Operator’s 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 anddocumentation is subject to Avedro, Inc. copyrights. All rights reserved 2016.
Microsoft and Windows are registered trademarks and trademarks, respectively, ofMicrosoft Corporation. Any other trademarks or service marks contained within thismanual 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 152513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299

0470

Copyright 2016

All Rights Reserved

Printed in U.S.A.

ML-00023 Revision B

Table of Contents
Chapter:1
Foreword .................................................................................................... 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
2
Introduction ............................................................................................... 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
3
System Set Up ............................................................................................ 3-1
3.1
Important Steps before Turning on the System ............................................. 3-1
3.2
Preparing the System ..................................................................................... 3-1
3.3Powering Up .................................................................................................. 3-1
3.4
Setting Optics Head Height ........................................................................... 3-1
3.5
Proximity Warning......................................................................................... 3-3
3.6
Startup Screen ................................................................................................ 3-3
4
Treatment 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
Mosaic System Operator’s Manual,
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4.5

4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
4.15
5
5.1

6
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11
6.12
6.13
6.14
6.15
7
8
9

4.4.4 Multiple Treatment Order .................................................................. 4-4
Treatment Activation Card ............................................................................ 4-5
4.5.1 Multi-use disposables ......................................................................... 4-5
4.5.2 Treatment Activation Card Limit ....................................................... 4-6
Set Riboflavin Induction Period..................................................................... 4-6
Preparing the Patient ...................................................................................... 4-7
Apply Riboflavin ........................................................................................... 4-7
Coarse Alignment with Laser Crosshairs ...................................................... 4-7
Visual Axis Marker Alignment Mode (No topography import) .................... 4-8
Auto-Alignment ............................................................................................. 4-9
4.11.1 Unsuccessful Auto-Alignment ....................................................... 4-10
Begin UV Treatment .................................................................................... 4-12
Treatment Complete..................................................................................... 4-14
Settings ......................................................................................................... 4-15
Powering Down the System ......................................................................... 4-15
Device Settings ........................................................................................... 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
5.1.4 Patient Prescreen Test ........................................................................ 5-3
Maintenance / Service ............................................................................... 6-1
Installation Policy .......................................................................................... 6-1
Customer Maintenance .................................................................................. 6-1
Warranty Information .................................................................................... 6-1
Per Patient Disposables .................................................................................. 6-1
Trouble Shooting ........................................................................................... 6-1
Directions for Sterilization or Disinfection.................................................... 6-1
Cleaning the System ...................................................................................... 6-2
Cleaning the Aperture .................................................................................... 6-2
Articulating Arm Adjustment ........................................................................ 6-2
Performing Periodic Maintenance ................................................................. 6-2
Moving the System ........................................................................................ 6-2
Storing the System ......................................................................................... 6-3
Software ......................................................................................................... 6-3
Identifying Risks Associated with Disposing of Waste Products .................. 6-4
Performing a Visual Check ............................................................................ 6-4
Equipment Classification ......................................................................... 7-1
Separation distance according to frequency of transmitter m ........................ 7-5
Symbol Library ......................................................................................... 8-1
Specifications.................................................................................................1

Mosaic System Operator’s Manual,
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Table of Figures
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 ............................................................................................ 4-5
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 5-4 Insert flash drive................................................................................................................... 5-3
Figure 5-5 Enter IOL Information .......................................................................................................... 5-3
Figure 5-6 Alignment Step ..................................................................................................................... 5-4
Figure 5-7 Screening step process ......................................................................................................... 5-4
Figure 5-8 First attempt fail ................................................................................................................... 5-5
Figure 5-9 Failed prescreen assessment ................................................................................................ 5-5
Figure 5-10 Confirm Patient Prescreen Results...................................................................................... 5-6
Figure 5-11 Prescreen test Pass ............................................................................................................. 5-6
Mosaic System Operator’s Manual,
ML-00023 Rev Bv

Figure 6-1 Moving Position of the Mosaic System ................................................................................. 6-3

Mosaic System Operator’s Manual,
ML-00023 Rev Bvi

1 Foreword
1.1

Intended Use of ManualThis manual is designed to serve the operators of the Avedro, Inc. Mosaic System. All operating
instructions, product illustrations, screen graphics, troubleshooting/error messages, and otherrelevant information are contained in this manual. It is the operator’ s responsibility to ensure that all
safety instructions in this manual are strictly followed.

1.2

Intended Use / Indications for Use

The Mosaic System delivers a uniform, metered dose of UV light to a targeted treatment area for theintended use of illuminating the cornea during corneal cross-linking procedures

1.3

Essential Requirements

The Mosaic System must maintain the programmed intensity and spatial characteristics of theemitted UV light while in treatment mode.

1.4

Design Change Disclaimer•

Due to design changes and product improvements, information in this manual is subject tochange 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 ofthis 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 correspondswith 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, arefictitious and representative only. No patient’ s confidentiality has been violated, with orwithout permission.

1.5

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.

1.6

User Operation Assistance Statement

Should you experience any difficulty in running your Mosaic System, please contact your local
Avedro authorized representative.

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Chapter 1 : Foreword

1.7

Contraindications, Warnings and Cautions

1.7.1 Contraindications
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

1.7.2 Warnings
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

1.7.3 Electrical Safety Warnings
For Equipment Classifications please refer to chapter 7: Equipment Classifications

WARNI NG: Any repair or service must be carried out by Avedro trained
personnel only.
WARNI NG: Do NOT modify this equipment without authorization of the
manufacturer.

WARNI NG: To avoid the risk of shock this equipment must only beconnected to a supply mains with protective earth.
To separate system connection to mains, grasp the power cord plug andpull it from outlet to disconnect.
The system is designed for continuous operation using the external
connector.
WARNI NG: 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.

WARNI NG: Remove the wall plug and turn off the power switch before
servicing or cleaning (disinfecting) the equipment.

Mosaic System Operator’s Manual,
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Chapter 1: Foreword

Never pull cords to remove the power cord from the outlet. Grasp thepower cord plug and pull it from the outlet to disconnect.
WARNI NG: Do not operate the equipment with a damaged power cord.
WARNI NG: Position the power cord so that it cannot be tripped over,walked on, rolled over, crimped, bent, pinched, or accidentally pulled fromthe wall outlet.
WARNI NG: 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.
WARNI NG: Do not use the instrument near water and be careful not tospill liquids on any part of it.

WARNI NG: Do not operate the M osaic System in the presence offlammable mixtures or anesthetics.
WARNI NG: Never look directly into the UV light beam. Never direct thebeam towards a person except for therapeutic purposes.

WARNI NG: I gnoring local regulations on use of electro-optical medical
devices may cause malfunction due to electromagnetic interference.

1.8•

Patient Safety
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’ shead should rest comfortably in a headrest. It is imperative that the table or patient’ s chairor the system not be moved during the treatment procedure.
CAUTI ON: The M osaic System is a medical device. I t may be operated, therefore, only inhealth care facilities or medical areas under the supervision of medically trained personnel.

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ML-00023 Rev B
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Chapter 1 : Foreword

1.9

Additional Safety Considerations•

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 opticalelements 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.

1.10 FCC Compliance NoticeThis 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 canradiate 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 guaranteethat interference will not occur in a particular installation. If this equipment does cause harmfulinterference 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 thereceiver 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,
ML-00023 Rev B
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2 Introduction
2.1

System Overview

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 riboflavinsolution 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 foralignment 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 thesystem. The LED is preset by the manufacturer to emit UV radiation at a wavelength of 365 nm at
an intensity of 10 mW/cm2 to 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.

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
M osaic main console with user interface•

M osaic accelerated cross-linking treatment kit (disposable supplied separately)•

USB port•

USB flash drive

2.1.2 Disposables
The following disposables (supplied separately) are required for performing treatments with the
Mosaic System:•

Riboflavin ophthalmic solutions•

Treatment Activation card

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ML-00023 Rev B
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Chapter 2 : Introduction

A
E
B
F

C

G

D

H

Figure 2-1. Overview Illustration of System with Callouts

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 HeadG

Stand by Switch

H

WheelsMosaic System Operator’s Manual,
ML-00023 Rev B
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Chapter 2: Introduction

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

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ML-00023 Rev B
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Chapter 2 : Introduction

2.1.3 Frequently Used Functions

FUNCTI ON

M ODETurn System On

Press Stand By switch under the keyboard in the 3.3
front of the Mosaic console

Go on Stand By

Select “ Power Off’ on main console display

Treatment Design

Select “ Design OD” / “ Design OS” . This initiates a 4.2
new treatment design.

Scan Treatment
Activation Card

Insert Treatment Activation card into slot on the 3.4
left side of main console

Begin UV Treatment

Select “ Begin UV Treatment” . This starts the eye 4.11
tracking capability of the system.

Pause

Select “ Pause” to interrupt treatment at any time.

Mosaic System Operator’s Manual,
ML-00023 Rev B
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SECTI ON

4.13

4.11

Chapter 2: Introduction

2.2

System Operation
Unpacking and installation of the Mosaic system should ONLY be carried out
by trained Avedro personnel.

2.2.1 Touchpad/Keyboard Use
The table below identifies and describes important touchpad keys and icons unique to Mosaic
System operation.
Touchpad Key
I conPower Offbutton(Initial screen)

Description/Function
Turns OFF electric power tothe personal computer and goeson Stand By Mode

Start New Treatment
button (Initial screen)

Directs the system to repeat theentire clinical treatment
protocol so the physician cantreat another patient.

UP arrow(various ClinicalProtocol screens)

Increases the value of thecurrent field.

DOWN arrow(various ClinicalProtocol screens)

Decreases the value of thecurrent field.

X button(various Device
Settings screens)

Cancels all the entries on aparticular screen and returns to
the previous screen.

Checkmark button(various ClinicalProtocol screens andDevice Settings screen)
Cancel Session button(various ClinicalProtocol screens)

Directs the system to accept thecurrent screen entries and toproceed to the next step.

Return button(various Device
Settings screen)

Cancels a treatment session for
a particular patient. A prompt
is then displayed to confirm
your decision.
Returns to the Device Settings
menu.

CAUTI ON: Only qualified and experienced personnel shall operate the M osaic System.

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ML-00023 Rev B
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Chapter 2 : Introduction

2.3

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.

•

The system tracks UV Energy, UV Power, UV Irradiation Time and Total Treatment
Time during the treatment.
•

Treatment Parameters:
Induction Period:
UV Energy:
UV Power:

1 second – 30 minutes
0 – 15 J/cm2
10 – 100 mW/cm2 (± 10%)

Please reference Riboflavin I nstructions for Use (IFU) for formulation information.

Mosaic System Operator’s Manual,
ML-00023 Rev B
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3 System Set Up
CAUTI ON: Only qualified and experienced personnel initially trained by Avedro shall
operate the M osaic System.

3.1
SystemImportant Steps before Turning on the•

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.

o

3.2

Take into consideration all local regulations for use of portable electro-optical
medical devices to minimize any risk of electromagnetic interferences.

Preparing the System•

Position the Mosaic System adjacent to the treatment table or chair. Lock the casters tosecure the device’s position.

•

Ensure that the power plug is readily accessible to the user and can be easily unpluggedby grasping the power cord plug and pulling on it.

3.3
•

3.4
•

Powering Up
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.

Setting Optics Head HeightContinuously press the up /down (+ / -) button and the main button ( ) )simultaneously
to raise or lower the optics head to the approximate desired height above the treatment
table or chair.
The lift only functions when BOTH buttons are pressed and is disabled during
treatment. I f the lift keeps moving when the buttons are released, press the StandBy button and contact your distributor or Customer Service immediately.

Mosaic System Operator’s Manual,
ML-00023 Rev B
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Chapter 3 : System Set Up

RecallPositions
Main Button
Up (+) and Down (-)

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 canstore 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 toflash and then press on (1), (2) or (3) for the desired recall position. The new userspecified 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) andthe 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 brakebuttons are let go, the head locks into place.
BrakesFigure 3-2 Optics HeadBrake release is disabled during treatment. I n case of emergency, the optics
head can be steered away from patient by grabbing the handles and moving thehead away.

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ML-00023 Rev B
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Chapter 3: System Set Up

3.5

Proximity Warning•

Moving the lift of the optical head too far down may trigger a proximity sensor. This is asafety 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 flashon the screen.

Figure 3-3 Proximity Warning: move lift up•

3.6

Move the lift back up to clear the proximity warning or ensure that no object isobstructing the optical head underneath the UV window.

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 andreference files.

•

The Mosaic software launches itself and the startup screen in Figure 3-4 is displayed.

•

To begin patient treatment, press Start.

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ML-00023 Rev B
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Chapter 3 : System Set Up

Figure 3-4. Startup Screen
NOTE: I f 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.

Mosaic System Operator’s Manual,
ML-00023 Rev B
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4 Treatment Procedure
4.1

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 theUSB flash drive. Patient topographies can be imported via the patient central from theUSB flash drive for guided treatment patterns.
A USB flash drive should be inserted in the USB slot (plan.

) to proceed to a treatment

4.1.1 Entering New Patient•Enter a new patient’ s data by clicking on “ New Patient” and filling in the fields with thepatient’ 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.

4.1.2 Importing Patient Topographies
Patient topographies are exported onto the main root menu of a USB flash drive thenused with the Mosaic system.
•

After inserting the USB flash drive, click on “ Import / Refresh Patient List” to refresh thepage and list all patients on the USB drive.

•

Patient data exported from a commercial topographer can be distinguished under the“ Source” column.

Mosaic System Operator’s Manual,
ML-00023 Rev B
4-1

Chapter 4 : Treatment Procedure

Doe

John

Doe

Mary

John
Dom

Mara

Doe

JohnnyDoe

Jack

Figure 4-1. Import/Enter Patient Data Screen

4.2

Creating Treatment map•

Select the patient to be treated.

•

Select “ Design OD” or “ Design OS” to create right or left eye treatments respectively. Thistakes the user to the Treatment Design Window.

Mosaic System Operator’s Manual,
ML-00023 Rev B
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Chapter 4: Treatment Procedure

4.3

Screen Layout – Treatment Design Window

Figure 4-2 Main Screen Layout
1

Patient Information

7

Design window with map overlay

2

Treatment/Shape Selection

8

Map Settings

3

Treatment change, edit or delete

9

X/Y Coordinate tracking

4

Irradiance power Selection –Continuous/Pulse UV selection

10

Indices

11

Secondary Map

5Back to Patient Central

12

Left/Right Eye

6Start New Treatment

4.4

Create Treatment Map
Select “ Add Shape” (2) 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 thatcan be juxtaposed or overlaid together.

4.4.1 KXL treatment (KXL treatment Activation Card Required)•Select the KXL treatment.

•

Click or touch on the Main Design Window to place a 9 mm circle.

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ML-00023 Rev B
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Chapter 4 : Treatment Procedure

Figure 4-3 Click/Drag to set KXL treatment•

The circle can then be centered on the limbus, pupil or vertex (if available). If noselection is made, the circle automatically centers around the vertex (fortopography imports) or centers around the grid (for no topography imports).

•

Adjust the energy dosage. Treatments energy and irradiance limits are controlled
by the KXL Treatment Activation Card. Tracking feature is not available during a
KXL treatment.

Increase Energy

Center Treatment

Figure 4-4 Adjust Energy for KXL treatment

4.4.2 PiXL treatment (PiXL treatment Activation Card Required)•Select the PiXL treatment from the “ Add Shape” menu.

•

Select a PiXL treatment shape from the drop down list:ocircular shapes of user-defined diameter (7 mm, 9 mm and 11 mm circles are
pre-set);oellipses of user-defined diameter and axis;osingle arcuate sector of user-defined size, thickness and angle;

Mosaic System Operator’s Manual,
ML-00023 Rev B
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Chapter 4: Treatment Procedureosymmetrical double arcuate sectors of user-defined size, thickness and angle;oannular surface with user-defined diameters;oor, any free-hand user-defined drawn surface.

Figure 4-5 Treatment Shape Selection•

Select the Up/Down Arrow (1) in Figure 4-6 to adjust the energy required for the specifictreatment shape. Treatment time automatically adjusts itself based on energy dose
selected.

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Figure 4-6 Selecting Energy Dose and Centering Pattern•

Use the X Position and Y Position (2) to adjust the location or center around the Limbus,
Pupil or Vertex (3) by selecting one of the three buttons.

•

Press green checkbox (4) to continue.

•

Up to four additional shapes can be added (total of 5) and each shape can be assignedwith its own total energy selection.
•

Press green checkbox to continue for each shape selected.

Figure 4-7. Power and Pulse Selection

4.4.3 Power (Irradiance) setting•

Power setting can be modified by clicking on the drop down menu beside the power(irradiance) value (see figure 4-7).

•

Pulsed or Continuous UV can be similarly selected. When Pulsed UV is selected, the timeon and off for Pulsed can be adjusted using the up/down arrows. Pulsing times range from
0.1 s – 4.0 s in 0.1 s increments.

•

Once energy, power and all other parameters have been entered, select “ Start Treatment”
to proceed with the treatment.

4.4.4 Multiple Treatment Order•

The shape layer order plays an important role. The first shape has higher priority than thenext shape in setting the DMD.
Altering the shape order changes the end treatment: the top shape layer has higher
priority and the DMD setting will be prioritized according to that higher priority
shape. The figure below shows an example of how changing the order of two
shapes changes the end treatment to the patient.
In the first treatment summary (Fig 4-8), the higher energy smaller circle hashigher priority; therefore, even when the 7 mm circle treatment is complete after
6 minutes, the DMD keeps the smaller circle ‘ on’ .

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Chapter 4: Treatment Procedure

In the second treatment summary, the 7 mm circle treatment has higher priority.
Therefore, when the 6 minute treatment is up, the DMD mirrors in that area shut
off since the treatment is up and the resultant treatment resembles the smaller
circle with an area cut off.

Figure 4-8. Resulting Treatment Pattern

4.5

Treatment Activation Card

NOTE: Screen shots are for demonstration purposes only and may have slight
modifications.

4.5.1 Multi-use disposables•

When “ Start Treatment” is selected, if no Treatment Activation card has yet been
inserted, an error message will show up to remind the user to insert the RFID card
now into the slot on the left side of the main console before proceeding. Once a multiuse activation card has been scanned, the display will show the number of treatments
remaining on the card.

Figure 4-9. Activation Card not detected•

Prior to the final treatment, a message will be displayed to warn the user of only one
treatment remaining.
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Chapter 4 : Treatment Procedure

Figure 4-10. Final Treatment

4.5.2 Treatment Activation Card Limit•

Once card has been read, a window will appear (“ Confirm Treatment Design &Parameters” ) showing the summary of the treatment parameters similar to Fig 4-8.

•

If the user has selected a parameter that is outside the allowable value(s) controlled by
the Treatment Activation card (UV power, energy, treatment time, etc.), the user will
not be allowed to proceed with the treatment. The user will have to go back and edit
the parameters that are accepted with the Treatment Activation Card.

4.6

Set Riboflavin Induction Period•

Specify the desired Riboflavin Induction Period (1 sec – 30 min).

•

When finished entering parameters, select the Checkmark button.

Figure 4-11. Induction Period Screen

NOTE: Default treatment parameters will auto-populate user selectable fields but
are adjustable.

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4.7

Preparing the Patient•

Ensure that the patient is lying flat on a patient table or chair. His or her head should
rest in a head rest.

•

Adjust the table or chair and head rest so that the patient can rest comfortably for theduration of the treatment without head movement.

•

When needed, mark the visual axis on the cornea using a corneal Gentian Violet
marker.

•Apply a lid speculum and optional drapes using standard clinical technique.
CAUTI ON: Riboflavin (vitamin B2) is not a part of the M osaic System described in thismanual. For details of component use, please refer to the component’s I nstructions for
Use.

4.8

Apply Riboflavin•

Apply Riboflavin to the area of treatment in accordance with the Riboflavin Instructions
for Use (IFU).

•

Once the Riboflavin is applied to the eye, start the induction by selecting “ Riboflavin
Applied: Start Timer” .

Figure 4-12. Apply Riboflavin & Start Timer Screen

4.9•

Coarse Alignment with Laser Crosshairs
Pressing the buttons on the handles of the articulating arm to disengage the brakes, steer
the optics head over the patient’ s head.
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Chapter 4 : Treatment Procedure•

Align the optics head such that the laser crosshairs are closely aligned/overlapped on eachother. The height of the optics head may require to be adjusted by using the lift system toalign the laser crosshairs.

•

Align the crosshairs on the Heads Up Display to the center of the pupil of the eye to betreated. Release the buttons to engage the brakes once closely aligned.

•

Alignment should aim to position the center of the pupil to the center of the crosshair andthe blue circle. The blue circle refers to the center of the DMD and the pupil should bealigned to this center for more optimum pupil tracking.

Figure 4-13 Coarse Alignment with lasers

4.10 Visual Axis Marker Alignment Mode (Notopography import)
Visual Axis Marker Alignment Mode should be used on patients who have had
their corneal axis marked along the horizontal meridian with a Corneal Gentian
Violet marker previously. If the corneal axis has not been previously marked
and if no axis registration is desired, user can bypass the manual axis alignment.
•

Once coarse alignment is over, select the Visual Axis Marker alignment mode toilluminate the cornea rendering the axis markers on the cornea clearly visible.

•

Pressing the buttons on the handles of the articulating arm to disengage the brakes, rotate
the optics head such that the visual axis markers are aligned with the horizontal blue lineon the Heads Up Display.

•

Alignment should continue aiming to position the center of the pupil to the center of thecross-hair and the blue circle.

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Chapter 4: Treatment Procedure•

Once aligned, release the brakes and select the Auto Alignment Mode.

Figure 4-14 Manual Axis Alignment Mode

4.11 Auto-Alignment••“ Start Auto-Alignment” is selected to engage the auto alignment process. The alignment
process is a three step process. The system:oauto-aligns in X-Y axes for pupil tracking;oauto-aligns in the Z axis for best focus;operforms iris registration (when available)

Iris registration uses the iris image from the imported topographer (when available) andperforms an iris registration to compensate for cyclo-torsion. For cases where a
topography is not available, the visual axis marker mode is available to allow the user tomanually adjust for cyclo-torsion when a patient’ s cornea is previously marked with acorneal gentian violet marker.

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Figure 4-15 Start Auto Alignment•

After the alignment sequence is performed, the user is alerted that alignment is complete.

Figure 4-16 Alignment Complete•

Once alignment is completed, and riboflavin induction is over, the “ Begin UV Treatment”
button appears and user can select to start treatment.

4.11.1 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 pop up to
notify the user.

•

Some causes for z-alignment failure may be due to the internal z-motors running out ofrange. In such a case, the error message will instruct the user to move the lift up or down
before re-alignment. The user should use the lift to move the head further up or down
until the image of the eye looks more focused. This will facilitate the auto focus
algorithm when the user re-starts the auto-alignment process.

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Chapter 4: Treatment Procedure

Figure 4-17 Z-Alignment Error•

If the iris registration fails, the user is notified of the failure and the user has the option to
re-start the auto-alignment or forego auto-alignment and proceed with manual alignment.

Figure 4-18 Iris Registration Error

Figure 4-19 Re-start Auto Alignment or Manual Alignment Option•

Skipping auto alignment to do manual alignment will provide the user of motor controls to
manually align in X-Y and Z direction.

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WARNING: In case of manual alignment for asymmetrical treatment shapes, theuser should manually perform rotational alignment in order to accurately apply thetreatment.
•

Within Manual Alignment Mode, the user can toggle between Manual Axis Alignment
mode for aligning the axis to corneal markings on the patient’s cornea, or the Alignment
lasers for manual alignment in X-Y and Z direction.

Figure 4-20 Toggling between Manual Axis Alignment & Alignment lasers

4.12 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. Once UV is on, the software will track the eye
and the UV pattern will follow the eye, irradiating the same specific region of the cornea.

WARNI NG: Start treatment only after the photosensitizer is applied.

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Chapter 4: Treatment Procedure

Figure 4-21 Begin UV Treatment•

A Treatment in Progress bar shows the progress of the UV treatment and Treatment Time
Remaining, Total Energy Delivered and Total Induction Period are displayed.

Figure 4-22 Treatment in Progress•

UV treatment can be paused or interrupted at any time by selecting the “ Pause button” .
This turns the UV irradiation off.

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Chapter 4 : Treatment Procedure

Figure 4-23 Pausing UV Treatment•

Prior to resuming UV treatment, ensure that the alignment is correct. The user can choose
to re-align or proceed without re-aligning and select “ Resume” to start the UV irradiation
again.

4.13 Treatment Complete•

At the completion of a treatment the Total Treatment Parameters will be displayed andthe screen will show Treatment complete.

Figure 4-24. Treatment Complete Screen•

To exit treatment and / or start a new treatment select “ Start New Treatment” .

•If treatments are complete Power OFF the system using the “ Power Off” button on theMain Screen and unplug the system.

•

Carefully remove the device from the patient area.

•

Remove speculum and provide post-op treatment according to appropriate clinicalprotocol.

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Chapter 4: Treatment Procedure

4.14•

Settings
The settings button allows the user to save a report of the treatment parameters to the
USB stick.

Figure 4-25 Settings to save report•

Select the “PDF” button. This saves a report to the USB drive.

4.15 Powering Down the System••

Press the “ Power Off” on the touch screen monitor to go on Stand By Mode.
Unplug the system to power down.

Figure 4-26. Power Down System

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5 Device Settings
5.1•

Using the Device Settings Menu
With the Initialization screen (New Patient Start) displayed, press and hold the Mosaic on
the touch screen.

Figure 5-1. Device Settings Menu

5.1.1 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 accesscard.

5.1.2 Transfer Data to USB•

Select “ Transfer Data to USB” on the Device Settings menu.

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Chapter 5 : Device Settings

Figure 5-2. Device Settings Transfer to USB•

Insert a USB device to a USB port and then select “Copy treatment data to USB” . The
system begins transferring the treatment data and shows a progress bar of the transfer
process as shown in the screen below.

•

Once complete, select “ Return” . The system will return you to the Device Settings menu.

5.1.3 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, Set UV Parameters
screens, Total Energy or Pulse and Continuous.

Figure 5-3. Edit Default Treatment Parameters (Continuous & Pulsed)•

When finished entering treatment parameters, select the green Checkmark.

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Chapter 5: Device Settings

5.1.4 Patient Prescreen Test
The patient prescreen test allows the user to prescreen a patient with an intra-ocular lens (IOL) toensure that the IOL will not interfere with the auto alignment and eye tracking system during afuture PiXL treatment. Prescreening should be performed with a lid speculum in place and room
lighting configured as it would be during a PiXL treatment. Note that no UV light is delivered
during the prescreen. Only diagnostic NIR and pulsed yellow light are used for this process.
•Select Patient Prescreen Test. User will be prompted to insert a USB drive (with at least 6
GB of available space) in the device.

Figure 5-4 Insert flash drive•

The user will then be prompted to enter information regarding the IOL brand, model andpower. This information is optional and is not required to proceed with the screening.

Figure 5-5 Enter IOL Information••

Image Recording Duration allows the user to modify the video recording length (varies
from 90s to 180s with default at 90s).
Once the information is entered and the image recording duration is specified, the user
can select Continue to proceed with the screening.

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Figure 5-6 Alignment Step

•
•
•
•

In the Patient Prescreen Test, the user is prompted to perform the coarse alignment
procedure (similar to section 4.9).
Once coarse alignment is performed, select “Start Auto Alignment” to start the autoalignment.
The device starts auto-alignment as well as image recording.
The Patient Prescreen Test Steps highlights each step as it is being performed.

Figure 5-7 Screening Step Process•••

The user should observe the screen throughout the recording period to confirm that thegreen circle is correctly tracking the pupil during the auto-alignment and image recording
steps.
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 notproceed with the PiXL treatment.

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Figure 5-8 First attempt fail•If auto-alignment succeeds but eye tracking failures are detected by the system during theimage recording period, the prescreen has failed and the user should not proceed with the
PiXL treatment.

Figure 5-9 Failed prescreen assessment due to eye tracking errors

Pass Mode
If auto-alignment passes and no eye tracking failures are detected by the system, the user
is then required to confirm that the green circle correctly tracked the pupil throughout therecording period.

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Chapter 5 : Device Settings
Figure 5-10 Confirm Patient Prescreen Results•

Following a positive confirmation, the prescreen test will indicate that the test has passed
and data will be transferred to the USB drive. Do not remove the USB drive during thisstep.

Figure 5-11 Prescreen test Pass•

If the patient passes the test, this patient can then be treated with PiXL treatment.

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6 Maintenance / Service
By definition, “ maintenance” refers to those non-technical procedures an everyday operator
should perform to keep the system working properly. The word “ service,” by contrast, refers totasks that are intended to be performed only by a qualified service representative.

6.1

Installation Policy•

For each new Mosaic System customer, your Avedro-authorized distributor provides afull initial installation and start-up of the system by trained personnel. Following initialinstallation and once the system is operating properly, the Avedro representative may also
provide basic training to a designated operator about the operation of the Mosaic System.

•

Consequently, this manual does not include any specific instructions relating toinstallation or set-up of the system. Per your service agreement, any further hardware
adjustment, other than what is specified for normal operation, should be performed by, orwith the guidance of, an Avedro-authorized distributor.

6.2
•

6.3
•

6.4
•

6.5
•

6.6
•

Customer MaintenanceIn general, there is no customer maintenance required for The Mosaic 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 thetroubleshooting section below or call your local Avedro Representative.

Warranty Information
A Warranty is supplied separately with the purchasing information.

Per Patient Disposables
Per Patient Disposables can be ordered from Avedro or your Avedro-authorized
distributor. Use only Avedro products or Avedro-approved products with yourM osaic System. Avedro shall not be liable for damage to or malfunction of the system,
which it deems, was caused by the use of unauthorized materials.

Trouble Shooting
The Mosaic System checks its status at start-up automatically. If the status is incorrect,
the software prevents the operator from initiating treatments when the system is in thenormal operating state.

Directions for Sterilization or Disinfection
No components of the Mosaic 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 small amounts of liquid and soft fiberfree wipes.
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Chapter 6 : Maintenance / Service

6.7

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 withdilute bleach, soapy water, or isopropyl alcohol.

•

A 70% isopropyl 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.
CAUTI ON: Remove the power supply cord from the main outlet and turn off the powerswitch prior to any cleaning procedure.
CAUTI ON: Aggressive cleaning agents, especially those containing abrasives oraggressive solvents can damage component surfaces.

•

The glass window of the beam aperture must not under any circumstances be in contact
with any of the aforementioned substances.

•

While cleaning the surfaces of the device, ensure that cleaning fluids do not seep insidethe device, as this leakage can damage the device.

6.8

Cleaning the Aperture•

Check the beam aperture routinely prior to treatment.

•

Use special camera lens wipes or compressed air to remove dust and particles from theglass surface of the aperture.

6.9

Articulating Arm Adjustment
If the articulating arm does not hold the Optical Head in a fix vertical position contact yourlocal Avedro service representative.

6.10

6.11

Performing Periodic MaintenanceI nterval

Specific Task

AnnualCalibration check by Avedro trained personnel.

Moving the System•

The Mosaic is designed as a movable system within an office environment.

•

When moving the system, ensure that the articulating arm and the head are retracted close
to the monitor as shown in the image below for safe motion from one place to another.

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Chapter 6: Maintenance / Service

Figure 6-1 Moving Position of the Mosaic System•

6.12

If it ever proves necessary to transport or ship the Mosaic System, for any reason, contact
your local Avedro representative. Packing and transporting the system should be
performed only by Avedro trained and authorized personnel.

Storing the System•

Follow all the storage temperature and humidity range specifications as listed in theSpecifications Chapter 9 and allow system to re-equilibrate to normal operating
temperatures and humidity ranges prior to re-starting system.

•

Close all panels on the system to prevent dust and moisture from entering; this ismandatory.

•

Turn OFF all the components and the main power supply as well. Disconnect the power
cord physically from its electrical outlet.

•

Cover the touch screen LCD display and keyboard with its original cover or packaging toprevent any damage.

•

Do not disassemble any part of the system as this could cause misalignment or damage.

6.13 Software•

Should the software become corrupt and fail to work correctly at some point, call yourlocal Avedro service representative. Software updates will only be carried out by Avedro
trained service representatives.

•

Should one of the following software errors occur, call your local Avedro service
representative with the error codes:

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6.14 Identifying Risks Associated with
Disposing of Waste Products•

When disposing of waste products, residues and Mosaic System and accessories, follow
all applicable local regulations or contact an Avedro authorized distributor.

6.15 Performing a Visual Check•

Check all components of the device routinely for damage or malfunction prior to eachtreatment.

•

Do not use a damaged or malfunctioning device. Use of such devices may harm the user
and/or patient.

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7 Equipment Classification
According to I EC60601-1:2005+A1:2012 M edical Device Electrical StandardoProtection against electrical shockoDegree of protection against electric shockoDisinfectable device

Degree of protection for use in the presence of a flammable such as aesthetic mixtureoCommon Devices IP20 (No protection against ingress of water)

Method of sterilization or disinfectiono

Not classified, equipment not provided with applied part

Degree of protection against ingress of wateroClass 1 (external electrical power source)

No protection

Use conditions
Continuous service

According to FCC Part 15, I EC55011 and I EC60601-1-2oClass B

According to I EC62471:2006 Photobiological safety of lamps and lamp systemso

UV LED is Risk Group 2

According to Annex I I .3 of Directive 93/42/EECoClass IIa

According to IEC 60825-1 Ed. 2.0 2007-03 Safety of laser productsoAlignment lasers are Class 1 Laser ProductAccording to IEC 60825-1 Ed. 3.0 2014-05 Safety of laser productso Alignment lasers are Class 1 Laser Product
Conforms to the following standards:ooooIEC 60601-1:2005+A1:2012
ANSI/AAMI ES 606061-1:2005+A1:2012
CSA C22.2 No 60601-1:14
IEC 62471:2006

EMC Requirements
The Mosaic System requires special precautions regarding electromagnetic compatibility(EMC). Installation and use should be carried out according to the EMC information provided inthis manual. Portable and mobile RF communications equipment may affect the Mosaic
System.
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Chapter 7 : Equipment Classification

The Mosaic System has been qualified for use with the following cables and accessories. Use of cables,
and accessories other than those listed may result in increased emissions or decreased immunity of the
Mosaic System.
CablesAccessories

None

USB 2.0 compliant flash drive

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
RF emissions

ComplianceGroup 1The Mosaic System uses RF energy only for its internalfunction. Therefore, its RF emissions are very low andare not likely to cause any interference in nearby
electronic equipment.

Class B

The Mosaic System is suitable for use in all
establishments including domestic establishments andthose directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.

CISPR 11
RF emissions
CISPR 11
Harmonic emissions

Electromagnetic environment — guidanceClass AIEC 61000-3-2
Voltage fluctuations/
flicker emissions

Complies

IEC 61000-3-3

The Mosaic System should not be used adjacent to, or stacked on top of other equipment. If
the Mosaic System must be used adjacent to or stacked on top of other equipment, verify that
the Mosaic System operates in an acceptable manner in the configuration in which it will beused.

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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 anenvironment.
Immunity test

IEC 60601
test level

Compliance
level

Electromagnetic environment- guidanceElectrostatic
discharge (ESD)
IEC 61000-4-2±6 kV contact±8 kV air

±6 kV contact±8 kV airElectrical fasttransient/burst
IEC 61000-4-4±2 kV for power
supply lines±1 kV for
input/output lines±2 kV for power
supply linesSurge
IEC 61000-4-5±1 kV line(s) toline(s)±2 kV line(s) toearth±1 kV line(s) toline(s)±2 kV line(s) toearth

Mains power quality should bethat of a typical commercial or
hospital environment.

Voltage dips, shortinterruptions andvoltage variations
on power supply
input lines
IEC 61000-4-11<5 % UT(>95 % dip in UT)
for 0,5 cycle
40% UT(60% dip in UT)
for 5 cycles
70% UT(30% dip in UT)
for 25 cycles<5% UT(>95 % dip in UT)
for 5 sec

<5 % UT(>95 % dip in UT)
for 0,5 cycle
40% UT(60% dip in UT)
for 5 cycles
70% UT(30% dip in UT)
for 25 cycles<5% UT(>95 % dip in UT)
for 5 sec

Mains power quality should bethat of a typical commercial or
hospital environment, If theuser of the Mosaic System
requires continued operation
during power mains
interruptions, it isrecommended that the Mosaic
System be powered from anuninterruptible power supply ora battery.

3 A/mPower frequency magnetic
fields should be at levels
characteristic of a typicallocation in a typical commercial
or hospital environment.

Not Applicable
Input /Output
Lines

Power frequency(50/60 Hz)
magnetic field
IEC 61000-4-8

3 A/m

Floors should be wood,concrete or ceramic tile. If
floors are covered withsynthetic material, the relative
humidity should be at least
30%.

Mains power quality should bethat of a typical commercial or
hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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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 ofthe Mosaic System should assure that it is used in such an environment.

Immunity test

IEC 60601 testlevel

Compliance
level

Electromagnetic environment — guidancePortable and mobile RF communications equipment
should be used no closer to any part of the Mosaic
System, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance

Conducted RF
IEC61000-4-6

3 Vrms150 kHz to 80 MHz

3 Vrmsd = 1,2 P

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to 2,5 GHz

3 V/m

d = 1,2 P 80 MHz to 800 MHz
d = 2,3 P 80 MHz to 2,5 GHz
where P is the maximum output power rating of thetransmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as determinedaby an electromagnetic site survey, should be less thanbthe compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength in the location in which the Mosaic System is used exceeds the applicable RFcompliance level above, the Mosaic System should be observed to verify normal operation. If abnormal performance is observed, additional measures may benecessary, such as re-orienting or relocating the Mosaic System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RFcommunications equipment and the Mosaic System

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Chapter 7: Equipment Classification

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 maintaining a minimum distance between portable and mobile RFcommunications equipment (transmitters) and the Mosaic System as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter m

Rated maximum
output power oftransmitter (W)150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

d = 1,2 P

d = 1,2 P

d = 2,3 P

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance din metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects and people.

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 withCISPR emission requirements.
Mosaic System Operator’s Manual,
ML-00023 Rev B
7-5

Chapter 7 : Equipment Classification

The Mosaic System contains the following RF transmitters:
RFID Reader••••

13.56MHz Reader/Writer
Integral Antenna: Maximum 4” Read Range
Max output power is 200mW
Meets: ISO18000-3, ISO15693
WiFi Adapter

Frequency Modulation

5 GHz (802.11a/n)

2.4 GHz (802.11b/g/n)

Frequency band

5.15 GHz - 5.85 GHz

2.400 - 2.4835 GHz(dependent on country)(dependent on country)

BPSK, QPSK, 16 QAM, 64

CCK, DQPSK, DBPSK

Modulation

QAM
Wireless Medium

Channels

5 GHz UNII: Orthogonal

2.4 GHz ISM: Orthogonal

Frequency Division

Frequency Division

Multiplexing (OFDM)

Multiplexing (OFDM)

4 to 12 (dependent on

Channel 1-11 (US only)

country)

Channel 1-13 (Japan,
Europe)Max Output Power< 100mW

Mosaic System Operator’s Manual,
ML-00023 Rev B
7-6<100mW

8 Symbol Library
Text Symbol

Symbol I llustration

Definition

1. No AP symbol in presence offlammable anesthetics

Danger, Risk of Explosion. Not foruse

2. AC symbol

Alternating current

3. “ I” in a bookAttention: Consult
ACCOMPANYING
DOCUMENTS

4. Ground symbol in circle

Protected earth (ground)

5. Ingress Protection Symbol

IP20

Ingress Protection solids under
12.5 mm and no protection against
water)

6. CE Mark

Conformity mark7. Manufacturer

Name and address of the
manufacturer

8. Date of Manufacture

Date manufactured

9. ! in a yellow triangle

Caution specific warning inoperators manual

10. Net Weight (kgs)
Gross Weight (kgs)

NW
GW

Net Weight
Gross Weight

11. Umbrella with raindrops

Keep Dry: Store protected frommoisture (symbol is with orwithout rain drops)

12. Wine glass with crack on itContents are fragile, handle withcareor
13. Two up arrows

Keep arrows on carton pointing up

Mosaic System Operator’s Manual,
ML-00023 Rev B
8-1

Chapter 8: Symbol Library

Text Symbol

Symbol I llustration

Definition

14. Percent sign on sea level

Humidity limits (percentages
below symbol are the acceptable
range for humidity)

15. Temperature limits

Temperature shipment limits

16. Reference Number

System reference number

17. Serial Number

System serial number

18. EC RP

European Authorized
Representative

19. Do not Push

Do no push unless in the rightmoving configuration

20. Do not Sit On

Do not Sit on Optical Head

21. Do not Step On

Do not Step on Optical Head

22. Atmospheric Pressure limits

Operate within atmosphericpressure limits shown on system

23. Stand By

System in Stand By Mode

24. Signal emitted

RF transmitted through device

Mosaic System Operator’s Manual,
ML-00023 Rev B
8-2

9 Specifications
Specification
Electrical

Description
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 – 100 mW/cm2
365 nmExternal I nterfaces
USB 2.0
Physical Dimensions
62 x 62 x 140 cm3 (Length x Width x Height)
WeightEnvironmental Operating Conditions
Ambient temperature
Relative humidity
Atmospheric pressure
Transport and Storage Conditions
Ambient temperature
Relative humidity
Atmospheric pressure

NW 124 Kg
GW 171 Kg
The system operates under the following
atmospheric conditions (no condensation).
+15 to +30ºC
20% to 80%, non-condensing
810 to 1050 mbar
The instrument withstands the following
transport and storage conditions without
damage or performance deterioration.
-15 to +60 ºC
10% to 80%, non-condensing
750 to 1060 mbar

Mosaic System Operator’s Manual,
ML-00023 Rev B
9-1

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