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 & BENEFITS
The predominant benefit of the product is enabling 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 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.
Purpose of the System
Always consult a physician before starting any new diet or exercise program. This system is
not to be used for diagnostic purposes and is not intended to be a substitute for the medical
advice or supervision of your personal physician.
Materials in the Armband have been evaluated for skin contact. Because everyone’s skin is
different you may experience irritation or redness after wearing the Armband. If this occurs,
discontinue use and consult your physician.
• If you have known metal allergies, consult your physician prior to wearing.
• Do not wear on an open wound, sore, or burn.
• To reduce potential for skin irritation, wear for a maximum of 23 hours per day. Be
sure to leave it off one hour per day.
• To reduce the potential risk of skin irritation, be sure to dry your arm thoroughly
before wearing.
• The tab at the end of the Armband strap should be aligned to avoid unintended
contact with the skin which may cause scratching.
• To avoid skin burns, do not wear when it has been exposed to excessively hot
temperatures including direct sun exposure.
Be careful not to over-tighten the strap while on your arm. If you feel constriction or loss of
circulation at any time, loosen the adjustable strap and re-fasten it to a more comfortable
setting. If you experience pain, bruising, swelling, or discoloration of the arm, discontinue
use and consult a physician.
This product is not defibrillation proof.
Do not place this equipment in close proximity to other devices that can cause
electromagnetic interferences of any nature.
The equipment is not suitable for use in the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE.
Medical electrical equipment requires special precautions regarding electromagnetic
environments (EMC) and must be installed and put into service according to the EMC
information provided in the User Guide. Portable and mobile radio frequency (RF)
communications equipment can effect medical electrical equipment.
Check the equipment for sharp edges or damage before each use.
Once plugged in, the armband lights will blink indicating proper connection and charge
progress. If no indication is seen, disconnect the cable and consult customer service.
Cautions
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