • Images can be taken at each stage throughout the treatment process. • To capture an image, select the camera button in the top right hand corner of eye image. • The image is automatically saved and available for review post treatment. KXL Operator’s Manual Rev A ML-00040 Page 43 of 74... -
Page 44: Treatment Complete
Figure 3-31 Capturing Images 3.17 Treatment Complete At the completion of a treatment the Total Treatment Parameters will be displayed and the screen will show Treatment complete. KXL Operator’s Manual Rev A ML-00040 Page 44 of 74... -
Page 45: Reviewing Images
Figure 3-32 Treatment Complete Screen • If treatments are complete, select “Done” and Power OFF the system using the “Power Off” button on the Main Screen. • Carefully remove the device from the patient area. • Follow up with normal post op care. •... -
Page 46: Figure 3-33 Select Trash To Delete
Figure 3-33 Select Trash to delete • Once a photo is selected for deletion, select “yes” to delete photo or select “no” to keep the image. • Once deletion is confirmed, photo will not be retrievable. KXL Operator’s Manual Rev A ML-00040 Page 46 of 74... -
Page 47: Figure 3-34 Select Yes To Delete
Figure 3-34 Select Yes to Delete • Select “Done” to confirm which photos will be displayed in the treatment report. Figure 3-35 Select Done KXL Operator’s Manual Rev A ML-00040 Page 47 of 74... -
Page 48: Patient Treatment Report
3.20 Patient Treatment Report • A treatment report is generated containing patient information, treatment details, photos taken throughout treatment and a notes section. • Treatment reports are generated even if treatments are paused or cancelled. • A green checkmark will be listed next to completed phases. •... -
Page 49: Adding Notes To A Patient Treatment Report
3.20.1 Adding Notes to a Patient Treatment Report • From the Patient Database screen, select the patients name. • Press the message icon to enter comments about the patient’s treatment. Figure 3-37 Comments Icon • Keyboard will become available to make comments to the patient’s report. -
Page 50: Exporting Treatment Report
• Report will be exported as PDF. Figure 3-39 Exporting Treatment Report • The screen will prompt to insert USB drive. • Avedro does not supply USB drive for storing patient data KXL Operator’s Manual Rev A ML-00040 Page 50 of 74... -
Page 51: Figure 3-40 Insert Usb
Figure 3-40 Insert USB • If the USB is full or the system is unable to read the USB, a message indicating the error will be displayed. Figure 3-41 USB Error KXL Operator’s Manual Rev A ML-00040 Page 51 of 74... -
Page 52: Figure 3-42 No Space Left On Usb
Figure 3-42 No space left on USB • Once USB is entered, “Generating treatment report” message will appear Figure 3-43 Generating treatment report • When Treatment report is exported, a confirmation message will appear KXL Operator’s Manual Rev A ML-00040 Page 52 of 74... -
Page 53: Viewing A Treatment Report
Figure 3-44 Treatment report exported 3.20.3 Viewing a Treatment Report • Full treatment report can be reviewed on system or USB (if exported). • Any photos or comments added will be included in report. KXL Operator’s Manual Rev A ML-00040 Page 53 of 74... -
Page 54: Figure 3-45 Page 1 Of 3: Treatment Details
Figure 3-45 Page 1 of 3: Treatment Details KXL Operator’s Manual Rev A ML-00040 Page 54 of 74... -
Page 55: Figure 3-46 Page 2 Of 3: Comments
Figure 3-46 Page 2 of 3: Comments KXL Operator’s Manual Rev A ML-00040 Page 55 of 74... -
Page 56: Figure 3-47 Page 3 Of 3: Photos
Figure 3-47 Page 3 of 3: Photos KXL Operator’s Manual Rev A ML-00040 Page 56 of 74... -
Page 57: Powering Down The System
3.21 Powering Down the System • Select the “Power Off” on the console. Figure 3-48 Power Off • Confirm powering off system KXL Operator’s Manual Rev A ML-00040 Page 57 of 74... -
Page 58: Figure 3-49 Power Off
Figure 3-49 Power Off • Wait for the software to shut down - the screen will be blank. • After the screen is blank and software shuts down, turn the master power switch to the “Off” position. Figure 3-50 Power Off Position KXL Operator’s Manual Rev A ML-00040 Page 58 of 74... -
Page 59: Using The System Settings Menu
3.22 Using the System Settings Menu • With the Patient database displayed, press the “Options” button, then press ‘System Settings” Figure 3-51 Press Options button KXL Operator’s Manual Rev A ML-00040 Page 59 of 74... -
Page 60: Service Settings
Figure 3-52 System Settings Menu 3.22.1 Service Settings • Service Settings are only available to Avedro and Service personnel with a KXL Advanced Settings access card. If selected the user will be prompted to scan an access card. 3.22.2 Editing System Language •... -
Page 61: Editing System Volume
Figure 3-54 Alignment Crosshairs Intensity 3.22.4 Editing System Volume • The Edit Volume option allows a user to edit the system volume level. • Select the Audio Volume button on the Device Settings menu. KXL Operator’s Manual Rev A ML-00040 Page 61 of 74... -
Page 62: Export Service Log
Figure 3-55 Edit Volume 3.22.5 Export Service Log • Select the Export Service log button on the Device Settings menu. Figure 3-56 Export Service log to USB • Insert a USB drive to the USB port. The system automatically begins transferring the service log and shows a progress bar of the transfer process as shown in the following figure. -
Page 63: Editing Beep Intervals
Figure 3-57 Export Service log in Progress • Once complete press the “OK” button. The system will return you to the System Settings menu. 3.22.6 Editing Beep Intervals • The Editing beep intervals option allows a user to set the default time between audible beeps while induction is in progress. -
Page 64: Editing Camera White Balance
Figure 3-58 Select Beep Intervals 3.22.7 Editing Camera White Balance • The Camera White Balance option allows a user to change the light conditions within the console. Typical office lighting is under 5000K. As a result, the default setting is Tungsten 2800K. If a different light source is used, it may be useful to edit the white balance condition. -
Page 65: Figure 3-59. Edit Camera White Balance
Figure 3-59. Edit Camera White Balance KXL Operator’s Manual Rev A ML-00040 Page 65 of 74... -
Page 66: Maintenance / Service
Avedro-authorized distributor. 4.2 Customer Maintenance • In general, there is no customer maintenance required for The KXL System. All technical maintenance or service will be performed by a qualified service representative while under service contract. If you have trouble with your system, refer to the troubleshooting section below or call your local Avedro Representative. -
Page 67: Trouble Shooting
4.6 Trouble Shooting • The KXL System checks its status at start-up automatically. If the status is incorrect, the software prevents the operator from initiating treatments. Wireless Remote • e KXL System uses a remote control with replaceable batteries. If the batteries run low the system will lose its connection with the remote and notify the user of the need to re-synchronize and will ask user to “Continue without remote”... -
Page 68: Directions For Sterilization Or Disinfection
Avedro Service Representative. 4.7 Directions for Sterilization or Disinfection • No components of the KXL System are designed to be sterilized by the operator. External cleaning and disinfection ONLY is recommended. For disinfection purposes, use only isopropyl alcohol spray or preparations. Use soft fiber-free wipes. -
Page 69: Storing The System
Avedro representative. Packing and transporting the system should be performed only by Avedro trained and authorized personnel. • Prior to moving the KXL System from one room to another, the monitor should be moved sideways and the optics head should be positioned close to the cart handle with the elbow protruding at the back. -
Page 70: Identifying Risks Associated With Disposing Of Waste Products
4.14 Identifying Risks Associated with Disposing of Waste Products • When disposing of waste products, follow all applicable local regulations. 4.15 Performing a Visible Check • Check all components of the device routinely for damage or malfunction prior to each treatment. KXL Operator’s Manual Rev A ML-00040 Page 70 of 74... -
Page 71: Equipment Classification
5 Equipment Classification According to EN60601-1 Medical Device Electrical Standard Protection against electrical shock Class 1 (external electrical power source) Degree of protection against electric shock Not classified, equipment not provided with applied part Ingress protection: IP20 Method of sterilization or disinfection ... -
Page 72: Symbol Library
6 Symbol Library Text Symbol Symbol Illustration Definition 1. No AP symbol in Danger, Risk of Explosion. presence of flammable Not for use anesthetics 2. AC symbol Alternating current 3. “I” in a book Attention: Consult ACCOMPANYING DOCUMENTS 4. Ground symbol in circle Protected earth (ground) 5. - Page 73 Text Symbol Symbol Illustration Definition 13. Umbrella with raindrops Keep Dry: Store protected from moisture (symbol is with or without rain drops) Contents are fragile, handle with care 15. Two up arrows Keep arrows on carton pointing up 16. Water drop in a box Humidity limits (percentages below symbol are the acceptable range for humidity)
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Page 74: Specifications
7 Specifications Specification Description Electrical Line voltages 100 – 240 volts AC Current 2A – 1A Single Phase RMS, 50/60 Hz Remote 2x AAA batteries List of cables and Accessories Wireless Remote Hospital Grade AC power cable (Lockable/Detachable) Energy Delivery UV Radiation 3 –...
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Hi. How can I purchase a activation card as the one for the machine is lost. Please advise