Spot VS100 Vision Screening Device
Instructions for Use
P/N 20126 Rev B
Table of Contents
WWeellccoommee ttoo SSppoott ................................................................................. 3
Intended Use ...................................................................................................................................................... 3
Indications for Use .......................................................................................................................................... 3
Box Contents ...................................................................................................................................................... 3
Device Description .......................................................................................................................................... 4
Product Registration ...................................................................................................................................... 4
BBaassiicc OOppeerraattiioonn ...................................................................................... 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
User Operation ............................................................................................ 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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TTeecchhnniiccaall DDeessccrriippttiioonn .......................................................................... 25
EEnnvviirroonnmmeennttaall PPrrootteeccttiioonn ................................................................... 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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LLiimmiitteedd WWaarrrraannttyy ............................................................................ 33
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P/N 20126 Rev B Page 2
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Figure 1
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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.
m
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 nonapproved 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.
P/N 20126 Rev B Page 3
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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Figure 3
Figure 2
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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.
P/N 20126 Rev B Page 5
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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Figure 4
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.
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.
P/N 20126 Rev B Page 7
Figure 5
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.
P/N 20126 Rev B Page 8
Figure 6
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.
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
P/N 20126 Rev B Page 9
Figure 7
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.
P/N 20126 Rev B Page 10
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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Figure 10
Figure 11
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.
Understanding the Results
Figure 11 below outlines the results screen and what it shows you:
P/N 20126 Rev B Page 12
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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Figure 12
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”
P/N 20126 Rev B Page 14
Figure 12
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).
P/N 20126 Rev B Page 15
Figure 13
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.
P/N 20126 Rev B Page 16
Figure 14
Figure 15
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.
P/N 20126 Rev B Page 17
Figure 16
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).
P/N 20126 Rev B Page 18
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.
P/N 20126 Rev B Page 19
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.
o This 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.
o For 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.
o Alpha 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.
P/N 20126 Rev B Page 20
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”
• No larger than 1MB
• Image must be 1376 x 240 pixels
To add a custom banner:
1. Place the banner.png file on the root/top-level directory of the USB.
2. Insert the USB in Spot. Go to Tools, then select Import/Export.
3. The import file option will highlight; select Import.
To verify that the file was imported successfully:
1. Screen a new subject or select a completed record and print the report.
2. Your new banner will be printed on the bottom of the report.
Web Access
When connected to a wireless network, Spot gives you the ability to view Spot files from a web
browser (Internet Explorer, Firefox, Safari, etc.) on a PC on the same network.
To access the webserver on Spot:
1. From your computer, open a web browser; enter Spot’s IP address in the address bar (this is
located on the top black bar on the Home Screen).
2. You will be prompted to enter the username and password.
• Username: spot
• Password: 0000
NOTE: If you have enabled “Security” on your device, the password will be your four-digit pin
code.
3. Default will go to the “report” folder. This contains the pdf folder where you can find subject
PDF files.
4. To view the SpotResults.csv file change to the “db” directory.
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Spot Licensing
In order to use the screening functionality of Spot, the device needs to be licensed. If your device
came new from the factory with this instruction document, your license is already installed and
active. If you have updated the software on your device, the licensing will need to be updated as
follows:
1. Connect an empty USB device to the Spot USB port.
2. Go to tools, then the Spot License button.
3. After a moment, a dialog box will appear indicating that the registration file has been exported
to the USB drive.
4. Send the file titled spot-[serial number].reg to PediaVision Support at support@pediavision.com
PediaVision Support will review your registration file and email you back a valid license key. Once
you receive the key, perform the following:
1. Save the file to the top level (root directory) of a USB Drive.
2. Insert the USB drive into the USB port on Spot.
3. From the Tools menu, select Spot License.
4. After a moment, a dialog box will appear indicating that the license file has been imported onto
the Spot device.
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System Restart
1. To power cycle Spot - press and hold the power button until a confirmation screen appears.
Select Confirm to power off.
2. When the screen turns black, wait 30 seconds and then press the power button to turn Spot back
on. Ensure Spot has power by plugging in the power cord.
System Freeze
In the event Spot locks up and is unresponsive to touch, you will need to perform a hard system
reset.
1. Press the power button.
2. If the Power Off window appears, select Confirm to shutdown the device.
3. If not, press and hold the power button until the screen goes black, then release the power
button.
4. Wait about one minute then perform the normal start-up process.
NOTE: This may cause some data loss (ex. printer configuration and subject data).
Printer Issues
Check that your printer is turned on and has sufficient ink or toner:
1. Print a test print page directly from the printer.
After you confirm your printer is in proper working order:
2. Verify 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:
3. Perform a “System Restart” (see above).
Wireless Issues
If you encounter problems connecting to a wireless network:
1. Verify all network settings are entered correctly.
2. If the settings are correct, try turning Spot off, then back on.
P/N 20126 Rev B Page 23
Message
Actions
Select Ok and the device will
Support.
issue
3. Check on the “Home” screen to see if a Network is identified in the upper left corner in the black
bar.
NOTE: Restarting helps to reinstate the connection to the network.
4. If the connection does not automatically reconnect, go to Tools, Network, select Security Type,
reselect the correct type (None, WEP, WPA) then select the highlighted “Ok”. This should reinstate the network connection.
System Messages
Specific system messages may appear while operating Spot. If so, the information below will assist
you in identifying what the messages indicate:
Message Text
Sorry for the inconvenience.
We need to reboot the
device.
Problem Encountered. Spot
needs to reboot.
The screening system is not
available.
The screening system is not
initialized.
Spot has not finished saving
the previous screening.
Ok or
Cancel
Reboot
None
None
None
Screening mode has encountered
a problem and the device needs
The system was not able to start
and has attempted to correct the
The Exam system did not
initialize, or is unresponsive.
The Exam system did not
initialize, or is unresponsive.
The system has detected that it is
still saving files to disk from a
Meaning Action
power cycle itself. If the problem
to be restarted.
previous exam.
persists, contact PediaVision
Select Reboot and try again. If
problem persists, contact
PediaVision Support.
Power cycle the device and try
again. If problem persists, contact
PediaVision Support.
Power cycle the device and try
again. If problem persists, contact
PediaVision Support.
Power cycle the device and try
again. If problem persists, contact
PediaVision Support.
For more information on troubleshooting or error messages, contact PediaVision’s support team
(refer to the last page of this manual for additional contact information).
P/N 20126 Rev B Page 24
TTeecchhnniiccaall DDeessccrriippttiioonn
General
• Spot model VS100 will be referred to as Spot.
• This Spot IFU document is valid for software version 2.0.16.
• 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 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:
Myopia (Near-sightedness)
o
Hyperopia (Far-sightedness)
o
Anisometropia (Unequal refractive power)
o
Astigmatism (Blurred vision, eye structure problem)
o
Anisocoria (Pupil size deviations)
o
Strabismus (Eye misalignment, Gaze)
o
• 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
front glass surface and the LCD display as needed.
P/N 20126 Rev B Page 25
meennttaall PPrrootteeccttiioonn
OR
• The USB port shall only be used for software download/upload via a USB flash drive and shall not
be cable connected to any other device.
• The power supply/charger’s supplied with Spot have the following characteristics:
Mfg: 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
Avg. Efficiency: 86.4% @ 115VAC; 85.7% @ 230VAC
Mfg: SL Power Electronics
Model: MENB1040A1503F01 or MEMB1040A1541F01
Input Voltage: 90 – 264VAC (100 – 240VAC Nominal)
Input Frequency: 47 – 63 Hz
Input Current: 100VAC: 1.1A
Avg. Efficiency: 81-87% @ 0-50 W, ≥87% @ >51 to 250
EEnnvviirroonnm
This device contains Lithium ion cells and other electronic materials. Please contact your local
government authorities for proper electronic waste recycling or disposal methods at end of life.
EMC Information
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 low-voltage 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.
•
The maximum wireless signal rate for the system is derived from IEEE Standard 802.11b/g/n
specifications. Actual data throughput will vary. Network conditions and environmental factors,
including the volume of network traffic, building materials and construction, and network overhead,
may lower actual data throughput rate. Environmental conditions will adversely affect wireless signal
range.
P/N 20126 Rev B Page 26
Emission Test
Compliance
Electromagnetic environment guide
RF Emission Cispr 11
Group 1
Spot must emit electromagnetic energy in
order to perform its intended function.
is suitable for use in all establishments
other than domestic and those directly
voltage power
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.
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.
Nearby electronic equipment may be affected.
RF Emission Cispr 11 Class A Spot
connected to the public lowsupplies 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 20126 Rev B Page 27
Spot is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is used within those
Immunity Test
Test level EN 60601-1-2
Conformity Level
Electromagnetic environment guide
Electrostatic
± 8kV air
Non-conforming
The floor should be in wood, concrete or ceramic tile.
Electrical Fast
±2 kV high voltage
±2 kV high voltage
The quality of the power supply should be that one
Surge EN 61000-4-5
Differential mode: ±1 kV
Differential mode: ±1 kV
The quality of the power supply should be that one
Voltage dips, short
The quality of the power supply should be that one
supply interruptions, it is recommended a backup
Magnetic field at
3 A /m
3 A /m
Power frequency magnetic fields should have
Spot is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is used within those
Immunity Test
Test level EN 60601-1-2
Conformity Level
Electromagnetic environment guide
Conducted RF
3 Veff from 150kHz to
3 Veff from 150kHz to 80MHz
cables, except when they follow the recommended
safety distance for separation, calculated with the
Where P is the nominal maximum power of the
separation distance expressed in meters (m).
Radiated RF
3 V/m from 80MHz to
3 V/m from 80MHz to 2.5GHz
Surge EN 61000-4-5
Differential mode: ±1 kV
Differential mode: ±1 kV
The field intensity of the fixed RF transmitters, as checked in an electromagnetic investigation of the locus, should be less than the conformity level
It is possible to have interference near devices marked with the symbol:
environmental conditions.
Immunity Guidance
Discharge (ESD) EN
61000-4-2
Transient/Burst EN
601000-4-4
interruptions and
voltage variations on
power supply input
lines EN 61000-4-11
power
frequency EN 610004-8
± 6kV contact
power line
Common mode: ±2kV
<5% UT (>95% dip of UT) for 0,5 cycle
40% UT (>60% dip of UT) for 5 cycle
70% UT (>30% dip of UT) for 25 cycle
<5% UT (>95% dip of UT) for 5
seconds
Immunity Radio Frequency Guidance
This unit is sensitive to ESD and
may require resetting
power line
Common mode: ±2kV
<5% UT (>95% dip of UT) for 0,5 cycle
40% UT (>60% dip of UT) for 5 cycle
70% UT (>30% dip of UT) for 25 cycle
<5% UT (>95% dip of UT) for 5 seconds
If the floor is covered with synthetic material, relative
humidity should be at least 30%.
of a typical commercial or clinical environment.
of a typical commercial or clinical environment.
of a typical commercial or clinical environment. If the
user requests a continuous functioning during power
power supply unit (UPS) or battery.
characteristic levels of a typical commercial or clinical
environment.
environmental conditions.
EN 61000-4-6
EN 61000-4-3
for each range of frequency.
P/N 20126 Rev B Page 28
80MHz
2.5GHz
Common mode: ±2kV
Common mode: ±2kV
The portable and mobile devices with RF communication
shouldn’t be used near any part of the device, including
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
transmitter output expressed in Watts (W) as specified by
the transmitter manufacturer and d is the recommended
Spot is manufactured to work in an electromagnetic environment in which the radiated RF disturbances are controlled. The operator or user of
Output maximum frequency
Separation distance at the transmitter Output maximum frequency (m)
from 150kHz to 80MHz
from 80MHz to 800MHz
from 800MHz to 2,5GHz
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
frequency of the transmitter, where P is the output maximum nominal power of the transmitter in Watts specified by
Recommended separation distance between portable or mobile devices for radio communication and
the device
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.
(m) nominal power of the
transmitter (W)
D= 1,2 x ÖP
D= 1,2 x ÖP
D= 2,3 x ÖP
applicable equation at the
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.
FCC Compliance Statement
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: This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference when the equipment is operated in a commercial environment. 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. Operation of this
equipment in a residential area is likely to cause harmful interference in which case the user will be
required to correct the interference at his own expense.
Warning: Changes or modifications not expressly approved by PediaVision could void the user’s
authority to operate the equipment.
P/N 20126 Rev B Page 29
IC Compliance Statement
This Class A digital apparatus complies with Canadian ICES-003.
Specifications
Dimensions (in): 8½ x 6¾ x 4¾ (LxWxH)
Weight (lbs.): ~2.55
Wireless Network: 802.11 b/g/n
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: 2.5 Years (Under Normal Usage)
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:
> 1.50D to 3.00D, ± 1.00D
0.00D to 1.50D, ± 0.50D
Cylindrical Axis:
• Range: 1 to 180 degrees in 1-degree increments
• Accuracy:
± 5 degrees (for cylinder values > 0.5D)
Pupil size:
• Range: 4.0 mm to 9.0 mm in 0.1 mm increments
• Accuracy:
P/N 20126 Rev B Page 30
± 0.1mm
mbboollss
IPX0
other countries, in accordance with local disposal and recycling laws.
Pupil distance:
• Range: 35mm to 80 mm in 1 mm increments
• Accuracy:
± 1 mm
Time per measurement: 1 s
Measuring distance: 1 m ± 5 cm
Fixation target: Random visual pattern and audible sound
Measurement principal: Optical reflex
SSyym
DC Power
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
ESD Protection Mark
P/N 20126 Rev B Page 31
USB Port (Software Updates Only)
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
Print Job in Progress
P/N 20126 Rev B Page 32
miitteedd
Waarrrraannttyy
LLiim
PediaVision provides the following limited warranty for the Spot VS100 device:
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
W
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 directly to the PediaVision support team within the warranty period.
Pediavision does not warrant accessories.
P/N 20126 Rev B Page 33
CCoonnttaacctt PPeeddiiaaVViissiioonn
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:
PediaVision’s main telephone number is 888.514.7338:
Contact: Email: Phone:
Technical Support support@pediavision.com Option 3
Sales Information sales@pediavision.com Option 2
General Information info@pediavision.com Option 0
Address:
PediaVision Holdings, LLC
200 Waymont Court, Suite 122
Lake Mary, FL 32746
USA
P/N 20126 Rev B Page 34
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