PLUSOPTIX PowerRef 3 User manual

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PowerRef 3 - plusoptiX R09
Binocular Pupillometer - plusoptiX P09
INSTRUCTION MANUAL
(Version 31.07.2019 / 5.0.22.0)
Plusoptix GmbH
Neumeyerstr. 48
90411 Nuernberg
Germany
www.plusoptix.eu
Englisch

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Table of contents
1. Safety instructions........................................................................................4
1.1 Warning and Symbols .................................................................................................4
1.2 Handling of the plusoptiX R09....................................................................................5
1.3 Exclusive use of the plusoptiX R09 ............................................................................5
1.4 Operation of the plusoptiX R09...................................................................................5
1.5 Duties of the operator ..................................................................................................5
2. Delivery.......................................................................................................6
2.1 Storage.........................................................................................................................7
2.2 Unpacking....................................................................................................................7
2.3 Setting up.....................................................................................................................7
3. Connecting and switching on the system....................................................8
3.1 Connection...................................................................................................................8
3.2 Switching on the system..............................................................................................8
4. Settings.......................................................................................................11
4.1 General (Basic settings).............................................................................................11
4.2 System .......................................................................................................................12
5. Measurement procedure.............................................................................13
5.1 Measurement procedure predefined Measurement Routine......................................13
5.2 Documentation Logfile..............................................................................................18
5.3 Viewing the video of the last measurement............................................................... 19
5.4 Storing a video...........................................................................................................19
5.5 Loading a video .........................................................................................................20
6. Predefined measurement routines..............................................................21
6.1 Graphical output ........................................................................................................ 21
7. How to create your own Measurement routines........................................24
7.1 How does it work?.....................................................................................................24
7.2 Using qemacs.............................................................................................................24
7.3 Create the command set for the measurement...........................................................24
7.4 Example: Standart_10sec.pox ...................................................................................25
7.5 Link the graphical output with the measurement routine..........................................25
8. Logging external events.............................................................................26
8.1 How does it work?.....................................................................................................26
8.2 How to install?...........................................................................................................26
9. Remote control...........................................................................................27
10.Switching off the system............................................................................28

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11. Measurement setup........................................................................................28
12. Warranty........................................................................................................29
13. Service and maintenance ...........................................................................29
13.1 Service .......................................................................................................................29
13.2 Maintenance...............................................................................................................30
14. Practical tips..................................................................................................30
14.1 Measurement results..................................................................................................30
14.2 Troubleshooting.........................................................................................................31
15. Specifications ................................................................................................32

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0123
1. Safety instructions
Please read all of the instructions in this manual by all means in order to avoid any
danger to life and health, to achieve reliable measurement results and to obtain the
device in good working conditions.
1.1 Warning and Symbols
ATTENTION: This symbol is intended to advise the user of the presence of
important operating or maintenance requirements.
Service or repair to be performed by qualified authorized personnel only.
There are no user serviceable parts inside the instrument. Opening this
device can expose the user to harmful invisible electrical shock.
Note: Disassembly of plusoptiX R09 device will void the warranty. Refer
all servicing to Plusoptix authorized service representatives listed in
the section Service and Maintenance (Chapter 11).
Do not sterilize the plusoptiX R09 device or any of the components.
CAUTION: Use of controls or adjustments or performance of procedures
other than those specified herein may result in wrong
measurements.
The CE mark on this device indicates that it has been tested and conforms
to the provisions noted within the 2007/47/EG Medical Device Directive.
At the end of life time (electronic waste).
ESD sensitive device: Discharge human body by touching a grounded plane
or use ground strips before installation or touching the connectors.
This symbol shows that this product keeps the requirements for an
application part type B of EN 60601-1.

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1.2 Handling of the plusoptiX R09
The plusoptiX R09 is an optical electronic measuring device. The construction and
functionality of the plusoptiX R09 is very similar of a video camera / camcorder. So,
please handle the device as carefully as you would use your own camcorder. If you
follow this advice, the plusoptiX R09 will last you for many years without any trouble.
1.3 Exclusive use of the plusoptiX R09
The exclusive use the plusoptiX R09 device is to measure dynamic refractive data,
asymmetry of the corneal reflexes, pupil size and pupil distance in real time. Both eyes
are measured at the same time (binocular) from one meter (3.3 ft) away from the
patient.
Note: The measurement is from one meter distance to the patient and so +1.00 dpt
accommodation is included into the measurement result.
This measurement setup should only be used for research purposes. Also it
should only be used by trained persons.
1.4 Operation of the plusoptiX R09
Check all cable connections from the mains as well as the VGA cable
between the plusoptiX R09 device and the monitor. Be sure the keyboard
and the mouse is switched on.
Make sure that any cables or connectors which show any damage are
replaced before switching on the plusoptiX R09 system.
Use only the delivered power adapter and the delivered cables.
The plusoptiX S09 complies with the requirements of the directive of medical devices
2007/47/EG.
1.5 Duties of the operator
The operator must ensure that only personnel who have been trained in handling of the
plusoptiX R09 are permitted to operate the system. All users must read the operating
manual and take note of the safety instructions and provisions.
Note: Training courses on the operation of the plusoptiX R09 subject to safety notes
and provisions for medical products are available on request.
Do not connect systems other than those supplied by Plusoptix.

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2. Delivery
The plusoptiX R09 device is delivered in a paper carton. The following information is
printed on the carton:
Only 5
cartons on
each other
This side
up
Fragile
Keep dry
Carton
manufactorer
CE conform
Recycleable
Inside the paper carton the measuring device is placed in a preformed inset to avoid
damages to the plusoptiX R09 device during transportation.
Paper carton size: 51 cm x 41 cm x 20 cm (20 inches x 16 inches x 8 inches)
Preformed insert: Polyurethane foam (volume weight 28 kg / CBM)
Weight: 3.5 kg (7.7LB) carton including plusoptiX R09 device
In case the paper carton shows any damages which may be caused by external force
during transportation, e.g. careless loading or unloading, please do not accept the
delivery and inform the company you have purchased the device from.
Cradle
Cover
Camera
Medical power
unit
Cables
1 USB Stick

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2.1 Storage
The plusoptiX R09 device can be stored in the original package when the storage room
fulfils the following requirements:
Temperature: 0°C to +50°C (32°F to 122°F)
Humidity: 10% to 85% (no condensation)
Keep the plusoptiX R09 device away from any heat source.
2.2 Unpacking
Open the carton only in position „This side up“.
After unpacking the plusoptiX R09 please check that all items are delivered which are
listed on the delivery note. Missing items can only be replaced when a claim has been
forwarded to the company you have the device purchased from within one week after
accepting the delivery.
Note: Please keep the original packing material in case later transportation may be
required.
Do not store the packing material in a room with an open fire place.
2.3 Setting up
When you set up the plusoptiX R09 make sure that no cable can be reached by
Probands.
Protect the plusoptiX R09 from direct sunlight.

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3. Connecting and switching on the system
3.1 Connection
For operation, the plusoptiX R09 must be connected to a monitor and keyboard with a
mouse. The monitor must fulfill the following system requirements:
Resolution: 1024 x 768 pixels
Interface: VGA
Four (4) USB ports of type A are available on the plusoptiX R09 for connecting e.g.
keyboard, mouse or USB-sticks.
Where a monitor is already available at a workstation, a switch (Monitor Switch TK 207
by “Trendnet”) can be used to connect this monitor to the plusoptiX R09. This allows
you to save space by using the monitor for the plusoptiX R09.
Connect the VGA cable from the monitor to the plusoptiX R09. The keyboard and
mouse can be connected to the plusoptiX R09 by means of a USB cable or a wireless
USB adapter. Attach the 12V DC connector to the plusoptiX R09 and the medical
power unit to a 110 –220 V AC (50 –60 Hz) power plug. Ensure that the power plug is
switched off after close of business. This is a precaution in case a short-circuit occurs
during night-time which may cause a fire.
Fig. 1: Location of the connectors on the plusoptiX R09
on/off switch
4 x USB
VGA
12VDC
RJ-45

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3.2 Switching on the system
Switch on the monitor before you switch on the plusoptiX R09.
After loading the software (approx. 1.5 minutes) the “plusoptiX R09 Start Page”
appears.
Note: When using the system for the first time, first click on “Settings”to adjust the
settings as required for operation.
plusoptiX R09 Start Page
This brief description only appears after the
system has been switched on.
Please make sure that no USB-stick is inserted in the plusoptiX R09 during switching
on, because it can lead to problems during booting.
Now plug in the delivered USB-stick. This USB-stick contains a normal Measurement
procedure and the files for the graphical output.
Settings
Instruction manual

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After the USB Key is inserted the plusoptiX R09 it will be detected automatically.
Now you are able to choose “Standart” on the Program.
Now the plusoptiX R09 is ready for measurement.

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4. Settings
For the first start-up it is recommended to adapt settings e.g. general (basic settings),
system to your custom conditions. With the exception of the general settings appears at
the “System” page a security query, where you have to type in “YES”, to perform
settings if you are authorized to do that. If you are not authorized click on “Cancel”.
Then you just can have a look at the existing settings and not perform any settings.
4.1 General (Basic settings)
Click on “Settings” and then on
"General" to perform basic settings.
Click here to switch the video image on the monitor from black and white to false colors. You
can see the brightness profile of the pupils in color.

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4.2 System
The system settings have been carried out by the company you have bought the device
from. In case you would like to change some system settings, please proceed as follows:
Click here to set the current data and time of day.
Click here to select the date format for entering the date of birth.
Click here to set the keyboard layout.
Click here to activate additional licenses.
Click here to select the language for the operator interface.

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5. Measurement procedure
5.1 Measurement procedure predefined Measurement Routine
Step 1: Plug in the delivered USB Storage device, which contains the predefined
Measurement routine.
Step 2: Please enter the logfile name. Please use a meaningful name for the logfile.
So it will be easier to find the logfile and/or the video which will be saved on
the USB Storage device.
Enter Logfile name. This brief description only appears after
the system has been switched on.

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Step 3: Choose a Standart Program.
Click here to choose a predefined measurement program
If you like to save a Video mark the checkbox Record Video.
Now place the patient on the chinrest. And ask the patient to focus to the target.

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Step 4: Press “Start camera” and be sure that the pupils will be detected continuously.
If the pupils are not found continuously please make sure the pupils are > 4mm
and no eye lit or eye shade will cover the eyes. In some cases it can be helpful
to deactivate the automatic brightness. And try to find a good regulation with
the manual brightness control.
Manual brightness control
Automatic Brightness

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Step 5: Start Measurement
Now press “Start” in order to perform a measurement. In the predefined
measurement program “Standart “ the measurement will not stop automatically.
To cancel a measurement click on “Stop”.
Click start to begin a Measurement.

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Step 6: Measurement Values
On the Predefined Measurement program there will be a graphical evaluation at
the end of the measurement. To watch the measured data proceed as follows:
Choose the logfile you want to evaluate, after that choose the preferred Graphic.
Click here to choose the logfile
Click “Start”, the measured logfile will be analyzed and displayed on the screen.
Click here to choose the preferred graphic

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5.2 Documentation Logfile
The documentation of the plusoptiX R09 is the logfile. The logfile is being saved on the
USB stick. The logfile is separated with semicolons. It contains the following
information:
Value
Description
Time [ms]
Time stamp of the measured values. Every 20ms there will be
one measured value.
Brightness [%]
LED brightness in percent
PupilFound (L and R)
1: Pupil found; 0: Pupil not found.
PupilPos (L and R).X/Y() [px]
Pupil position in px from left upper corner.
PupilsizeMM(L and R).X() [mm]
Pupil width right eye and left eye
PupilsizeMM(L and R).Y() [mm]
Pupil height right eye and left eye
PupilBrightness(L and R) [DU]
Qualitative pupil brightness left and right eye in values.
PurkinjeSize(L and R).X() [px]
Horizontal dimension of the purkinje reflex in pixel.
PurkinjeSize(L and R).Y() [px]
Vertical dimension of the purkinje reflex in pixel.
Decentration(L and R).X() [mm]
Horizontal distance of the purkinje reflex from the middle of
the pupil.
Decentration(L and R).Y() [mm]
Vertical distance of the purkinje reflex from the middle of the
pupil.
Gaze(L and R).X() [°]
Angle of the horizontal gaze in degrees.
Gaze(L and R).Y() [°]
Angle of the vertical gaze in degrees.
Refraction(L and R).Sphere() [dpt]
Measured refraction in diopters of each frame. If it is not
possible to calculate the refraction this value will be set to “-
100”.
RefractionLeft(resp. Right) Contents()
Value between 0-10. Describes the actual state of the average
calculation of the refractionLeft(resp. Right).Mean() [dpt].
RefractionLeft(resp. Right).Mean() [dpt]
Average of the last 10 frames in diopters.
RefractionLeft(resp.
Right).StdDeviation() [dpt]
The standard deviation of the last ten frames.
InterpupDist() [mm]
Pupil distance in mm.
InterpupAngle() [°]
Angle of the camera to the horizontal.
Trigger
Trigger signal 0x0 0xFF

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5.3 Viewing the video of the last measurement
If you marked to record a Video you can watch the recorded Video directly after the
measurement ends. Please note: The Video begins at the start of the measurement and
last at least 360 Frames. After that 360 Frames the Video recording stops, but the
measurement will carry on as long the measurement program lasts or the “Stop” Button
is being pressed.
Click here to play back the video of the measurements in individual
images. The available measurement values from each image are
displayed on the screen.
Click here to play back the video of the measurement in real time.
Click here to rewind the video to the beginning.
5.4 Storing a video
The Videos are stored automatically on the USB Key. The name will be corresponding
with the name of the logfile.

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5.5 Loading a video
The plusoptiX R09 allows you to load videos directly from a USB stick and to view
them. You can only play back videos that have been recorded and stored using the
plusoptiX R09.
1. Click on “Load video”. The window containing the available videos
opens.
2. Select the video that you wish to play back and click on “Open”.
3. Click here to play the loaded video.