Welch Allyn Spot VS100 Manual

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Welch Allyn
®
Spot
®
Vision Screener Model VS100
Directions for use

ii Welch Allyn Spot Vision Screener VS100
DRAFT
© 2015 Welch Allyn. All rights are reserved. To support the intended use of the product described in this
publication, the purchaser of the product is permitted to copy this publication, for internal distribution only,
from the media provided by Welch Allyn. No other use, reproduction, or distribution of the publication, or
any part of it, is permitted without written permission from Welch Allyn.
Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the
product, that may result from failure to use this product in accordance with the instructions, cautions,
warnings, or statement of intended use published in this manual.
Welch Allyn®and Spot®are registered trademarks of Welch Allyn.
Software in this product is Copyright 2014 Welch Allyn or its vendors. All rights are reserved. The software
is protected by United States of America copyright laws and international treaty provisions applicable
worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with
this instrument as intended in the operation of the product in which it is embedded. The software may not
be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable
form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the
software remain with Welch Allyn or its vendors.
This product may contain "free" or "open source" software (FOSS). To learn more about Welch Allyn's use
and support of FOSS, please visit http://www.welchallyn.com/opensource.
For patent information, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact Welch Allyn Technical Support:
www.welchallyn.com/about/company/locations.htm.
Manual Material No. 722911 Ver A
DIR 80019921
Revision date: 2015-01
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
This manual applies to 901029 Vision Screener.
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland

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Introduction
This Directions for use manual is a comprehensive guide designed to help you understand
the capabilities and operation of your Spot Vision Screener VS100. The information in this
manual includes all options available with the Spot Vision Screener. The applicability of
some sections of this manual depends on the configuration of your particular device.
Read this manual thoroughly before attempting to use the device.
The vision screener 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. The vision screener provides visual and
audible cues to attract subject’s attention and gaze. The device 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.
Intended use
The Spot Vision screener is intended to measure the refractive power of the eye by
measuring light reflexes from the retina. It also estimates pupil size, pupil distance and
eye gaze deviation. It is intended for use on subjects six months of age through adults.
Indications for use
The Spot Vision screener is indicated for use by healthcare professionals or under the
direction of a healthcare professional to screen or evaluate individuals for potential
refractive errors associated with poor vision.
Contraindications
The Spot Vision Screener has no known contraindications.

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Symbols
Documentation symbols
Power symbols
Miscellaneous symbols
Consult operating instructions/directions for use (DFU). A copy of the DFU is available on this website. A printed copy of the
DFU can be ordered from Welch Allyn for delivery within 7 calendar days.
WARNING The warning statements in this manual identify conditions or practices that could lead to loss of data, illness,
injury, or death.
CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the
equipment or other property.
Rated power input, DC
Battery inside (Not user replaceable)
Power On/Off
USB port
DC power input port, Center pin positive
IPXØ
Equipment is not protected against the ingress of liquid
Non-ionizing electromagnetic radiation
This symbol is applicable for EC member countries only. To avoid potential negative consequences for the environment and
possibly human health, this instrument should be disposed of (i) for EU member countries - in accordance with WEEE
(Directive on Waste Electrical and Electronic Equipment) or (ii) for all other countries, in accordance with local disposal and
recycling laws.

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User Interface Symbols
The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the 93/42/
EEC Medical Device Directive.
Battery status/level indicator
Battery charging (Flashing) or charged (Continuous)
Wireless On/Off button
Connected to the wireless network
No wireless network in range
No IP address assigned by the router
Unknown network
IP
?

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Cannot connect to configured network
Sound off
Sound on
Continue
Back
Exit
Print job in progress
!

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Warnings and cautions
WARNING The warning statements in this manual identify conditions or
practices that could lead to loss of data, illness, injury, or death.
CAUTION The caution statements in this manual identify conditions or practices
that could result in damage to the equipment or other property.
WARNING Risk of electric shock. All signal input and output (SIP/SOP)
connectors are intended for connection of only other medical devices, medical
systems or non-medical devices complying with IEC 60601-1, or other IEC
standards appropriate to the device. For example, a printer connected via USB
must comply with IEC 60950. Connecting additional unapproved devices to the
device might increase chassis or patient leakage currents.
WARNING Risk of electric shock. No modification of this equipment is allowed.
WARNING Risk of electric shock. Do not open the device or attempt repairs.
The device has no user-serviceable internal parts. Only perform routine cleaning
and maintenance procedures specifically described in this manual. Inspection
and servicing of internal parts shall only be performed by qualified service
personnel. Attempt to modify this device may result in bodily harm and will void
product warranty.
WARNING Risk of electric shock. Do not allow the patient to make contact with
accessible conductive parts (DC adaptor output connector, power input
connector and USB port). Additionally, you should not make contact with the
patient and any accessible conductive parts at the same time.
WARNING To avoid a possible explosion, do not use the device in the presence
of flammable anesthetics: mixtures containing air, oxygen, or nitrous oxide.
WARNING Risk of data loss. If a reboot is required during a system freeze, data
loss, such as printer configuration and subject data, can occur.
WARNING Lithium ion battery. Risk of fire, explosion, and burns. Do not handle
or disassemble the battery pack.
WARNING Use only accessories approved by Welch Allyn. Visit
www.welchallyn.com. The use of any other accessories can result in inaccurate
patient data, can damage the equipment, and can void your product warranty.
WARNING Injury risk and equipment damage risk. When charging the device,
properly secure all DC transformer cords to minimize trip hazards.
WARNING Patient injury risk. Verify patient identity on the device after manual
or barcode entry and before printing or transferring patient records.

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Caution The device is a precision instrument. Do not subject it to physical
shock.
Caution Do not use the wrist strap as a means to carry the device; it is not
designed to carry the weight of the device.
Caution The device is not waterproof. If you accidentally drop it into liquid or
liquid is spilled on the device, contact Welch Allyn Technical Support
immediately. If minor water droplets are found on the device, wipe off with a
soft dry cloth.
Caution Do not store the device in the foam or case while the DC power
adapter is plugged in; this may cause damage to the power cord and to the
device.
Caution Do not leave the device in excessive heat or in direct sunlight. High
temperatures can cause the device to malfunction.
Caution When plugging the DC power connector into the device, do not force
the power connector into the device; this may cause damage to the device,
which will not be covered under warranty.
Caution Do not push or scratch the touchscreen display with stiff or rigid
objects. This may cause damage to the device. A stylus is acceptable for use
with the device.

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Contents Checklist
The main shipping box contains the vision screener, Directions for use, and the Accessory
box. The Accessory box contains:
AC Power Cord.
Power Supply/Charger.
Cleaning Cloth.
Velcro Cable Straps.
NOTE: Please do not discard the box and foam. Damages incurred by shipping the device
in non-approved packing material will void the limited warranty (see warranty for details).
If you purchased a carrying case, place the foam from the shipping box inside the carrying
case for safer transport. Do not store your vision screener in the foam or case while the
Power cord is plugged in.

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