Warnings And Cautions - Welch Allyn Spot VS100 Directions For Use Manual

Directions For Use

Warnings and cautions

Patient Safety
Data and Performance
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 The Directions for Use (DFU) contains important instructions
for successful and safe use, maintenance, cleaning, transport, storage, and
operation of the device as well as a troubleshooting guide with additional
support. Read instructions thoroughly and store the DFU for future
reference. Contact Welch Allyn if any instructions are not understood.
WARNING Photosensitivity risk. While this device is considered low risk
according to IEEE 1789, Practices for Modulating Current in High-
Brightness LEDs for Mitigating Health Risks to Viewers, this device uses
flickering lights to attract patient attention. A very small percentage of
individuals may experience epileptic seizures when exposed to certain light
patterns or flashing lights. Apply clinical judgment when using this device.
WARNING Exposure to sound. This device uses sound cues to attract
patient attention. If the sound creates discomfort for the patient, please
mute the device in the settings.
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 Use only accessories approved by Welch Allyn. Visit
www.welchallyn.com. The use of any other accessories can result in
inaccurate subject data, can damage the equipment, and can void your
product warranty.
WARNING Subject injury risk. Verify subject identity on the device after
manual entry and before printing or transferring subject records.
WARNING False positive and false negative results may occur in a
healthcare screening. Vision screening does not replace a complete eye
examination by an ophthalmologist or optometrist.
WARNING The use of screening results for recommending therapy is
reserved exclusively for eye care professionals.
WARNING The screening results of this autorefractor are not to be used
directly for the prescription of corrective eyewear.
WARNING If the pupils are too small, the vision screener notifies you on
screen. You may want to adjust the lighting in the room.
CAUTION HIPAA and GDPR requires healthcare providers to protect
patient data from unauthorized viewing and use. Use of lock screen and
other data security protections available on this device are recommended.
Introduction 5