GALILEI G6 Operator Manual

Operator manual Operator manual

CONTENTS 1

2

3

4

5

6

7

GENERAL

3

1.1 About this manual

3

1.2 How to use this manual

3

1.3 Maintenance & customer service information

4

1.4 Supporting manuals

5

1.5 Explanation of symbols

5

1.6 Terms and abbreviations

6

1.7 Safety instructions

7

1.8 Warnings

8

GENERAL SYSTEM DESCRIPTION

9

2.1 Indications for use

9

2.2 System description

9

2.3 System components

9

2.4 Graphical user interface and workflow

10

MAINTENANCE AND CLEANING

12

3.1 Measurement verification

12

3.2 Cleaning

12

GETTING STARTED

13

4.1 Connect to power and turn on the device

13

4.2 Login

13

4.3 Initial screen

13

DATABASE

15

5.1 Enter a new patient

15

5.2 Starting a measurement

16

5.3 Creating and using a worklist

16

5.4 Search for a patient

16

5.5 Edit an existing patient

16

5.6 Avoiding patient mix-up

16

TAKING A MEASUREMENT

17

6.1 Preparations

17

6.2 Using the joystick

17

6.3 The scan process

18

QUALITY CHECK

19

7.1 Automatic quality check

19

7.2 Visual quality check

20

7.3 Peak detection

21

© 2013 Ziemer Ophthalmic Systems AG

Doc. No. 3912-200-0002-03

1

CONTENTS 1

2

3

4

5

6

7

GENERAL

3

1.1 About this manual

3

1.2 How to use this manual

3

1.3 Maintenance & customer service information

4

1.4 Supporting manuals

5

1.5 Explanation of symbols

5

1.6 Terms and abbreviations

6

1.7 Safety instructions

7

1.8 Warnings

8

GENERAL SYSTEM DESCRIPTION

9

2.1 Indications for use

9

2.2 System description

9

2.3 System components

9

2.4 Graphical user interface and workflow

10

MAINTENANCE AND CLEANING

12

3.1 Measurement verification

12

3.2 Cleaning

12

GETTING STARTED

13

4.1 Connect to power and turn on the device

13

4.2 Login

13

4.3 Initial screen

13

DATABASE

15

5.1 Enter a new patient

15

5.2 Starting a measurement

16

5.3 Creating and using a worklist

16

5.4 Search for a patient

16

5.5 Edit an existing patient

16

5.6 Avoiding patient mix-up

16

TAKING A MEASUREMENT

17

6.1 Preparations

17

6.2 Using the joystick

17

6.3 The scan process

18

QUALITY CHECK

19

7.1 Automatic quality check

19

7.2 Visual quality check

20

7.3 Peak detection

21


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8

9

IOL REPORT

22

8.1 Step 1 (a), Target refraction

22

8.2 Step 1 (b), Phakic or aphakic eye

23

8.3 Step 1 (c), Verify parameters

23

8.4 Step 2 (a), Select IOL type

24

8.5 Step 2 (b), Select IOL formula

24

8.6 Step 3, Computed IOL power and refraction

24

8.7 Printing the IOL report

25

THE BIOMETRY REPORT

26

10 THE ADVANCED IOL REPORT

28

11 THE IOL EDITOR

29

11.1 Managing the IOL database

29

11.2 Importing IOL data into the database

31

12 TECHNICAL SPECIFICATIONS

32

12.1 Device label

32

12.2 Technical data

33

12.3 IOL power calculation formulas; literature references

34

12.4 Precision and Agreement

34

2

© 2013 Ziemer Ophthalmi Ophthalmicc Systems AG

Doc. No. 3912-200-0002-03

1

General

Thank you for your decision to purchase this Ziemer product. Please read through the instructions in this manual carefully to have best reliable and trouble-free usage of the product.

1.1

About this manual

This manual describes the functioning and the operation of the GALILEI G6 and its software, as well as the basics for the interpretation of analytical results generated with it. Title

GALILEI G6 Lens Professional™ - Operator Manual

Part number

REF 410.951.005

Document number

CM3912-200-0002

Revision

Version 3

Release date

November 2013

Product

GALILEI G6 Lens Professional

Authors

AKO/GSC/AWI

Disclaimer

Please note that while every effort has been made to ensure that the data provided in this document is accurate, it is the policy of Ziemer *) to continuously improve the operating performance and overall quality of its medical devices. Accordingly, the information, figures, illustrations, tables, specifications and schematics herein are subject to change without notice.

Copyright Notice

© 2013 ZIEMER OPHTHALMIC SYSTEMS AG *) This manual contains proprietary information. All rights are reserved. This document may not in whole or in part be copied, photocopied, reproduced, translated or reduced to any electronic medium or machine readable form without prior consent in writing from Surgical Instrument Systems AG.

Trademarks

GALILEI™ is a trademark of Ziemer Group *). Other trademark names are used in an editorial fashion only with no intention of infringement of the trademark of the respective owner.

Manufacturer

SIS LTD., SURGICAL INSTRUMENT SYSTEMS *), a Ziemer Group Company.

Licensee and distributor

ZIEMER OPHTHALMIC SYSTEMS AG *), a Ziemer Group Company *) Allmendstrasse 11, CH-2562 Port, Switzerland www.ziemergroup.com

*) Note: Throughout this manual, Ziemer Group and its subsidiaries, namely SIS Surgical Instrument Systems Ltd. and Ziemer Ophthalmic Systems AG, will be collectively referred to as “Ziemer”.

1.2

How to use this manual

This operator manual provides important information regarding the use and maintenance of the GALILEI G6 Lens Professional system. The system will be referred to in this document as “ GALILEI G6”.


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Physicians and staff using the GALILEI G6 should read the manual thoroughly prior to operating the device. The operator manual serves only to provide the doctor, surgeon and medical assistants with general operating instructions and areas where special attention is required to avoid instrument damage or patient injury. This manual is about using the GALILEI G6; it does NOT provide instructions or recommendations on the diagnosis based on results generated by the device; it does NOT make a diagnosis. References and information concerning any measurement procedure found in this manual are intended to serve as recommendations or guidelines only. The attending physician and/or surgeon must decide, based on the patients’ individual situation, which surgical techniques and medical procedures are to be followed, based on interpretation of measurement results. The manufacturer or its representatives cannot be held responsible or liable for the techniques chosen and used during any surgery or medical treatment. This manual is only applicable for GALILEI G6 software version #1.0 or higher.

1.3

Maintenance & customer service information

No part of the GALILEI G6 may be serviced by users. All service must be carried out by a Ziemer customer service specialist or an authorized service center. Do not implement any modifications on the GALILEI yourself. Only spare parts or components and accessories obtained from Ziemer may be used with the GALILEI G6 . Use of any non-Ziemer parts will void all warranties. For service assistance and to order accessories or replacement parts, contact the Ziemer customer service department. For each instrument, an individual service contract will be signed between Ziemer or its distributor and the customer, detailing the conditions of response. As your first point of contact for support we strongly recommend to always contact the distributor from whom you purchased your instrument. The list of distributors can be found at http://www.ziemergroup.ch/product/GALILEI. Please direct all inquiries and correspondence regarding support to:

Ziemer Ophthalmic Systems AG Allmendstrasse 11 4

CH-2562 Port / Switzerland Phone: E-mail:

+41 (0)848 943 637 (Europe and anywhere around the world) 866-708-4472 (USA and Canada) support(at)ziemergroup.com

Website: www.ziemergroup.com

Maintenance and product life: The GALILEI G6 is a solid state biometry device. It needs essentially no maintenance or adjustments by the user. The GALILEI G6 system does not have a specified life time. Each unit is installed and set up by a trained technician at the operating site (e.g., doctor's office) according to an installation and service manual. After every year of operation or 10’000 procedures (whichever comes first), the device prompts the operator to arrange for a maintenance service. Upon successful maintenance and testing, the service technician can release the unit for another cycle. The maintenance service includes a verification of the calibration with an artificial standard target. Maintenance service must be provided by a specially trained Ziemer representative.


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1.4

Supporting manuals

The following documents are to be used in conjunction with this manual:

Part number

Document number

Galilei G6 Setup and Installation Guide

-

3941-0151

GALILEI G4 Operator Manual

410.951.003

3941-0081

Service Manual

-

3941-0160

1.5

Explanation of symbols

On product labeling and in manuals, certain icons are used. Their meaning is explained below: Table 1 Explanation of symbols

Symbol

Name and significance Electrical shock; Type B applied part Waste electronic or medical equipment. According to EU directive 2002/96EC, disposal to municipal waste is prohibited. Item must be returned to the distributor or manufacturer for disposal Attention symbol. Consult accompanying document, e.g. Operator Manual or Directions for Use (DFU) before operating the device. Manufacturer's part no. / order no.

Caution: The caution symbol indicates an action or procedure which, if not performed correctly, can result in incorrect operation or destruction of the device. Comply strictly with the instructions. Note: This symbol indicates an action or procedure which, if not performed correctly, can have an indirect effect on operation or trigger an unexpected response on the part of the instrument (The word ‘Note’ may be replaced by another meaningful title). Warning: A warning indicates an action or procedure which, if not performed correctly, can result in injury or a safety hazard. Comply strictly with the instructions and proceed with care. Hints for helping the user to work more efficiently or to display data more clearly are marked with the green “HINT” arrow.


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1.6

Terms and abbreviations

Table 2 Terms and abbreviations

6

Abbreviation

Meaning

ACD

Anterior Chamber Depth

AL

Axial Length

AQD

Aqueous Depth (= ACD – CCT)

Astig

Astigmatism

CLMI

Cone Location Magnitude Index

CCT

Central Corneal Thickness

EBR accessory

Technical designation of the Low Coherence Interferometry Module

G4

Current version of the GALILEI Dual Scheimpflug Analyzer (without EBR accessory module)

G6

Current version of the GALILEI G6 Lens Professional (includes Dual Scheimpflug Camera, Placido Topographer, and EBR accessory module)

GUI

Graphical User Interface

LT

Lens Thickness

n

Index of refraction

R

Average Corneal Radius

R1 / R2

Corneal Radius along the steepest / flattest meridian

SimK (flat/steep)

Simulated Keratometry (central anterior power, axial curvature) along the flattest / steepest meridian

SNR

signal/noise ratio (in dB)

TCP

Total Corneal Power

WTW (N-T)

White-to-white distance (nasal – temporal)


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1.7

Safety instructions

To assure safe operation, it is imperative that the instrument is used according to the instructions in this manual. Therefore, you should be thoroughly familiar with the content of the instruction manual before operating the system. Only operate the instrument with the original components supplied by Ziemer and when the instrument is in good working condition. Should the instrument be defective, do not operate it, and contact the supplier immediately. Before maintenance and cleaning of the instrument, always carefully disconnect the power cord from the wall socket to the GALILEI. Also disconnect all peripheral equipment attached to the GALILEI, for example, a printer. When connecting the power cable, ensure that the power cord cable plug pins match the socket. When connecting the power cable, ensure that the pins and socket match. If there is any resistance and it is impossible to make a connection, then check to see whether the power cable plug pins should fit into the socket. If you have any questions, contact your authorized dealer or our service department. When disconnecting the electrical power cords, always grasp the outside of the plug end to disconnect and avoid pulling directly on the cables. Supplementary equipment (e.g. printers) which is connected to the analog or digital interfaces of the instrument must comply with pertinent EN / IEC specifications. All configurations must conform consistently to standard IEC 60601-1: 2005. Do not operate the GALILEI - in areas with risk of explosion, - in areas with risk of standing water, or - in the presence of flammable liquids including anesthetics or volatile solvents. Do not use or store the instrument in a damp room. Avoid placing the instrument in the vicinity of dripping, running or spraying water and ensure that no moisture can penetrate the instrument. For this reason, do not place any containers filled with fluids near the instrument. When cleaning the instrument, use a lightly damp cloth, be sure to dampen the cloth directly and wipe the device so that no excess moisture enters it. Do not cover any computer ventilation holes in the measurement head and computer housing. Do not simultaneously touch the patient and any electrical contacts on the PC housing. The motor for lowering and raising the table has a 1/10 intermittent duty cycle (operating time 1 min, cooling time 9 min). It is not intended for continuous operation. When moving the table up or down, make sure that operator and patient are clear of the column due to crushing hazard. This instrument is a high-quality technical product containing sophisticated optics. In order to assure accurate results, faultless and safe operation, service inspections must be performed according to the service plan of Ziemer Ophthalmic Systems AG. Ocular examinations with the device should not be unnecessarily prolonged to avoid risks associated with prolonged intense light exposure that could affect the retina. While no acute optical radiation hazards have been identified for slit lamps, it is recommended that the amount of light directed into the patient’s eye be limited to the minimum level which is necessary for diagnosis. Infants, aphakes (subjects without an intraocular lens) and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been subject to retinal photography.


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1.8

Warnings WARNING: During a measurement with the GALILEI G6, the eye of the patient is exposed to various light sources emitted from the device. Maximum irradiation values to the eye as defined in Standard EN-ISO 15004-2 must not be exceeded to ensure eye safety. Irradiation, as determined by measuring and normalizing the intensities of the various continuous-wave and pulsed light sources in use during a GALILEI G6 measurement, are below maximum permissible levels described in Standard EN-ISO 15004-2, both when evaluating irradiations from the light sources separately, and when evaluated in combination. Considering that the total, daily light energy delivered to the eye must be limited to 10 J/cm2 (EN-ISO 15004-2), no more than 6 measurements should be performed per eye and per day with the GALILEI G6 . The GALILEI G6 belongs to Laser Class I under IEC Standard 15004-2, and all functionalities and instructions are compliant with 15004-2. The limit values of the Optical Coherence beam as specified for Class I laser devices to EN 60825-1 will be observed if the device is operated as intended.

IMPORTANT: Please make sure that only trained personal is taking the measurement with the device. Avoid taking a measurement without training and make sure that all relevant safety instructions and instructions on how to use the device have been read carefully and understood clearly. WARNING: If the following message appears, do not proceed with the measurement with this patient in no case “The maximum permissible light energy to this eye within 24h is exceeded. Cancel the measurement and continue on another day”.

8

PRECAUTION: The accuracy and precision of the outputs of this device have only been evaluated in patients with no cataracts or cataracts of mild severity (grades 1 – 2). The results for axial length and lens thickness measurements in patients with moderate to severe severity of cataract (if obtainable) are of unknown accuracy and precision. Results from such measurements should be interpreted with caution.


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General system description

2.1

Indications for use

The GALILEI G6 Lens Professional is intended to be used for measuring the positions relative to the anterior cornea, of the •

posterior cornea, the anterior lens surface

•

the posterior lens surface

•

the retina

and to calculate and analyze

2.2

•

anterior chamber depth (anterior cornea to anterior lens; ACD)

•

aqueous depth (posterior cornea to anterior lens; AQD)

•

lens thickness (anterior lens to posterior lens; LT)

•

axial length (anterior cornea to retina; AL)

•

appropriate IOL powers based on a menu of IOL types and equations

System description

Ziemer’s GALILEI G6 Lens Professional™ is a medical instrument exclusively designed for use in ophthalmic diagnosis. It includes the GALILEI EBR Accessory, which is an add-on low-coherence interferometry module to the existing GALILEI G4 Dual Scheimpflug Analyzer. In addition to the values described in the indications for use, the GALILEI G6 Lens Professional measures all data provided by the Dual Scheimpflug and Placido System, known as GALILEI G4. The GALILEI G6 Lens Professional is a combination of the GALILEI G4 and the GALILEI EBR Accessory. The GALILEI G6 Lens Professional is classified as a class II medical device in the EU and USA.

2.3

9

System components

The GALILEI G6 Lens Professional is an integrated biometry device based on the Optical Coherence Technology which is used commonly to calculate and select IOLs for cataract surgery. The GALILEI G6 can measure axial length, the anterior and posterior positions of the crystalline lens, and calculate and select the appropriate IOL power and type from several IOL manufacturers. The GALILEI G6 also includes the combined Placido and Dual Scheimpflug Camera System as known from the GALILEI G4. This system is used for topographic as well as anterior segment measurement of an eye. For further information, please refer to the operator manual of the GALILEI G4. The GALIILEI G6 Lens Professional comes with two monitors, one small device display for adjustments to take a measurement and the large monitor on the table. Please follow the instructions on the small monitor for taking a measurement. However, there will be some functions that can be chosen on the smaller device monitor. The mouse cursor can be moved from the small device monitor to the large monitor by a simple movement to the left and right.


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Fig. 1 GALILEI G6 system, viewed from operator side

Make sure the GALIILEI G6 Lens Professional is set up firmly (with brakes activated) in a horizontal position and used in an environment that corresponds to the specifications of temperature and humidity. Avoid exposure to direct sun light and dust or dirt.

2.4

Graphical user interface and workflow

Operating the GALILEI G6 is supported by an intuitive and easy-to-understand graphical user interface (GUI). A workflow bar appears always on top of the device monitor to show you which step you are currently undertaking (red arrow) and how many further steps need to be followed (gray arrows). A description of the current step (in red letters) and of the next step (in grey letters) are displayed next to the arrow symbols.

Workflow step 1; work list entry selection:

10

Workflow step 2; anterior segment scan:

Workflow step 3; retina scan:

Workflow step 4; quality check:

Workflow step 5; report generation and filing:


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While operating, you can always use the right-arrow button to proceed to the next step in the workflow. You can always use the home button (on either monitor) to move back to the initial display. You can always use the abort button (on either monitor) to abort an ongoing measurement. The gray bars on the bottom of the screen will indicate available next steps or general supporting information. Mouseover messages (red bars), such as the example shown on the left, can be found on any button or action field throughout the entire workflow of the system. Whenever you need information or help, move your mouse to hover over the respective symbol or field, and a message will appear automatically.

Please read this entire operator manual carefully before taking the first measurement!

11


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3 3.1

Maintenance and cleaning Measurement verification IMPORTANT : The GALILEI G6 Lens Professional requires yearly preventive maintenance. For further information, refer to the instructions in section 1.3.

WARNING: Different to other systems, the GALILEI G6 Lens Professional will not block automatically when verification has not been done. Please notice that proper verification of the system is needed for best measurement results. If verification is not done according to the instructions, this may have a negative impact on the parameters measured with this device and result in incorrect output. Please always comply strictly with the verification instructions.

3.2

Cleaning

To assure patient safety and avoid any transmission of germs, please always swipe the head- and chinrest with a tissue soaked in alcohol after each patient that has been measured. Please always remove the used paper at the chin-rest after every patient. When the Placido-disk is dirty, swipe carefully with lint-free tissue dampened within alcohol.

12


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4

Getting started

4.1

Connect to power and turn on the device

Make sure the power cord is plugged in and connected correctly to the device. Turn the power switch on the left side of the PC to “On”. The system will start up and lead to the initial screen.

4.2

Login

No Login is required. The GALILEI G6 software starts automatically and the initial screen is displayed (see section 4.3.). If you choose to work with the G4 software and functionalities, exit the software and start the G4 software by clicking Start  GALILEI G4.

The initial screen (home screen) after starting the device will allow you to choose between the main functionalities “Measure” and “Analyze”. A further routine that can be accessed from the initial screen provides for editing the G6’s internal IOL database.

13

Fig. 2 Initial screen (main monitor). Mouseover messages (red bars) are only displayed while hovering over one of the buttons.

Measure To measure, i.e. to record a scan, click on the “Measure” button. This will take you to the database screen (section 5, page 15), where you can select a patient or create a new one.

Analyze To analyze existing measurements and patient data, click on the “Analyze” button. The patient list with all recorded scans will be presented to select the desired data set (see section 8, page 22).


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Fig. 3 Selecting a patient

In the column on the left, you can choose the desired patient either by typing part of the name into the searching field (on top) or by scrolling through the entire patient list using the scroll bar.

Next step: To select a patient, click on the patient’s name and the system will display all data sets (previously recorded measurements) available for this patient below his/her name. Click on a data set and the corresponding data will appear on the right side of the screen, as shown in the picture above. 14


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5

Database

If you have chosen to take a measurement on the initial screen, a window with the patient database will appear to start taking a measurement.

5.1

Enter a new patient

Taking a measurement with a new patient starts by entering the patient data into the patient database. You are now in Workflow step #1, Work list entry selection:

Fig. 4 Workflow step #1 (device monitor)

15

Fig. 5 Workflow step #1 (main monitor)

button to create a new patient record. Enter the following patient-related Next step: click on the information in the patient entry fields: −

Clinic ID (the patient’s ID code used in your clinic)

−

Last name / first name

−

Date of birth (mm/dd/yy)

−

Gender (click on the corresponding symbol)

Any text entered into the “Notes” field will be permanently associated with the patient record. After the data has been entered, click on the button to save all data. The patient then appears in the list on the left side of the display.


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5.2

Starting a measurement

After a patient record has been created, the patient appears on the main monitor. A measurement can now be started either by double-clicking on the patient entry or by clicking on the scan symbol on the left hand side of the patient entry.

5.3

Creating and using a worklist

By clicking on the arrow on the left hand side of the patient entry, the patient will appear in a worklist on the device monitor. This way, a list of patients for an entire session, can be created. From this “worklist” the next patient can be selected and measured directly on the small device monitor without having to search for the patient in the initial database each time.

5.4

Search for a patient

You can always search for a patient in the database by typing the first or last name in the search field. The GALILEI G6 uses an intelligent search algorithm. By typing only the first 3 letters of the patient’s name, it will find all possible combinations and come to a result very fast.

5.5

Edit an existing patient

You can always add, change or delete data from existing patients in your database by clicking onto the symbol for editing.

Next Step: After you have chosen your patient or entered a new patient, click onto the leftarrow button next to the patient’s name. The patient’s record will appear on the device monitor. Proceed to the next workflow step, Measurement of anterior segment, by clicking on the “Scan” button on either screen. 16

5.6

Avoiding patient mix-up

Acquired data is automatically saved under the name of the patient who is being measured. Data from subsequent measurement sessions on the same patient will be added to previous data (patient file), but with the new time and date information. When a new patient file is created for a patient with an already existing patient file, a warning message will appear. If both the right (OD) and the left eye (OS) are scanned within the same session, both measurements will be stored into the same data set. This will ensure that paired data sets will always stay together and that a comparison of right and left eye data will always be performed on scans that were recorded at the same time / date.


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6 6.1

Taking a measurement Preparations

You are now prepared to take a measurement. Ask the patient to firmly place the head on the chin rest while slightly touching the head bar at the top with the forehead. The chin rest has three positions, allowing to rotate the patient’s head slightly to the right or left, in order to minimize nose shadow in the Placido image. It is recommended to rotate the chin rest to the lefthand position (relative to patient’s direction of view) when measuring the patient’s right eye, and vice versa. Upon moving the measurement head in front of either patient eye using the joystick, you will see the image shown below on the device monitor. “OD” or “OS” will be shown depending which eye the head is centered on. You are now in Workflow step #2, Measurement of anterior segment. Enter patient’s spectacle refraction by clicking in the field “Eye Refraction” and select the current entry (initially, “0.00 D” will appear). Set the desired value using the mouse wheel, or by typing. By setting the correct refraction, the patient will see the fixation target properly focused. Instruct the patient to fixate on the target. Enter any remarks to the current measurement session into the field showing the default entry “(exam label)”.

6.2

Fig. 6 Setting patient’s spectacle refraction

17

Using the joystick 1: Observe the bottom image and align the horizontal red line as a tangent to the cornea, by moving the joystick forward and backward. The line should not intersect the cornea, but just touch it.

2

2: Observe the top image and align the red crosshair lines with the four dots, vertically (joystick rotation) and horizontally (joystick back/forth adjustments). 3: Bring the rings in the top image into focus by making small forward / back adjustments with the joystick.

1

4: Ask the patient to blink, then to open his / her eyes wide and to keep head and eyes motionless until told to relax. 5: Activate the scan by clicking on the button of the joystick.


Fig. 7 Workflow step #2, Anterior Segment scan: Focusing

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6.3

The scan process

The progress of the anterior segment scan ( workflow step # 2 ) and of the retina scan ( workflow step # 3) will be indicated by an on-screen progress clock. When the scans are completed, the clock will turn green and the message “patient may relax” will appear.

To initiate the retina scan, repeat the alignment process and press the scan button (joystick) again. 18

Next step: The acquired data will be processed and checked for quality. The results of the quality check will be displayed on the device monitor.

Fig. 8 Workflow steps #2 & 3; scanning anterior segment and retina


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7 7.1

Quality check Automatic quality check

After the measurement has been completed, the following display will appear on the device screen for quality check. You are now in Workflow step #4, Quality Check. If the scan data meet internal quality requirements, topographic and keratometric parameters as well as Anterior Segment distances and Retina position will be computed. Green “traffic lights” will indicate if the quality of the measurement results is adequate for IOL calculation.

Fig. 9 Workflow step #4; Quality Check. Left: all quality checks OK; right: some data missing or out of range.

If one or several traffic lights will be shown yellow, IOL calculation and other analysis may still be performed but the quality of the results will be questionable. Click on the “More: ” button (at bottom right) to review the scan data (see Fig. 10).

Navigation in quality check By pressing the joystick button, you can proceed directly to scanning the other eye. Clicking the joystick button after the second eye has been measured will take you back to the worklist to measure the next patient. In the quality check screen, several navigation buttons are available (top right of the screen):

Plus button: save and take another measurement. Proceed to other eye: restart at Workflow step 2 to scan the other eye. Save and show IOL report: the system will automatically calculate all values to determine the IOL and will display the IOL report screen (section 8).


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19

7.2

Visual quality check

Quality of scan data It is strongly recommended to perform a visual quality check of the optical A-scan. For a visual check of the quality of the recorded data inspect the anterior part (left) and the posterior part (right) of the optical biometry curve. Ensure that the leftmost group of peaks within the anterior segment portion representing the corneal reflections was detected, as indicated by a grey box marking their left and right edges. In eyes with strong cataract, the retina and / or the posterior lens surface may not be detected.

Fig. 10 Quality check: the averaged (“Anterior Segment”; left) and (“Retina”; right) parts of the optical biometry curve are displayed on the device monitor

Make a left click into the curve window and drag the mouse cursor to the right to zoom in, or drag it to the left to zoom out. 20

Number of scans taken For a measurement, three scans of the anterior segment and retina, respectively, are averaged and intraocular distances (peak locations) are determined in the averaged scan. If the software detects that an individual scan is not valid, for example because of blinks, closed eyes, eye movements, or poor fixation, up to three additional scans are immediately and automatically taken to replace the invalid scan(s). A minimum of three scans (typical case) and a maximum of six scans each are taken of the anterior segment and the retina.


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Quality of recorded images The quality of the recorded images may be affected by improper alignment of the patient eye, or by patient movements or closing the eye during the scanning process. For verification, navigate to “Save and show” (click on the button); then click on the “images” button ( ) on the main monitor. Inspection of the recorded images will reveal any irregularities in image quality.

Fig. 11 Main monitor: Top View, Placido, and Scheimpflug images used for computing anterior chamber and cornea metrics

7.3

21

Peak detection

By zooming in on the various peak areas shown in the biometry report (from left to right: cornea, lens, and retina), details can be revealed, i.e. main peaks and secondary peaks. Peak locations corresponding to reflections from the anterior and posterior surfaces of the cornea and crystalline lens, as well as from the posterior surface of the retina, are detected objectively by a peak detection algorithm. Distances from the anterior cornea to the various surfaces are computed and displayed. As current equations for calculating the appropriate intra-ocular lens (IOL) power employ AL as defined to the anterior - rather than posterior - retinal surface, a constant of 0.2 mm representing average retinal thickness is subtracted from AL, determined with the GALILEI G6 before the numeric value for AL is displayed and transferred to the IOL calculator. When intra-ocular distances, as measured with the GALILEI G6, fall outside plausible (pre-set) ranges, e.g. due to detection of peak artifacts or algorithmic limitations, results will be displayed as “n/a”.

Next step: Proceed to Workflow step #5, to generate and review the IOL report, or resume from Workflow step #2 to scan the patient’s other eye.

NOTE: The raw images (Fig. 11) can only be viewed after the measurement has been accepted and calculated.


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8

IOL report

After you decided to proceed to the IOL report, the following screen, as shown below, will appear on the main monitor. At the same time the device monitor screen will be inactive, as shown at the right. You are now in Workflow step #5, Report and Filing. The screen is divided in single steps which you can follow from step 1 to 3 for IOL calculation and selection. On the left hand side, the list of available data sets, i.e. patients with associated measurements, is displayed. The current data set (i.e. the measurement recorded last) is shown in red letters.

NOTE: Another data set may be selected at this time. Click on the appropriate patient name ( ), then on one of the data sets appearing*) below the patient name ( ). *) Patient database is visible only in Analyze Mode.

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Fig. 12 IOL selection and calculation (main screen)

8.1

Step 1 (a), Target refraction

The field “Target Refraction” is initially empty. Before any IOL calculation can be performed, a value in Diopters must be entered. Positive or negative entries as well as a value of zero are permitted.


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8.2

Step 1 (b), Phakic or aphakic eye

The selection field below the step 1 bar, next to the “target refraction” field, is usually set to its default value “Phakic eye”. This field can be set to “Aphakic eye” or to “Pseudophakic eye” when appropriate. For the latter two types of eyes, only the Haigis formula can be used . For all other formulas, the calculation result fields (step 3) will remain empty.

8.3

Step 1 (c), Verify parameters

In the upper part of the screen, the ocular parameters belonging to the selected measurement are displayed. They are grouped into basic parameters (parameters actively used for IOL calculation, on the left) and advanced parameters (parameters not actually used for IOL calculation, on the right). The meanings of the acronyms are explained in the table below. Table 3 IOL calculation parameters (Basic and Advanced)

Basic IOL calculation parameters (used for IOL calculation

Advanced parameters (not used for IOL calculation)

AL

Axial Length (mm)

CCT

Central Corneal Thickness (µm)

ACD

Anterior Chamber Depth (mm)

LT

Lens Thickness (mm)

R1

Corneal Radius, flat axis (mm)

TCP

Total Corneal Power (D)

R2

Corneal Radius, steep axis (mm)

WTW

White-to-White, nasal-temporal (mm)

R

Average corneal radius (computed from R1 and R2)

n

Index of refraction

SimKf

Simulated Keratometry along flat meridian (D)

SimKs

SimK along steep meridian (D)

Steep Axis Angle (degrees)

SimKavg Average SimK (D) 23 The GALILEI G6 allows to enter parameters manually, overwriting those that were determined by the system. In that case, manually entered parameters will be used for the calculation of IOL powers and types. This feature allows the user to work with differing values; e.g. values that may have been obtained on other devices. Internal plausibility checks ensure that manually entered parameters fall within possible ranges of intraocular distances, to help prevent typing errors resulting in inaccurate IOL results. Any parameter which has been modified by a manual entry will be marked by an asterisk (e.g. R1*), and the undo button next to it, which is usually greyed out ( ), will become active ( ). Clicking on an active undo button will restore the modified parameter to the original parameter determined by the system.

Fig. 13 Modification of basic IOL Calculation Parameters (detail; see text).


If one of the SimK entries is modified, the index of refraction field n will be active. Enter the value appropriate for the device from which the modified entry was obtained.

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8.4

Step 2 (a), Select IOL type

In section 2, (center part of the screen), a choice of 5 preferred IOL types can be selected from dropdown menus. For each selected IOL type, its manufacturer will also be displayed. Available items are taken from a factory-installed IOL database. The available IOL types are sorted by manufacturer from A to Z.

Fig. 14 Steps 2(a) and (b); dropdown menus for IOL models and formulas

8.5

Step 2 (b), Select IOL formula

Below the selected IOL types, the desired IOL calculation formulas can be chosen from a dropdown menu. Implemented formulas, with their associated lens constant data, are taken from a factory-installed database.

NOTE: Lens constants may depend on the type of equipment used for axial length measurement, individual surgical technique and other factors. For optimal results, user may wish to adjust lens constants in the IOL database (see section 11, The IOL editor). In the current software version, the IOL formulas listed in the table below are implemented. These standard, non-proprietary formulas have been published in the scientific literature (see section 12.3, IOL power calculation formulas; literature references). Haigis

24

8.6

Hoffer Q

Holladay I

SRK/T

SRK II

Step 3, Computed IOL power and refraction

When all required entries have been made, computed IOL power and expected patient refraction will be displayed (Fig. 15). To optimize the results, modify Target Refraction (Step 1a), Basic Parameters (Step 1b), or change your selection of IOL types (Step 2a) or formulas (Step 2b). The table of re-calculated results will be displayed instantly in the lower part of the main screen (Fig. 15). The IOL models resulting in the expected refraction closest to the target refraction are displayed in red boxes (see image below). At the bottom of the table, the hypothetic IOL Diopter values that would result in (a) on-target refraction or (b) emmetropia are displayed.

Fig. 15 IOL calculation table (main monitor)


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Next steps: At this point, you may either generate a pdf document of the report for subsequent printing (see section 8.7); or you may revert to the refractive report for further study of the case (see section 9).

8.7

Printing the IOL report

Upon clicking the “PDF” button (top right on the IOL Report screen), a pdf file is generated and displayed. It can subsequently be saved either on the system hard drive or on an external USB storage device. The USB connector for connecting a USB storage device is on the left side of the computer cabinet, underneath the table.

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Fig. 16 IOL report (printable pdf document)


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9

The biometry report

Upon clicking the “Biometry Report” button (top right on the IOL report screen), a report featuring two corneal maps and the axial scan will be displayed:

26

Fig. 17 Biometry report (main monitor) with topographic maps and A-scan

In the default setting, the Anterior Axial Curvature map, in Diopters, will be displayed on the left hand side, and the Corneal Pachymetry map will appear on the right hand side. Local numeric values, main axes, thinnest location, pupil center, and CLMI (cone location) will be displayed as appropriate for each map. Right-clicking on either map will bring up a context menu, from which various display options can be selected:

Fig. 18 Context menu for changing settings of map display


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In the upper part of the context menu, general settings affecting both maps can be selected: (a) both maps can be computed for the keratometric index of refraction or for the corneal index of refraction, and (b) the map size can be set to full, 9 mm, 6 mm, or 3 mm diameter. In the lower part of the context menu, multiple options can be deselected independently for the left or the right map (depending on which map is right-clicked): 

“Numeric values” brings up localized numeric values (in Diopters); “Thinnest Location” will set a small black circle at the location where the cornea is thinnest;



“Pupil” will display the center and circumference of the pupil



“Axis” will display a cross with the right and blue arms indicating the position of the steepest and flattest meridian, respectively.



“CLMI” will indicate the location of the center of the cone in any keratoconic (or suspect) cornea.



All of the above options are selected and displayed by default and can be deselected in this context menu. Clicking on “Maps” on top of the context menu will open a submenu with a choice of map types that can be selected:

27 Fig. 19 Map Type selection context menu

For details on keratometric maps, refer to the GALILEI G4 Operator Manual. Functionalities of the scan display in the lower part of the screen have been discussed in sections 7.2 Visual quality check and 7.3 Peak detection).


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10 The advanced IOL report Upon clicking the “Advanced IOL Report” button (top right on the IOL report screen, a detailed report featuring four keratometric maps and complete numerical details of keratometric parameters will be displayed:

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In the default settings, the following four standard maps will be displayed: •

Anterior Axial Curvature map, in Diopters (top left),

•

Posterior Axial Curvature map in Diopters (bottom left),

•

Total Corneal Power map in Diopters (ray-traced TCP; top right),

•

Coma map in Diopters (bottom right)

Local numeric values, main axes, thinnest location, pupil center, and CLMI (cone location) are displayed as appropriate for each map. Right-clicking on either map will bring up a context menu from which various display options can be selected (see Fig. 18). Clicking on “Maps” on top of the context menu will open a submenu with a choice of map types that can be selected (Fig. 19). A detailed list of refractive and biometric numerical parameters is provided on the right side of the report. For full detail on the meaning of these parameters, refer to the GALILEI G4 Operator Manual.


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11 The IOL editor The GALILEI G6 software features an internal database which contains a sample IOL. Additional IOL data can be entered as described in section 11.1. The IOL constants used with the GALILEI G6 must be optimized for optical biometers. Please request appropriate constants from the respective IOL manufacturer. Some IOL manufacturers may suggest the use of the ULIB constants (User Group for Laser Interference Biometry, URL: http://www.augenklinik.uniwuerzburg.de/ulib/index.htm). Please note that ULIB constants are optimized for various optical biometers, but not yet specifically for the GALILEI G6 Lens Professional. Ziemer strongly recommends personalizing and optimizing the constants based on pre-operative data measured with the GALILEI G6 and a post-operative refraction analysis under stable conditions.

11.1

Managing the IOL database

You may add, copy, or delete entries in your IOL database. Existing entries may be edited and optimized individually. To access the IOL database, click on the IOL icon on the home screen.

IOL database view: 29 Import IOL

Delete IOL

Add IOL

Copy IOL

Cancel Edit IOL

Save

•

• •

Edit IOL: Click on any IOL in the IOL database and click [Edit]. You can now modify all lens constants according to your preferences and clinical expertise. Add IOL: To add a new IOL, click on the [Add] button and enter the necessary data. Copy IOL: To copy an existing IOL (to alter values but keep the existing IOL), click [Copy]. A new IOL entry is created and can be edited.


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•

Delete IOL: To delete an IOL, select it in the list and click [Delete]

•

Save / cancel: To confirm an entry, click [Save], and to abort click [Cancel].

Caution: When importing files or editing/adding IOL data manually, all values entered must be verified. Add new entries to the database, or modify factory settings at your own risk. Ziemer does not accept any responsibility for manually entered or altered ranges and values.

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11.2

Importing IOL data into the database

A set of IOLs can be imported to the IOL database as a *.csv file. CSV (comma-separated values) files can be created using Microsoft Excel. The file must have the following row order and naming (field name only): Field name

Description

manufacturer_name

Name of the manufacturer of the IOL model

name

Name of the IOL model

type

Type of the IOL model

remarks

Notes for this IOL model

range_from

First available IOL in range in [D]

range_to

Last available IOL in range in [D]

range_increment

Increment to next available IOL starting from range_from in [D]

manufacturer_acd

The manufacturer's ACD constant

manufacturer_a

The manufacturer's A constant

srk2_a

The A constant used in SRK2 formula

srkt_a

The A constant used in SRKT formula

haigis_a0

The a0 constant used in Haigis formula

haigis_a1


haigis_a2


hofferq_pacd

The pACD constant used in Hoffer Q formula

holladay_sf

The SF constant used in Holladay formula 31

Step 1: To import IOLs, go to the IOL Database and Click the [Import] button:

Import IOL

Step 2: An Explorer window opens. Navigate to your .csv file and click [Open]. The IOLs are added to the list. Note: If a list is imported multiple times, the IOL dataset will be added each time.


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12 Technical specifications 12.1

Device label

“XXXX” = serial number

Only valid together with the GALILEI Dual Scheimpflug Analyzer device label:

32 “XXXX” = serial number


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12.2

Technical data

Electrical conditions: Power requirement: Fuses (110/230V):

100-240VAC, 50/60Hz, 400W 2x T6, 3AH, 250VAC

Measurement unit characteristics: Measuring principle: Optical A-Scan based on optical coherence technology Observation illumination: SLED Technical data: Placido disc:

20 rings

Measurement speed:

60 images in 1 second

Number of measurement points – Scheimpflug/

up to 100 000 measurement points

Placido: Displayed map coverage:

max. 10 mm

Axial Length:

14-40 mm (default 14-35 mm)

Central Corneal Thickness:

250-800 μm

Anterior Chamber Depth:

1.5-6.5 mm

Lens Thickness:

0.5-6.5 mm

Keratometry:

25-75 D (4.5-13.5 mm)

White-to-White:

6-14 mm

Pupillometry:

0.5-10 mm

Axial length in-vivo repeatability: Central Corneal Thickness in-vivo repeatability: Anterior Chamber Depth in-vivo repeatability: Lens Thickness in-vivo repeatability: Keratometry in-vivo repeatability:

+/- 0.025 mm*

33 +/- 2 μm*

+/- 0.034 mm*

+/- 0.034 mm*

+/- 0.1 D*

* Values represent the standard deviation of repeated measurements with one device.

Operating conditions: Temperature: +15°C to +35°C Relative humidity: 30% to 75% non-condensing Air pressure: 700 hPa to 1060 hPa Transport and storage conditions: Ambient temperature: 0° C to +50° C, 32° F to +122 F Relative humidity: 10% to 80% non-condensing Air pressure: 500 hPa to 1060 hPa For additional technical data, refer to the GALILEI G4 Operator Manual, Appendix D.


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12.3

IOL power calculation formulas; literature references

For IOL Power calculation, the equations commonly used in commercial A-Scan biometers and published in the scientific literature (see Table 4) have been implemented in the GALILEI G6.

Table 4 Literature References for IOL Power calculation formulas

Formula name

Literature reference

SRK II

Sanders DR, Retzlaff J, Kraff MC: Comparison of the SRK II formula and other second generation formulas. J Cataract Refract Surg 14: 136-141, 1988

SRK/T

Retzlaff J, Sanders DR, Kraff MC: Development of the SRK/T intraocular lens implant power calculation formula. J Cataract Refract Surg 16 (3): 333-340, 1990

Hoffer Q

Hoffer KJ: The Hoffer Q formula: A Comparison of theoretic regression formulas. J Cataract Refract Surg 19: 700-712, 1993; Errata 20:677, 1994

Haigis

http://www.augenklinik.uni-wuerzburg.de/uslab/ioltxt/haid.htm

Holladay I

Holladay JT, Prager TC, Chandler TY et al. A three part system for refining intraocular lens power calculations. J Cataract Refract Surg 14(7): 17-24, 1988

12.4

Precision and Agreement

For the evaluation of precision and agreement of the measured values, a clinical study was conducted. PURPOSE: To evaluate precision and agreement between multiple GALILEI G6 Lens Professionals and predicate devices in measuring ocular parameters.

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METHODS: 12 cataract eyes and 17 normal eyes, including 12 eyes in normal adults and 5 eyes in children, were measured twice each with three different GALILEI G6 Lens Professionals, each operated by a different operator, and with an IOL Master (Zeiss) and a Lenstar (Haag.Streit). Evaluated parameters were central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT), axial length (AL), corneal curvature (K) along the flat and steep meridians (Kflat, Ksteep), and horizontal White-toWhite (WtW). Precision of the devices was estimated using average standard deviations of repeated measurements, and with a random effect analysis of variance; correlation between the GALILEI G6 Lens Professionals was evaluated with Deming regression analyses. Agreement to predicate devices was evaluated using Bland-Altman plots. Also evaluated were differences between the three GALILEI G6 Lens Professionals and the predicate devices in measuring right and left eyes, and in measuring childrens’ eyes. RESULTS: The precision in measuring the various parameters in normal and cataract eyes was comparable to that of the predicate devices as obtained from the brochure and user manual, respectively (Table 1). Reproducibility values as determined with ANOVA are shown at the bottom.


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Device GALILEI

Condition CCT (mm) ACD (mm)

LT (mm)

AL (mm)

Kflat (D)

Ksteep D)

WtW (mm)

Normal

0.002

0.035

0.077

0.039

0.10

0.11

0.07

Cataract

0.002

0.021

0.122

0.039

0.13

0.15

0.10

IOLMaster*

Normal

na

0.033

na

0.026

0.07

0.07

0.10

Lenstar**

Cataract

0.002

0.040

0.080

0,035

0.14

0.14

0.04

GALILEI***

Normal

0.005

0.045

0.134

0.080

0.25

0.20

0.16

Cataract

0.004

0.036

0.210

0.050

0.20

0.21

0.18

Precision in measuring ocular parameters with GALILEI G6 Lens Professional and predicate devices. *: From Brochure IOL Master; ** : From User Manual Lenstar; ***: Reproducibility values as calculated with ANOVA, defined as the square root of the sum of the [operator+device variance component plus the repeatability (residual) variance component. Deming regression plots indicated a strong correlation between the three GALILEI Lens Professionals. As an example, the Deming regression plot for AL in cataract eyes between devices CMS1303 and CMS3516 is illustrated in Fig. 1.

A Deming regression plot between GALILEI G6 Lens Professional devices CMS1303 and CMS3516 shows a strong correlation in measuring axial length (AL). Shown are slope, intercept, 95% confidence interval, identity line and the Pearson’s correlation coefficient.

Bland-Altman plots demonstrated a strong agreement of the GALILEI G6 Lens Professional devices with predicate devices. As an example, the agreement between device CMS1303 and the IOL Master is illustrated in Fig. 2. AL differences between the two devices were within a ±0.17 mm range and centered approximately at 0.0 mm

A Bland-Altman plot between GALILEI G6 Lens Professional device CMS1303 and the IOL Master shows a strong agreement in measuring axial length (AL) in cataract eyes. Shown are slope, intercept, 95% confidence interval, identity line and the Pearson’s correlation coefficient.


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Correlations between GALILEI G6 Lens Professionals are poorer in cataract eyes for some of the parameters, which is likely due to differences in the scattering properties of the ocular media and a reduced capability at a relatively older average age in this subgroup to fixate steadily and open the eye wide for a measurement. When evaluating right and left eyes separately, parameters measured with the three GALILEI G6 Lens Professionals agreed well between themselves and when compared to those measured with the IOL Master and Lenstar. Parameters measured in children correlate well among the three GALILEI G6 Lens Professionals. The correlation for ACD and LT is weaker in children than in adults, and both intercept and slope are further away from identity, which may be due to a child's lack of reliable fixation of the target than can lead to fluctuations in accommodation, which affects both ACD and LT. CONCLUSIONS: Parameters measured with the three GALILEI G6 Lens Professionals agree well with those measured with the IOL Master and Lenstar. Measurements with the GALILEI G6 Lens Professional do not depend on eye side. The GALILEI G6 Lens Professional is safe and effective when used in a pediatric population. •

•

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NOTES

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GALILEI G6 Operator Manual

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