BodyMedia MF Users Manual

R
Getting Started
4 Smithfi eld Street
11th Floor
Pittsburgh, PA 15222
USA
P.412.288.9901
F.412.288.9902
© Copyright 2007 BodyMedia, Inc.
100346_REV1
®
WMS takes you step-by-step
®
Weight Management Solution (WMS). The
®
solution will allow you to easily collect, manage, and analyze
®
SenseWear
Welcome to the SenseWear
introductiontable of contents
physiological and lifestyle data. Please read and follow the instructions in-
cluded in this guide before using the armband and WMS website.
armband, and collect and retrieve data from your armband via the
WMS website. It is very important that you read and follow these
®
®
through the set up of your system. It tells you how to confi gure and wear the
SenseWear
This Getting Started Guide for SenseWear
SenseWear
directions to ensure the accuracy of your data.
This product complies with the general requirements for a safe medical device.
However, this product alone is not meant to substitute for proper medical
diagnosis, care, or treatment.
®
WMS
armband
One (1) standard wing/
One (1) SenseWear
package includes:
The SenseWear
strap assembly and one
(1) large size wing/strap
assembly
One (1) USB cable
PLACEHOLDER
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 02
Important . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03
®
armband . . . . . . . . . . . . . . . . . . . . . 12
Features of the SenseWear
®
armband. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Your SenseWear
Registration & Account Creation . . . . . . . . . . . . . . . . . . . . . . . . 18
Wearing the armband . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Uploading Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Legal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
1 2
armband and wireless communicator out of reach of
®
wireless communicator should not be used in airplanes,
®
hospitals or locations where cellular telephones or electronic devices are
prohibited.
Keep the SenseWear
children. Both products contain smaller, removable parts which can become
importantimportant
Please be sure to verify equipment is connected and used compliant to
UL1950.
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided on pages 8-11. Portable and mobile RF communications equipment
can affect medical electrical equipment.
The equipment or system should not be used adjacent to or stacked with
other equipment and if adjacent or stacked use is necessary, the equipment or
system should be observed to verify normal operation in the confi guration in
which it will be used.
The SenseWear
choking hazards.
armband should not be used for life critical applica-
®
Wear comfortably
Be careful not to over-tighten the armband while on your arm. If, at any time,
you feel constriction or loss of circulation, simply loosen the adjustable strap
and re-fasten it to a more comfortable setting.
Be sure that both your arm and the sensors on the back of the armband are
cleaned daily. To clean the sensors, wipe with a soft, damp cloth. If you de-
velop a rash where the armband comes in contact with your skin, discontinue
armband can be used as a monitor for applications such as:
®
tions; improper usage may result in harm or even death to the wearer.
This product is non-defi brillation proof.
Intended Use
The SenseWear
nutritional diagnostics, metabolic diseases, pediatrics, pulmonary and cardiac
studies, geriatrics, internal medicine, occupational medicine, neurology, psy-
chiatrics, sleep screening, and in general anywhere it is necessary to monitor
caloric and energy consumption, movement, physical activity, quality of life,
lifestyle, behavior and/or stress.
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. Clinicians should
not make drastic changes to a user’s lifestyle based solely on data from the
armband. The SenseWear armband has been clinically validated for subjects
between 7 and 65 years of age who are engaged in resting, ambulatory, station-
ary biking, motoring and weight-lifting activities, etc. Due to metabolic varia-
tions, subjects who are 1) outside this age range or 2) engaged in alternate
or obscure activities may see decreased accuracy in the data. Any decisions
based on the data from this device should be made only by medical or para-
medic personnel and should consider the condition and lifestyle of the subject
tested. The SenseWear
Do not get the device close to other devices that can cause electromagnetic
interferences of any nature.
This EQUIPMENT not suitable for use in the presence of a FLAMMABLE AN-
AESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE.
3 4
armband was designed for wearability and long-term
®
Data accuracy may become compromised if the sensing module is
submerged in water.
The wing seal must be in good condition and the wing must be properly
attached to the sensing module to avoid damaging the unit.
Do not get the sensing module wet while removed from the wing assemble
importantimportant
as damage will occur.
use, it is a sensitive monitoring device. Rough handling can break internal
components. Never drop or shock the armband and always store it in a safe
place when not in use.
Avoid exposing the armband to extreme temperatures, direct sunlight, mois-
ture, sand, dust, or mechanical shock.
To prevent possible damage to the USB cable, grasp the plug end when dis-
Handling
Though the SenseWear
connecting the USB cable. Replace the cable if it becomes frayed.
Dispose of device in accordance with local, state, federal, or country specifi c
regulations.
Maintenance
Do not attempt to open the armband yourself. It contains no user-serviceable
parts. Refer all servicing to qualifi ed Service Personnel. Opening the armband
yourself will void the warranty.
use and consult your physician before continuing regular use of the armband.
The design of the armband involved many materials experts, physicians, and
suppliers who are familiar with wearable materials and products. Each mate-
rial was chosen for its precedent in other skin contact products or has been
independently approved for skin contact. However, everyone’s skin is different
and wearers with very sensitive skin may experience irritation or redness after
wearing the armband. If this occurs, discontinue use and consult your physi-
cian. If you have known metals allergies, you should consult your physician
prior to wearing. Do not wear armband when open sores are present.
Check armband for sharp edges or damage before each use.
There have been reports of scratches/cuts associated with the Velcro tab of the
strap. The Velcro tab should be aligned with the strap to avoid contact with the
skin. Also, excessively hot armbands, such as those left in a car in the summer,
may cause skin burns if they are not allowed to cool before use.
When the armband is on the arm, DO NOT connect it to the USB cable.
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.
Water resistance
The armband is not intended for long term operation under water. The arm-
band 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.
5 6
Please note when submerging the armband in water:
2.5m
1.5m 1.5m
Diagram not to scale.
ments, including domestic, and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
The Product MF uses RF energy only for its inernal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
purposes.
importantimportant
Patient Environment
1.5m
Computer and Wireless Communicator
armband) is intended for use in the electromagnetic environment
®
Guidance and Manufacturer’s Declaration - Emissions
specifi ed below. The customer or user of the Product MF should ensure that it is used in such an
environment.
The Product MF (SenseWear
N/A
Class B, Group 1
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
N/A The Product MF is suitable for use in all establish-
Flicker
Harmonics
IEC 6100-3-3
IEC 6100-3-2
Changes or modifi cations to this equipment not expressly approved by the
party responsible for compliance could void the user’s authority to operate
the equipment.
If the armband is dropped, ensure that it is working properly and not physi-
cally damaged before relying on readings.
Cleaning
Always clean and dry the armband after vigorous sweating activities or when
it becomes noticeably moist or dirty. Failure to keep the armband clean, or
improper cleaning, may irritate the skin and affect the sensor performance.
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.
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.
7 8
Loading...
+ 9 hidden pages