User Manual
63 Pages
Preview
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Mobile Vision Screener "plusoptiX S12C"
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. Page 1/63
Contents 1 2 2.1 2.2 2.3 2.4 2.5 3 3.1 3.2 3.3 3.4 3.5 3.6 4 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.5.1 4.1.5.2 4.1.6 4.1.7 4.1.8 4.1.9 4.1.10 4.1.11 4.1.12 4.1.13 4.1.14 4.1.15 4.2 4.2.1 4.2.2 4.2.3 5 6 6.1 6.2 6.3 6.4 6.5 6.6
Use According to Purpose and Responsibility of the Operator ... 4 Commissioning the Device ...6 Checking the scope of delivery...6 Learning about the device ...7 Inserting and charging the batteries ...9 Switching the device on and off ...10 Screen displays and help texts ...11 Performing Measurements...12 Environmental considerations ...12 Preparing for a measurement ...13 Entering patient data ...14 Starting a measurement and positioning the camera ...17 Checking and documenting measurement results ...20 Perform next measurement ...25 Practical Tips ...26 Handling clues...26 Adjust settings ...26 Customize basic settings ...27 Set-up screen lock ...28 Activate WLAN ...29 Connect to EMR ...33 Transferring data in CSV format ...33 Transferring data in GDT format ...35 Export data ...37 Import patient data ...39 Choose referral criteria ...40 Retrieve patients from database ...42 Conduct an anonymous measurement ...43 Save and print a measurement report ...44 Compatible printers and network printing ...46 SD card and USB interfaces ...48 Micro-USB interface...48 External mouse or keyboard ...49 Trouble-shooting guide...50 Trouble-shooting when switching device on ...50 Malfunctions when using touch screen ...51 Error messages when performing a measurement...52 Maintenance, Calibration, Servicing and Warranty... 59 Technical specifications ...60 Measurements ...60 Interfaces and standards ...60 Power supply and rechargeable batteries...61 Ambient conditions for operation and storage...61 Size and weight with and without carrying case...61 Guidance and manufacturer´s declaration – electromagnetic emissions/ immunity 62
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Table of figures Figure 1: Device in carrying case ... 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: Overview of patient data input ... 14 Figure 8: Holding the camera and operating the shutter ... 17 Figure 9: Aligning camera at the correct angle ... 17 Figure 10: Recognizing correct measurement distance ... 18 Figure 11: Overview of measurement result pages... 20 Figure 12: Example of a CSV table ... 39 Figure 13: Sensitivity, Specificity, False-Positive-Rate and False-Negative-Rate ... 41 Figure 14: Screening report sample... 45 Figure 15: Self-adhesive label sample ... 46
Table of screenshots Screenshot 1: Setting date and time ... 10 Screenshot 2: Start screen ... 13 Screenshot 3: Entering the date of birth ... 15 Screenshot 4: Entering a first name... 16 Screenshot 5: Review video screen... 22 Screenshot 6: Check measurement result screen ... 23 Screenshot 7: Review database entries screen ... 24 Screenshot 8: Printing or deleting measurements from database entry ... 24 Screenshot 9: Start screen with a pre-selection of the last patient measured ... 25 Screenshot 10: Settings overview ... 26 Screenshot 11: Basic settings ... 27 Screenshot 12: Setting up screen locking ... 28 Screenshot 13: Activating WLAN... 29 Screenshot 14: List of active WLAN connections... 30 Screenshot 15: Selecting a ZEBRA printer ... 31 Screenshot 16: Viewing an active network connection ... 31 Screenshot 17: WLAN error messages ... 32 Screenshot 18: CSV settings for EMR integration ... 33 Screenshot 19: GDT settings for EMR integration ... 35 Screenshot 20: Start screen with an active connection to EMR ... 36 Screenshot 21: Saving a backup copy... 37 Screenshot 22: Saving a report ... 38 Screenshot 23: Choose referral criteria ... 40 Screenshot 24: Help text page 2 with referral criteria benchmarks ... 40 Screenshot 25: Retrieving patients from the database ... 42 Screenshot 26: Start screen with highlighted age group ... 43 Screenshot 27: Measurement result page after a "Measurement cancellation" ... 52
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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 S12C" complies with the specifications of 0123 Guideline 2007/47/EG for medical devices.
Mobile Vision Screener "plusoptiX S12C" complies with the specifications of an application part of type B in EN 60601-1.
12V
Only connect Mobile Vision Screener "plusoptiX S12C" 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)
+50°C The device can be stored and transported at temperatures from 0°C to +50°C (32°F 0°C
to 122°F). A temperature between +10°C and +50°C (50°F to 122°F) with noncondensing 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.
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Use according to purpose Mobile Vision Screener "plusoptiX S12C" 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 S12C" 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 S12C" 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 S12C". 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 carrying case 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.
6 AA batteries plusoptiX S12C
220V power cord
SD card
Power adapter with 12V charging cable
Figure 1: Device in carrying case Please check that the contents of the packaging are complete at time of delivery. The scope of delivery includes: -
Mobile Vision Screener "plusoptiX S12C" Power adapter (medical) with 12V charging cable 220V power cord (in compartment under the "plusoptiX S12C") 6 x AA batteries (rechargeable) SD card (inserted into device)
If the delivery is incomplete, please inform the seller of the device immediately.
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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 Camera lens behind hexagonal nose
Figure 2: Front view of the device
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The 5.7 inch screen with capacitive touch sensor is located on the rear side of the device. To activate one of the functions displayed on the screen, all you need to do is gently touch the screen. The screen and touch sensor are protected from damage behind a thin glass shield. However this glass shield can become scratched due to improper operation, and can also break if the device is dropped. If you need to put the device on its rear side, e.g. to insert or replace the batteries, please place a soft cloth under the device.
Screen Shutter
USB
On/Off button
Micro USB SD card 12V input
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 3.4 "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 4.1.13 "SD card and USB interfaces" and 4.1.14 "Micro-USB 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. Page 8/63
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.
+ - + - + -
Battery compartment
- + - + - +
Type plate
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 1201S-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.
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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.
Buttons for time format
Buttons for date format
Screenshot 1: Setting date and time The time and date format selected is highlighted in color (1). Set the current date and time by touching the orange 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 (standby 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.
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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. Header Information section Navigation bar
Help text
Buttons explained in the help text
Figure 5: Switching between a screen and the help text The header displays date and time on the left side and WLAN (1) and battery status (2) on the right side. WLAN status information (1) is only displayed if WLAN is activated in Settings. A warning symbol (3) appears if the batteries require recharging or WLAN reception is interrupted. Battery status symbol (2) 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 Tool button (4) to move to Settings, and the Padlock button (5) to lock the screen. Padlock button (5) is only displayed if the screen lock is activated in Settings. Checkmark button (6) confirms and saves, while Cancel button (7) aborts without saving. Touch Information button (8) to open a help screen. Use Cancel button (7) 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.
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3 Performing Measurements Mobile Vision Screener "plusoptiX S12C" 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. No direct sunlight
1 meter measuring distance
At eye level Pupil diameter Minimum 4 mm Maximum 8 mm 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!
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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
After setting date and time, the start screen is displayed every time the device is switched on.
Screenshot 2: Start screen
On the Start screen you can choose: a) Entering patient data before measurement (1) (see chapter 3.3 „Entering patient data“) b) Retrieving patient data from database before measurement (1) (see chapter 4.1.9 “Retrieve patients from database”) c) Repeat a measurement (2) (the latest entered or called up patient data is used) d) Select an age group for an anonymous measurement (3) (see chapter 4.1.10 „Conduct an anonymous measurement“) Patient data can be entered or retrieved after an anonymous measurement. To enter patient data touch button (1).
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3.3
Entering patient data
To be able to uniquely identify a patient in the database, you need to enter either date of birth, first name and last name, or an ID number. As an option, examination location and/or contact information can also be saved in the database (shown with a dotted line in the figure below).
Data entry with first name and last name
Data entry with ID number
Figure 7: Overview of patient data input Pressing the Shutter will start a measurement only, once the patient data has been entered completely. You must enter either: Date of birth + First name + Last name or Date of birth + ID number Entries of examination location and contact information are always optional.
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You can enter the date of birth in any form you wish. Touch button (1) to enter the year of birth, button (2) to enter the month of birth and button (3) to enter the day of birth.
Screenshot 3: Entering the date of birth After entering the date of birth, you will see a green checkmark (4) as confirmation on the tab. You have to enter first name and last name or a patient ID number next. This additional information is necessary to be able to uniquely identify the patient in the database at a later stage. Simply touch the next tab (5) to move to the next input.
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Use touch screen keyboard to enter patient data. Touch Shift-key (1) to toggle between lower case and upper case letters, and SYM button (2) to enter special characters. Use Backspace (3) to delete the last character. Please read chapter 4.1.15 "External mouse or keyboard" if you prefer this option for entering data.
Screenshot 4: Entering a first name After entering a first name, you have to enter a last name. Once all necessary patient data has been entered, that is, either date of birth and first name and last name, or date of birth and patient ID, the Checkmark button (4) in the navigation bar is activated. You can now either perform a measurement by pressing the Shutter or save the patient data without performing a measurement. To save the data, simply touch the Checkmark button (4).
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3.4
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.
Figure 8: Holding the camera and operating the shutter 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.
Figure 9: Aligning camera at the correct angle The screen is fixed at a 45° angle to the camera axis. Tilt your wrists downwards to align the camera.
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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 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.
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). Figure 10: 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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3.5
Checking and documenting measurement results
Screen size is limited and therefore measurement results are presented on three screens for better readability. These three measurement result screens are: • • •
Review video screen Check measurement results screen Review database entries screen To exit these three measurement result screens, i.e. to return to the Start screen and to perform another measurement, you have to press the Shutter.
Touch orange 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. Review video screen Check measurement results screen Review database entries screen
Figure 11: Overview of measurement result pages If prior to a measurement a SD-Card was inserted and patient data was entered or pulled from the database, a measurement report (see chapter 4.1.11 “Save and print a measurement report”) is saved to the SD-Card automatically. If no patient data was entered or pulled from the database prior to a measurement, a measurement report can be saved manually by touching Print button (3). Touching Print button (3) will open Patient data enter screen (see chapter 3.3 “Entering patient data”).
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