User's Manual

BodyMedia FIT Armband and Display Manual

Regulatory Statement ............................................................ 24

Table of Contents

Intended Use

The weight management system records, analyzes and reports physiological

parameters. These objective health metrics assist you to maintain a healthy weight

and an active lifestyle, which are continually cited as the keys to combating and

managing serious medical conditions including obesity, cardiovascular disease and

diabetes. The information presented by the system can be used by your physician

or healthcare practitioner in the assessment and treatment of medical conditions

inﬂuenced by weight and activity.

Risks and Beneﬁts

The predominant beneﬁt of the product is enabling of the monitoring and manage-

ment 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