Welch Allyn Spot VS100 Directions For Use Manual page 10

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6 Introduction Welch Allyn Spot Vision Screener Model VS100
WARNING The VS100 transmits patient data as read-only PDFs.
Nevertheless, the possibility of security breaches cannot be completely
excluded. Verify that patient data matches the correct record and that it has
not been altered prior to making treatment decisions.
CAUTION Product security exploits can cause the device or device data to
become unavailable or cause data security breaches. Avoid inserting
uncontrolled or unsecured USB drives into the USB port or connecting to a
wireless network with incomplete security.
WARNING Patient Risk - selecting "hide recommendation" causes the
device to not show Pass/Refer messages during screening.
WARNING Patient Risk - When performing repeated measurements, use
the first reading (and referral) for most accurate results.
WARNING Device System Date is used in Pass/Refer determination.
Insure that the System Time is correct to prevent incorrect referrals
WARNING Risk of false positive and false negative results. Modification of
referral criteria should be performed only by a vision specialist.
Electrical and Fire
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 subject
leakage currents.
WARNING Risk of electric shock. No modification of this equipment is
allowed. 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
voids product warranty.
WARNING Risk of electric shock. Do not allow the subject 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 subject 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 Lithium ion battery. Risk of fire, explosion, and burns. Do not
handle or disassemble the battery pack.
WARNING Injury risk and equipment damage risk. When charging the
device, properly secure all DC transformer cords to minimize trip hazards.
WARNING The power cord set may not be used with any other
equipment other than the Welch Allyn Spot Vision Screener VS100.