I. INTENDED USE
The SurroSense Rx™ is a wearable
plantar pressure monitoring system
that is indicated for patients who have
decreased or absent sensation in the
feet resulting from a condition known
as peripheral neuropathy. As the
patient goes about their daily routine,
data from the inserts are wirelessly
transmitted to the SurroSense Rx™
smartwatch. The device can be worn
both indoors and outdoors as often as
desired by the patient; or as
recommended by Podiatrist/ Physician.
If the feedback is properly adhered to,
the medical benefits of using the
system may include the prevention of
peripheral neuropathy-related
complications including the
development of blisters and ulcers,
which can lead to surgical amputation.
Use of the SurroSense Rx™ device
does not negate the need for regular
diabetic foot care with a health care
professional.
II. CONTRAINDICATIONS
There are no known contraindications
for the SurroSense Rx™ system at this
time.
III. WARNINGS AND PRECAUTIONS
WARNING: Disregarding WARNING
information may cause improper
operation and inaccurate results.
CAUTION: Disregarding CAUTION
information may reduce the life
expectancy of the product and/or
damage to the product.
CAUTION: This product uses and
receives radio frequency signals. For
proper operation, this product must be
configured and operated as per the
instructions provided in the manual.
WARNING: This product uses low
power radio communications and can
affect other medical electrical;
equipment.
SURROSENSE RX™SYSTEM Instructions for Use 3
