PLUSOPTIX S12R User manual

User Manual
Plusoptix “Vision Screener”
Edition: 05.06.2020 / CA
Plusoptix GmbH
Nordostpark 21
90411 Nuremberg
Germany
www.plusoptix.de
English
“plusoptiX S12R”

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Thank you for choosing to purchase this device!
Please read this user manual before using the device for the first time!
It contains important information.
According to EU Medical Device Regulation 2017/745 concerning medical devices,
we are required to inform you of the duty to report serious adverse events. These
must be reported to the competent national authorities for medical devices and to
the manufacturer.
Table of contents
1. Intended use .................................................................................................................4
2. Responsibility of the operator........................................................................................5
3. Initial operation of the Plusoptix Vision Screener...........................................................6
3.1. Checking the scope of delivery and getting to know the device................................6
3.2. The home screen.....................................................................................................7
4. Starting a measurement and aligning the device...........................................................7
5. Maintenance, service and warranty.............................................................................10
6. Technical specifications ..............................................................................................11
Additional short manuals and training videos
In addition to this User Manual, you may access the short manuals available on our
homepage. These contain detailed descriptions of the additional functions of the device.
Simply scan one of the QR codes on the next page, or go to “Support” on our homepage
(plusoptix.com) to download the corresponding short manual. In addition to the short
manuals, you will also find training videos there.

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Short manuals
www.plusoptix.com/user-manuals
QR Codes
plusoptiX S1R
Short manual 1
Checking the scope of delivery and getting to know the device
1
Short manual 2
Adjusting settings and setting up WLAN
2
Short manual 3
Preparing and performing a measurement
3
Short manual 4
Viewing the measurement results
4
Short manual 5
Entering, retrieving or deleting patient data
5
Short manual 6
Documenting measurement results electronically
6
Short manual 7
Documenting measurement results on paper
7
Short manual 8
Exporting back-ups and reports
(only plusoptiX S12C and S16)
8
Short manual 9
Downloading software updates
9
Short manual 10
Troubleshooting malfunctions and measurement interruptions
10
S12R
S12R
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S12R

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1.Intended use
The used symbols have the following meaning:
Warnings are identified by this Attention symbol.
Tips & tricks are identified by this light bulb icon.
Only the included medical power adapter GSM36B12-P1J may be
connected to the device for power supply.
The Plusoptix Vision Screener is used for the early detection of vision disorders (preventive
eye care). These vision disorders can cause permanent loss of vision (amblyopia) if they are
not detected and treated in the early years of a child’s life.
To detect vision disorders, the Plusoptix Vision Screener measures the sphere, cylinder,
axis, line of vision and pupil size of both eyes at the same time. Using these measurement
values, the spherical equivalent, gaze symmetry and interpupillary distance are calculated.
All measurement values are compared with age-based referral criteria. “Refer” is
automatically displayed as a precautionary result for every patient requiring an
ophthalmologist appointment.
Note:
False-positive and false-negative results can occur in any type of preventive
examination.
Note:
Preventive eye care with the Plusoptix Vision Screener does not replace the eye
examination carried out by an eye care professional. An eye care professional
remains the only person qualified to interpret the measurement values and
establish a diagnosis. The measurement values must not be used directly to
prescribe glasses or contact lenses.
All patients who are not already being treated by an eye care professional should undergo a
preventive eye care examination. The first preventive eye care examination should be
performed before the child's first birthday. In the event of a family history of visual disorders,
an earlier preventive eye care examination at ages between 5 and 8 months is
recommended. The examination should then be repeated regularly, as the eyes can change
during growth and new visual disorders can manifest at any time.

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2.Responsibility of the operator
The operator is responsible for ensuring that only trained users work with the Plusoptix
Vision Screener.
Training
Training must at least include reading the user manual and a briefing on the operation of the
device. The briefing on the operation of the device is provided by Plusoptix, by Plusoptix
authorised dealers, or can be carried out by a previously trained user.
Electrical safety and electromagnetic compatibility
The operator is responsible for ensuring that external equipment connected to the device
meets the standards IEC 60601-1 and IEC 60601-1-2 in respect to electrical safety and
electromagnetic compatibility together with the equipment.
Attention:
The device may not be opened. Opening the device runs the risk of receiving an
(invisible) electric shock, and it will invalidate its approval as a medical device.
The operator is responsible for ensuring that the device is sent to Plusoptix or an
authorised Plusoptix dealer for service or warranty cases.
Attention:
If you insert batteries other than the supplied rechargeable batteries, only use
rechargeable Nickel Metal Hydride NiMH/AA HR6 batteries with a capacity of
1,900 to 2,100 mAh and a quick-charge rate of at least 1 A. When inserting the
batteries, check for the correct polarity.
In accordance with Standard IEC 60601-1-2, we are required to provide the following
warnings:
Attention:
The use of accessories, transducers and cables that have not been approved or
provided by the manufacturer may result in increased electromagnetic emission
or reduced electromagnetic immunity of the device resulting in faulty operation.
Attention:
Avoid use of the device next to or in conjunction with other equipment, as this
could result in faulty operation. If such a use is required, the devices should be
monitored to ensure correct function.

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3.Initial operation of the Plusoptix Vision Screener
3.1. Checking the scope of delivery and getting to know the device
Upon delivery, please check that the contents of the packaging are complete. If any parts are
missing, please notify the dealer immediately.
Scope of delivery:
- This User Manual
- Medical power adapter for power supply (GSM36B12-P1J)
- Power cord (in the compartment under the device)
- 6 x rechargeable AA batteries
- SD card (inserted into device)
Interfaces:
- 12V connection for medical power adapter
- USB interface
- Infrared interface (IR)
- SD card
- Mini USB interface
Turning the device on and off: -
Briefly press the power button on the handle to turn the device on. The screen will come on
immediately and the device will start up. After approx. 1 minute, the device is ready for use.
Briefly press the power button to turn the device off. The device will shut down.
Note:
If necessary, press and hold the power button to force the device to shut down.
For more information on the devices and their interfaces, refer to Short Manuals 1 and 2.
Power
button
Shutter
Figure 1: “plusoptiX S12R” rear view with touchscreen

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3.2. The home screen
After the start up, you will see the start screen. Similarly to all the screen displays of the
device, it has the following structure: the header is arranged at the top, the information part in
the middle, and the navigation bar at the bottom.
Figure 2: Home screen
4.Starting a measurement and aligning the device
- Select an age group by touching the appropriate age range on the time bar. You must
select the age group in order to ensure that the measurement values of the patient are
compared with the correct age-specific referral criteria.
- Hold the device at eye level to the patient, about 1.2 meters away. The measuring
distance is one meter, but it requires practice to correctly estimate this measuring
distance. It is easier to hold the device further away when starting the measurement and
then slowly move it towards the patient.
Figure 3: Measuring environment
1 meter
measuring
At eye level
No direct sunlight
Pupil diameter
Minimum 3 mm
Maximum 8 mm
Select age group
(see Chapter 4)
Make settings
Enter or retrieve
patient data
Date and time
Battery status
Status
SD card
Start measurement
(see Chapter 4)
View on-screen help
and training videos

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- Press the shutter on the handle or touch the flashing “GO” button (1) on the screen to start
the measurement; you will hear a warble sound. Instead of the start screen, you will now
see the camera image.
Note:
Touch the camera image if you wish to discontinue a started measurement.
Note:
The screen of the plusoptiX S12R is fixed at a 45° angle to the camera axis. Tilt
your wrists downwards to align the device.
- Align the device so that both eyes can be seen on the screen, and then slowly move the
device towards the patient until the camera image can be seen in high-definition on the
screen (individual hairs of the eyebrows and the eyelashes must be visible).
Note:
If a patient is not looking at the nose of the smiley face during the measurement,
this can cause a termination of the measurement. The nose and the knees of the
patient must always be directed towards the device.
1)
Figure 4: Aligning the plusoptiX S12R
Figure 5: Detecting the correct measuring distance

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- The end of the measurement is confirmed by a “PING” sound. After the measurement,
you will first see the “camera image” results page.
- Touch the appropriate icon in the middle of the navigation bar to access each of the three
results pages:
Note:
Tap the camera image to zoom into the pupils.
This allows you to accurately examine the pupils
for media opacities and abnormal reflexes
(Bruckner or red reflex test).
In addition to the measurement values, a screening result is displayed:
The measurement has been successfully completed and the “Refer”
or “Pass” screening result is displayed. “Refer” is automatically
displayed as a preAttentionary result for every patient requiring an
eye care professional appointment.
The measurement concluded without result and a “Try again” or
“Refer or Try again” status is displayed. In this case, check the
measuring environment (see figure 2).
Was the measurement discontinued due to direct sunlight, an
incorrect measuring distance or a too small or too large pupil size?
For more information on measurements without result, refer to Short
Manual 10.
For more information on performing a measurement and on viewing as well as documenting
the measurement results, refer to Short Manuals 3 to 7.
Results page
Camera image
Results page
Measurement values
Figure 6: Overview of the results pages

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5.Maintenance, service and warranty
This device is an opto-electronic measuring device. The mechanical structure and functional
principle is comparable to a video camera. If you handle the device as carefully as you
handle your own video camera, your device will provide you with many years of problem-
free, good service.
Maintenance and calibration
The device is maintenance-free and does not need calibrating. When it is not being used,
store it in the original packaging for safekeeping.
Cleaning
Use a slightly damp microfiber cloth for cleaning the device. Should it be necessary to
disinfect the device, use Bacillol 30 Tissues, Clorox Healthcare Bleach Wipes or Teccare
Control Tissues. These are approved for cleaning the device.
Service
If your device is not working correctly, please read the information on troubleshooting in
Short Manual 10 first. Please contact Plusoptix or a Plusoptix authorized dealer only if you
fail to find a solution in the manual.
Free software updates
Please check every 12 months to determine whether a new software version is available for
download. To access the free download of our latest software version, please go to “Support”
on our homepage.
Warranty
The device is supplied with a 12-month warranty from initial purchase. You may purchase an
extended warranty. Please contact Plusoptix should you wish to do so. The warranty is
invalidated in the case of external damage, improper use, incorrect cleaning or transportation
without the original packaging (device cardboard box or Plusoptix carrier bag). The warranty
is also invalidated if the device has been opened. External devices such as the SD card,
USB memory stick, keypad and mouse are not covered by the warranty.
Shipping the device
In the case of a warranty claim or required service, please send us the device in its original
packaging at your expense. After the repair, we will return it to you at our expense.
Note:
If patient data is stored on the device, it must be removed from the device for data
privacy reasons. Export a copy of your database prior to shipping, and re-import it
once you have received the repaired device. For more information on importing
and exporting patient data, refer to Short Manual 8.
Our address is:
in Europe:
Plusoptix GmbH
Nordostpark 21
90411 Nuremberg
Germany
Tel: [phone]
in North and South America:
Plusoptix Service & Warranty
Attn: Richard Christensen
8736 SE 165th Mulberry Lane
Suite 220
Lady Lake, Fl 32162

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6.Technical specifications
Requirements & directives
The device meets the requirements of Medical Devices Directive
2007/47/EC.
The device has been tested and certified for compliance with applicable US
American and Canadian standards by the Nationally Recognized Test
Laboratory (NRTL).
The device has been certified according to Brazilian requirements and may
therefore bear the INMETRO certification mark.
The device meets the requirements for a Type B application part as per IEC
60601-1.
The device can be stored and transported at temperatures between 0°C to
+50°C (i.e 32°F to 122°F). Operation requires a temperature between +10°C
and +40°C (i.e. 50°F to 104°F) at 20% to 80% relative humidity (non-
condensing).
Disposal
Do not dispose of the device as domestic waste. Please send the device to
Plusoptix for environmentally sound disposal. We will reimburse you for the
cost of the return.
Measurement values
Measurement value
Measuring range and tolerance
Sphere
-7 to +5 dpt in 0.25 dpt steps ± 0.25 dpt
Cylinder
-7 to +5 dpt in 0.25 dpt steps ± 0.25 dpt
Axis
1 to 180° in 1° steps ± 15°
Pupil diameter
3 to 8 mm in 0.1 mm steps ± 5%
Interpupillary distance
25 to 85 mm in 0.1 mm steps ± 5%
Gaze asymmetry
0 to 25° in 0.1° steps ± 2.62°
Head angle
-71 to +71° in 1° steps ± 0.75°
Gaze direction
-30 to +30° for 5 mm pupil size; in 0.1° steps ± 1,85°
Power supply
Power supply
(medical power adapter
GSM36B12-P1J)
Input
100–240 V AC, 50/60 Hz, 0.9–0.45 A
Output
12 V DC, 3A, 36 W max.
Rechargeable batteries
Type / size
Nickel metal hydride NiMH / AA HR6
Electric charge /
number
1,900 to 2,100 mAh / 6 pieces

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Operation, interfaces and standards
Touch screen operation
4.3 inch (resistive), Aspect ratio 5:3,(800 x 480 pixels)
Interfaces
12V, USB, IR, Mini-USB, SD
Standards
EN 60601-1
IR
Devices use infrared light with a wavelength of 870nm and a
maximum intensity of 135mW/sr.
Environmental conditions for operation and storage
According to standard IEC 60601-1-2, we are required to inform you that the device has
been designed for the environment category "Environment in areas of domestic health care,
except for vehicles and planes”. It must be stored in its original packaging. Do not place the
original packaging near heat sources (radiators, fan heaters, etc.). When you remove the
device from its original packaging, do not expose it to sunlight.
Storage
Temperature
0 to +50 °C (+32 to +122 °F)
Humidity
10 to 80 % non-condensing
Operation
Temperature
+10 to +40 °C (+50 to +104 °F)
Humidity
20 to 80 % non-condensing
Max. height
Max. storage height
<2000 m (6,560 ft)
Max.operating
height
<2000 m (6,560 ft)
Dimensions and weight with and without cardboard box
plusoptiX S12R
without cardboard
box
Dimensions (LWH)
5.90 x 7.87 x 5.31 in (150 x 200 x 135 mm)
Weight
38.80 oz (1,1 kg)
plusoptiX S12R
in cardboard box
Dimensions (LWH)
10.63 x 16.54 x 8.27 in (270 x 420 x 210 mm)
Weight
67.02 oz (1,9 kg)

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Manufacturer’s declaration on electromagnetic compatibility (EMC)
The device is intended for use in the electromagnetic environments listed below. Owners and users of the device are
responsible for ensuring that these environment conditions are met.
This product conforms to the EMC standard (IEC 60601-1-2).
Emissions test
Conformity
Electromagnetic environment –Instructions
RF Emission CISPR 11
Group 1
The radiation is low and causes no interferences with electronic
devices found nearby.
RF Emission CISPR 11
Category B
The device can be used in all areas which are connected to the
public electricity supply.
Harmonic Emissions
IEC 61000-3-2
Category A
Voltage fluctuations / flicker IEC
61000-3-3
Compliant
Attention:
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the device including cables. Otherwise,
degradation of the performance of this equipment could result.
Recommended safety distances between portable and mobile RF telecommunication devices and the device
The device is intended for use in an electromagnetic environment with controlled HF disturbance variables. The customer or user
of the device can contribute to avoiding electromagnetic disturbances by complying with the minimum distance between portable
and mobile HF telecommunication devices (transmitters) and the device – depending on the output power of the communication
device, as stated below.
Maximum output power of the
transmitter (in W)
Safety distance depending on the transmission frequency (in meters)
150kHz - 80MHz
d = 0.35 √ P
80MHz - 800MHz
d = 0.35 √ P
800MHz - 2.7GHz
d = 0.7 √ P
0.01
0.035
0.035
0.07
0.1
0.11
0.11
0.22
1
0.35
0.35
0.7
10
1.11
1.11
2.21
100
3.5
3.5
7
For transmitters, whose maximum nominal output is not stated in the above table, the recommended safety distance in meters
(m) can be calculated using the equation from the relevant column, wherein P equals the maximum nominal output of the
transmitter in watts (W) as per information by the transmitter’s manufacturer.
COMMENT 1 At 80 MHz and 800 MHz, the higher frequency range applies.
COMMENT 2 These guidelines may not be applicable in all cases. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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Immunity test
IEC 60601 test values
Conformity values
Electromagnetic environment –
Instructions
ESD IEC 61000-4-2
± 8 kV contact
± 2, 4, 8, 15 kV air
± 8 kV contact
± 2, 4, 8, 15 kV air
The floor should be made of wood,
ceramic or stone. If the floor is
covered with a synthetic material,
the relative air humidity should not
be less than 30%.
Electrical fast transient /
burst
IEC 61000-4-4
± 2 kV
± 2 kV
Only outlets that are usually
available in domestic or clinical
areas should be used.
Surge
IEC 61000-4-5
± 0.5 kV
± 1 kV
± 2 kV
± 0.5 kV
± 1 kV
± 2 kV
Voltage dips, short
interruptions on
power supply input lines
IEC 61000-4-11
0% 0.5 cycles
@ 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0% 1 cycle
70% 25 cycles
0% 250 cycles
0% 0.5 cycles
@ 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°
0% 1 cycle
70% 25 cycles
0% 250 cycles
Power frequencies (50/60
Hz) and magnetic fields
IEC 61000-4-8
30 A/m, 50/60Hz
30 A/m, 50/60Hz
Magnetic fields should not exceed
the usual ranges.
Conducted RF
disturbances
IEC 61000-4-6
3 V
0.15 MHz –80 MHz
6 V
in ISM and amateur
radio bands between
0.15 MHz and 80 MHz
80 % AM at 1 kHz
3 V
0.15 MHz –80 MHz
6 V
in ISM and amateur
radio bands between
0.15 MHz and 80 MHz
80 % AM at 1 kHz
120V / 60 Hz
230V / 50 Hz
3 V
0.15 MHz –80 MHz
6 V
in ISM and amateur
radio bands between
0.15 MHz and 80 MHz
80 % AM at 1 kHz
3 V
0.15 MHz –80 MHz
6 V
in ISM and amateur
radio bands between
0.15 MHz and 80 MHz
80 % AM at 1 kHz
120V / 60 Hz
230V / 50 Hz
Portable and mobile radio
equipment must not be operated in
a distance to the device (including
the electrical lines) less than the
recommenced safe distance
calculated using the appropriate
equation for the transmission
frequency.
Recommended safe distance:
d=(3.5/10) x √ P
d=(3.5/10) x √ P 80MHz - 800MHz
d=(7/10) x √ P 800MHz - 2,7GHz
where P is the maximum output
power rating of the transmitter in
watts (W) as indicated by the
transmitter manufacturer and d is
the recommended safe distance in
metres (m).
The field strength of fixed RF
transmitters
as determined by a site survey
should be less than the
compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked by
the
pictogram shown.
Radio-frequency
electromagnetic fields
IEC 61000-4-3
10 V/m
80 MHz - 2.7GHz
80% AM, 1KHz
27 V/m
385 MHz
PM 50%, 18 Hz
28 V/m
450 MHz
PM 50%, 18 Hz
9 V/m
710,745,780 MHz
PM 50%, 217 Hz
28 V/m
810, 870, 930 MHz
PM 50%, 18 Hz
28 V/m
1720, 1845, 1970 MHz
PM 50%, 217 Hz
28 V/m
2450 MHz
PM 50%, 217 Hz
9 V/m
5240, 5500, 5785 MHz
PM 50%, 217 Hz
10 V/m
80 MHz - 2.7GHz
80% AM, 1KHz
27 V/m
385 MHz
PM 50%, 18 Hz
28 V/m
450 MHz
PM 50%, 18 Hz
9 V/m
710,745,780 MHz
PM 50%, 217 Hz
28 V/m
810, 870, 930 MHz
PM 50%, 18 Hz
28 V/m
1720, 1845, 1970 MHz
PM 50%, 217 Hz
28 V/m
2450 MHz
PM 50%, 217 Hz
9 V/m
5240, 5500, 5785 MHz
PM 50%, 217 Hz
COMMENT 1 At 80 MHz and 800 MHz, the higher frequency range applies.
COMMENT 2 These guidelines may not be applicable in all cases. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.