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Summary of Contents for Avedro Mosaic System
- Page 1 Avedro, Inc. Mosaic® System Operator’s Manual Copyright 2019. All Rights Reserved. Printed in U.S.A. Mosaic Operator’s Manual Rev F ML-00023...
- Page 2 Patents, Trademarks, Copyrights The Mosaic System may be covered by one or more patent applications issued or pending in the United States and worldwide. “Mosaic” and the Avedro logo design are registered trademarks or trademarks of Avedro, Inc. All software and documentation are subject to Avedro, Inc.
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Page 3: Table Of Contents
System Overview ..........................8 2.1.1 Major Components ......................9 2.1.2 Disposables ......................... 10 2.1.3 Mosaic System Labels .....................11 2.1.4 Frequently Used Functions ..................12 System Operation ........................13 Touchpad/Keyboard Use ......................13 UV Energy (Dose) ......................... 14 System Set Up ........................15 Important Steps before Turning on the System ............ - Page 4 Set the Riboflavin Induction Time ..................29 5.4.1 Mosaic Induction Timer ....................30 5.4.2 External Induction Timer ................... 30 Prepare the Patient ........................30 Apply Riboflavin ..........................31 Coarse Alignment of Laser Crosshairs ................32 Manual Axis Alignment Mode ....................33 Auto Alignment ..........................
- Page 5 Table of Figures Figure 2-1. Overview Illustration of Mosaic System ................9 Figure 2-2. System Overview with Callouts .................... 10 Figure 2-3. Mosaic Label ............................ 11 Figure 2-4. UV Safety Label ..........................11 Figure 2-5. Laser Classification Label ......................11 Figure 2-6.
- Page 6 Figure 6-9. Failed Prescreen Assessment Due to Eye Tracking Errors ........45 Figure 6-10. Confirm Patient Prescreen Results ...................46 Figure 6-11. Prescreen Test Pass ........................46 Figure 7-1. Moving Position of the Mosaic System ................50 Figure 7-2. Example Error Message Box ....................51 Mosaic Operator’s Manual Rev F...
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Page 7: Foreword
Intended Use / Indications for Use The Mosaic System delivers a uniform, metered dose of UVA light to a targeted treatment area for the intended use of illuminating the cornea during corneal cross-linking procedures. -
Page 8: Reproduction Disclaimer
Neither this manual nor any part of it may be reproduced, photocopied, or electronically transmitted in any way without the advanced written permission of Avedro. User Operation Assistance Statement Should you experience any difficulty in running your Mosaic System, please contact your local Avedro authorized representative. Contraindications, Warnings, and Cautions 1.7.1... -
Page 9: Electrical Safety Warnings
Portable and mobile RF communications equipment can affect • medical electrical equipment such as the Mosaic System. For Equipment Classifications, please refer to Chapter 7: Equipment Classifications WARNING: Any repair or service must be carried out by Avedro trained personnel only. - Page 10 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 Mosaic 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 11: Radiation Safety Warnings
Portable communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the Avedro Mosaic System (110-03029), including cables specified manufacturer. Otherwise, degradation of the performance of this equipment could result. -
Page 12: Patient Safety
System not be moved during the treatment procedure. CAUTION: The Mosaic 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 13 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.
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Page 14: Introduction
UV Treatment Patterns, UV Power and UV Pulse Cycle Times) are selected through the user interface touchscreen. The Mosaic System is used in conjunction with an ophthalmic riboflavin solution and a Treatment Activation card. NOTE: The depictions of the Mosaic System and user interface screenshots included in this manual are for demonstration purposes only. -
Page 15: Major Components
AVEDRO | 9 of 62 2.1.1 Major Components The major components of the Mosaic System include the following: Articulating arm with optics head with UV source and heads up • display Mosaic console with user interface • Mosaic Accelerated Crosslinking Treatment Kit (disposable •... -
Page 16: Disposables
G Stand by Switch H Wheels Figure 2-2. System Overview with Callouts 2.1.2 Disposables The following disposables (supplied separately) are required for performing treatments with the Mosaic System: Riboflavin ophthalmic solutions • Treatment Activation card • Boost Goggles (optional) •... -
Page 17: Mosaic System Labels
AVEDRO | 11 of 62 2.1.3 Mosaic System Labels Figure 2-3. Mosaic Label Figure 2-4. UV Safety Label Figure 2-5. Laser Classification Label Figure 2-6. Do Not Sit/Step On Label ML-00023... -
Page 18: Frequently Used Functions
Mosaic Operator’s Manual Rev F | Page 12 2.1.4 Frequently Used Functions The table below identifies the System functions that are most frequently used and where to find these functions described in this Manual. Manual Function Mode Section Turn System On Press Stand By switch under the keyboard in the front of the Mosaic console Treatment Select “Design OD”/ “Design OS”. -
Page 19: System Operation
AVEDRO | 13 of 62 3 System Operation Touchpad/Keyboard Use The table below identifies and describes important touchpad keys and icons unique to Mosaic System operation. Touchpad Key Icon Description/Function Power Off button Turns OFF electric power to (Initial screen) the console and goes on Stand By Mode. -
Page 20: Uv Energy (Dose)
Mosaic Operator’s Manual Rev F | Page 14 CAUTION: Only qualified and experienced personnel shall operate the Mosaic System. UV Energy (Dose) The UV Energy (Dose) is the product of the UV Power • (Intensity) and the UV Irradiation Time. The UV Energy, UV Power and pulsing times are adjustable and the calculated total treatment time is displayed. -
Page 21: System Set Up
AVEDRO | 15 of 62 4 System Set Up Important Steps before Turning on the System The user is responsible for assuring that the Mosaic System is • functioning properly, is within normal operating ranges for temperature and humidity, and is in good-working condition before starting a treatment. -
Page 22: Startup Screen
Once the single stand by switch above the keyboard is turned on, • the Mosaic System begins a power-up sequence, loading the operating system and all configuration and reference files. The Mosaic software launches itself and the startup screen in •... -
Page 23: Setting Optics Head Height
AVEDRO | 17 of 62 Setting Optics Head Height Continuously press the up /down (+ / -) button, shown below in • Figure 4-2, to raise or lower the optics head to the approximate desired height above the treatment table or chair. -
Page 24: Proximity Warning
Mosaic Operator’s Manual Rev F | Page 18 Proximity Warning Moving the lift of the optical head too far down may trigger a • proximity sensor. This is a safety feature for the optical head not to get too close to the patient’s head. If the proximity sensor is triggered, the lift will stop responding and •... -
Page 25: Treatment Procedure
AVEDRO | 19 of 62 5 Treatment Procedure Patient Central Patient Central is the main page where patient information can be imported or new patient files can be created. No information is stored on the System but is instead saved on the USB flash drive. Patient topographies can be imported via Patient Central from the USB flash drive for guided treatment patterns. -
Page 26: Importing Patient Topographies
5.1.2 Importing Patient Topographies Patient topographies exported onto a USB flash drive may be used with the Mosaic System. Insert the USB flash drive into the Mosaic USB port. • Click on “Import/Refresh Patient List” to refresh the page and list •... -
Page 27: Overview Of The Treatment Designer
AVEDRO | 21 of 62 If the location is confirmed, the user can proceed to the Treatment • Designer depicted in Section 5.3. The user must confirm the pupil location for each patient record. If the pupil location needs to be reconfirmed, the user can manually access the Settings Menu (see Section 5.2.7) and select the “eye”... -
Page 28: Treatment Type Options
Mosaic Operator’s Manual Rev F | Page 22 5.2.3 Treatment Type Options Select “Add Shape” to select the type of treatment per clinical requirements. KXL treatments are limited to one 9 mm circle. • PiXL treatments can have up to five shapes that can be •... -
Page 29: Designing A Pixl Or Curv Treatment
AVEDRO | 23 of 62 Adjust Energy Center Shape Figure 5-5. Adjust Energy for KXL Treatment 5.2.5 Designing a PiXL or CuRV Treatment NOTE: Requires PiXL Treatment Activation Card Open the “Add Shape” menu and select the “PiXL” tab. •... -
Page 30: Figure 5-6. Treatment Shape Selection
Mosaic Operator’s Manual Rev F | Page 24 Figure 5-6. Treatment Shape Selection As shown in Figure 5-7, select the up/down arrow (1) to adjust • the energy required for the specific treatment shape. Treatment time automatically adjusts itself based on energy dose selected. Use the X Position and Y Position (2) to adjust the location or •... -
Page 31: Multi-Shape Treatments
AVEDRO | 25 of 62 5.2.6 Multi-Shape Treatments The order of shapes included in a multi-shape treatment design plays an important role. The first shape has higher priority and the DMD setting will be prioritized according to that higher priority shape. Figure 5-8 depicts an example of how changing the order of two shapes results in different patient treatments. -
Page 32: Figure 5-9. Settings Menu
Mosaic Operator’s Manual Rev F | Page 26 Figure 5-9. Settings Menu The Map Options settings menu, shown in Figure 5-10, allows the user to choose the treatment map options (when applicable) to use on both the Main Design Map (Main View) and the Secondary Map (Auxiliary View). -
Page 33: Adjusting Power (Irradiance) And Uv Mode
AVEDRO | 27 of 62 5.2.8 Adjusting Power (Irradiance) and UV Mode Power and UV mode (pulsed or continuous) settings can be • modified by clicking on the drop-down menu beside the power (irradiance) value (see Figure 5-11). Figure 5-11. Power and Pulse Settings When Pulsed UV is selected, the time on and off for Pulsed can •... -
Page 34: Treatment Activation Card
Mosaic Operator’s Manual Rev F | Page 28 Figure 5-12. Confirm Treatment Design Window Treatment Activation Card After treatment design is confirmed, a treatment activation card • must be inserted to proceed with the patient treatment. If no card has yet been inserted, an error message will appear •... -
Page 35: Multi-Use Treatment Activation Cards
AVEDRO | 29 of 62 5.3.1 Multi-use Treatment Activation Cards When a multi-use activation card has been scanned, the display • will show the number of treatments remaining on the card. Prior to using the final treatment on a multi-use activation card, •... -
Page 36: Mosaic Induction Timer
Mosaic Operator’s Manual Rev F | Page 30 5.4.1 Mosaic Induction Timer The Mosaic Induction Timer is a system-based timer that may be used for either a single or a two-part induction process. See Figure 5-16. Figure 5-16. Two-Part Induction Timer User specifies the desired riboflavin induction period (1 sec –... -
Page 37: Apply Riboflavin
Apply Riboflavin to the area of treatment in accordance with • the Riboflavin Instructions for Use (IFU). CAUTION: Riboflavin is not a part of the Mosaic System described in this manual. For details, please refer to the Riboflavin Instructions for Use. -
Page 38: Coarse Alignment Of Laser Crosshairs
Mosaic Operator’s Manual Rev F | Page 32 Coarse Alignment of Laser Crosshairs The goal of the Coarse Alignment process is center the red crosshairs and the blue circle over the treatment eye pupil, as shown in Figure 5-18. The blue circle refers to the center of the DMD and the pupil should be aligned to this center for optimal pupil tracking during treatment. -
Page 39: Manual Axis Alignment Mode
AVEDRO | 33 of 62 Manual Axis Alignment Mode NOTE: Manual Axis Alignment Mode should only be selected for patients who have had their corneal axis marked along the horizontal meridian with a Corneal Gentian Violet marker. If the corneal axis has not been previously marked and if no axis registration is desired, user should select “Bypass Manual Axis Alignment.”... -
Page 40: Figure 5-20. Alignment In Progress
Mosaic Operator’s Manual Rev F | Page 34 Compensates for cyclo-torsion • Performs iris registration from the imported topographer (when available) For cases where a topography is not available, the Manual Axis Alignment allows the user to manually adjust for cyclo-torsion. Figure 5-20 displays the onscreen auto alignment process and Figure 5-21 shows the onscreen user alert when auto alignment successfully completes. -
Page 41: Unsuccessful Auto Alignment
AVEDRO | 35 of 62 5.9.1 Unsuccessful Auto Alignment Auto alignment may fail during any of the three processes for • various reasons including the head being out of range, or poor image contrast. If so, an error message will appear as shown in Figure 5-22 to notify the user. -
Page 42: Figure 5-24. Restart Auto Alignment Or Manual Alignment Option
Mosaic Operator’s Manual Rev F | Page 36 Figure 5-24. Restart Auto Alignment or Manual Alignment Option Selecting manual alignment provides use of motor controls to • manually align in X-Y and Z direction. WARNING: In case of manual alignment for asymmetrical treatment shapes, the user should manually perform rotational alignment in order to accurately apply the treatment. -
Page 43: Begin Uv Treatment
AVEDRO | 37 of 62 Begin UV Treatment The user is notified by an audible sound once induction and alignment is complete. Select “Begin UV Treatment” to start UV irradiation. • WARNING: Start treatment only after the photosensitizer is applied. -
Page 44: Treatment Complete
Mosaic Operator’s Manual Rev F | Page 38 UV treatment can be paused or interrupted at any time by • selecting the “Pause button”. This turns the UV irradiation off. Figure 5-28. Pausing UV Treatment Prior to resuming UV treatment, ensure that the alignment is •... -
Page 45: Treatment Incomplete
AVEDRO | 39 of 62 Carefully remove the device from the patient area. • Remove speculum and provide post-op treatment according to • appropriate clinical protocol. Treatment Incomplete If for some reason, the treatment is cancelled or stopped before •... -
Page 46: Figure 5-31. Power Down System
Mosaic Operator’s Manual Rev F | Page 40 Figure 5-31. Power Down System ML-00023... -
Page 47: Device Settings
Settings Menu as shown in Figure 6-1. Figure 6-1. Device Settings Menu 6.1.1 Advanced Settings Advanced Settings are only available to Avedro and Service personnel with a Mosaic Advanced Settings access card. If selected, the user will be prompted to scan an access card. 6.1.2 Transfer Data to USB Select “Transfer Data to USB”... -
Page 48: Edit Default Treatment Parameters
Mosaic Operator’s Manual Rev F | Page 42 Figure 6-2. Device Settings Transfer to USB Insert a USB device into the USB port. • Press the checkbox to copy treatment data to the USB. The • System begins transferring the treatment data and shows a progress bar of the transfer process. -
Page 49: Patient Prescreen Test
AVEDRO | 43 of 62 6.1.4 Patient Prescreen Test The patient prescreen test allows the user to prescreen a patient with an intra-ocular lens (IOL) or a cataract to ensure that the IOL will not interfere with the auto alignment and eye tracking system during a future treatment. -
Page 50: Figure 6-6. Alignment Step
Mosaic Operator’s Manual Rev F | Page 44 Select “Continue to” proceed with the screening. • Figure 6-6. Alignment Step In the Patient Prescreen Test, the user is prompted to perform • the coarse alignment procedure (see Section 5.7). Once coarse alignment is complete, select “Start Auto •... -
Page 51: Figure 6-8. First Attempt Fail
AVEDRO | 45 of 62 Failure Modes • If auto alignment fails, the user has two more attempts to repeat the auto alignment. Confirm that the patient is properly positioned prior to repeating auto alignment. If all three auto alignment attempts fail, the prescreen has failed and the user should not proceed with the treatment. -
Page 52: Figure 6-10. Confirm Patient Prescreen Results
Mosaic Operator’s Manual Rev F | Page 46 Pass Mode • Auto alignment passes and no eye tracking failures are detected by the System User is asked to confirm that the green circle correctly tracked the pupil throughout the recording period. Figure 6-10. -
Page 53: Demo Mode
AVEDRO | 47 of 62 6.1.5 Demo Mode NOTE: Not for use in treating patients Demo mode allows users to train on use of the Mosaic System without requiring treatment cards and without using UV light. Select “Demo Mode” •... -
Page 54: Maintenance / Service
“Service,” by contrast, refers to tasks that are intended to be performed only by a qualified service representative. Installation Policy For each new Mosaic System customer, a trained person may • provide a full initial installation and start-up of the System. -
Page 55: Trouble Shooting
Cleaning the System Use a soft damp cloth to clean the System. • The exterior of the Mosaic System can be cleaned using a lint- • free cloth dampened with soapy water. A 70% isopropyl alcohol or 10% chlorine bleach solution can also be used, if necessary. -
Page 56: Cleaning The Aperture
Figure 7-1. Moving Position of the Mosaic System Transport or shipment of the Mosaic System should be • performed only by Avedro trained and authorized personnel. -
Page 57: Storing The System
Software updates will only be performed by Avedro-trained • service representatives. Contact your local Avedro service representative if an error • message appears as displayed below in Figure 7-1. Record and share the error code with your Avedro service representative. -
Page 58: Identifying Risks Associated With Disposing Of Waste Products
Mosaic Operator’s Manual Rev F | Page 52 Identifying Risks Associated with Disposing of Waste Products When disposing of waste products, residues, Mosaic System, • and accessories, follow all applicable local regulations or contact an Avedro-authorized distributor. Performing a Visual Check Check all components of the device routinely for damage or •... -
Page 59: Equipment Classification
AVEDRO | 53 of 62 8 Equipment Classification According to IEC60601-1:2005+A1:2012 Medical Device Electrical Standard Protection against electrical shock • o Class 1 (external electrical power source) Degree of protection against electric shock • o Not classified, equipment not provided with applied part Degree of protection against ingress of water •... -
Page 60: Emc Requirements
Guidance and manufacturer’s declaration - electromagnetic emissions The Mosaic System is intended for use in the electromagnetic environment specified below. The customer or the user of the Mosaic System should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment —... - Page 61 Guidance and manufacturer’s declaration — electromagnetic immunity The Mosaic System is intended for use in the electromagnetic environment specified below. The customer or the user of the Mosaic System should assure that it is used in such an environment. Immunity test...
- Page 62 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Mosaic System is used exceeds the applicable RF compliance level above, the Mosaic System should be observed to verify normal operation.
- Page 63 Recommended separation distances between portable and mobile RF communications equipment and the Mosaic System The Mosaic System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Mosaic System can help prevent electromagnetic interference by...
- Page 64 Mosaic Operator’s Manual Rev F | Page 58 The Mosaic System contains an RFID function which transmits and receives at the 13.56 MHz frequency. This functionality may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.
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Page 65: Symbol Library
AVEDRO | 59 of 62 9 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... - Page 66 Mosaic Operator’s Manual Rev F | Page 60 Text Symbol Symbol Illustration Definition 12. Wine glass with crack Contents are fragile, handle on it with care 13. Two up arrows Keep arrows on carton pointing up 14. Percent sign on sea Humidity limits level (percentages below...
- Page 67 AVEDRO | 61 of 62 Text Symbol Symbol Illustration Definition 22. Atmospheric Pressure Operate within limits atmospheric pressure limits shown on System 23. Stand By System in Stand By Mode 24. Signal emitted RF transmitted through device ML-00023...
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Page 68: Specifications
Mosaic Operator’s Manual Rev F | Page 62 10 Specifications Specification Description Electrical Line voltages 100 – 240 volts AC, ± 10% Current 10A – 5A Single Phase 50/60 Hz, ± 5% Fuse: T 10H, 250V Energy Delivery UV Radiation 10 –... - Page 69 This page intentionally left blank.
- Page 70 Mosaic Operator’s Manual Rev F ML-00023...
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