Intended Use
The system records and analyzes physiological parameters, and uses algorithms to report daily movement,
calories burned, degree of physical activity, and steps taken. These objective health metrics facilitate main-
tenance of a healthy weight and an active lifestyle, and in conjunction with a balanced diet can result in a
favorable influence on overall health. Maintaining a healthy weight, balanced diet and active lifestyle are
routinely cited as key to combating and managing serious medical conditions including obesity, cardiovascu-
lar disease and diabetes. The information presented by the system can be used by a physician or healthcare
practitioner and may aid the assessment and medical management of conditions influenced by weight and
activity.
Risks and Benefits
The predominant benefit of the product is the enabling of the monitoring and management of daily meta-
bolic and lifestyle data in order to reach your activity and weight goals. In addition to weight management,
known benefits of increasing activity levels include increased life expectancy, improved sleep, and enhanced
appearance and self perception.
Analysis and post market surveillance indicate that risks of using the products are extremely low. No signifi-
cant health risks have been identified. The most frequently reported health risk, occurring in less than 1%
of users, is a mild to severe skin irritation resulting from wearing the Armband. The issue is often resolved
by following proper wear and cleaning guidelines. Skin irritation may still occur for individuals with highly
sensitive skin or for those with a specific allergy to materials used in the Armband and/or strap. However, it
is best to discontinue use and consult a physician regarding skin irritations.
If you have a known metal allergy, consult your physician prior to using the Armband. Read the instructions
provided and review the Cautions section of this manual before using the Armband or optional Display.
Purpose of the System
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