10.
Seek Scan has been designed to be used in conjunction with
ISO/TR 13154:2017
and
IEC 80601-2-59
.
Seek Scan is not 510(k) cleared or intended to replace a medical thermometer. However, based on new FDA guidelines
published April 2020, the FDA stated that it accepts the use of thermal cameras for initial body temperature assessment for
triage use without a 510(k) clearance during the health emergency, provided the thermal imaging system meets the standards
set forth in the guidance. Seek Scan meets all of these applicable standards. Seek Scan should not be solely or primarily
relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease. While this device can be used by anyone
for initial body temperature assessment for triage use, only public health officials, through their experience with the device
in the particular environment of use, can determine the significance of any fever or elevated temperature based on a skin
telethermographic temperature measurement. Elevated body temperature in the context of use should be confirmed with
secondary evaluation methods (e.g., an NCIT or clinical grade contact thermometer).
Seek Scan should be used “as designed” to measure only one subject’s temperature at a time. The thermal image displayed
in the software is a heat map representation of the temperature data collected from the thermal sensor and only intended
for locating the points from which to extract the thermal measurement. The reference body site used for temperature
measurement is primarily the inner canthus although other areas of the face may also be used for measurement.
FCC:
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. Note: Any changes or modifications not expressly approved by the Seek
Thermal Inc. could void the user’s authority to operate the equipment.
WEEE:
This symbol on the product(s) and / or accompanying documents means that used electrical and electronic equipment
should not be mixed with general household waste. For proper treatment, recovery and recycling, please take this product(s)
to designated collection points where it will be accepted free of charge. Alternatively, in some countries, you may be able to
return your products to your local retailer upon purchase of an equivalent new product. Please contact your local authority for
further details of your nearest designated collection point. Penalties may be applicable for incorrect disposal of this waste, in
accordance with you national legislation.
ROHS:
This RoHS-compliant product conforms to the European Union Restriction of the Use of Certain Hazardous Substances
(RoHS) in Electrical and Electronic Equipment. Seek Thermal Inc. ensures RoHS conformance by requiring supplier Declarations
of Conformity, monitoring incoming materials, and maintaining manufacturing process controls.
Industry Canada:
This Class A digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe A est
conforme à la norme
REGULATORY AND COMPLIANCE INFORMATION
