PLUSOPTIX S12R User manual

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Mobile Vision Screener
"plusoptiX S12R"
User Manual
Release: 2014-06-02
Plusoptix GmbH
Neumeyerstrasse 48
90411 Nuremberg
Germany
www.plusoptix.de
Please read this user manual before use! It explains the basic functioning of the
device. Once the device has been switched on, additional information can be
called up by touching the blue "i" button on screen. This additional information
describes the individual screenshots in detail.

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Contents
1Use According to Purpose and Responsibility of the Operator..................................4
2Commissioning the Device .......................................................................................6
2.1Checking the scope of delivery.................................................................................6
2.2 Learning about the device........................................................................................7
2.3 Inserting and charging the batteries .........................................................................9
2.4 Switching the device on and off..............................................................................10
2.5 Screen displays and help texts...............................................................................11
3Performing Measurements......................................................................................12
3.1 Environmental considerations ................................................................................12
3.2 Preparing for a measurement.................................................................................13
3.3 Starting a measurement and positioning the camera..............................................14
3.4 Checking and documenting measurement results..................................................17
3.5 Perform next measurement....................................................................................20
4Practical Tips..........................................................................................................21
4.1 Handling clues........................................................................................................21
4.1.1 Adjust settings........................................................................................................21
4.1.2 Customize basic settings........................................................................................22
4.1.3 Choose referral criteria ...........................................................................................23
4.1.4 Compatible printer ..................................................................................................25
4.1.5 USB interface .........................................................................................................25
4.1.6 Micro-USB and SD card interface...........................................................................25
4.2 Trouble-shooting guide...........................................................................................26
4.2.1 Trouble-shooting when switching device on............................................................26
4.2.2 Malfunctions when using touch screen ...................................................................27
4.2.3 Error messages when performing a measurement..................................................28
5Maintenance, Calibration, Servicing and Warranty..................................................36
6Technical specifications..........................................................................................37
6.1Measurements .......................................................................................................37
6.2 Interfaces and standards........................................................................................37
6.3 Power supply and rechargeable batteries...............................................................37
6.4 Ambient conditions for operation and storage.........................................................37
6.5 Size and weight with and without cardboard box....................................................37
6.6 Guidance and manufacturer´s declaration –electromagnetic emissions/ immunity 38

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Table of figures
Figure 1: Device in cardboard box......................................................................................... 6
Figure 2: Front view of the device.......................................................................................... 7
Figure 3: Rear view of the device .......................................................................................... 8
Figure 4: Battery compartment view of the device................................................................. 9
Figure 5: Switching between a screen and the help text.......................................................11
Figure 6: Measuring environment.........................................................................................12
Figure 7: Holding the camera and operating the shutter.......................................................14
Figure 8: Positioning camera at the correct angle.................................................................14
Figure 9: Recognizing correct measurement distance..........................................................15
Figure 10: Overview of measurement result pages...............................................................17
Figure 11: Sensitivity, Specificity, False-Positive-Rate and False-Negative-Rate .................24
Figure 12: Self-adhesive label sample..................................................................................25
Table of screenshots
Screenshot 1: Setting date and time.....................................................................................10
Screenshot 2: Start screen with selected age group.............................................................13
Screenshot 3: Review video screen......................................................................................18
Screenshot 4: Check measurement result screen ................................................................19
Screenshot 5: Start screen with a pre-selection of the last age group measured..................20
Screenshot 6: Settings overview ..........................................................................................21
Screenshot 7: Basic settings ................................................................................................22
Screenshot 8: Choose referral criteria..................................................................................23
Screenshot 9: Help text page 2 with referral criteria benchmarks .........................................23
Screenshot 10: Measurement result page after a "Measurement cancellation" ....................28

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0123
1 Use According to Purpose and Responsibility of the Operator
Please observe the directions in this user manual. In doing so, you will avoid risks and obtain
correct measurement results. The symbols used have the following meanings:
Read this user manual.
Warning notes are designated using this warning symbol.
Mobile Vision Screener "plusoptiX S12R" complies with the specifications of
Guideline 2007/47/EG for medical devices.
Mobile Vision Screener "plusoptiX S12R" complies with the specifications of an
application part of type B in EN 60601-1.
Only connect Mobile Vision Screener "plusoptiX S12R" to the supplied medical
power adapter MES30B-3P1J.
Only use AA NimH rechargeable batteries with a capacity of at least 1900 mAh
and a quick-charge rate of min. 1 A, e.g. Sanyo HR-3UTGA 1.2V.
On/Off button (pressure-operated)
The device can be stored and transported at temperatures from 0°C to +50°C
(32°F to 122°F). A temperature between +10°C and +50°C (50°F to 122°F) with
non-condensing air humidity between 20% and 80% is required for operation.
Do not discard the device in household rubbish. Please send the device to
Plusoptix (Plusoptix GmbH, Neumeyerstrasse 46, 90411 Nuremberg, Germany)
for environmentally friendly disposal. Plusoptix will reimburse you the costs for
return of the device.
0°C
+50°C
12V

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Use according to purpose
Mobile Vision Screener "plusoptiX S12R" measures the sphere, cylinder, axis, gaze and
pupil diameter in both eyes simultaneously (binocular) in a non-dilated pupil (miosis). These
measurement values are used to calculate gaze asymmetry and inter pupillary distance.
Anisometropia can only be detected in miosis reliably by means of a binocular refraction
measurement. In this regard, it is irrelevant whether the child accommodates during
measurement, as the refraction differential of both eyes remains constant, despite
accommodation.
The spherical measurement values take into account +1.00 dpt to compensate for the
accommodation on the camera at a distance of one meter. Manual correction is not required.
The interpretation of the measurement values for recommending therapy is
reserved exclusively for the eye care professional.
The measurement values may not be used directly for the prescription of glasses
or contact lenses.
Responsibility of the operator
The operator must ensure that only trained users operate the device. At a minimum, the
training must consist of reading this user manual and instruction in the use of the device. A
user already trained can perform instruction in the use of the device. In addition, training is
offered by Plusoptix and authorized Plusoptix distributors.
The operator is responsible for ensuring that external devices connected to
Mobile Vision Screener "plusoptiX S12R" comply with the EN 60601-1 and EN
60601-1-1 norms together with the device.
The operator is responsible for ensuring that in the case of servicing or a
warranty claim, Mobile Vision Screener "plusoptiX S12R" is only opened by
Plusoptix or an authorized Plusoptix distributor. Opening the device exposes you
to a risk of an invisible electric shock. In addition, the device warranty becomes
null and void, as does the approval as a medical device.

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2 Commissioning the Device
Thank you for purchasing a Mobile Vision Screener "plusoptiX S12R". Plusoptix is the world
leader in the development, production and distribution of medical devices for pediatric
ophthalmic examination. Please contact us should you have further questions after reading
the user manual.
2.1 Checking the scope of delivery
The device is supplied in a cardboard box with foam padding that protects the device from
damage. If the device packaging shows signs of damage at the time of delivery, please
inform the seller of the device immediately.
Figure 1: Device in cardboard box
Please check that the contents of the packaging are complete at time of delivery. The scope
of delivery includes:
- Mobile Vision Screener "plusoptiX S12R"
- Power adapter (medical) with 12V charging cable
- 220V power cord (in compartment under the "plusoptiX S12R")
- 6 x AA batteries (rechargeable)
If the delivery is incomplete, please inform the seller of the device immediately.
6 AA batteries
220V power
cord
Power adapter
with 12V
charging cable
plusoptiX
S12R

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2.2 Learning about the device
During a measurement, the device records a series of images. To attract the attention of the
child during the measurement, the device plays a "warble" sound. The speaker required for
this is located behind the vertical slits on the front side of the device.
The camera lens and the LEDs required for illuminating the images are located behind the
black protective shield with the stylized face. This face is also used as a fixation aid.
Do not use additional, external fixation aids! If a child does not look at the camera
lens behind the hexagonal nose in the center during the measurement, this can
cause a measurement to abort or lead to incorrect measurement values for gaze
asymmetry.
To prevent the protective shield from becoming dirty, we recommend that you do not touch it.
If the protective shield does become dirty, read chapter 5 "Maintenance, Calibration,
Servicing and Warranty" for cleaning instructions.
Speaker
Protective
shield
with face
ciwegvmmitmm
mmmmmmm
Camera lens
behind
hexagonal nose
Figure 2: Front view of the device

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The 4.3 inch screen with resistive touch sensor is located on the rear side of the device. To
activate a function shown on the screen, all you need to do is tap the screen with your
fingertip. Screen and touch sensor are protected behind a thin transparent plastic cover.
Please note that this plastic cover can scratch with improper use.
Figure 3: Rear view of the device
Two orange buttons are visible –the On/Off button (on the right side below the screen), and
the Shutter (on the handle to the right, next to the screen). Chapters 2.4 "Switching the
device on and off" and 3.3 "Starting a measurement and positioning the camera" deal with
the functions of these buttons.
The device has three interfaces –USB, Micro-USB and SD card –which are located in the
center below the screen. Chapters 4.1.5 "USB interface" and 4.1.6 "Micro-USB and SD card
interface" explain how to use these interfaces.
All interfaces are mounted upside down. This means that all media (i.e. USB
flash drives, micro-USB plugs and SD cards) must be connected with the upper
side facing down.
The left lower edge contains the connection for the 12V charging cable of the medical power
adapter.
Screen
Shutter
On/Off button
12V input
USB
Micro USB
SD card

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2.3 Inserting and charging the batteries
To insert the batteries, please put the device on a level working surface on its rear side.
Please place a soft cloth under the device to prevent the glass shield from becoming
scratched. Now remove the battery compartment cover using a 1-cent coin, and insert the
supplied batteries.
Figure 4: Battery compartment view of the device
When inserting batteries, please ensure that the contacts are located on the
correct side. If you insert batteries other than those supplied, you should
exclusively use rechargeable Nickel Metal Hydride NiMH/AA HR6 batteries with a
capacity of at least 1900 mAh and a quick-charge rate of min. 1 A.
The type plate with the serial number (S/N 1202S-xxx-xxxxxxxx) is located under the battery
compartment.
If you contact us regarding extended service or warranty questions, please
remember to always quote the serial number of your device. The S/N number
helps us to answer your question quickly.
After inserting the batteries, close the battery compartment cover and place the device in
front of you. Now connect the medical power adapter with its power cable to the wall socket
and check whether voltage is present (green light diode at the top of the medical power
adapter lights up). Then connect the 12V charging cable of the medical power adapter to the
device.
The inserted batteries will now be charged automatically. The charging time of the batteries
depends on the charge level of the batteries. The maximum battery charging time is 3 hours.
+
-
+
-
+
-
+
-
+
-
+
-
+
-
Battery
compartment
Type plate

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2.4 Switching the device on and off
To switch on the device, briefly press the On/Off button. The screen switches on immediately
and the device is booted. The device is ready for use after approx. 25 seconds. After
inserting the batteries, the date and time settings page is displayed on the screen.
The time and date format selected is highlighted in color (1). Set the current date and time by
touching the green arrows (2 or 3). Use Checkmark button (4) to confirm your entries. You
can change the date and time as well as the display formats at a later stage in Settings (5)
(see chapter 4.1.2 "Customize basic settings").
If the device is not used for 30 seconds, the screen switches off automatically
(stand-by mode). Touch the screen to reactivate it. If the device is not used for 5
minutes, the device switches-off completely. To switch on again, you need to
press the On/Off button. These two time windows can be individually adjusted in
Settings (5) (see chapter 4.1.2 "Customize basic settings").
To switch off the device, briefly press the On/Off button. The screen switches off immediately
and the device is shut down. If the screen does not switch off, press and hold the On/Off
button until the screen switches off.
1) 2) 3) 4) 5)
Screenshot 1: Setting date and time
Buttons for
time format
Buttons for
date format

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2.5 Screen displays and help texts
All screen displays are designed in the same manner. The Header is located at the top, the
Information section in the center, and the Navigation bar at the bottom.
The header displays date and time on the left side battery status (1) on the right side. A
warning symbol (2) appears if the batteries require recharging. Battery status symbol (1)
flashes once 12V charging cable is connected and the batteries are being charged.
In the Navigation bar, active buttons are displayed in color and inactive buttons in gray.
Touch Information button (6) to open a help screen. Use Cancel button (5) to close help
screen. Help screen explains the buttons for the screen view in question. To save space, the
buttons are replaced by sequential numbers in the text (as is the case here). The lower part
of the help screen displays the buttons that the numbers represent. All buttons that are
displayed on the help screen are inactive. These buttons are displayed in color for a better
visualization only.
1) 2) 3) 4) 5) 6)
Figure 5: Switching between a screen and the help text
Information
section
Navigation bar
Buttons
explained in
the help text
Help text
Header

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3 Performing Measurements
Mobile Vision Screener "plusoptiX S12R" measures both eyes simultaneously (binocular) in
0.5 seconds at a distance of one meter (3.3 feet). Therefore even small children with a short
attention span can be measured starting at age six months. The simultaneous measurement
of both eyes also enables a reliable comparison of the measurement values of both eyes.
3.1 Environmental considerations
The device uses infrared light to perform measurements. The same infrared light is part of
sunlight and emitted by all incandescent light sources such as light bulbs and halogen spots.
This infrared light is invisible to the human eye and nonhazardous. To obtain accurate
measurements it is important to avoid interfering infrared ambient light in the examination
room. Curtains, blinds or shutters should be closed to exclude sunlight. Switch off all heat-
emitting light sources. However, examination room does not need to be dark. Cold light
sources such as energy saving lamps or neon tubes do not affect measurement results.
Figure 6: Measuring environment
To be able to perform a measurement, the child must look at the device. Ensure that the
child is sitting straight and does turn his head across the shoulder. The child's knees and
nose must point towards the camera.
The attentiveness of small children is attracted by playing a special "warble" sound on the
device. However, this works only if the child is not distracted by other persons or objects in
the examination room. Ensure that you close the door to the examination room and avoid
activities that divert the child's attention such as walking around or snapping your fingers. Do
not use additional fixation aids!
1 meter measuring
distance
At eye level
See chapter 4.2
No direct sunlight
See chapter 3.5
Pupil diameter
Minimum 4 mm
Maximum 8 mm

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The attention span of small children is extremely short. Take advantage of the fact that the
examination room is new to the child. An unusual "warble" sound in this unfamiliar
environment always evokes interest. Enter the patient data into the device before calling the
child into the examination room or after completing the measurement. Avoid protracted
information exchange with parents before the measurement.
3.2 Preparing for a measurement
You need to define the age group of a patient prior to performing a measurement. Selecting
an age group is necessary to make sure that readings are compared to correct age-specific
referral criteria. Numbers in age group buttons (1) indicate age of patient in months (e.g. 30-
50 represents children aged between the first day of the 30th month and the first day of the
50th month).
Screenshot 2: Start screen with selected age group
Once you touch an age group button (1) it is highlighted in orange (2) to confirm your
selection.
1) 2)

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3.3 Starting a measurement and positioning the camera
Hold the device as you would hold a tablet PC and press the Shutter with your right thumb.
Place the device approximately 1.2 meters (4 feet) away from the child at eye level. Although
the measurement distance is one meter (3.3 feet), a degree of practice is required to
estimate this distance. It is easier to hold the device a little further away at the start of a
measurement and then to move it slowly towards the child.
The screen is fixed at a 45° angle to the camera axis. Tilt your wrists downwards
to align the camera.
Figure 8: Positioning camera at the correct angle
Figure 7: Holding the camera and operating the shutter

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Align camera so that both eyes can be seen on the screen. Then slowly move towards
patient until camera picture on screen is in clear focus. In the beginning the pupils are framed
with white boxes (i.e. the picture is blurred), then by red circles and finally by green circles.
Stop moving once a green line is plotted in between both pupils and a second “warble” sound
can be heard. The measurement starts at this point in time automatically.
A "ping" sound signals that the measurement is complete. In addition to the camera image,
the measurement results are now also displayed on screen.
The picture is blurred. The head of the patient is seen almost completely, because the
measurement distance is too big. Move the device towards the patient until the picture is in
clear focus (see next picture).
The picture is blurred. The eyes are close to the edge of the screen, because the
measurement distance is too small. Move the device away from the patient until the picture
is in clear focus (see previous picture).
The picture is in clear focus. Both pupils are framed by a green circle, the line between the
pupils appears in green and an additional "warble" sound can be heard. The device is now
one meter from the child, and the measurement begins automatically. This second "warble"
sound ensures that the child continues to look at the camera during the measurement.
Refrain from moving the device, and wait until the measurement is complete.
Figure 9: Recognizing correct measurement distance

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If you do not obtain measurement results, check whether the following
measurement prerequisites are met:
a) Measurement distance is correct:
Measurement distance must be in between 95 cm (3.1 feet) and 105 cm (3.9
feet). Check whether the camera image on screen is in focus. You should be
able to see individual hairs of eyelashes and eyebrows on screen.
b) Patient is looking at the camera lens:
The device and the patient's eyes must be aligned with one another. The
patient must be looking at the hexagonal nose in the camera face. Therefore
avoid additional fixation aids. Check whether green dots are plotted in Gaze
charts.
c) Both pupils of the patient can be seen completely:
Both pupils must not be covered by eyelids, eyelashes, eyebrows or long hair,
for example. Check whether you can see both pupils completely on screen
and that both are encircled in green.
d) Pupil sizes are between 4 and 8 mm:
Both pupils must have a diameter in between 4 and 8 mm.
If a red error message is displayed, please read chapter 4.2.3 “Error messages
when performing a measurement”.

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3.4 Checking and documenting measurement results
Screen size is limited and therefore measurement results are presented on two screens for
better readability. These two measurement result screens are:
Review video screen
Check measurement results screen
To exit these two measurement result screens, i.e. to return to the Start screen
and to perform another measurement, you have to press the Shutter.
Touch green arrows (1) and (2) located in Navigation bar to toggle in between measurement
result screens. An orange dot in between the arrows (1) and (2) indicates which of the three
measurement result screens is displayed.
Whenever you touch Print button (2), an additional print job will be added to print
spooler. As soon as the compatible printer is connected (see chapter 4.1.4
“Compatible printer”) it will print all print jobs in chronological order.
All print jobs in print spooler are deleted once device is switched off or switches
off for power saving automatically.
1) 2) 3)
Figure 10: Overview of measurement result pages
Check measurement results screen
Review video screen

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Review video screen
A “pass” or “refer” screening result is displayed in the status line immediately after a
measurement was performed. After an inconclusive measurement, an error message is
displayed in the status line. In this case read chapter 4.2.3 "Error messages when performing
a measurement". To measure the same patient again, simply press the Shutter twice (once
to return to Start screen and a second time to start the next measurement for the same
patient). You do not need to touch the screen during this process.
Touch Play button (1) in navigation bar to play back the entire measurement video in slow
motion. During playback Play button (1) is replaced by Pause button (2). Touch Pause button
(2) to interrupt playback and inspect a single picture closely. The inspection of images is
primarily used for detecting media opacities that do not cause a measurement to abort.
Touch Play button (1) to continue playback.
Check after every measurement whether both pupils are equally bright and
whether structures are visible within the pupils. If brightness is different or
structures can be seen, the eyes need to be examined closely.
Video pictures can help identifying the reason for a measurement to abort. Pay attention to
both pupils. They have to be visible entirely and must not be covered or partly covered by
hair, eyelashes or eyelids for example.
1) 2)
Screenshot 3: Review video screen
Status line

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Check measurement result screen
Measurement results for Spherical equivalent (SE), Cylinder (CYL), Axis (A) and Pupil
diameter (Ø) are displayed separately for right eye (OD) and left eye (OS). Measurement
results for Pupil distance (PD) and Gaze asymmetry (ASY) are displayed below.
If measurement results exceed measurement range, only hyperopia (HYP) or myopia (MYO)
is displayed instead of a quantitative numerical value.
Gaze charts are displayed for each eye on left and right screen borders. These illustrate the
lines of vision during measurement. Red dots are plotted if an eye is aligned more than 10
degrees off camera axis (i.e. outside the inner circle). In this case measurement is aborted
inconclusively. Make sure patient looks at the hexagonal nose within camera face when
repeating the measurement. Avoid distractions within the examination room, and do not use
additional fixation aids.
The device compares the line of vision of both eyes and indicates the extent of Asymmetry
(ASY) in between. In this regard, an ASY of 0° indicates perfect symmetry. Asymmetric lines
of vision can be caused by strabismus or decentral fixation. The angle displayed on screen is
not the angle of strabismus!
Screenshot 4: Check measurement result screen
Gaze chart OS
Status line
Gaze chart OD

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3.5 Perform next measurement
Press Shutter to return to start screen. You can return directly to start screen from any
measurement result page or settings page or help text page by pressing the shutter.
Pressing Shutter deletes video file and measurement results from RAM memory.
Once Shutter has been pressed last video file cannot be reviewed and
measurement results cannot be printed or saved any more.
If you want to measure the same patient or a coeval patient you do not need to touch the
screen. The pre-selected age group (1) is pre-set. Hold on to the device and simply press the
shutter.
You have to let one hand go and touch the screen only if you want to measure an older or
younger patient. Select the age group of the following patient and start the measurement by
pressing the shutter.
1)
Screenshot 5: Start screen with a pre-selection of the last age group measured