Spot Instructions for Use - PN 20079 Rev A - Lions District 11-E1

Spot Instructions for Use - PN 20079 Rev A - Lions District 11-E1
Spot Instructions for Use
MODEL: VS100
SOFTWARE VERSION: 1.1.51
P/N 20079 REV A
Table of Contents
Welcome to Spot ..................................................................................... 3 Box Contents .................................................................................................................................... 3 Product Registration.................................................................................... 3 Basic Operation........................................................................................... 4 Terminology ...................................................................................................................................... 4 Basic Camera Care ......................................................................................................................... 5 Front Glass Care ............................................................................................................................. 5 Warnings ............................................................................................................................................. 6 Screening Environment ............................................................................................................. 6 Getting Started............................................................................................ 7 Charging Spot .................................................................................................................................. 7 Powering Spot On and Off ....................................................................................................... 7 Wrist Strap ......................................................................................................................................... 7 Optional Neck Strap .................................................................................................................... 8 Helpful Hints .................................................................................................................................... 8 User Operation............................................................................................ 9 Main Menu......................................................................................................................................... 9 Subject Data Entry ...................................................................................................................... 10 Screening a Subject ..................................................................................................................... 12 Monocular Screening ................................................................................................................. 13 Viewing the Results .................................................................................................................... 14 Tools ....................................................................................................... 15 Setting the Date and Time...................................................................................................... 16 Wireless Network Configuration........................................................................................ 16 Printer Configuration ............................................................................................................... 18 Import & Export .......................................................................................................................... 20 Viewing Criteria ............................................................................................................................ 23 Results Configuration ............................................................................................................... 23 Security .............................................................................................................................................. 24 Touchscreen Calibration ......................................................................................................... 25 Web Access ......................................................................................................................................26 Records .................................................................................................. 26 Deleting Subject Records ........................................................................................................ 27 Basic Troubleshooting ......................................................................... 28 Technical Description................................................................................. 29 Environmental Protection .......................................................................... 30 EMC Information........................................................................................................................ 30 Electromagnetic Compatibility ........................................................................................... 31 EMC Table ........................................................................................................................................ 31 Specifications ................................................................................................................................. 33 Measurements ............................................................................................................................... 34 Symbols ................................................................................................... 35 Limited Warranty ................................................................................ 37 Contacting PediaVision ....................................................................... 38 P/N 20079 Rev A
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Welcome to Spot
Welcome to the PediaVision VS100 vision screener, otherwise known as Spot. This instructions for
Use document will help you learn to navigate Spot so you can make the most of your screening
experiences.
Box Contents
Remove Spot and the accessories box
from the packaging. In addition to
the items listed (Figure 1), you will
find a Cleaning Cloth and Velcro
Cable Straps in the accessories box.
NOTE: Please do not discard the box
and foam. Damages incurred by
shipping Spot in non-approved packing
material will void the limited warranty
(see page 37 for warranty details).
If you have a Spot carrying case, place
the foam from the shipping box
inside the carrying case for safer
transport.
Figure 1
Product Registration
IMPORTANT:
Before you begin to use Spot, it needs to be registered with PediaVision.
To register your device, please go to pediavision.com/register and provide some basic
information. This will keep you in tune with the latest software updates and support
services, as well as ensure warranty coverage.
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Basic Operation
This section explains preparatory steps before you start screening with Spot and basic
operation.
Terminology
Figure 2
NOTE: The USB port shall only be used for software installations and import/export of data via
a USB flash drive. It shall not be cable connected to any other device.
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Basic Camera Care
1.
Spot is a precision instrument.
DO NOT drop it or subject it to physical shock.
2.
Spot is NOT waterproof. If you accidentally drop it into liquid or liquid is spilled on it,
please promptly contact PediaVision Customer Service. If minor water droplets are found
on Spot, please wipe them off with a soft dry cloth.
3.
DO NOT leave Spot in excessive heat such as in a car or in direct sunlight.
temperatures can cause Spot to malfunction.
4.
Spot contains precision electronic circuitry.
This will void any warranty.
5.
DO NOT use cleaners that contain organic solvents to clean Spot’s body or front glass.
For stubborn dirt, use the provided cleaning cloth with a small amount of water or a nonabrasive cleaner. If you have any questions about proper cleaning procedures, please
contact PediaVision Customer Service.
6.
When plugging the AC power connector into Spot, be sure NOT to force the power
connector into the Spot device as this may cause damage not covered under warranty.
7.
The safety wrist strap on Spot is intended to assist in the event the device slips or is
dropped. It is not to be used to carry or support the weight of Spot.
High
Never attempt to disassemble Spot yourself.
Display Care
Spot has an all-in-one 5” LCD Display and touchscreen. To ensure long lasting
functionality and performance, please be aware of the following:
1.
DO NOT push or scratch display surface with anything stiff or rigid.
2.
DO NOT spill liquids on the display.
on LCD panel surface immediately.
Please wipe off drops of liquid like saliva and water
Front Glass Care
Spot uses a piece of optical glass with a special coating. If dirt or fingerprints are visible,
use a soft cloth to wipe clean. For stubborn dirt, try using the provided cleaning cloth
with a small amount of water or a non-abrasive cleaner.
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Warnings
1. Changes or modifications not expressly approved by PediaVision could void the user’s
authority to operate the equipment.
2. The supplied cord set is to be used. Replacement or substitution may only be done with a
CSA or UL approved hospital grade power supply/charger cord set.
3. The supplied power supply/charger may not be substituted and shall only be replaced by an
approved unit supplied by PediaVision.
4. Interconnection of this medical device with other medical devices, medical used systems or
non-medical devices shall be evaluated to the requirements of CSA/IEC 60601-1-1 in the end
use application.
5. This equipment is ESD sensitive; do not touch connector pins during use.
6. If the power cord or external power supply becomes damaged or its integrity is suspect, or the
building power receptacle outlet is ungrounded, then the Spot shall only be used with the
internal battery power until replacement parts become available.
7. The operator shall not touch accessible conductive parts (ac/dc adaptor output connector,
camera power input connector and USB port) and the subject simultaneously.
Screening Environment
For the best screening results, be sure to screen in a proper, subdued lighting
environment.
Take care to eliminate sunlight and/or incandescent light.
Florescent light is acceptable but note that the subject’s pupil size will be affected by light
in the room and will decrease your chances of a successful screening. Subject’s pupils
should be greater than 5mm for best results.
NOTE: A minimum pupil size of 4mm is required for screening to occur and may be
difficult to achieve in a room with any light source. Subject’s pupils should be greater
than 5mm in size for best results.
Best screening environment (minimal fluorescent light):
Figure 3
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Getting Started
Charging Spot
Spot contains a rechargeable battery for mobile use. To charge the battery, first connect
the provided AC power cord to the provided power supply/charger. Tilt Spot forward
and find the power connector port
, then gently insert the AC power connector as
seen below.
DO NOT force the AC power connector into the AC power port on Spot.
It should easily insert. Forceful insertion can cause damage to Spot and potentially void
the limited warranty. Finally, plug the power cable into an available AC outlet. When
the battery charge indicator (green LED) is steady, no further charging is required (Figure
4). Spot will also run directly off the AC power source.
Powering Spot On and Off
To power on Spot, press and release the power
button. The system will take approximately
30 seconds to complete its start-up process.
When complete you will be on the Main Menu
with the blue Spot logo.
To power off Spot, hold the power button for
about 2 seconds. A confirmation screen will
appear to confirm shutdown of the device.
Wrist Strap
Figure 4
Use the included wrist strap as extra precaution to help prevent damage to Spot if it slips
from your hands. Attach the wrist strap to the pin located under the handle.
DO NOT carry Spot by the wrist strap. The wrist strap is an extra precaution but does not
guarantee damage will be prevented if dropped.
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Optional Neck Strap
PediaVision offers an optional neck strap to assist during extended usage. The neck
strap connects to the two tabs located below the display on Spot. Please contact
PediaVision Customer Service to order a neck strap.
Helpful Hints
•
When there is no activity on Spot, the device will automatically dim the screen and then turn
the screen black. Simply touch the screen to bring the application back.
•
To delete ALL records from Spot, go to the Records screen and touch the trash can icon.
will bring up the Delete All Records screen.
•
Be sure you have correctly exported any desired data to a USB drive, then select Delete All
Records.
•
You can also turn the capture sound on and off by pressing the
corner of the capture scree.
•
Spot has several keyboard layouts to provide all characters you may need while screening.
Simply select the shift key or the special character keys to switch back and forth.
•
The best way to know if your Spot is connected to a wireless network, is to go to the Main
Menu and see if you see your network name and IP address are in the lower left corner.
•
Spot requires a minimum pupil size of 4mm for screening to occur and this may be difficult to
achieve in a room with any light source. Subject’s pupils should be greater than 5mm in size
for best results.
•
To power off Spot, press the power button for about 2 seconds.
appear to confirm shutdown of the device.
•
Do not power off Spot during a screening.
then power down the device normally.
•
Holding down the
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This
icon in the bottom left
A confirmation screen will
Instead, exit the screening by selecting the
,
button on any input screen will delete all data from the field.
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Figure 5
User Operation
Main Menu
When Spot is powered on, the main menu screen (Figure 5) will appear with the following
information and features. If Spot is connected to a network, the network name and IP
address will be visible in the lower left corner as seen in Figure 5 above.
Start:
To begin the screening process, select the Start function (the blue Spot logo). This will
allow you to enter subject information, find queued subjects, begin the capture process,
and review and print screening results.
Records:
The records section will allow you to view already screened subjects (complete records)
and select individual records to review results, select queued subjects from a list to begin
the screening capture process and delete all records from Spot.
Tools:
The tools section allows you to customize Spot to meet your specific needs. From Tools,
you will be able to set things such as the date & time, set up a printer & print a test page,
connect to a wireless network, enable a security pin, review screening criteria, set the
measurement formats, recalibrate your touchscreen, import/export data and view the
software version currently running on your Spot device.
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Subject Data Entry
To begin screening, select the Start function (blue Spot logo) from the main menu.
Using the onscreen keyboard (Figure 6), enter subject information as outlined below:
Figure 6
1. Subject ID (Optional) – If you use an ID number for the subject you are screening, enter it here.
If not, you may leave this field blank and proceed to the next entry by selecting “ok” or the
continue icon
. You may also use the ID field to search for records you previously
imported onto Spot. Simply type the queued subjects ID number (case sensitive) and touch
the continue icon. You will skip the rest of the input screens and go straight to the Subject
Confirmation screen.
additional keyboards.
If you don’t see the character you need, select the
icon for
2. First Name (Optional) – The next screen will ask you for the subject’s First Name.
After entry,
select “ok” or the continue icon
.
3. Last Name (Optional) – The next screen will ask you for the subject’s Last Name.
select “ok” or the continue icon
After entry,
.
4. Gender (Optional) – The next screen will ask you to select the subject’s Gender (Figure 7).
After you make your selection, you will be moved to the DOB screen or select the continue
icon
.
Figure 7
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5. Date of Birth/Age (Required) – On the final entry screen, you will be asked to enter the
subject’s date of birth (DOB) or age in months and/or years (Figure 8). For the DOB, use the
format MM/DD/YY. If entering an age, simply enter the number of months, years, or a
combination of both. Example, 3 Years and 4 months would be 3y4m. After entry, select
“ok” or the continue icon
.
Figure 8
6. Subject Screen – On the subject screen (Figure 9), confirm all data is correct. To change or
add information, simply select the desired field. If the DOB/age is missing or incomplete, the
date of birth box will be highlighted red. Simply touch the red box to add/edit the age data.
You can also select whether or not the subject has a vision prescription for glasses or contacts.
After all information is confirmed, select the continue icon
to begin the capture process.
Figure 9
7. Eyewear Confirmation Screen – If you selected that a subject has a vision prescription on the
subject screen, you will be asked if the subject is currently wearing their prescription. Simply
select Yes or No. The screening will then begin.
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Screening a Subject
When all information is entered position yourself about 1 meter from the subject, as
shown below (Figure 10).
Figure 10
Check the lighting in your environment per the instructions on page 6 and then position
yourself appropriately. Have the subject sit, cradle Spot in your left hand and hold the
right handle. Prior to screening, hold the nose of Spot pointing down. Begin the
screening by slowly rotating Spot upward to meet both of the subject’s eyes. Adjust
your distance to the subject until both eyes are clear on the screen. A blue screen
indicates you are too close or too far from the subject.
NOTE: Keeping Spot even (on axis) with the subject’s eyes will promote quicker results
and help ensure you are not capturing other objects.
Position yourself with one foot in front of the other and slowly lean forward and back until
the spinning icon appears, indicating you are in range (Figure 11). Hold the device
steady until the screening process is complete.
Figure 11
You can also turn the capture sound on and off by pressing the
corner of the capture screen.
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icon in the bottom left
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NOTE: Do not power off Spot during a screening.
selecting the
Instead, exit the screening by
, then power down the device normally.
If you are unable to capture the subject or select the exit icon
from the screening
process, you will be presented with a Screening Options menu (Figure 12). From here
you can try to Re-Screen subject again, switch to Monocular screening mode, Flag the
subject as unscreened, or return to the Main Menu.
return you to the subject information screen.
Selecting the exit icon
will
Figure 12
Monocular Screening
In monocular mode, you will be given the option (Figure 13) to choose which eye to
screen. Simply touch the side of the screen that corresponds with the eye you would like
to screen. When complete, you can repeat the process with the other eye by choosing
Monocular from the Results Menu.
Figure 13
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Viewing the Results
The results screen will appear at the end of the screening process (Figure 14).
Results that are out-of-range are indicated
in red. The screener/user will make the
final recommendation regarding a follow
up exam with an eye care professional.
On the Results screen, you can toggle the
results data between raw and formatted
results by touching the values in the box
under the eyes. You can also toggle
between positive and negative cylinder
conventions by selecting the
label
found between the boxes. At any time
you can select
to close this screen and
return to the main menu or select the
for additional options.
continue icon
Figure 14
From the Results Menu screen (Figure 15), you can print the screening results certificate,
re-screen the current subject, switch to monocular mode or return to the Main Menu.
Figure 15
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Tools
The tools menu will allow you to customize and configure Spot.
gives you the following options:
The main tools menu
This section displays Spot’s firmware version, software application version and serial number.
Also displayed is a quick reference of important Spot features.
This section allows you to set the current date and time for your device.
The Network section allows you to connect Spot to a wireless network. You can manually enter
your network name (SSID), select the security type, and enter the passphrase for your network.
From this page you can view and change your TCP/IP settings.
This section allows you to configure a network printer and print a test page.
view printer status.
It also lets you
This section enables you to import and export using an inserted USB storage device.
Here you can view the age-based criteria settings used for exam recommendations.
This section allows you to configure how data is displayed on the Results screen when a
screening is complete.
This section allows you to set a security PIN for your device.
This section allows you to calibrate the touchscreen on your device.
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Setting the Date and Time
From the Tools menu, select the Date/Time icon.
visible as seen in (Figure 16).
If it is correct, select
The currently set date and time will be
to return to the Tools menu.
Figure 16
To change the time, touch the time field and the keypad will appear. After you enter
the correct time, select the “ok” button to save your changes and return the previous
screen.
screen.
Alternatively, select the
button to cancel changes and return to the previous
Repeat these steps to reset the date field.
Wireless Network Configuration
To connect Spot to a wireless network, you will need to access the Network section
(Figure 17) of the Tools Menu. The current network settings are displayed on the screen.
To add or edit any of the fields, see instructions below.
be returned to the Tools menu.
If they are correct, select
to
Figure 17
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To add/change the network name (SSID), touch the SSID Name field and the keyboard
will appear. Enter the SSID and select the “ok” button to save your changes and return
the previous screen.
To add/select the security type, just touch the Security Type field.
appropriate security type and you will be returned to the Network screen.
Select the
To add/change the passphrase (password), touch the Passphrase button, and the edit
screen will appear with a keyboard. This is only available with the security field is set to
WEP or WPA.
Enter the Passphrase and select the “Ok” button to save your changes and return the
previous screen.
The “Ok” button on the network screen will be darkened and available to select if any
changes have been made. Select “Ok” to apply all changes made to the network
settings (Figure 17).
NOTE: If you do not select “ok”, changes will not be applied.
You can enable or disable the wireless capabilities on Spot by selecting the
“On/Off” button from the network menu.
to return to the Tools menu, or select
After changes have been applied, you can select
TCP/IP (Figure 18) to view advanced network settings. From here you can view your
current TCP/IP address as assigned by your network, or for more advanced network
configurations, you can select “Static” to manually configure your network address and
settings. Also available on this screen is the MAC Address of your Spot.
Figure 18
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Printer Configuration
When you select the Printer icon from the Tools menu, you will be presented with a list of
available printers on your network on the Printer Tools Screen (Figure 19).
NOTE: Spot will search your network for available printers. For this feature to function
properly, Spot will need to be connected to a wireless network before adding a printer.
Figure 19
To select or change a default printer, find the desired printer in the list, highlight it by
touching it once, then touch the Set as Default button. To add a printer to your list,
pressing the Add
button will take you to the Add Printer screen (See Adding a Printer
on Page 19).
•
To configure a printer, view the printer status, or print a test page, select the printer from
the list then press the Edit
button. This will take you to the Printer Details Screen
(See Adding, Editing or Viewing Print Configurations).
•
To remove a printer, select the printer from the list and press the Delete
popup will appear asking you to confirm deletion of the printer.
button.
A
•
To restore the printing system to factory defaults, press the trash can button.
popup will appear asking you to confirm restoring the printing system to factory. This
will remove all current printer configurations and reinstall the default Spot printer.
A
You can exit this screen at any time by selecting exit icon
Tools menu.
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, which will return you to the
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Adding a Printer When you select the Add
button from the Printer Screen (Figure 19), you are directed
to the Add Printer screen (Figure 20) where you can add a network ready printer. If the
Printer is discovered on the network, it will show up in the list. If you wish to add this
printer to Spot, select it from the list and press the continue icon . If the network
printer you want does not show on the list, then select Add New Printer and press the
continue icon . Confirm the settings and press the Save button.
Figure 20
Adding, Editing or Viewing Print Configuration When you select the Edit
button or you select to add a printer from the Add printer
screen, you are directed to the Add Printer Details Screen (Figure 21). The default Spot
printer information will be populated, which can be edited if needed.
Figure 21
On the Add Printer Details screen, you can change the displayed name of your printer by
touching the Name field.
To select a printer driver, touch the Driver field and you will be presented with a list of
available drivers. Use the search function at the top of the driver list to narrow down the
number of visible drivers.
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NOTE: The list of print drivers represents all printers supported by Spot.
The Location is the network location of the printer, and is automatically given a local
name by Spot. To select a custom TCP/IP address location of the printer, touch the
Location field and enter a new location as “socket://xxx.xxx.xxx.xxx” where xxx.xxx.xxx.xxx
is the TCP/IP address of the printer.
When all printer settings are complete and valid, the Save button will be dark grey.
Touch the Save button to save all settings, or at any time press the exit icon
to the previous screen without making changes.
to return
NOTE: It may take several minutes after hitting save for the changes to take affect.
When your printer settings have been saved, the Print Test Page will be dark grey. Press
the Print Test Page button to test the printer configuration. A print icon will appear in
the menu bar indicating the job is processing. Also, the number of jobs in the print
queue will show up in the Jobs box at the top of the screen, along with the current printer
status as shown in (Figure 22).
Figure 22
NOTE: If you are having a problem with your printer or a job is stuck in the queue, select
the reset button to clear the print job and reset the printer.
Import & Export
Importing and Exporting files to and from Spot is quick and easy. Simply insert a USB
storage device into the USB port on Spot (refer to Page 4 - Terminology for USB port
location). From the Tools menu, select Import/Export and you will be directed to the
Import/Export screen (Figure 23). When a USB device has been detected, the Import
and Export buttons will be available to select. The Import button will only become
available if Spot recognizes a valid import file on the USB drive.
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Figure 23
NOTE: If the buttons do not highlight within 5 seconds of inserting the USB drive,
remove the USB, insert it into your PC and delete all files from the drive. If you are
importing a file, be sure to put the import file back on the USB drive before continuing.
Export - To export data from Spot, select the Export button. You will be asked
whether or not to exclude personal data. The Exclude Personal Data function will
export a single Comma Separated Values (.csv) file with all screening data, except
the subject’s first name, last name, and DOB. To exclude personal information, press
the Exclude Personal Data label on the screen and an [X] will appear next to the label.
Select the Export button, and do not remove the USB drive until the export is complete.
Spot will indicate “Export Successful” when the export completes and it is then safe to
remove the USB drive. If the USB is withdrawn prior to the export being complete,
incomplete or corrupted data may be the result. This may cause problems with both
Spot and your USB drive.
If you do not select the exclude personal data option, Spot will export the following
information:
1) PDF’s of all completed subject screenings (located in the “current” folder).
2) Spot Results file (located in the “current” folder).
2) Spot Criteria file (located in the “config” folder).
3) Spot Subjects Template file (located in the “config” folder).
4) Spot’s Complete database file (located in the “db” folder).
NOTE: When data is exported to Spot, a new folder will be created on the USB drive.
The folder will be in the format of ‘Spot_SerialNumber_YYYYMMDD_HHMMSS’. All
export data will be put into this folder.
Import - All files must be located in the root or top directory of the USB drive (not in a
folder) and must have the correct naming convention for Spot to recognize it for import.
With Spot’s import function, you can import an updated Criteria file, an upcoming
subjects file, or a custom banner for the screening reports.
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Spot Criteria
The easiest way to modify the current criteria being used on the Spot is to first export the
current criteria file. This gives you a copy of the current criteria file located in the
“config” folder. After the export is complete, insert the USB in your PC and go to the USB
drive folder on your PC. Select the Spot folder that you just exported, then select the
“config” folder. Here you will find a file called “SpotCriteria.csv”. Make a copy of the
criteria file and paste it into the main directory of the USB drive (root or top directory
level). Make any desired changes (using Microsoft Excel, or similar) then save the file as a
Comma Separated Values (csv) file. Ensure the file is still called “SpotCriteria.csv”.
Remove the USB drive from your PC and insert it into Spot. Go to the “Tools” menu, then
“Import / Export”. Select the “Import” option to import the updated criteria file. To
check to see if the file was imported successfully, go to the Tools menu then to Criteria
and review the new criteria settings.
Spot Subjects
Spot gives you the ability to be ahead of the game with the Subject import function. The
easiest way to import subjects is to first export the subject from Spot. This gives you a
template to use for the import file. After the export is complete, insert the USB into your
PC and go to the USB drive on your PC. Select the Spot folder that you just exported,
then select the “config” folder. Here you will find a file called “SpotSubjects.csv”. The
file will contain 6 columns. It is imperative that you do not change any of the column
headings. Only add information to the columns, as shown below:
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1.
Subject ID – You can use any combination of alpha, numeric characters and symbols. This
field is also used for the subject lookup feature. To quickly look-up queued subjects the
best combination is Alphanumeric characters only.
2.
First Name – Enter the first name.
Use any combination of alpha characters.
3.
Last Name – Enter the last name.
Use any combination of alpha characters.
4.
Date of Birth – Enter the data of birth in the format MM/DD/YY or YYYY. You may also
enter the age of the subject in years, months or a combination of both. Example: a
subject that is 2 years and 10 months old would be entered 2Y10M. Use numeric and
alpha characters.
5.
Gender – Enter Male or M, or Female or F.
blank will default to Male when importing.
Alpha characters only.
6.
Eyewear – Enter None, Glasses, or Contacts.
as the default when importing.
Leaving the field blank will result in ‘None’
Leaving the field
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After updating the import file, ensure you save it as a Comma Separated Values (.csv) file,
and that the file name is SpotSubjects.csv. Follow the import procedures to load the file
onto Spot. To verify that the file was imported successfully, go to the Records menu and
select “Queue” to view the new records.
Custom Banner
PediaVision offers the ability to add a custom banner to the bottom of the printable
reports. Banner files must be named “banner.png” and be no larger than 1MB. The
banner image must be 1376 x 240 pixels or it will not fit on the printout. Place the
banner.png file on the root/top directory level of the USB then place the USB in the Spot.
The import file option will highlight, select Import. To verify that the file was imported
successfully, either screen a new subject or select a completed record and print the
certificate. Ensure the new banner has been properly inserted on the bottom of the
printable report.
Viewing Criteria
To view the current age based criteria on your device, select Criteria from the tools menu.
A table will be displayed that shows the current criteria used to compute the screening
results. To change the criteria, please see the Import / Export section for details on how
to update the Spot Criteria file.
Results Configuration
To change how results are displayed on the Results Window after a screening, select the
Results option from the Tools Menu. You will be presented with a Results Options
screen from which you can customize your Results (Figure 24). When a selection is
made, the changes will take effect immediately for the next screening.
Figure 24
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Data Format – The changes to this configuration will show either formatted or raw
refractive values on the Subject Results screen. If Formatted version is chosen, Spot will
round the refractive results to the nearest quarter diopter. You can toggle between the
formatted and raw versions on the results screen by touching the data boxes of either
eye. The settings here indicate which version is shown by default on the Subject Results
screen.
Cylinder Convention – The changes to this configuration will show either positive or
negative cylinder convention on the Subject Results screen. You can toggle the
between positive and negative on the results screen by tapping on the
icon
between the data fields. Please note that the Axis will shift by 90°. The settings here
indicate which version is shown by default on the Subject Results screen.
Measurements – After a screening is complete, Spot will present eye measurements on
the screen and on the printed certificate. Selecting “Hide” will prevent Spot from
showing these measurements on the screen. The data will be saved to the database on
Spot and can be recalled later.
NOTE: If you select “Hide” Measurements, the device will automatically hide the
recommendation as well.
Recommendation – Spot will inform you if a subject is “in” or “out” of range and if a full
comprehensive eye exam should be recommended. Selecting Hide will prevent Spot
from making a recommendation on the Results Screen or Printed Reports.
Security
Spot gives you the ability to add a layer of security to your device through the use of a
PIN code. To enable the use of the PIN code, select Security from the tools menu. You
will be asked if you would like to use a security pin code. If you select this option Spot
will ask you to enter a 4-digit pin code and then re-enter the same pin to confirm.
Security will then be enabled. To disable, simply uncheck “Use Security Pin Code” and
you will be asked to confirm by entering your PIN.
To lock the screen, simply press and hold the power button for 2 seconds, until the power
off popup appears. Spot will ask you if you would like to Power Off, Lock, or Cancel.
Select Lock and your Spot will be locked. If you let Spot sit idle for more then five
minutes, or power off Spot with Security enabled, you will be prompted to enter your pin
before you can use Spot (Figure 25).
P/N 20079 Rev A
Page 24
Figure 25
Touchscreen Calibration
The Spot touchscreen can be calibrated by selecting Touchscreen from the tools menu.
You will be asked to confirm whether or not you want to calibrate the screen. If you
select Calibrate, it is a simple two-step process to complete calibration:
Step 1 – A series of 5 crosshairs will appear one after the other, starting in the upper left
hand corner (Figure 26). Simply touch each target as close to center as possible (a stylus
is a useful tool for calibrating the touchscreen). After all 5 targets have been touched,
move to Step 2.
NOTE: If you do not touch the first target within 15 seconds, the calibration will be
cancelled.
Figure 26
Step 2 – A series of 5 confirmation targets will appear
one after the other, starting in the
upper left hand corner again (Figure 27). Simply touch the crosshairs without going
outside the circle surrounding each target, and the calibration will be complete.
P/N 20079 Rev A
Page 25
Figure 27
NOTE: If you touch outside the confirmation circle for the targets, the calibration will be
cancelled and the previous settings will be used.
Web Access
When connected to a wireless network, Spot gives you the ability to view the PDF reports
and the SpotResults.csv file from a Web Browser (Internet Explorer, Firefox, Safari, etc.) on
another PC on the same network. To access the webserver on Spot, simply open your
web browser and enter Spot’s IP address in the address bar. The Username is spot and
the default password is 0000. If you have enabled security on your device, the password
will be your PIN code.
Records
On the Records page (Figure 28) you can view previously screened subjects (Complete
tab), as well as any queued subject data (Queue tab) that was previously imported or
subjects of incomplete screenings that still require screening. The maximum storage
capacity of Spot is 3000 completed screenings.
Figure 28
P/N 20079 Rev A
Page 26
Red square indicates a subject that has been screened and at least one
result was out-of-range based on criteria at time of screening.
Green indicates the subject has been screened and all readings were within
the range based on the criteria at time of screening.
Subjects with no color indicate the subject has not yet been screened.
If you select a previously screened/complete subject, the final results page will be
displayed. If you selected a queued subject, you will be directed to the Subject
Information screen to verify the data and start a new screening.
Deleting Subject Records
To delete all records on Spot, select the trash can icon
located on the bottom left
corner of the Records screen (Figure 28). All subject data will be deleted permanently so
ensure you have exported any data you wish to save with the Import/Export function
located in the Tools menu. Once you select the trash can icon, the “Delete All Records?”
screen will appear. To remove all subject records, select “Delete All Records”, otherwise
select “Cancel” to return to the Records menu and no data will be removed.
NOTE: Regularly deleting the records will ensure you always have enough storage
space on Spot.
P/N 20079 Rev A
Page 27
Basic Troubleshooting
System Restart
To power cycle Spot, simply press and release the power button. After confirming
shutdown, Spot will turn itself off. After the screen is black, wait 30 seconds and then
press the power button to turn Spot back on.
System Freeze
In the event the Spot locks up and is unresponsive to touch, you will need to perform a
hard system reset. To reset Spot, press the power button. If the Power Off window
appears, select the Power Off button to shutdown the device. If not, press and hold the
power button until the screen goes black. Release the power button. Wait about 1
minute, then perform the normal start-up process.
NOTE: This may cause some data loss (ex. printer configuration and subject data).
Printer Issues
First always check that your printer is turned on and has sufficient ink. You can usually
do this by printing a test print page directly from the printer. After you confirm your
printer is in proper working order ensure the printer is on a local network by printing to
the printer from a PC on the same local network. If all of the above are in working order
then try restarting Spot as stated under “System Restart”. If issues continue, please
contact Pediavision Customer Service for further assistance.
For more information on troubleshooting or error messages, visit pediavision.com (refer
to the last page of this manual for additional contact information).
Wireless Issues
If you encounter problems connecting to a wireless network, first ensure all network
settings are entered correctly. If the settings are correct, try turning Spot off then back
on. Often it will help initiate the connection to the network with a restart.
For more information on troubleshooting or error messages, visit pediavision.com (refer
to the last page of this manual for additional contact information).
P/N 20079 Rev A
Page 28
Technical Description
General
Spot model VS100 will be referred to as Spot below.
The external power supply/charger supplied is a Class I equipment and the Spot is also a
Class I equipment when connected to the external power supply/charger.
Spot is internally powered by equipment (battery) when not connected to the external
power supply/charger.
Protection against electric shock, no applied part.
Spot is rated IPX0 and thus not protected from the ingress of water.
Spot does not require sterilization or disinfection. DO NOT use cleaners that contain
organic solvents to clean Spot’s housing or front glass. For stubborn dirt, try using a soft
cloth with a small amount of water or a non-abrasive cleaner.
Spot is not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
Spot is suitable for continuous operation.
Spot is a breakthrough device that quickly and easily detects vision issues across all age
groups starting at 6 months.
Spot helps ensure children have an opportunity to reach their full potential. Designed to
work as easily with toddlers as with teenagers; Spot provides reliable data in seconds.
With Spot, educators, healthcare professionals, and charitable organizations can now
confidently assess eyesight for all ages. Spot is powered by sophisticated technology that
quickly detects the indication of the following vision issues:
Near-sightedness (myopia)
Far-sightedness (hyperopia)
Unequal refractive power (anisometropia)
Blurred vision, eye structure problem (astigmatism)
Pupil size deviations (anisocoria)
Eye misalignment (strabismus)
In just seconds, Spot provides a comprehensive, reliable analysis that enables informed
decision making about the need for care with a vision specialist.
Pediavision suggests a battery replacement, at an appointed Pediavision repair facility,
every 2.5 years at the owner’s expense. Spot regular maintenance consists of wiping
dust or dirt off the surface as needed.
The USB port shall only be used for software download/upload via a USB key and shall not
be cable connected to any other device.
P/N 20079 Rev A
Page 29
The power supply/charger supplied with Spot has the following characteristics:
International Power Corporation, Elpac Power Systems,
Model MW4015-760F-NC-BK
Input Voltage 85 – 264VAC (100 – 240VAC Nominal)
Input Frequency 47 – 63 Hz
Input Current < 1A rms
Efficiency Avg. Efficiency 86.4% @ 115VAC; 85.7% @ 230VAC
Environmental Protection
This device contains Lithium ion cells. Please contact PediaVision for proper disposal
instructions at end of life.
EMC Information
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
NOTE: Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment. This equipment has
been tested and found to comply with the limits for a Class A digital devices, pursuant to
Part 15 of the FCC Rules. This medical device equipment is suitable for use in all
establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instruction manual, may cause harmful interference to
radio communications. However, there is no guarantee that interference will not occur in
a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:
Reorient or relocate the receiving antenna
Increase the separation between the equipment and receiver
Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
Consult the dealer or an experienced radio/TV technician for help.
P/N 20079 Rev A
Page 30
Electromagnetic Compatibility
This product conforms to the EMC standard (IEC 60601-1-2:2007).
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in the
accompanying documents.
Connectors should not be touched and connections should not be made to these
connectors unless ESD precautionary procedures are used. Provided ESD connector covers
shall be installed when the connector is not in use.
ESD protection mark may be used in lieu of protective covers.
Portable and mobile RF communications equipment can effect medical electrical
equipment.
The use of accessories and cables other than those supplied with the instrument exception
for cables sold by the manufacturer of the equipment as replacement parts, may result in
increase emission or decrease immunity of the equipment or system.
The equipment or system should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the equipment or system should be observed to
verify normal operation in the configuration in which it will be used.
EMC Table
Emission Guidance
The Pediavision Spot is intended for use in the electromagnetic environment specified below. The operator or the user of Spot should assure that
it is used in such an environment.
Emission Test
Compliance
Electromagnetic environment guide
RF Emission Cispr 11
Group 1
Spot must emit electromagnetic energy in
order to perform its intended function.
Nearby electronic equipment may be affected.
RF Emission Cispr 11
Class A
Spot is suitable for use in all establishments
other than domestic and those directly
connected to the public low-voltage power
supplies building used for domestic purposes.
Harmonic Emission IEC 61000-3-2
Class A
Compliant
Voltage Fluctuation/flicker Emission IEC
61000-3-3
Compliant
P/N 20079 Rev A
Page 31
Immunity Guidance
Spot is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is used within those
environmental conditions.
Immunity Test
Test level EN 60601-1-2
Conformity Level
Electromagnetic environment guide
Electrostatic
Discharge (ESD) EN
61000-4-2
± 8kV air
± 6kV contact
Non-conforming
This unit is sensitive to ESD and
may require resetting
The floor should be in wood, concrete or ceramic tile.
If the floor is covered with synthetic material, relative
humidity should be at least 30%.
Electrical Fast
Transient/Burst EN
601000-4-4
±2 kV high voltage
power line
±2 kV high voltage
power line
The quality of the power supply should be that one
of a typical commercial or clinical environment.
Surge EN 61000-4-5
Differential mode: ±1 kV
Common mode: ±2kV
Differential mode: ±1 kV
Common mode: ±2kV
The quality of the power supply should be that one
of a typical commercial or clinical environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines EN 61000-4-11
<5% UT (>95% dip of UT) for 0,5 cycle
<5% UT (>95% dip of UT) for 0,5 cycle
40% UT (>60% dip of UT) for 5 cycle
40% UT (>60% dip of UT) for 5 cycle
70% UT (>30% dip of UT) for 25 cycle
70% UT (>30% dip of UT) for 25 cycle
<5% UT (>95% dip of UT) for 5
<5% UT (>95% dip of UT) for 5 seconds
The quality of the power supply should be that one
of a typical commercial or clinical environment. If the
user requests a continuous functioning during power
supply interruptions, it is recommended a backup
power supply unit (UPS) or battery.
Magnetic field at
power
frequency EN 610004-8
3 A /m
seconds
3 A /m
Power frequency magnetic fields should have
characteristic levels of a typical commercial or clinical
environment.
Immunity Radio Frequency Guidance
Spot is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is used within those
environmental conditions.
Immunity Test
Test level EN 60601-1-2
Conformity Level
Conducted RF
EN 61000-4-6
3 Veff from 150kHz to
80MHz
3 Veff from 150kHz to 80MHz
Radiated RF
EN 61000-4-3
3 V/m from 80MHz to
2.5GHz
3 V/m from 80MHz to 2.5GHz
Surge EN 61000-4-5
Differential mode: ±1 kV
Common mode: ±2kV
Differential mode: ±1 kV
Common mode: ±2kV
Electromagnetic environment guide
The portable and mobile devices with RF communication
shouldn’t be used near any part of the device, including
cables, except when they follow the recommended
safety distance for separation, calculated with the
equation applicable to the frequency of the transmitter.
Recommended safety distance for separation:
D= 1,2 x √P from 150kHz to 80MHz
D= 1,2 x √P from 80MHz to 800MHz
D= 2,3 x √P from 800MHz to 2,5GHz
Where P is the nominal maximum power of the
transmitter output expressed in Watts (W) as specified by
the transmitter manufacturer and d is the recommended
separation distance expressed in meters (m).
The field intensity of the fixed RF transmitters, as checked in an electromagnetic investigation of the locus, should be less than the conformity level
for each range of frequency.
It is possible to have interference near devices marked with the symbol:
P/N 20079 Rev A
Page 32
Recommended separation distance between portable or mobile devices for radio communication and
the device
Spot is manufactured to work in an electromagnetic environment in which the radiated RF disturbances are controlled. The operator or user of
the device could prevent electromagnetic interferences by assuring a minimal distance between the portable or mobile RF communication
devices (transmitter) and the device as recommended in the chart below, in respect of the output maximum power of the radio-communication
devices.
Output maximum frequency
(m) nominal power of the
transmitter (W)
Separation distance at the transmitter Output maximum frequency (m)
from 150kHz to 80MHz
D= 1,2 x ÖP
from 80MHz to 800MHz
D= 1,2 x ÖP
from 800MHz to 2,5GHz
D= 2,3 x ÖP
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For the transmitter with output maximum nominal power not reported above, the separation distance d in meters can be calculated using the
applicable equation at the frequency of the transmitter, where P is the output maximum nominal power of the transmitter in Watts specified by
the transmitter manufacturer.
Notes:
(1) At 80 MHz and 800 MHz it is applicable the higher frequency range.
(2) This line guide could not be applicable in every circumstance. The electromagnetic propagation is affected by the absorption and
the reflection of structures, people or objects.
Specifications
Dimensions (in):
Weight (lbs):
8½ x 6¾ x 4¾ (LxWxH)
~2.55
Operating Temperatures (°C):
+10 to +40
Operating Humidity: 30% to 75% Relative Humidity (non-condensing)
Storage/Shipping Temperatures (°C):
0 to 50
Storage/Shipping Humidity: 0% to 75% Relative Humidity (non-condensing)
Storage/Shipping Atmospheric Pressure: 800 hPA to 1060 hPA
Expected Battery Life:
P/N 20079 Rev A
2.5 Years (Under Normal Usage)
Page 33
Measurements
Refraction
Spherical Equivalent:
•
Range:
-7.50D to +7.50D in 0.25D increments
•
Accuracy:
-3.50D to 3.50D, ± 0.50D
-7.50D to < -3.50D, ± 1.00D
> 3.50D to 6.00D, ± 1.00D
Cylindrical:
•
Range:
0.00D to +3.00D in 0.25D increments
•
Accuracy:
0.00D to 1.50D, ± 0.50D
> 1.50D to 3.00D, ± 1.00D
Cylindrical Axis:
•
Range:
1 to 180 degrees in 1 degree increments
•
Accuracy:
± 5 degrees (for cylinder values > 0.5D)
Pupil size:
•
•
Range:
Accuracy:
4.0 mm to 9.0 mm in 0.1 mm increments
± 0.1mm
Pupil distance:
•
Range:
35mm to 80 mm in 1 mm increments
•
Accuracy:
± 1 mm
Time per measurement:
1s
Measuring distance:
1 m ± 5 cm
Fixation target:
Random visual pattern and audible sound.
Measurement principal:
Optical reflex.
P/N 20079 Rev A
Page 34
Symbols
DC Power
IPX0
Ingress protection
Battery inside (not user replaceable)
Battery charging (flashing) charged (continuous)
Power On/Off
Non-ionizing electromagnetic radiation
Refer to instruction manual
This symbol is applicable for EC member countries only.
To avoid potential negative
consequences for the environment and possibly human health, this instrument should be disposed of (i) for EU
member countries - in accordance with WEEE (Directive on Waste Electrical and Electronic Equipment) or (ii) for all
other countries, in accordance with local disposal and recycling laws.
ESD Protection Mark
USB (software updates only)
P/N 20079 Rev A
Page 35
DC power input port, center pin positive
Battery Status/Level Indicator (Graphics Display Icon)
Connected to the wireless network (Graphics Display Icon)
No wireless network in range (Graphics Display Icon)
No IP address assigned by the router (Graphics Display Icon)
Unknown network (Graphics Display Icon)
Cannot connect to configured network (Graphics Display Icon)
Sound Off (Graphics Display Icon)
Sound On (Graphics Display Icon)
Continue Icon
Back Icon
Exit to Previous Screen or Main Menu
P/N 20079 Rev A
Page 36
Print Job in Progress
Limited Warranty
PediaVision provides the following limited warranty for Equipment:
PediaVision provides a limited repair or replacement warranty and agrees and warrants only
that Equipment (Equipment means the medical device outlined in this document, model
number VS100 “Spot”) will be fit for its intended purpose and without material defect in
workmanship and materials for the one (1) year period following delivery date. Equipment
shall not be considered defective if it is a different color than shown in PediaVision’s materials
and no warranty is made relating to color. All requests for warranty work are subject to
Equipment inspection at PediaVision contracted facilities. End User must ship the Equipment
for inspection to PediaVision’s dedicated warranty and repair facility at User’s expense.
Misuse, improper usage and/or handling, dropping, improper repairs, improper maintenance
and care, or accidental, abusive, or negligent treatment of the Equipment will invalidate
PediaVision’s warranty. PediaVision shall not be responsible after delivery of the Equipment to
End User for maintenance or support of the Equipment, only for warranty services. This
warranty is not a guarantee that the Equipment will not through use or handling develop
wear, tear, and mechanical breakdown from time to time, the repair of which is the sole
responsibility of the End User if beyond the stated warranty period or excluded from warranty
coverage for the reasons stated hereinabove. If a returned item of Equipment is evaluated
and found defective and the warranty for such Equipment is in force, PediaVision will bear the
cost of shipping the repaired or replacement Equipment to End User; otherwise, all shipping
costs will be borne solely by the End User. No statement, remark, or representation of any
employee or representative of PediaVision may vary this limited warranty unless in writing
and signed by an officer of PediaVision. This warranty shall be void if User loads or uses any
software programs or applications on Equipment other than the software installed and
licensed to User by PediaVision. This warranty shall be void if PediaVision finds that
Equipment has been opened or the hardware has been altered in any way. All warranty claims
must be made in writing addressed to PediaVision within the warranty period.
Pediavision does not warrant accessories.
P/N 20079 Rev A
Page 37
Contacting PediaVision
If you have questions about Spot, PediaVision Support is available Monday – Friday, 9:00
am – 5:30 pm ET, excluding holidays. Visit us online anytime at pediavision.com, email
your questions or call during normal business hours:
Email:
Customer Service
[email protected]
Sales
[email protected]
General Information
[email protected]
Phone:
Customer Service
888.514.7338 x 102
Operator
888.514.7338 x 100
Address:
PediaVision Holdings, LLC
200 Waymont Court, Suite 122
Lake Mary, FL 32746
USA
P/N 20079 Rev A
Page 38
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