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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....................................................................... 34
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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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P/N 20126 Rev B Page 4
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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