Visiometrics HD Analyzer OQAS User manual

USER’S MANUAL
Version 2.4
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MODEL: OQAS –HDA
Optical Quality Analysis System –High Definition Analyzer
BRAND: HD Analyzer
APPLICABLE PARTS:
Chin guard (Type B)
CODE:2
REVIEW:1
2017/08
PRINTED IN SPAIN

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Table of Contents
WARNINGS.......................................................................................................... 6
PRECAUTIONS.................................................................................................... 8
1INTRODUCTION............................................................................................ 9
1.1 GENERAL DESCRIPTION....................................................................................9
1.1.1 Double-pass technique................................................................................10
1.1.2 What is OSI?................................................................................................11
1.1.3 What is MTF? ..............................................................................................12
1.2 CHARACTERISTICS...........................................................................................14
1.3 APPLICATIONS...................................................................................................15
1.4 TECHNICAL SPECIFICATIONS OF THE HD ANALYZER™..............................16
1.4.1 Hardware specifications...............................................................................16
1.4.2 Program specifications ................................................................................17
1.4.3 Accessories .................................................................................................17
1.4.3.1 Computer (PC or laptop)..........................................................................17
1.5 PRODUCT SERVICE LIFE..................................................................................17
1.6 ACCURACY OF THE MANUAL...........................................................................18
2HD ANALYZER™ HARDWARE INSTALLATION AND MAINTENANCE ... 19
2.1 HD ANALYZER™ INSTALLATION......................................................................19
2.2 MAINTENANCE AND CALIBRATION.................................................................19
3FUNCTIONING OF THE HD ANALYZER™................................................ 22
3.1 USING THE PROGRAM WITHOUT THE HD ANALYZER™...............................22
3.2 USING THE PROGRAM WITH THE HD ANALYZER™......................................22
3.2.1 User guidelines............................................................................................22
3.2.2 Patient guidelines ........................................................................................23
3.2.2.1 General guidelines...................................................................................23
3.2.2.2 Instructions to the patient during the "Best Focus" measurement...........23
3.2.2.3 Instructions to the patient during the "OSI" and "Light Condition"
measurements.........................................................................................................24
3.2.2.4 Instructions to the patient during the "Tear Film" measurement .............24
3.2.2.5 Instructions to the patient during "Depth of Focus" measurement..........24
3.2.2.6 Instructions to the patient during the Purkinje sequence.........................24
3.3 START MENU......................................................................................................25
3.4 DATABASE..........................................................................................................26
3.4.1 General description......................................................................................26
3.4.2 Working with patients...................................................................................28
3.4.2.1 Add data on a new patient.......................................................................28
3.4.2.2 Modify data on an existing patient...........................................................29
3.4.2.3 Delete a patient’s data.............................................................................29

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3.4.3 Working with measurements .......................................................................30
3.4.3.1 Loading a specific measurement.............................................................30
3.4.3.2 Printing various measurements ...............................................................31
3.4.3.3 Comparing various measurements..........................................................31
3.4.3.4 Deleting measurements...........................................................................32
3.5 MEASUREMENTS ..............................................................................................32
3.5.1 How to perform an acquisition.....................................................................36
3.5.2 Best Focus...................................................................................................39
3.5.3 Types of measurement................................................................................40
3.5.3.1 OSI and Light Condition...........................................................................40
3.5.3.2 Tear Film..................................................................................................42
3.5.3.3 Depth of Focus.........................................................................................43
3.5.4 Monitoring of results.....................................................................................45
3.5.4.1 OSI and Light Condition...........................................................................46
3.5.4.2 Tear Film..................................................................................................55
3.5.4.3 Depth of Focus.........................................................................................59
3.5.4.4 Result comparison screens .....................................................................61
3.5.5 Purkinje Measurement.................................................................................63
3.5.5.1 Introducing the subjective refraction........................................................63
3.5.5.2 Selecting the Purkinje option...................................................................65
3.5.5.3 Move the machine away from the patient and focus the eye ..................65
3.5.5.4 Select the appropriate option...................................................................66
3.5.5.5 Focus with the help of the directional arrows ..........................................67
3.5.5.6 Automatic capture of images and detection of searched items...............72
3.5.5.7 Validating a partial image ........................................................................74
3.5.5.8 Acquire and validate the remaining partial images..................................76
3.5.5.9 Final results..............................................................................................78
3.5.6 Printing and exporting a report of the results...............................................79
3.6 SETUP.................................................................................................................87
3.6.1 Identification.................................................................................................87
3.6.2 General visual behavior...............................................................................87
3.6.3 Save and export...........................................................................................88
3.6.4 Visual options for "OSI"................................................................................88
3.6.5 Tear Film options.........................................................................................89
3.6.6Visual options for Purkinje ...........................................................................89
3.6.7 Modify and Cancel buttons ..........................................................................89
3.6.8 Additional buttons ........................................................................................89
3.7 BACKUP..............................................................................................................90
4MEASUREMENT EXAMPLES.....................................................................91
4.1 NORMAL EYE......................................................................................................91
4.2 EYEWITH CATARACT .......................................................................................92
4.3 POST-LASIK EYE................................................................................................93
5TROUBLESHOOTING.................................................................................95
5.1 ERROR MESSAGES...........................................................................................95

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5.2 WARNING MESSAGES ......................................................................................96
6MANUFACTURER....................................................................................... 98
7REGULATORY INFORMATION.................................................................. 99
8SYMBOLS................................................................................................. 100
9ELECTROMAGNETIC IMMUNITY............................................................. 100

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WARNINGS
PLEASE, THOROUGHLY READ THIS COMPLETE USER’S MANUAL BEFORE
CARRYING OUT ANY OPERATION WITH THE EQUIPMENT.
THIS EQUIPMENT MUST BE OPERATED BY PEOPLE WHO ARE FAMILIAR
WITH THE USE OF OPHTHALMOLOGICAL DIAGNOSIS AND MONITORING
INSTRUMENTS (OPHTHALMOLOGISTS, OPTOMETRISTS, NURSING STAFF,
ASSISTANTS, ETC.).
THIS EQUIPMENT MUST BE OPERATED USING A POWER SUPPLY
APPROVED BY VISIOMETRICS.
THE EQUIPMENT MUST NOT BE POSITIONED IN A WAY THAT HINDERS
ACCESS TO EQUIPMENT’S POWER CONNECTION TO THE ELECTRICAL
NETWORK.
TURN OFF OR UNPLUG THE DEVICE WHEN NOT IN USE.
TO AVOID THE RISK OF FIRE AND ELECTRIC SHOCK, DO NOT EXPOSE THE
HD Analyzer ™UNIT TO RAIN OR MOISTURE.
THIS DEVICE IS NOT WATER OR SPLASHPROOF. IF ANY LIQUID, WATER,
OR MOISTURE GETS INSIDE THE INSTRUMENT, UNPLUG IT IMMEDIATELY
AND CONTACT TECHNICAL SERVICES BEFORE USING THE DEVICE AGAIN.
KEEP THIS DEVICE DRY.
FOR INDOOR USE ONLY. IT IS NOT DESIGNED FOR OUTDOOR USE.
ANY ATTEMPT TO REMOVE THE CASING OF THE UNIT AND/OR ALTER THE
UNIT WIL VOID THE WARRANTY.
TO GUARANTEE PROPER FUNCTIONING OF THE EQUIPMENT, IT SHOULD
BE CALIBRATED ANNUALLY.

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NOT SUITABLE FOR USE IN FLAMMABLE ENVIRONMENTS.
THERE ARE NO PARTS INSIDE THE DEVICE THAT CAN BE REPAIRED BY
THE USER. CONTACT YOUR SUPPLIER OR TECHNICAL SERVICE.
IN CASE OF BROKEN OR DAMAGED EXTERNAL PARTS, PLEASE, CONTACT
TECHNICAL SERVICES BEFORE USING THE DEVICE AGAIN.
DO NOT TOUCH THE GLASS OF THE EQUIPMENT’S OUTPUT WINDOW.

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PRECAUTIONS
Do not attempt to disassemble, alter, or repair the HD Analyzer™ instrument.
The instrument contains a class 3R laser product. Avoid direct eye exposure.
Do not expose the instrument to bright light such as sunlight for extended
periods. Do not operate at temperatures above or below the recommended
range.
This equipment must be connected to the electrical network. Take domestic
precautions upon connecting it to the network.
If the equipment stops working normally, error messages will appear on the
computer screen. In this case, do not try to repair it. Refer to your supplier or
technical service.
If the equipment stops working or stops working normally (error messages
appear on the computer screen) due to exposure, in reasonably predictable
environmental conditions, to magnetic fields, external electrical influences,
electrostatic discharge, pressure or pressure variations, acceleration, thermal
sources of ignition, or other causes, do not try to repair it. Refer to your
supplier or technical service.
Contact VISIOMETRICS to ask for help.

HD Analyzer™ Chapter 1: Introduction
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1 INTRODUCTION
1.1 GENERAL DESCRIPTION
Due to the pressing need to measure visual quality in an objective way,
VISIOMETRICS has developed the HD Analyzer™, an instrument based on the
double-pass technique that provides an objective clinical evaluation of the optical
quality of the eye.
It originated from an isolated light source produced by a laser beam whose image
is formed on the retina of the eye. Upon reflecting on the retina, the light crosses
the ocular medium twice. The HD Analyzer™ analyzes the size and shape of the
reflected light source.
HD Analyzer™ images contain all the information about the optical quality of the
eye, including high order aberrations and diffuse light, which are not usually taken
into account by most aberrometric techniques. These higher-order aberrations can
have a major impact on refractive surgery in the same way as diffuse light in the
senile eye.
The HD Analyzer™ allows you to perform measurements in a variety of clinical
situations. One of the most promising areas of application for the HD Analyzer™ is
cataract detection and classification, as well as refractive surgery. Also, its
functionalities for the evaluation of the pseudoaccommodation and for the
evaluation of the degradation of the tear film over time are useful tools for the study
of presbyopia and dry-eye syndrome.
The HD Analyzer™ has a measurement control and acquisition program that
provides additionalbenefits: easy operation, intuitive working environment,and real-
time control.

HD Analyzer™ Chapter 1: Introduction
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1.1.1 Double-pass technique
The Figure 1 sample shows a schematic diagram of a double-pass system similar
to that of the HD Analyzer™.
The light source consists of a laser diode that is 780 nm in wavelength. The beam
is spatially filtered and collimated. After the beam is reflected in a dividing film, it is
transmitted by the L2 and L3 lenses that form a Badal system in the patient's eye.
Through the FC moving head, to which two mirrors are attached, the correction of
the spherical refraction of the eye to be measured is produced. This is achieved by
modifying the optical paths between lenses L2 and L3.
Figure 1. Double-pass diagram
The eye forms the image of the isolated source on the retina. The optical path
described so far constitutes the first step of the system.
The second step is that which the light determines in its path from the retina to the
CCD camera (aerial or double-pass image). This path starts with the light that is
reflected in the retina with a certain pattern due to the diffusive behavior of this

HD Analyzer™ Chapter 1: Introduction
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surface. The reflected light passes through the ocular optics, from the Badal system
to the beam splitter. The transmitted light finds in its path the second artificial pupil
(PA2) that is combined with the pupillary plane of the eye. This pupil is variable and
acts as the effective exit pupil when the natural pupil of the eye has a diameter
greater than PA2. The effective pupil will always be the smaller of the two. A lens
focuses the aerial image on the CCD camera. Measurements can be made with
different pupillary outlet diameters (PA2).
1.1.2 What is OSI?
OSI = Objective Scattering Index
OSI is a parameter that allows the objective evaluation of intraocular scattering. It is
calculated from the assessment of the amount of light that is on the outside of the
patient's double-pass image, relative to the amount of light in its central part.
Accordingly, the higher the OSI value, the greater the level of intraocular scattering.
It is the only objective parameter that allows the objective quantification of
intraocular scattering. It is of interest in all clinical situations where there may be
diffuse light: cataract development and surgery, refractive surgery, intraocular
lenses, age, dry-eye syndrome, etc.
The OSI has proven its validity for a new objective classification of cataract
development, more robust and precise than the subjective ones that have existed
up to now. For eyes with a normal scattering level (young) the OSI value is less than
1.0. For eyes in which a cataract is developing, the OSI value is between 1.5 and 4.
For eyes with mature cataract the OSI value is greater than 4.

HD Analyzer™ Chapter 1: Introduction
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1.1.3 What is MTF?
MTF = Modulation Transfer Function
The MTF of an optical system is a function that allows for the evaluation of the
degree of detail that the system is able to distinguish, or similarly, it evaluates the
relation between the contrast of the real scene and the contrast of the image that
forms the system. Our eye is an optical system, so it also has an associated MTF,
and it indicates how much the contrast decreases in the image formed in the retina
with respect to the real scene.
In any optical system, the contrast reduction is greater for high spatial frequencies
(fine details and contours in the image). Therefore, in our case, of the following bar
codes, the codes on the right are perceived as grayer (lower contrast) than those
on the left, despite them all having the same definition. This agrees with the fact that
the more details and contours (greater spatial frequency) there are in the real
scene, the more the contrast between those details and contours is reduced in the
image formed in our retina.
Figure 2. Bar patterns with different spatial frequencies
Therefore, MTF is a function that relates the spatial frequencies, measured in cycles
per degree, with the decrease in contrast obtained for each of them in the image of
the system, in our case, the image formed in the retina.
In the following figure we have symbolized, with a key, a distance that we will
assimilate to a degree. We can observe that the number of complete space cycles
(pattern formed by one black and one white stripe) that fall in a degree, varies
according to the frequency. For the first bar code, the spatial frequency is 1, while
for the following it is 2, 4, 8 and 16, respectively. In fact, the higher the spatial
frequency, the lower the contrast in the image formed in the retina.

HD Analyzer™ Chapter 1: Introduction
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Figure 3. Bar patterns with different spatial frequencies and reference mark symbolizing a degree.
If the contrast in the system image were the same as the contrast in the real scene,
the MTF value would be 1, the maximum possible. As the frequency increases, the
MTF decreases because the contrast in the system image is increasingly less than
the real scene contrast. This relationship, expressed mathematically, is the
following:
𝐶𝑜𝑛𝑡𝑟𝑎𝑠𝑡 𝑜𝑓 𝑠𝑦𝑠𝑡𝑒𝑚 𝑖𝑚𝑎𝑔𝑒
𝐶𝑜𝑛𝑡𝑟𝑎𝑠𝑡 𝑜𝑓 𝑟𝑒𝑎𝑙 𝑠𝑐𝑒𝑛𝑒
Figure 4. Comparison of the contrast (C) of the real scene (A) with respect to the contrast (D) of the image
formed by the optical system (B).
And finally, if we represent the curve oftheMTF in agraph,we get something similar
to the following:

HD Analyzer™ Chapter 1: Introduction
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Figure 5. MTF graph: in the Y axis, the frequencies, in the X the MTF associated with each one.
The MFT also varies with the size of the pupil. It is therefore important to look at the
pupil’s diameter with which different measurements were taken before comparing
them. This value will be the one we chose as an artificial pupil before the acquisition,
provided that it is smaller than the actual pupil diameter of the patient. Since the
patient's pupil dilates and contracts consistently, we recommend performing the
measurement with an artificial pupil diameter that is less than the natural pupil
diameter, so that the measurement conditions are reproducible.
1.2 CHARACTERISTICS
•Quantitative and objective assessment of intraocular scattering.
•Quantitative and objective assessment of the optical quality of the eye.
•Quantitative and objective assessment of optical quality loss due to tear film
degradation.
•Quantitative and objective assessment of pseudo accommodation.
•Qualitative assessment of the quality of the eye through two-dimensional
and three-dimensional maps of the double-pass retinal image, as well as the
simulation of the image of a scene projected onto the retina.
•Assessment of the position of the optical axis with respect to the center of
the pupil.

HD Analyzer™ Chapter 1: Introduction
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•In case an inlay KAMRA™ is implanted, assessment of the position of the
implanted inlay with respect to the center of the pupil and with respect to the
optical axis.
•Tools for optimal visualization and quantification of images, such as zoom,
rotation, profiles, and measurements on the image.
•Patient database useful and easy to use.
•Print reports with the results and measurement data.
•Easy acquisition and manipulation of images.
1.3 APPLICATIONS
•Assessment of intraocular scattering degree (OSI) for the early detection of
cataracts or to determine their degree of maturity. Objective measurement
of halos and glare.
•Comparison of pre- and post-surgery cataract and refractive surgery.
•Assessment of the quality of the tear film, especially in patients suffering
from dry eye.
•Objective measurement of the pseudoaccommodation range.
•Diagnosis of pathologies.
•Precise measurement of the ocular MTF (Modulation Transfer Function) in
all situations. The aberrometers overestimate the MTF when there is
scattering produced, for example, by cataracts.
•It shows the effect of ocular aberrations on visual acuity (including higher
order aberrations, which are not usually taken intoaccount by most standard
aberrometers).
•It shows the effect of lacrimal film degradation on the quality of the retinal
image.
•Assessment of the Purkinje image of an eye without an implanted KAMRA™
inlay, detecting the exact position of its optical axis with respect to the center
of its pupil, and allowing one to see the position required for the correct
implantation of the KAMRA™ inlay.
•Assessment of the Purkinje image of an eye with an implanted KAMRA™
inlay, detecting the exact position of the implanted inlay with respect to its
optical axis, allowing one to quantify how close the implanted inlay has been
positioned with respect to its optimal position (the optical axis).

HD Analyzer™ Chapter 1: Introduction
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1.4 TECHNICAL SPECIFICATIONS OF THE HD ANALYZER™
1.4.1 Hardware specifications
Type B
Scope of measurements:
Between +5 D and -8 D E.E. (upper ametropias,
including astigmatism, must be neutralized with
an additional lens)
•Reproducibility: +/- 0.25 D
•Precision: +/- 0.25 D
Repeatability of the diopter
value with the best focus:
± 0.125 D of the middle point
Measurement of the natural
diameter of the pupil:
Automatic
•Precision: +/- 0.5mm (for a pupillary
diameter of 8mm)
Artificial diameter of the pupil:
From 2 to 7 mm
Image capture time:
240 ms
Laser diode wavelength:
780 nm
Selection of laser power:
Automatic
Maximum laserpower inpupil
plane:
45.39 μW
Best focus position:
Automatic
Fixation target:
Landscape with house
XY Movement:
Joystick
Size:
415 (L) x 350 (An) x 530 (Al) mm
Recommended work space:
2.5 m²
Weight:
20 kg
External power supply:
Entrance:
Exit:
100-240 VAC, 50-60 Hz, max. 1 A
12 V DC, 3.5 A, 42 W
Environmental conditions
Temperature
Relative humidity
Functioning
+10 ºC to +35 ºC
30% to 90%
Storage
-10 ºC to +55 ºC
10% to 95%.
Transport
-40 ºC to +70 ºC
10% to 95%
Regarding the Purkinje measurement:
Selection of laser power:
Automatic
Purkinje detection:
Error less than 142 μm in more than 95% of the
measurements.
Detection of offset Purkinje -
inlay KAMRA™
Detection of offset Pupil -
inlay KAMRA™

HD Analyzer™ Chapter 1: Introduction
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Class II
This symbol indicates that the degree of electrical
insulation of the HD Analyzer™ with respect to the
power feed parts is Class II. This means that there
is double electrical insulation, so a safety
grounding point is not necessary.
1.4.2 Program specifications
CPU:
Compatible with Pentium 1.6 MHz or higher
RAM:
512 MB minimum
Screen resolution:
Minimum 1280 x 768; recommended 1366 x 768
Operating system:
Windows XP, Windows Vista, and Windows 7 (32 bits)
Minimum USB ports
1 USB 2.0 port
1.4.3 Accessories
1.4.3.1 Computer (PC or laptop).
Used to run the instrument control program. Must meet the following minimum
specifications:
Processor:
2.10 Ghz, 3 MB
Screen resolution:
Minimum 1280 x 768; recommended 1366 x 768
Memory:
4 GB 1600 MHz DDR3
Hard drive:
320 GB
Operating system:
Windows XP, Windows Vista, and Windows 7 (32 and
64 bits)
Minimum USB ports
1 USB 2.0 port (2 recommended)
1.5 PRODUCT SERVICE LIFE
The power supply delivered with the HD Analyzer™ equipment has a 3-year service
life and must be replaced after this time.
This equipment must be operated by using a power supply
approved by Visiometrics.

HD Analyzer™ Chapter 1: Introduction
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VISIOMETRICS estimates that the useful life of the equipment, having properly
replaced the power supply, is 5 years. Regular use of the HD Analyzer™ over a 5-
year period places the dynamic elements of the equipment below 15% of their
service lives.
1.6 ACCURACY OF THE MANUAL
It is possible that some of the screens shown in the various images in this manual
do not match the visible screens of your program with total accuracy.
In any case, the possible differences will be due to different setup options.

HD Analyzer™ Chapter 2: Hardware installation
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2 HD ANALYZER™HARDWARE INSTALLATION AND
MAINTENANCE
2.1 HD ANALYZER™ INSTALLATION
Installation of the HD Analyzer™ equipment must be carried out by an authorized
installer.
The equipment is not designed to be portable. Once installed, moving it to another
location is discouraged. If it is necessary to move it to a nearby location, we
recommend that two people move it, lifting the instrument by its base, each person
on one side of the instrument.
Never seize the HD Analyzer™except from its base. The moving
part is very fragile and could damage the interior elements.
If transport to a distant location is necessary, you should contact your local
distributor or the manufacturer to carry out the packaging process correctly and the
subsequent installation at the new destination.
2.2 MAINTENANCE AND CALIBRATION
Calibration
It is recommended that you contact your distributor to perform a calibration once a
year. The user must not carry out any calibration work on this equipment, as this
must be carried out by specialized personnel.
The unit label contains the date of the next recommended calibration. In addition,
the program itself, in its setup, stores that date, so it will notify you 30 days before
that date, or when it detects that date has already passed.

HD Analyzer™ Chapter 2: Hardware installation
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Cleaning
The only maintenance operation to be performed on the equipment by the user is
cleaning, which must be performed as explained below.
Always unplug the HD Analyzer™ before cleaning. Wipe the plastic surfaces with a
soft cloth slightly moistened with water. Do not use solvents or abrasive cleaners.
Disinfection
The HD Analyzer™ has a risk of infection derived from its use since the patient is in
contact with the instrument through the skin via the chin and forehead that rest on
the chin rest, and through the hands with which they can grasp the chin rest.
This risk, which can be classified as Non-Critical, and as a consequence will only
require a low level of disinfection, is further minimized bythe use of protective paper
for the chin area (the instrument comes with an initial pack of 100 papers).
The patient is in contact with the instrument through intact skin via the chin and
forehead that rest on the chin rest, and through the hands with which they can grasp
the chin rest. These contact areas can be periodically disinfected using a
disinfectant with a low disinfection level suchas quaternary ammonium compounds.
It is recommended that this maintenance work be carried out on a quarterly basis.