BodyMedia 908901PROD2 Summary operating manual
body monitoring system
Instructions For Use
SenseWear
SenseWear® software
®
Professional software
SenseWear® armband
and data collection
TABLE OF CONTENTS
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Important Information About the SenseWear® armband . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Retrieving armband Data to Your Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Viewing and Analyzing the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Viewing and Editing Health Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Advanced Graphing of the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Annotating the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Creating Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Exporting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Application Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Using the Software to Congure an armband and display . . . . . . . . . . . . . . . . . . . . . . . . . .28
Features of the SenseWear® armband . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Important Troubleshooting Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
NOTE:
Read these instructions and the Warnings and Cautions on pages 2-6 before using the
Body Monitoring System.
Introduction
This manual will instruct you in the use of the
SenseWear® Body Monitoring System™. It covers
the routine operations and frequently-used
features of the SenseWear® software,
SenseWear® Professional software and the
SenseWear® armband.
If you have not done so already, please refer
to the Getting Started Guide included in the
System box to install the SenseWear software or
SenseWear Professional software and congure the
armband. After completing the initial set-up
(Step 3), you may proceed with this manual.
IMPORTANT
To run the SenseWear software or
SenseWear Professional software,
the minimum requirements for your
PC are Pentium III or higher, with at
least 256 MB of RAM, Windows 2000
SP3 or later/XP/Vista and a USB
port for the armband connection.
For the SenseWear Professional you
will need an additional USB port to
accommodate the license key.
Important Information About the SenseWear® armband
Intended Use
The SenseWear® armband can be used as a monitor for applications such as: nutritional diagnostics, metabolic diseases, pediatrics, pulmonary and cardiac studies, geriatrics, internal medicine, occupational medicine, neurology, psychiatrics, 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.
WARNINGS
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 Body Monitoring System has been clinically validated for subjects between 7 and 65 years of age who are engaged in resting, ambulatory, stationary biking,
motoring and weight-lifting activities, etc. Due to metabolic variations, subjects who are 1) out-
2
Important Information About the SenseWear® armband
WARNINGS
side 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
paramedic personnel and should consider the condition and lifestyle of the subject tested. The
SenseWear® armband should not be used for life critical applications; improper usage may result
in harm or even death to the wearer.
This product is non-debrillation proof.
Do not get the device close to other devices that can cause electromagnetic interferences of
any nature.
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH
AIR or WITH OXYGEN OR NITROUS OXIDE.
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 7-10. 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 conguration in which it will be used.
The SenseWear® wireless communicator should not be used in airplanes, hospitals or locations
where cellular telephones or electronic devices are prohibited.
Keep the SenseWear® armband and wireless communicator out of reach of children. Both products contain smaller, removable parts which can become chocking hazards.
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Important Information About the SenseWear® armband
WARNINGS
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 develop a rash where the armband comes
in contact with your skin, discontinue 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 material 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 physician. 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. 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.
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Important Information About the SenseWear® armband
WARNINGS
Water resistance
DO NOT IMMERSE THE ARMBAND IN WATER. The monitor is not designed to be used underwater or
to come in continuous contact with water. To prevent a shock hazard, never use the armband in
water environments (e.g., in the shower, swimming pool, or rain). IPX0 classied.
Ordinary Protection, not protected against ingress to moisture.
CAUTIONS
Batteries
Batteries may explode or leak and can cause burn injury if recharged, disposed of in re, or disassembled. Do not remove the battery label. Dispose of properly. For further information about
the disposal of the battery, please follow manufacturer’s instructions.
Batteries may present a choking hazard for small children.
Remove battery if armband will not be used for over 30 days.
Handling
Though the SenseWear® armband was designed for wearability and long-term 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, moisture, sand, dust, or
mechanical shock.
To prevent possible damage to the USB cable, grasp the plug end when disconnecting the USB
cable. Replace the cable if it becomes frayed.
5
Important Information About the SenseWear® armband
CAUTIONS
Dispose of device in accordance with local, state, federal, or country specic regulations.
Maintenance
Do not attempt to open the armband yourself. It contains no user-serviceable parts. Refer all
servicing to qualied Service Personnel. Opening the armband yourself will void the warranty.
Changes or modications 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 physically 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 may affect the performance and lifespan of the strap.
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.
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Important Information About the SenseWear® armband
Computer and Wireless Communicator
1.5m
Diagram not to scale.
1.5m 1.5m
2.5m
Patient Environment
Guidance and Manufacturer’s Declaration - Emissions
The 908901PROD2 (SenseWear® armband) is intended for use in the electromagnetic environment specified below. The
customer or user of the 908901PROD2 should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Harmonics
IEC 6100-3-2
Flicker
IEC 6100-3-3
Class B, Group 1
N/A The 908901PROD2 is suitable for use in all establishments,
N/A
The 908901PROD2 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.
including domestic, and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
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