BodyMedia FIT Operations Instructions download pdf (Page 3)

BodyMedia FIT Armband and Display Manual

User Environment ................................................................. 24

Regulatory Statement ............................................................ 28

Table of Contents

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 maintenance 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, cardiovascular 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 metabolic 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 signiﬁcant health risks have been identiﬁed. The most frequently

reported health risk, occurring in less than 1% of users, is a mild to severe skin irri-

tation 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 physi-

cian 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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BodyMedia FIT Operations Instructions Page 3