Avedro Mosaic KXL UV User manual

Patents, Trademarks, Copyrights
The Mosaic System may be covered by one or more patent applications issued or pending
in the United States and worldwide.
Avedro logo design is a registered trademarks of Avedro, Inc. All software and
documentation is subject to Avedro, Inc. copyrights. All rights reserved 2015.
Microsoft and Windows are registered trademarks and trademarks, respectively, of
Microsoft Corporation. Any other trademarks or service marks contained within this
manual are the property of their respective owners.
For more information, contact: Your Local Avedro-authorized distributor
Avedro, Inc.
230 Third Avenue
Waltham, MA 02451
Authorized Representative
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: [phone]
Fax: [phone]
0470
Copyright 2015 All Rights Reserved
Printed in U.S.A. ML-00023 Revision A

Mosaic System Operator’s Manual,
ML-00023 Rev A
iii
Chapter:
1Forward ..................................................................................................... 1-1
1.1 Intended Use of Manual................................................................................. 1-1
1.2 Intended Use / Indications for Use................................................................. 1-1
1.3 Essential Requirements.................................................................................. 1-1
1.4 Design Change Disclaimer ............................................................................ 1-1
1.5 Reproduction Disclaimer ............................................................................... 1-1
1.6 User Operation Assistance Statement............................................................ 1-1
1.7 Contraindications, Warnings and Cautions.................................................... 1-2
1.7.1 Contraindications ............................................................................... 1-2
1.7.2 Warnings ............................................................................................ 1-2
1.7.3 Electrical Safety Warnings................................................................. 1-2
1.8 Patient Safety ................................................................................................. 1-3
1.9 Additional Safety Considerations .................................................................. 1-4
1.10 FCC Compliance Notice ................................................................................ 1-4
2Introduction............................................................................................... 2-1
2.1 System Overview ........................................................................................... 2-1
2.1.1 Major Components............................................................................. 2-1
2.1.2 Disposables......................................................................................... 2-1
2.1.3 Frequently Used Functions................................................................. 2-4
2.2 System Operation........................................................................................... 2-5
2.2.1 Touchpad/Keyboard Use.................................................................... 2-5
2.3 UV Energy (Dose) ......................................................................................... 2-6
3System Set Up............................................................................................ 3-1
3.1 Important Steps before Turning on the System ............................................. 3-1
3.2 Preparing the System ..................................................................................... 3-1
3.3 Powering Up .................................................................................................. 3-1
3.4 Setting Optics Head Height ........................................................................... 3-1
3.5 Proximity Warning......................................................................................... 3-3
3.6 Startup Screen ................................................................................................ 3-3
4Treatment Procedure................................................................................ 4-1
4.1 Patient Central................................................................................................ 4-1
4.1.1 Entering New Patient ......................................................................... 4-1
4.1.2 Importing Patient Topographies......................................................... 4-1
4.2 Creating Treatment map ................................................................................ 4-2
4.3 Screen Layout –Treatment Design Window................................................. 4-3
4.4 Create Treatment Map ................................................................................... 4-3
4.4.1 KXL treatment (KXL treatment Activation Card Required) ............. 4-3
4.4.2 PiXL treatment (PiXL treatment Activation Card Required) ............ 4-2
4.4.3 Power (Irradiance) setting .................................................................. 4-4

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4.4.4 Multiple Treatment Order .................................................................. 4-4
4.5 Treatment Activation Card ............................................................................ 4-5
4.5.1 Multi-use disposables......................................................................... 4-5
4.5.2 Treatment Activation Card Limit ....................................................... 4-6
4.6 Set Riboflavin Induction Period..................................................................... 4-6
4.7 Preparing the Patient ...................................................................................... 4-7
4.8 Apply Riboflavin ........................................................................................... 4-7
4.9 Coarse Alignment with Laser Crosshairs ...................................................... 4-8
4.10 Visual Axis Marker Alignment Mode (No topography import).................... 4-8
4.11 Auto-Alignment ............................................................................................. 4-9
4.11.1 Unsuccessful Auto-Alignment ....................................................... 4-10
4.12 Begin UV Treatment.................................................................................... 4-12
4.13 Treatment Complete..................................................................................... 4-14
4.14 Settings......................................................................................................... 4-15
4.15 Powering Down the System......................................................................... 4-15
5Advanced Settings..................................................................................... 5-1
5.1 Using the Device Settings Menu.................................................................... 5-1
5.1.1 Advanced Settings.............................................................................. 5-1
5.1.2 Transfer Data to USB......................................................................... 5-1
5.1.3 Editing Default Treatment Parameters Screen ................................... 5-2
6Maintenance / Service............................................................................... 6-1
6.1 Installation Policy .......................................................................................... 6-1
6.2 Customer Maintenance .................................................................................. 6-1
6.3 Warranty Information .................................................................................... 6-1
6.4 Per Patient Disposables.................................................................................. 6-1
6.5 Trouble Shooting ........................................................................................... 6-1
6.6 Directions for Sterilization or Disinfection.................................................... 6-1
6.7 Cleaning the System ...................................................................................... 6-2
6.8 Cleaning the Aperture .................................................................................... 6-2
6.9 Articulating Arm Adjustment ........................................................................ 6-2
6.10 Performing Periodic Maintenance ................................................................. 6-2
6.11 Moving the System ........................................................................................ 6-2
6.12 Storing the System ......................................................................................... 6-3
6.13 Software ......................................................................................................... 6-3
6.14 Identifying Risks Associated with Disposing of Waste Products.................. 6-4
6.15 Performing a Visual Check............................................................................ 6-4
7Equipment Classification ......................................................................... 7-1
Separation distance according to frequency of transmitter m........................ 7-5
8Symbol Library......................................................................................... 8-1
9Specifications............................................................................................. 9-1

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Figure 2-1. Overview Illustration of System with Callouts ..................................................................... 2-2
Figure 2-2. Mosaic Label........................................................................................................................ 2-3
Figure 2-3. UV emitting Label ................................................................................................................ 2-3
Figure 2-4 Laser Classification Label ...................................................................................................... 2-3
Figure 2-5 Do Not Sit or Step on Label................................................................................................... 2-3
Figure 3-1 Lift Buttons........................................................................................................................... 3-2
Figure 3-2 Optics Head .......................................................................................................................... 3-2
Figure 3-3 Proximity Warning: move lift up........................................................................................... 3-3
Figure 3-4. Startup Screen..................................................................................................................... 3-4
Figure 4-1. Import/Enter Patient Data Screen ....................................................................................... 4-2
Figure 4-2 Main Screen Layout .............................................................................................................. 4-3
Figure 4-3 Click/Drag to set KXL treatment ........................................................................................... 4-2
Figure 4-4 Adjust Energy for KXL treatment .......................................................................................... 4-2
Figure 4-5 Treatment Shape Selection................................................................................................... 4-3
Figure 4-6 Selecting Energy Dose and Centering Pattern ....................................................................... 4-4
Figure 4-7. Power and Pulse Selection .................................................................................................. 4-4
Figure 4-8. Resulting Treatment Pattern ............................................................................................... 4-5
Figure 4-9. Activation Card not detected ............................................................................................ 4-6
Figure 4-10. Final Treatment .............................................................................................................. 4-6
Figure 4-11. Induction Period Screen .................................................................................................... 4-6
Figure 4-12. Apply Riboflavin & Start Timer Screen............................................................................... 4-7
Figure 4-13 Coarse Alignment with lasers ............................................................................................. 4-8
Figure 4-14 Manual Axis Alignment Mode ............................................................................................ 4-9
Figure 4-15 Start Auto Alignment........................................................................................................ 4-10
Figure 4-16 Alignment Complete......................................................................................................... 4-10
Figure 4-17 Z-Alignment Error ............................................................................................................. 4-11
Figure 4-18 Iris Registration Error ....................................................................................................... 4-11
Figure 4-19 Re-start Auto Alignment or Manual Alignment Option..................................................... 4-11
Figure 4-20 Toggling between Manual Axis Alignment & Alignment lasers ......................................... 4-12
Figure 4-21 Begin UV Treatment ......................................................................................................... 4-13
Figure 4-22 Treatment in Progress ...................................................................................................... 4-13
Figure 4-23 Pausing UV Treatment...................................................................................................... 4-14
Figure 4-24. Treatment Complete Screen ............................................................................................ 4-14
Figure 4-25 Settings to save report ..................................................................................................... 4-15
Figure 4-26. Power Down System........................................................................................................ 4-15
Figure 5-1. Device Settings Menu .......................................................................................................... 5-1
Figure 5-2. Device Settings Transfer to USB........................................................................................... 5-2
Figure 5-3. Edit Default Treatment Parameters (Continuous & Pulsed) ................................................. 5-2
Figure 6-1 Moving Position of the Mosaic System ................................................................................. 6-3

Mosaic System Operator’s Manual,
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1-1
This manual is designed to serve the operators of the Avedro, Inc. Mosaic 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 strictly followed.
The Mosaic System delivers a uniform, metered dose of UV light to a targeted treatment area for the
intended use of illuminating the cornea during corneal cross-linking procedures
The Mosaic System must maintain the programmed intensity and spatial characteristics of the emitted
UV light while in treatment mode.
Due to design changes and product improvements, information in this manual is subject to
change without notice. Avedro, Inc. (hereafter called ‘‘Avedro’’) reserves 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. Avedro will
make every reasonable effort to ensure that this manual is up to date and corresponds with
the shipped Mosaic System.
The computer display screens depicted in this manual are representative only. Depending on
the software version of the system, minor differences may appear between the actual
computer displays and those shown in this manual.
All patient data appearing in this document, including the sample screen graphics, are
fictitious and representative only. No patient’s confidentiality has been violated, with or
without permission.
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.
Should you experience any difficulty in running your Mosaic System, please contact your local
Avedro authorized representative.

Chapter 1 : Forward
Mosaic System Operator’s Manual,
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This section describes situations in which the device should not be used because the risk of use clearly
outweighs any possible benefit. Conditions that may contraindicate the use of the device include:
Corneal thickness, with epithelium of less than < 375 microns.
Corneal melting disorders
Aphakic patients
Pseudophakic patients without UV blocking lens implanted
Pregnant and nursing women
Physicians should evaluate the potential benefits in patients with the following conditions:
Herpes simplex, herpes zoster keratitis, recurrent corneal erosion, corneal dystrophy
Epithelial healing disorders
For Equipment Classifications please refer to chapter 7: Equipment Classifications
WARNING: Any repair or service must be carried out by Avedro trained
personnel only.
WARNING: Do NOT modify this equipment without authorization of the
manufacturer.
WARNING: To avoid the risk of shock this equipment must only be
connected to a supply mains with protective earth.
To separate system connection to mains, grasp the power cord plug and pull
it from outlet to disconnect.
The system is designed for continuous operation using the external
connector.
WARNING: This equipment is operated with hazardous voltages that can
shock, burn, or cause death. To reduce the possibility of electrical shock and
inadvertent UV exposure do not remove any fixed panels.

Chapter 1: Forward
Mosaic System Operator’s Manual,
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WARNING: Remove the wall plug and turn off the power switch before
servicing or cleaning (disinfecting) the equipment.
Never pull cords to remove the power cord from the outlet. Grasp the power
cord plug and pull it from the outlet to disconnect.
WARNING: Do not operate the equipment with a damaged power cord.
WARNING: Position the power cord so that it cannot be tripped over,
walked on, rolled over, crimped, bent, pinched, or accidentally pulled from
the wall outlet.
WARNING: To remove power completely from the system, unplug power
cord from mains outlet. Always keep power cord area free to effectively
unplug cord and remove power from system.
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.
WARNING: Ignoring local regulations on use of electro-optical medical
devices may cause malfunction due to electromagnetic interference.
The treatment should take place in a quiet and relaxed atmosphere in order not to distract the
attention of the patient. The patient should lie on a table or patient's chair. The patient’s head
should rest comfortably in a headrest. It is imperative that the table or patient’s chair or the
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.

Chapter 1 : Forward
Mosaic System Operator’s Manual,
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UV irradiance of the Mosaic System is calibrated by the manufacturer and must be checked
annually. Any modification of the system's external light beam by means of optical elements
is strictly prohibited.
Plastic instrumentation such as speculums or eye shields may be damaged when impacted by
the UV beam, possibly resulting in product degradation. Therefore, only Avedro
recommended accessories or stainless steel surgical instruments should be used.
Smooth metallic surfaces can reflect despite the effort to blank them. Therefore, only laser
grade instruments should be used.
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential environment. This equipment generates, 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 guarantee
that interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an electrical outlet on a circuit different from that to which the
receiver is connected.
Consult Avedro Customer Service for help.
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.

Mosaic System Operator’s Manual,
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The Mosaic System is an electronic medical device which delivers ultraviolet light (365 nm
wavelength) in a programmable pattern onto the cornea after a solution of ophthalmic riboflavin
solution has been applied. UV flux and irradiation time (i.e., fluence) at the cornea are controlled
by an onboard computer system.
The Mosaic is a portable system with an articulating arm to allow movement of the system for
alignment of the UV Beam to the patient’s cornea. The Optics Head houses the UV irradiation
mechanism. The height of the Optics Head can be adjusted through a lift in the body of the system.
The LED is preset by the manufacturer to emit UV radiation at a wavelength of 365 nm at an
intensity of 10 mW/cm2to 100 mW/cm2(±10%).
The treatment parameters (Riboflavin Induction Period, Total UV Energy, UV treatment patterns,
UV Power and UV Pulse Cycle Times) are selected through the user interface touch screen
computer.
The Mosaic System is used in conjunction with an ophthalmic riboflavin solution and a Treatment
Activation card.
The major components of the Mosaic System include the following:
Articulating arm with optics head with UV source and heads up display
Mosaic main console with user interface
Mosaic accelerated cross-linking treatment kit (disposable supplied separately)
USB port
USB flash drive
The following disposables (supplied separately) are required for performing treatments with the
Mosaic System:
Riboflavin ophthalmic solutions
Treatment Activation card

Chapter 2 : Introduction
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ML-00023 Rev A
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A Main Console with USB flash drive and treatment activation slot
B System Keyboard
C System Body with lift system
D Articulating Arm
E Heads Up Display
F Optical Head
G Stand by Switch
H Wheels
Figure 2-1. Overview Illustration of System with Callouts
B
C
D
E
F
G
H
A

Chapter 2: Introduction
Mosaic System Operator’s Manual,
ML-00023 Rev A
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Figure 2-2. Mosaic Label
Figure 2-3. UV emitting Label
Figure 2-4 Laser Classification Label
Figure 2-5 Do Not Sit or Step on Label

Chapter 2 : Introduction
Mosaic System Operator’s Manual,
ML-00023 Rev A
2-4
FUNCTION
MODE
SECTION
Turn System On
Press Stand By switch under the keyboard in the
front of the Mosaic console
3.3
Go on Stand By
Select ‘‘Power Off’ on main console display
4.13
Treatment Design
Select ‘‘Design OD’’/ ‘‘Design OS’’. This
initiates a new treatment design.
4.2
Scan Treatment
Activation Card
Insert Treatment Activation card into slot on the
left side of main console
3.4
Begin UV Treatment
Select ‘‘Begin UV Treatment’’. This starts the
eye tracking capability of the system.
4.11
Pause
Select ‘‘Pause’’ to interrupt treatment at any time.
4.11

Chapter 2: Introduction
Mosaic System Operator’s Manual,
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Unpacking and installation of the Mosaic system should ONLY be carried out
by trained Avedro personnel.
The table below identifies and describes important touchpad keys and icons unique to Mosaic
System operation.
Touchpad Key
Icon
Description/Function
Power Off button
(Initial screen)
Turns OFF electric power to
the personal computer and goes
on Stand By Mode
Start New Treatment
button (Initial screen)
Directs the system to repeat
the entire clinical treatment
protocol so the physician can
treat another patient.
UP arrow
(various Clinical
Protocol screens)
Increases the value of the
current field.
DOWN arrow
(various Clinical
Protocol screens)
Decreases the value of the
current field.
X button
(various Device
Settings screens)
Cancels all the entries on a
particular screen and returns to
the previous screen.
Checkmark 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
Protocol screens)
Cancels a treatment session for
a particular patient. A prompt is
then displayed to confirm your
decision.
Return button
(various Device
Settings screen)
Returns to the Device Settings
menu.
CAUTION: Only qualified and experienced personnel shall operate the Mosaic System.

Chapter 2 : Introduction
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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.
The system tracks UV Energy, UV Power, UV Irradiation Time and Total Treatment Time
during the treatment.
Treatment Parameters:
Induction Period: 1 second --- 30 minutes
UV Energy: 0 --- 15 J/cm2
UV Power: 10 --- 100 mW/cm2(± 10%)
Please reference Riboflavin Instructions for Use (IFU) for formulation information.

Mosaic System Operator’s Manual,
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3System Set Up
CAUTION: Only qualified and experienced personnel initially trained by Avedro shall
operate the Mosaic 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.
To ensure the system is functioning properly, consider the following mandatory points:
oInspect the device, accessories, and connecting cables for visible damage.
Carefully inspect the power cord for any possible damage prior to powering
up the system.
oTake into consideration all local regulations for use of portable electro-optical
medical devices to minimize any risk of electromagnetic interferences.
Position the Mosaic System adjacent to the treatment table or chair. Lock the casters to
secure the device’s position.
Ensure that the power plug is readily accessible to the user and can be easily unplugged by
grasping the power cord plug and pulling on it.
Turn ON the single stand by switch under the keyboard in the front of the Mosaic console.
This switch turns on all the system components and loads the Mosaic software.
Continuously press the up /down (+ / -) button and the main button ( ) )simultaneously
to raise or lower the optics head to theapproximate desired height above the treatment table
or chair.
The lift only functions when BOTH buttons are pressed and is disabled during
treatment. If the lift keeps moving when the buttons are released, press the Stand
By button and contact your distributor or Customer Service immediately.
)

Chapter 3 : System Set Up
Mosaic System Operator’s Manual,
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Figure 3-1 Lift Buttons
There are three memory recall positions. Factory default for (1) , (2) and (3) is
set to lower height, mid height and upper height positions respectively. The user can store
a user- specific height in the memory for future use.
In order to save a desired height to memory, press the memory button once, wait for it to
flash and then press on (1), (2) or (3) for the desired recall position. The new user-specified
height will now be stored in this designated recall position.
To move the head to one of the stored memory positions, press on the (1), (2) or (3) and the
main button simultaneously.
Steer the optics head and align to desired position by continuously pressing on either brake
button (left or right) to disengage the brakes of the articulating arm. Once the brake buttons
are let go, the head locks into place.
Figure 3-2 Optics Head
Brake release is disabledduring treatment. In case of emergency, the optics head
can be steered away from patient by grabbing the handles and moving the head
away.
Up (+) and Down (-)
Main Button
Recall
Positions
Brakes

Chapter 3: System Set Up
Mosaic System Operator’s Manual,
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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 a warning will flash
on the screen.
Figure 3-3 Proximity Warning: move lift up
Move the lift back up to clear the proximity warning or ensure that no object is obstructing
the optical head underneath the UV window.
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 Figure 3-4 is displayed.
To begin patient treatment, press Start.

Chapter 3 : System Set Up
Mosaic System Operator’s Manual,
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Figure 3-4. Startup Screen
NOTE: If there is a Start-up error, please note any error messages and contact your
distributor or Customer Service immediately.
NOTE: Screen shots are for demonstration purposes only and may have slight
modifications.

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4
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 the patient central from the USB
flash drive for guided treatment patterns.
Enter a new patient’s data by clicking on ‘‘New Patient’’ and filling in the fields with the
patient’s information.
oNote: Patient’s ‘‘First Name’’ and ‘‘Last Name’’ and Patient ‘‘ID’’ are required fields.
‘‘Sex’’ and ‘‘D.O.B’’ will remain as default if not edited.
Patient topographies are exported onto the main root menu of a USB flash drive then used
with the Mosaic system.
After inserting the USB flash drive, click on ‘‘Import / Refresh Patient List’’ to refresh the
page and list all patients on the USB drive.
Patient data exported from a commercial topographer can be distinguished under the
‘‘Source’’ column.