00346_REV1 4 Smithfield Street 11th Floor Pittsburgh, PA 15222 USA P.412.288.9901 F.412.288.9902 www.bodymedia.com © Copyright 2007 BodyMedia, Inc.
1 Legal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Uploading Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Wearing the armband . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Registration & Account Creation . . . . . . . . . . . . . . . . . . . . . . . . 18 Your SenseWear® armband. . . . . . . . . . . . . . . . . . . . . . . .
This EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE. Do not get the device close to other devices that can cause electromagnetic interferences of any nature. This product is non-defibrillation proof. This product complies with the general requirements for a safe medical device under applicable directives. However, this product alone is not meant to substitute for proper medical diagnosis, care, or treatment.
5 Please note when submerging the armband in water: Water resistance The armband is not intended for long term operation under water. The armband is IP67 water resistant to 1 meter under water for 30 minutes. Loss of data may occur if the armband is under water for a longer period of time. Users with sensitive skin should avoid wearing the armband excessively. If you have sensitive skin, remove the armband 1 hour for every 24 hours of wear time to reduce potential for skin irritation.
7 Disinfecting Wipe back of armband with soft cloth dampened with 70% isopropyl alcohol. Allow armband to dry for 5-10 minutes before wearing DO NOT STERILIZE THIS UNIT. Moisten a soft cloth or towel with mild disinfectant soap and water. Wipe and dry the skin-touching side of the armband. Never use solvents to clean the armband, only for disinfecting (see below). The adjustable strap should be hand-washed with mild soap and warm water, then air-dried. Machine drying should be avoided.
9 Magnetic Field IEC 61000-4-8 Power Frequency 50/60Hz N/A >95% Dip for 0.
11 0.3689 1.1666 3.6893 11.6666 0.1 1 10 100 11.6666 3.6893 1.1666 0.3689 0.1166 D=(3.5/V1)(Sqrt P) D=(3.5/V1)(Sqrt P) 0.1166 Separation (m) 80 to 800MHz Separation (m) 150kHz to 80MHz 0.01 Max Output Power (Watts) 23.3333 7.3786 2.3333 0.7378 0.2333 D=(7/E1)(Sqrt P) Separation (m) 800MHz to 2.5GHz The Product MF (SenseWear® armband) is intended for use in the electromagnetic environment specified below.
13 Skin Temperature • Calibrated Range is 20.00ºC to 40.00ºC • A minimum resolution of 0.05ºC • Two standard deviation accuracy of +/- 0.80°C Galvanic Skin Response • Calibrated Range is 56KΩ to 20MΩ (50.00 nSiemens – 17.00 uSiemens) • Two-standard-deviation accuracy of +/- 7.00 nSiemen up to 233.34 nSiemens reading • Two-standard-deviation accuracy of +/- 3.00% of expected value otherwise Heat Flux • Calibrated Range is 0.00 W/m2 to 300.00W/m2 • A minimum resolution of 1.
15 FCC 47CFR 15C TCB - 47 CFR Part 15 Subpart C Intentional Radiator Certification Test • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit separate from the receiver. • Consult the dealer or an experienced radio/TV technician for help.
17 18 3. Use the user id and password provided to you to login. 4. You can now add facilitators. These are your health professionals that will be administering the WMS program to your patients. 5. Once the facilitators have been registered, they can log in to the system and begin entering Member (patient) accounts and setting up MBA or Weight Management Programs. 6. Once an account and program are created, there are 5 steps to complete set up: Step 1. Agree to end user license agreement. Click Next.
19 3. If using the SenseWear® wireless communicator, attach the wireless communicator to the USB cable. Windows will detect the new hardware and display the Found New Hardware Wizard. 4. After completing the New Hardware Wizard, click Finish. 5. Click Register to configure the armband. The armband is now ready to collect data. Skip Step 3 if not using SenseWear® wireless communicator. 1. Plug the USB cable into a USB port on your computer. 2. Plug the opposite end of the USB cable into the armband.
21 NOTE: When the armband is on the arm, DO NOT connect it to the USB cable. NOTE: Fully charge the battery before first use. the battery will arrive with a small, inital charge. 22 7. When your data has been uploaded, you will see the summary screen showing the comparison of your targets versus your actual data. 1. Go to www.sensewear.com and click on the link For Health Practitioners or For Patients. 2. You will then be required to enter your user id and password.
23 When I try to upload data from my armband, I get an error message. 1. If you are having difficulty uploading your armband data, it could be one of several reasons. Please double check the following and try again. If the problem still persists, please contact Technical Support. 2. If you are uploading wirelessly, make sure you are within 10 feet of your PC. If you wander outside of this range, the upload may not work. Also, make sure that your armband has had a chance to turn on.
25 SenseWear® and BodyMedia® are registered trademarks of BodyMedia, Inc. 26 Patents and patents pending. The SenseWear® Weight Management Solution armband, display and wireless communicator are covered by one or more of the following patents: United States Patent Nos.: D439,981, 6,527,711, 6,595,929, 6,605,038, 7,020,508, 7,153,262; European Patent Nos.: 1,292,217, 1,292,218; and various worldwide patents pending. This notice is accurate as of August 14, 2007. For latest information please see www.
