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rtx1 User's Guide rev D DUT 012g October 2011

User's Guide

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File Name: rtx1_user_s_guide_rev_d_dut_012g_october_2011.pdf

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User’s Guide

INDEX

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INDEX INDEX ... 1 CHAPTER 1 - INTRODUCTION... 2 How the rtx1 works... 2 Indications for use ... 2 Intended target population ... 2 Intended user ... 3 Lecture notes ... 3

CHAPTER 2 – GENERAL INFORMATION ... 4 Label symbol key ... 4 Warning symbol ... 4 Label on the Device ... 4 Product components ... 5 Equipment specifications ... 6 Legal notices ... 7

CHAPTER 3 – INSTRUCTIONS FOR USE ... 8 Installation of the Device ... 8 Start up... 8 Preparation for imaging ... 10 Imaging ... 13 Data acquisition and recording ... 15 Data processing... 18 Data storage and backup ... 20 Additional image processing ... 21 Turning off the system ... 24

CHAPTER 4 - CLEANING INSTRUCTIONS AND HYGIENE GUIDELINES ...25 CHAPTER 5 – EQUIPMENT DISPOSAL ...26 CHAPTER 6 – WARNINGS ...27 CHAPTER 7 – REPAIRS AND MAINTENANCE ...29 Repairs... 29 Storage ... 29 Maintenance ... 29 Transport – short distance ... 29

CHAPTER 8 - TROUBLESHOOTING ...30 Possible image artefacts ... 30

CHAPTER 9 – WARRANTY CONDITIONS ...32 CHAPTER 10 - ASSISTANCE ...33 APPENDIX A - RTX1 IMAGE SPECIFICATIONS ...34 1 ©Copyright 2011 Imagine Eyes. All rights reserved. User’s Guide revision D DUT 012 g / October 2011

CHAPTER 1 - INTRODUCTION

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CHAPTER 1 - INTRODUCTION Any person who will operate the rtx1 AO Retinal Camera (hereafter “the Device) must read this guide thoroughly and completely understand the Device’s operation and indications for use. The use of the Device D must be under the responsibility of a qualified medical edical doctor or ophthalmic researcher.. The intended user is an ophthalmologist ophthalmologist or a technician with competences in retinal imaging and specifically trained to use the Device. D Operators must give special attention to the warnings in Chapter 6.

How the rtx1 works While the subject fixes their gaze on a target located inside the rtx1,, an extremely fine beam of infrared light is directed towards the eye’s eye fundus. The beam is reflected back (backscattered) by the retina and travels back through the eye and pupil. This Th exit beam is then corrected using adaptive optics to compensate for the optical defects in the eye. A high resolution image of the subject’s retina can thereafter be acquired. acquired.

Indications for use The Device is intended ed for Research Use Only (RUO) for capturing images of the retina of the eye and presenting the data to the ophthalmic researcher. This information is not to be used as a diagnostic aid in identifying or treating retinal diseases. The device can be used on eyes treated with a mydriatic solution as well as without.

Intended target population The Device has not been designed for use on infants. If governing law in the country of use permits imaging minors in clinical investigations, use use this instrument with particular caution these subjects. Using the Device is contraindicated in the following subjects: • •

•

The subject who has a history of photosensitivity. photosensitivity The subject who has just received the treatment of photodynamic therapy (PDT) (for the prohibition period, refer to the package insert of the photosensitive substance used in the procedure). procedure) The subject treated with medicine that can cause photosensitivity as a side effect.

This Device must be used with caution for the following subjects: • • •

The subject who has epidemic kerato conjunctivitis orr any other infectious disease. The subject who has skin lesions located at chin or forehead areas as contact with a chinrest is inadvisable. The subject who is at high risk for the optical radiation hazard, such as subjects with aphakic eye, infants infant or subjects with diminished sensibility to light due to fundus disease.

The use of the Device may be difficult or impossible in the following cases: • • • •

Advanced cataract or significant opacities of the anterior eye segment. Uncontrolled nystagmus, trembling or movements of the eyes or the head. Incapacity of the subject to maintain a stable position while seated Spherical refractive error in excess of -12 to + 6 D 2 ©Copyright Copyright 2011 Imagine Eyes. All rights reserved. User’s Guide revision D DUT 012 g / October 2011

CHAPTER 1 - INTRODUCTION

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If the subject’s pupil diameter is inferior to the minimum pupil diameter as defined in the Device’s specifications (pages 6 and 7), cycloplegic treatment for dilatation may be necessary. In this case, the indications and precautions advised for this medicine must be respected.

Intended user The Device is intended to be used by an ophthalmic professional duly accredited in the country of use or by a technician under supervision of the aforementioned professional.

Lecture notes Throughout this User’s Guide, a text in italic bold refers to the name of a software window. A text in italic refers to a button or control in such window. This User’s Guide revision applies to rtx1 units driven by the software versions 000.000.20110318 and 000.000.20110319.

CHAPTER 2- GENERAL INFORMATION

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CHAPTER 2 – GENERAL INFORMATION Label symbol key The following symbols can be found on the labels affixed to the rtx1:

Refer to instructions for use

Grounded electrical device

Important operating and maintenance instruction must be read in the User’s Guide.

Direct current

Date of manufacture

Name of manufacturer

Type B electrical equipment

2002/96/CEE Waste electrical and electronic equipment

AAAA

REF

Catalog reference

Serial number

Warning symbol In the present User's Guide, the symbol indicates a warning concerning operations that may lead to personal injury, injury potential damage to the Device or the operating environment if not performed correctly. correctly

Label on the Device The label below is visible on the Device. Device REF PR rtx1

SN 0xx

2011

Research Use Only

CHAPTER 2- GENERAL INFORMATION

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Product components The Device includes the following components: •

optical instrument head

•

chinrest with attached external fixation target

•

standard ophthalmic examination table

•

PC equipped with acquisition cards and standard peripheral devices

•

electronic unit for the deformable mirror

•

medical grade isolation transformer

•

cables

•

rtx1 software

Optical instrument head Chinrest

Computer screen

Joystick

Deformable mirror electronic unit

Keyboard and mouse

Ophthalmic table with buttons for adjustable height PC

Isolation transformer

Figure 1: The complete rtx1 workstation with optical instrument head, chinrest, PC equipped with standard peripheral devices, deformable mirror electronic unit, and ophthalmic table.

CHAPTER 2- GENERAL INFORMATION

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The optical instrument head contains lenses and mirrors, several cameras and light sources at different wavelengths. The Device is operated using rtx1 software.

Equipment specifications Imaging specifications

Imaging type

En face reflectance imaging

Illumination type

Flashed, non-coherent flood illumination

Central illumination wavelength

850 nm (infrared)

Detection type

Low noise CCD camera

Frame rate

9.5 fps

Camera pixel resolution

1.6 µm1 or 0.0054°

Transverse optical resolution

250 line pairs per millimeter (lppmm)1, 2

Imaging field of view

4° x 4° 1

System field of view

±30° from locus of fixation1, 3 H ±10° / V ±8° from locus of fixation 1, 4

Image file format

PNG (Portable Network Graphic)

Adaptive optics specifications

Adaptive optics control

Fully automated

Adaptive optics illumination

750 nm (infrared) SLD (SuperLuminescent Diode)

Other system

Spherical ametropia compensation range

-12 / +6 D sphere

Pupil diameter range

4 - 10 mm

Focusing range – retinal equivalent

800 µm1

Working distance

50 mm

Internal fixation target

Miniature OLED display

Internal fixation target gaze angle (max)

H ±10° / V ±8°

External fixation target

LED light attached to chinrest

Intended use

Research Use Only5

Dimensions (instrument head only)

L 35 x W 17.5 x H 50 cm

Weight (instrument head only)

13 Kg

Optical power output

Infrared, ISO 15004-2:2007 classification group 1

specifications

General specifications

(no potential hazard) Input voltage

Medical-grade isolation transformer

CHAPTER 2- GENERAL INFORMATION

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100-130 & 220-240 AC / 50-60 Hz Transformer complies with EN60601-1 standard Output voltage

PC to instrument head: 12 VDC / 0.5 A and 5 VDC / 2 A Deformable mirror electronics driver: ±25 VDC max / 2A

1. Some specifications are dependent on ocular biometry, pupil diameter, optical defects, ocular media transparency as well as other factors. 2. System can image line pairs of 2 µm in line width. 3. Using external fixation target. 4. Using internal fixation target. 5. The rtx1 is intended for research use only (RUO). Not for use in diagnostic procedures. It is not CE marked or FDA approved for use as a medical diagnostic device.

Legal notices STATEMENT OF PROPRIETORY INFORMATION This User's Guide is protected by copyright. This document and the included information may not be redistributed in any manner without express permission of Imagine Eyes.

CHAPTER 3. INSTRUCTIONS FOR USE

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CHAPTER 3 – INSTRUCTIONS FOR USE Installation of the Device The installation of the Device must be performed by a qualified and approved representative of Imagine Eyes, in an environment specifically reserved for clinical investigations. Special care must be taken to ensure that the Device is not located in proximity to other equipment sensitive to electromagnetic interference or that is vital to patient health (e.g. clinical investigations using life support systems in the same or adjacent rooms).

Start up 1. Turn on, in the following order, the isolation transformer, the ophthalmic table, and the PC. 2. When Windows is completely launched and three icons are visible in the toolbar at the lower right corner of the screen, turn on the deformable mirror electronic unit with the power switch on the unit’s rear side. The green LED labelled Power is lit and remains so as long as the unit is turned on. Power switch

Figure 2: The power switch to turn on the deformable mirror electronic unit is situated on the rear side of the unit

NB: If the deformable mirror electronic unit goes into protection mode, i.e. if the orange LED labelled Protect remains lit, see troubleshooting in chapter 8.

3. Launch the rtx1 software by clicking on the rtx1 icon. Seven windows will open. NB: The Patient sphere window requires about half a minute to open.

CHAPTER 3. INSTRUCTIONS FOR USE

Data Processing Patient position

Patient target

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Focusing

Retina images

Patient sphere

Figure 3: The rtx1 (seven windows) software is open. The Patient sphere window requires slightly longer time than the others to launch. The Data processing window is placed behind the Patient position window at this stage.

4. The seven open windows are the following: o

o o

rtx1 Manages the different operating modes: Standby, Standby Positioning and Imaging.. Patient position Window that displays the subject’s eye for pupil alignment. alignment Patient target Shows the position of the fixation target in order to select the area of the retina to image. The fixation target the same yellow cross displayed to the subject. Patient sphere Correction of the subject’s spherical ametropia. Retina images Displays the live image of the retina during the Imaging maging phase. Acquisition of retinal image. Focusing. Adjustment of imaging depth. Data processing Automated data processing.

5. When turning on the Device, always verify that the software is working correctly before using it with a subject. If any of the functionalities is not working correctly, or if any malfunction is detected during operation of the Device, interrupt any data acquisition and contact Imagine Eyes.

CHAPTER 3. INSTRUCTIONS FOR USE

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Preparation for imaging 1. Adjust the height of the ophthalmic table by means of the appropriate buttons on the front side of the table in order to make the subject as comfortable as possible. Adjust the height of the chinrest for precise positioning.

Figure 4: Buttons to adjust the height of the ophthalmic table.

2. Verify that the subject can see the yellow cross when looking into the device.

3. Patient sphere: If the subject’s spherical ametropia is known, enter this value following the instructions below. Otherwise, proceed in steps of 0.5D to find the position where the subject can see the target sharply then fine-tune in steps of 0.25D. The strength of the spherical ametropia is selected by moving the cursor and thereafter clicking on Apply. Note that when the selected value differs from the currently applied value, this latter is marked in red as shown below. Verify that the subject can see the yellow cross and that is sharp, to ensure a good correction of the spherical ametropia

Figure 5: The selected value of spherical ametropia is not yet applied.

Figure 6: The selected value of spherical ametropia corresponds to the value currently applied.

CHAPTER 3. INSTRUCTIONS FOR USE

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4. Patient target: By default, the fixation target is placed at 0° x 0° of foveal eccentricity at start-up.

5. Patient target: Choose the eye to be imaged (OD/OS). Verify that the selection corresponds to which of the subject’s eyes that is really exposed to imaging.

Patient target: Choose the area of the retina to image by adjusting the eccentricity using the yellow cross. This is accomplished by dragging the yellow cross or by clicking and dragging the cursors on the borders of the window. Ask the subject to fix their gaze on the cross and to follow its position with the eye. The range of the internal fixation target is ±10° horizontally and ±8° vertically. Verify that the position of the target as seen by the subject corresponds to the position displayed on the Device’s computer screen. NB: It is necessary to select the right or left eye by clicking the OD/OS radio buttons, in order to have the correct nasal / temporal coordinates

Cursors to move the yellow cross

The position of the yellow cross can also be adjusted by moving the red square

The current target position

Selection between right and left eye

Figure 7: The position of the fixation target can be chosen either by moving the center of the cross (red square), or by moving the vertical and horizontal cursors.

6. For imaging at foveal eccentricities outside of the system's standard fixation range, use the external fixation LED on the chinrest. This LED is turned on by the toggle button on the bottom right side of the optical instrument. 11 ©Copyright 2011 Imagine Eyes. All rights reserved. User’s Guide revision D DUT 012 g / October 2011

CHAPTER 3. INSTRUCTIONS FOR USE

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Toggle button for fixation LED

7. rtx1: Click on the button Positioning to view the subject’s pupil in the Patient position window.

Figure 8: During the Positioning phase, the subject’s pupil is aligned.

8. Patient position: Align the subject’s pupil by means of the Device’s joystick (three dimensions). If the height displacement achievable with the joystick is not sufficient, adjust the height of the chinrest. The green cross should ideally be centred in the middle of the four white spots visible in the pupil.

Figure 9: Example of a well aligned pupil with the green cross centred in the middle of the four white spots.

CHAPTER 3. INSTRUCTIONS FOR USE

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Imaging 1. rtx1: Click on the button Imaging to launch the imaging phase. The adaptive optics correction system and the retinal camera are activated and live images are shown in the Retina images window.

Figure 10: During the Imaging phase, retinal images can be acquired. The retinal image is displayed in real time in the window Retina images.

NB: Verify that neither the message “AO: no eye detected” nor “AO: invalid pupil” is displayed in the Focusing window. When such a message is displayed, the adaptive optics correction is turned off and, although imaging is still possible, image quality and resolution will be significantly diminished.

Figure 11: The imaging system does not detect a pupil (left), or the pupil is too small or misaligned (right). No high resolution images can be acquired.

Focusing: Choose the imaging depth in the range of -400 µm (anterior retina) to 400 µm (posterior retina) by moving the vertical cursor up and down or clicking on the arrow. A click on a single arrow, , moves the cursor to the closest multiple of 10 µm in the given direction and a click on a double arrow, , to the 13 ©Copyright 2011 Imagine Eyes. All rights reserved. User’s Guide revision D DUT 012 g / October 2011

CHAPTER 3. INSTRUCTIONS FOR USE

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closest multiple of 100 µm. For a finer adjustment, the cursor can be moved stepwise along the bar. A click on makes the cursor return to 0 µm. Observe the live image in the Retina images window while changing the focusing depth. When the desired retinal layer appears clearly, the focusing depth is appropriate and images can be acquired. NB: These units in µm indicate a displacement relative to a reference point in the retina. This reference point varies between subjects and depends on aspects such as the optical biometry. The message at the bottom line of the window indicates that the AO loop is operating correctly (see figure 11 below). The numerical value is an indicator of the level of the AO correction. Verify this value before data acquisition to ensure the correction quality; the lower this value, the better the correction.

Posterior retina

Anterior retina

Figure 12: The fine focus adjustment can be achieved by moving the vertical cursor.

3. Retina images: If necessary, for example if the live image appears very dark and is visualized with difficulty, the intensity and the contrast of the image can be adjusted by moving the horizontal cursors, see Figure 13 in the next section. 4. rtx: Before acquiring data, ask the subject to blink in order to verify that a possible delay in the image display will not affect the use of the device. Blinking before the data acquisition will also help to avoid blinking during acquisition.

NB: Do not expose the subject’s eye to consecutive imaging for longer than 40 minutes. During normal operation this limit is not critical, but it is a safety limit in the unlikely event of hardware failure.

CHAPTER 3. INSTRUCTIONS FOR USE

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Data acquisition and recording 1. Retina images: To begin the acquisition process, push the button Acquire. A progress bar shows that image acquisition is in progress.

Contrast and intensity settings

Live images of the retina

Acquisition in progress

Figure 13: The live image is shown in the Retina image window.

CHAPTER 3. INSTRUCTIONS FOR USE

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2. When the data acquisition is finished, a window called Data record is opened.

Figure 14: Data record window.

3. rtx1: Click on the Standby button. This turns off the light sources used for imaging, so that the subject notices when data acquisition is finished.

Figure 15: When in Standby mode, the light sources for imaging the retina are inactive.

NB: It is important to put the Device into Standby mode after imaging is completed. If the operator does not put the Device in Standby mode, the Device shows a message and automatically goes into Standby after 40 minutes. 4. In the Data record window, enter the subject’s personal information: eye, gender, surname, name, and date of birth. Click Save to register the data.

Figure 16: The subject’s personal information is entered in the Data record window.

CHAPTER 3. INSTRUCTIONS FOR USE

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NB: Make sure to write the subject’s name without any spaces. If the subject has more than one first name and/or last name, write those together as one single name. If there is a space between two names, an error will occur during data processing. Subject information is stored for management of consecutive imaging sessions with the same subject. When saving images with pre-entered subject information, the following message is displayed.

Figure 17: A dialog box opens when attempting to save data to an existing subject. Click Yes if it is the same subject, or No to return to the Data Record window and enter new subject information (e.g.: a middle initial).

NB: Be careful not to automatically save a new subject’s data using the previous subject’s name. NB: It is not possible to change any of the subject’s information in already saved data. If any information is incorrect, the data may be saved in a folder for another subject or in a folder for a non-existing subject.

CHAPTER 3. INSTRUCTIONS FOR USE

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Data processing 1. Select the Data processing window.

Figure 18: Data processing window.

2. Click on Load to show unprocessed data. If multiple data acquisitions have been made, they can be processed simultaneously. When clicking on Load, all unprocessed data will be displayed.

Figure 19: All untreated data is listed when clicking Load.

CHAPTER 3. INSTRUCTIONS FOR USE

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3. Click in the tick box to select one or more data acquisitions, or Select all to select all the displayed data.

Figure 20: Some or all unprocessed data can be selected for processing.

4. Click on Process to start the processing of the selected data. The status bar at the bottom of the Data processing window displays the progress.

Figure 21: Data processing in progress.

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