SPOT VS100 Vision Screening Device User manual

Spot VS100 Vision Screening Device
Instructions for Use
P/N 20126 Rev B

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P/N 20126 Rev B Page 2
Table of Contents
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................................................................................. 3
Intended Use ...................................................................................................................................................... 3
Indications for Use.......................................................................................................................................... 3
Box Contents...................................................................................................................................................... 3
Device Description .......................................................................................................................................... 4
Product Registration...................................................................................................................................... 4
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...................................................................................... 5
Terminology – Spot Details........................................................................................................................ 5
Basic Care ............................................................................................................................................................. 6
Warnings............................................................................................................................................................... 6
Screening Environment............................................................................................................................... 7
Getting Started............................................................................................ 7
Charging Spot .................................................................................................................................................... 7
Powering Spot On and Off......................................................................................................................... 8
Tripod Mount..................................................................................................................................................... 8
Helpful Hints...................................................................................................................................................... 8
UserOperation............................................................................................ 9
Main Menu – Home Screen ........................................................................................................................9
Screening a Subject....................................................................................................................................... 10
How to Focus Spot ......................................................................................................................................... 11
Monocular Mode ............................................................................................................................................. 11
Viewing the Results.......................................................................................................................................12
Understanding the Results .......................................................................................................................12
Tools .......................................................................................................13
Wireless Network Configuration...........................................................................................................14
Printer Configuration ..................................................................................................................................15
Import & Export ..............................................................................................................................................18
Web Access .........................................................................................................................................................21
Spot Licensing ................................................................................................................................................. 22
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................................................................... 26
EMC Information...........................................................................................................................................26
Electromagnetic Compatibility ............................................................................................................. 27
EMC Table.......................................................................................................................................................... 27
FCC Compliance Statement ....................................................................................................................29
IC Compliance Statement.........................................................................................................................30
Specifications...................................................................................................................................................30
Measurements.................................................................................................................................................30
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............................................................................ 33
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P/N 20126 Rev B Page 3
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Welcome to the PediaVision VS100 vision screener, otherwise known as Spot. The Spot Instructions
for Use is designed to assist you, the user, in making the most of your screening experience.
Intended Use
Spot is intended for vision screening of subjects from the age of 6 months through adults. The
device evaluates a subject’s refraction, pupil size and visual gaze for determining the need for referral
to a medical (vision) professional for further evaluation.
Indications for Use
Spot VS100 is indicated for use when evaluation of individuals for poor vision and refractive errors is
needed.
Box Contents
The main shipping box contains Spot, this Spot
Instructions for Use document and the Accessory box.
The Accessory box contains:
1. AC Power Cord
2. Power Supply/Charger
3. Cleaning Cloth
4. Velcro Cable Straps
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 33 for warranty details).
If you purchased a Spot carrying case, place the foam from the shipping box inside the carrying case
for safer transport. Do NOT store your Spot in the foam or case while the Power cord is plugged in.
Figure 1
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Device Description
Spot is a hand-held instrument with a video display on the rear of the unit that provides subject
visualization and alignment. Video display also provides user interface functionality for data input
and display. Operation is as simple as using a digital point and shoot camera. Spot provides visual
and audible cue to attract subject’s attention and gaze. Spot provides a fast data collect for easy
evaluation of the most difficult pediatric subjects of limited compliance. Each evaluation provides
simultaneous binocular assessment of the subject’s refraction, pupil size and gaze
Product Registration
IMPORTANT: You will need to register with PediaVision before you begin using Spot.
1. To register your device, go to pediavision.com/register
2. Enter the information requested.

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P/N 20126 Rev B Page 5
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Terminology – Spot Details
NOTE:The USB port will only be used for PediaVision Spot software installations and
import/export of Spot data via a USB flash drive. No cable connection to any other device is
permissible.
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Figure 3
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Figure 2
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P/N 20126 Rev B Page 6
Basic 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 the device, contact
PediaVision Support immediately. If minor water droplets are found on Spot, wipe off with a soft dry cloth.
3. DO NOT leave Spot in excessive heat, such as in a car or in direct sunlight. High temperatures can cause
Spot to malfunction.
4. Spot contains precision electronic circuitry. Never attempt to disassemble Spot; this may result in bodily
harm and will void any warranty.
5. DO NOT use cleaners that contain organic solvents to clean Spot’s body or the front glass. Instead, use the
provided cleaning cloth and for stubborn stains use with a small amount of water or a non-abrasive
cleaner. Always keep the front glass free of fingerprints, dirt and dust.
6. When plugging the AC power connector into Spot, DO NOT force the power connector into the Spot
device as this may cause damage and will not be covered under warranty.
7. DO NOT store Spot in its case with the power cord plugged in, this could cause damage to both the power
cord and the Spot device. If plugged in, store in a location with no interference with the power cord.
8. DO NOT use the wrist strap as a means to carry the device, it is not designed to carry the weight of Spot.
9. DO NOT push or scratch the touchscreen display surface with anything stiff or rigid.A stylist is
acceptable for use with the device.
10. DO NOT spill liquids on Spot. Please wipe off drops of liquid like saliva and water on LCD panel surface
immediately.
Warnings
1. Changes or modifications not expressly approved by PediaVision could void the user’s authority to
operate the equipment.
2. The supplied AC cord set should be used exclusively. Replacement or substitution may only be done with a
CSA or UL approved hospital-grade AC 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 systems or non-medical
devices shall be evaluated to the requirements of CSA/IEC 60601-1 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, power input
connector and USB port) and the subject simultaneously.

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P/N 20126 Rev B Page 7
Screening Environment
For optimal screening results, screen in an environment with lower level subdued lighting. Be sure
to eliminate or block any sources of sunlight and/or incandescent light from reflecting on the
subject’s eyes (See Figure 4). Florescent light is acceptable but note that the subject’s pupil size can
be affected and can decrease your chances of a successful screening.
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. If the pupils are too small, Spot will notify you on
screen to adjust the lighting in the room. For best results, subject’s pupils should be 5mm or
greater.
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Getting Started
Charging Spot
1. Connect provided AC cord set and power supply/charger together.
2. Gently lift the back of Spot to view the available connections.
3. Locate the DC power connector on Spot and connect the power supply/charger (see
Figure 5). The DC power connector on the power supply/charger will easily insert into the DC
power connector on Spot. Using force to connect the power charger can damage Spot and will
void the warranty.
4. Plug the AC power cord into an available AC wall outlet to charge Spot.
Figure 4
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P/N 20126 Rev B Page 8
Powering Spot On and Off
1. To turn Spot on, press and release the power
button (start-up process takes approximately
30 seconds). Once powered on, you will see
the Main Menu on-screen with the blue Spot
logo.
2. To turn the device off, press and hold power
button for two seconds. A confirmation
screen will appear to confirm shut down.
Tripod Mount
Spot can be mounted to a standard photographic tripod. A ¼-20 threaded mount located on the
bottom of Spot is available for attaching a tripod.
Helpful Hints
•No activity on Spot—After 60 seconds the screen will dim; after 5 minutes the screen will
automatically turn black to conserve battery power. Tap the screen to ‘wake up’ Spot or press the
power button. If the screen does not light up, plug in the power cord and try again.
•Exporting/Delete Historical Records—Verify you have successfully exported desired data to a
USB drive before you select “Delete All Records”.
•Routinely Delete ALL Records from Spot—Go to the History screen and select Clear All icon.
Select “Delete All Records”. You may also delete all Queued records.
•Avoid Powering Off during a Screening—Once the screening takes place, exit by selecting the
button, then power down the device normally.
•Input Screen—Holding down the button on any input (keyboard) screen will delete all
data from the field.
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Figure 5
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P/N 20126 Rev B Page 9
User Operation
Main Menu – Home Screen
When Spot is powered on, the main menu or “Home Screen” will appear (Figure 6). If Spot is
connected to a network, the network name and IP address will be visible in the upper left corner in
the black bar.
Start: To begin the data entry and screening process, select the Start button, this will allow you to:
•Enter subject information such as ID, First and Last Name, Gender and DOB/Age (Required)
•Find queued subjects (exact match on the ID screen)
•Begin the screening process (Binocular and Monocular available)
•Review and print screening results
OR
Select an Age Range:To begin instant screening, with no personal subject data, select an age
range of the subject from the Home screen. You will be able to enter subject data after the
screening if desired.
Icons on bottom of screen:
•Queue – View, select or search for queued subjects from a list to begin the screening process.
•History – View already screened subjects (completed records).
•Tools – A variety of options to customize Spot.
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Subject Information Screen
On the subject information screen (Figure 7), confirm all data is correct. You can modify information
by touching the field you wish to change. After the change is completed select “ok” and you will
come back to the subject information screen. DOB/Age is required and will highlight in red if there
Figure 6
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P/N 20126 Rev B Page 10
is no age or if it is not a valid birthdate or age (under 6 months). Select GO to begin the screening
process.
Screening a Subject
1. Position yourself approximately 1 meter from the subject, as shown in.
•If using a tripod, place the tripod approximately 1 meter from subject.
2. Start screening and slowly rotate Spot upward to meet both of the subject’s eyes. Adjust your
distance from the subject until both eyes are clear on the screen.
•With a tripod, adjust the tripods position up or down and side to side until the subjects
eyes are in focus on the screen.
NOTE: Keeping Spot even (on axis) with the subject’s eyes will promote quicker results and help
ensure you are not capturing other objects.
3. A blue screen indicates you are too close or too far from the subject.
4. Position yourself with one foot in front of the other, slowly rock forward and back until the screen
turns grey, indicating you are in the capture range.
•When using a tripod, move the tripod as needed to ensure focus on the subject’s
pupils until the screen turns grey.
5. Keep Spot device steady until the screening wheel appears, indicating the capture process is
underway.
6. If you were unable to capture the subject’s pupils with a successful screening, the measurement
will be stopped, at this point you can retry, flag the record, try monocular mode or return to the
“Home” screen.
7. If the pupils are too small, Spot will notify you on screen to adjust the lighting in the room to
promote larger pupil size.
Figure 7
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P/N 20126 Rev B Page 11
How to Focus Spot
Monocular Mode
In monocular mode, you will be given the option to choose which eye to screen. This should be
attempted when binocular screening does not capture the subjects’ pupils.
1. Touch the side of the screen that corresponds with the eye you would like to screen. (OD =
subjects right eye; OS = subjects left eye).
2. When complete, you can repeat the process with the other eye by choosing Monocular from the
Results Menu.
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P/N 20126 Rev B Page 12
Viewing the Results
•The results screen will appear at the end of the screening process (Figure 10).
•Results that are out-of-range are indicated in red.
•All results viewing options are in the Tools menu under Results including; defaulting to a
summary screen or the detailed results screen, hiding recommendations or measurements,
cylinder convention options and raw or rounded data.
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Understanding the Results
Figure 11 below outlines the results screen and what it shows you:
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Figure 10
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Figure 11
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P/N 20126 Rev B Page 13
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Tools
The “Tools” menu will allow you to customize and configure Spot with the following options:
Displays Spot’s firmware version, software application version and serial number. Also displayed is a quick
reference of important Spot features, including memory storage levels of Spot
View the age-based criteria settings used for exam recommendations that are currently active on Spot.
Allows you to set the current date and time for your Spot.
Enables you to import and export using an inserted USB storage device.
Location allows you to set a location for a screening and all subjects will be tied to that location.
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.
Allows you to configure a network printer and print a test page. It also lets you view printer status.
Allows you to configure how data is displayed on the Results screen when a screening is complete. This
includes data format, cylinder convention, displaying or hiding measurements and recommendations, setting
default screening display and screening time-outs.
Helps you set a security PIN for your device for added security.If enabled a PIN will be required whenever you
start the device or upon waking it.
Activate the license on Spot.
Gives you to the option calibrate the touchscreen on your device.

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P/N 20126 Rev B Page 14
Wireless Network Configuration
1. From the “Tools” menu, select the Network icon.
2. Current network settings are displayed on the screen (Figure 12).
3. To add or edit any of the fields, see instructions below.
4. If they are correct, select to be returned to the “Tools” menu.
To add/change the network name (SSID):
1. Touch the SSID Name field; a keyboard will appear.
2. Enter the SSID (case sensitive); select “ok” to save your changes and return the previous screen.
“Ok” button will turn dark when changes have been made and are available to be saved.
To add/select the security type:
1. Touch the security type field.
2. Select the appropriate security type None, WEP, or WPA.
NOTE:WPA option supports WPA Personal/WPA2 Personal.
To add/change the passphrase (password):
1. Touch the passphrase button; a keyboard will appear (this is only available when the security field
is set to WEP or WPA).
2. Enter the passphrase (case sensitive) and select “ok”
Figure 12
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P/N 20126 Rev B Page 15
3. On the Network screen, select “Ok” to save changes, otherwise changes will not be applied.
To enable or disable the wireless capabilities on Spot:
1. Select the “On/Off” button from the network menu.
2. You will be prompted to Disable or Cancel. If you Disable wireless, the Spot will need to be
rebooted to turn Wireless On. After rebooting, go to Networks and select “On/Off” then
confirm Enable. NOTE: Wireless must be on for printing to be enabled.
To view advanced network settings, select TCP/IP. From here, you can also view your current
TCP/IP address as assigned by your network. For additional network configurations, select “Static”
to manually configure your network address and settings. (Also available is the MAC address of your
Spot - Figure 12).
Printer Configuration
Spot is capable of connecting and printing to most network capable Hewlett-Packard (HP) printers.
Spot also contains some generic PCL drivers that can be used with non-HP printers, as well as a
custom driver that supports the Brother QL-720NW label printer.
NOTE:In order to install the QL-720NW on spot, it must have QL-720 in its name on the network
and you must select the driver labeled QL-720NW from the driver list. Use Brother DK2205
Continuous Length Paper Tape or equivalent.
1. From the “Tools” menu, select the printer icon.
2. The next screen will list the available printers on Spot. This is a list of all printers already added
to Spot. (Figure 13).
Figure 12
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P/N 20126 Rev B Page 16
To select or change a default printer:
1. From the printer list, find and select the desired printer (it will auto-highlight in blue.) If more
than one printer is listed, touch Set as Default button for the highlighted printer.
To add a printer to your list, press the Add button (Refer to “Adding a Printer” section below).
To configure a printer, select a printer then press the Edit button to view printer Status or print
a test page.
To delete a printer:
1. Select the printer from the available printer list; touch the button to delete.
2. A pop-up will appear asking you to confirm deletion of the printer.
To reset the printer system which will delete all printers:
1. Touch the trashcan icon.
2. A pop-up will appear; select “Delete”. This will remove all current printer configurations.
Adding a Printer
1. From the “Printers Available” screen, select the plus sign to add a printer. (Figure 13).
2. If any printers are found on the network, they will appear in the list. If your printer is not shown,
select “+ Add New Printer” at the top of the screen (Figure 14) or you can select the printer you
wish to add then the continue icon
NOTE:Make sure you are connected to a wireless network with available printers for Spot to
show printers available.
Figure 13
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P/N 20126 Rev B Page 17
3. Review the printer details (Name, Driver and Location). To change or add a settings touch the
field you wish to change (Figure 15). If you need to add a Driver, you can use the search feature by
typing part of the driver name in the Search field.
NOTE: PCL drivers are available for non-HP printers. It is not guaranteed that every printer will work
with Spot.
4. Once changes have been made, select Save.
5. Once saved, the Print Test Page will appear dark.
6. A print icon will appear in the menu bar indicating the job is processing. The number of jobs in
the print queue will show up in the Jobs box at the top of the Printer Details screen, along with
the current printer Status (See Figure 15).
NOTE: If you are having a problem with your printer or a print job is stuck in the queue, select the
reset button to clear the print job and reset the printer.
7. Return to the Printers Available screen (Figure 13) and be sure to highlight the desired installed
printer and set is as the default be selecting the “Set as Default” button.
Figure 14
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Figure 15
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P/N 20126 Rev B Page 18
Import & Export
1. From the “Tools” menu, select Import/Export and you will be directed to the Import/Export
screen.
Caution – USB port is electrostatic sensitive. Be sure to take proper precautions to avoid potential
ESD damage to the USB port.
2. Insert a USB storage device into the USB port on Spot (Recommended USB size is 8GB or larger).
3. Once the USB device is detected, the Import and Export buttons will be available for selection
and you will see the USB symbol in the upper right black bar next to the date. (Figure 16)
4. The Import button will only become available if Spot recognizes a valid import file. Number of
import files found will be shown on the screen.
•NOTE:If the buttons do not highlight within five seconds of inserting the USB drive, remove the
USB, insert it into your PC and remove all files from the drive before attempting to retry.
Export
Select the Export button. If you wish to export one file containing no subject specific data select
“Exclude Personal Data”. If you do not choose this option, then all data will be exported. Select
Export button again to begin the export process.
Wait until the message “Export Finished successfully” displays, select “ok” then you may safely
remove the USB drive from Spot.
The exported folder name on the USB will be Spot_SerialNumber_YYYYMMDD_HHMMSS’. It will
contain:
Spot Criteria file (located in the “import” folder).
Figure 16
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P/N 20126 Rev B Page 19
Spot Subjects Template file (located in the “db” folder).
Spot Results file (located in the “db” folder).
Spot Banner file (located in the “import” folder).
Subject PDF files (located in the “pdf” folder). NOTE:If the USB drive is removed prior to export
completion, data transfer may be incomplete or become corrupted as a result.
Import
With the important function, you can import:
•Updated criteria files (SpotCriteria.csv)
•Future, queued, screening files (SpotSubjects.csv or Location.csv By using a Location in the
name of the file, this will default all subjects in the file to a location via the name of the file, ex
LakeMary.csv would default to “LakeMary” as the location for all subjects in this file)
•Custom banner for the screening reports (banner.png)
The file must follow the correct naming convention for a successful import (i.e., banner.png,
SpotCriteria.csv, SpotSubjects.csv. Remember SpotSubjects can have a location as the name of the file).
Spot Criteria
To modify current screening criteria:
1. Perform an export and insert the USB drive into your PC.
2. Go to the USB drive folder and open the Spot folder that you just exported; select the “import”
folder.
3. Copy the file “SpotCriteria.csv” to the top folder on the USB drive (the file cannot be within a
folder). Once copied, open the file.
4. Make any desired changes using Microsoft Excel or compatible program.
5. Save file as a Comma Separated Value (.csv) file. You must make sure the file is called
“SpotCriteria.csv”. Eject the USB drive from your PC and insert into Spot.
6. Go to the “Tools” menu and select “Import/Export”.
7. Select the “Import” button to import the updated criteria file.
8. To verify the file was imported successfully, go to the “Tools” menu and select Criteria; review
new settings.

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P/N 20126 Rev B Page 20
Spot Subjects
Spot gives you the ability to populate a subject list for “Queued” subjects.
1. Perform an export, once complete, remove the USB drive from Spot and insert it into your PC.
2. Select the Spot folder that was just created.
3. Select the “db” folder.
4. Select the “SpotSubjects.csv” file.
5. The SpotSubjects.csv file contains six columns; do not change any of the column headings.
Simply add information to the columns as shown below:
NOTE: You may add a column before the Patient Id column and call it Location if you need to
create specific locations for each subject.
•Patient ID—You can use any combination of alpha, numeric characters and symbols.
oThis field is used for quick subject look-ups.
•First Name—Enter the first name. Use any combination of alpha characters.
•Last Name—Enter the last name. Use any combination of alpha characters.
•Date of Birth—Enter the date of birth in the format MM/DD/YYYY. You can enter the age of subject
in years, months or a combination of both. This field is required for the import to work.
oFor example: If a subject were 2 years and 10 months old, you would enter 2Y10M. Use numeric
and alpha characters.
•Gender—Select Male or enter M; select Female or enter F.
oAlpha characters only; leaving the field blank will default to no gender identified.
•Eyewear—Select None, Glasses, or Contacts. By leaving the field blank, ‘None’ will be set as the
default.
After updating the import file:
1. Confirm the file is saved as a Comma Separated Values (.csv) file.
2. Verify file name is ‘SpotSubjects.csv’ or ‘DesiredLocation.csv’.
NOTE: If labeling your subject file(s) with a location, Spot will import all files found on the USB
drive at the same time.
3. Follow the import procedures to load the file onto Spot. To verify the file was imported
successfully:
4. Return to the Home screen and go to the Queue icon to view the new records.