BodyMedia BT24 SenseWear (R) biotransceiver User Manual BT 2 4 WS LIT indd

BodyMedia, Inc. SenseWear (R) biotransceiver BT 2 4 WS LIT indd

Contents

Weigh scale manual

© Copyright 2007 BodyMedia, Inc.BT-2.4-WS-LIT Rev.1
®
4 Smithfi eld Street
11th Floor
Pittsburgh, PA 15222
USA
P.412.288.9901
F.412.288.9902
www.bodymedia.com
BodyMedia International Srl
Via G. Balzaretti, 15
20133 Milan, Italy
P.+39-02-2774121
F.+39-02-27741250
www.bodymedia.eu
biotransceiver
Operating Manual
for use with Tanita® HD351 Weight Scale
2
Important Information About the SenseWear biotransceiver . . . . . . . . . . . . . . . . . . . . . . . .02
Taking a Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Sending a Reading to SenseWear® armband . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Sending a Reading to SenseWear® wireless gateway . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Copyright, Patent and Trademark Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
FCC Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Intended Use
The SenseWear® biotransceiver can be used to collect data from OEM biometric monitors and
upload it to the SenseWear® PRO3 armbands or SenseWear® wireless gateway 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.
Important Information About the SenseWear® biotransceiver
TABLE OF CONTENTS
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. Any decisions based on the data from this device should be made only by
medical personnel and should consider the condition and lifestyle of the subject tested. The
SenseWear® biotransceiver should not be used for life critical applications; improper usage may
result in harm or even death to the wearer.
This product is non-defi brillation 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.
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 5-8. Portable and
mobile RF communications equipment can affect medical electrical equipment.
NOTE:
Read these instructions and the Warnings and Cautions on pages 2-4 before using the
Body Monitoring System.
3 4
WARNINGS
Important Information About the SenseWear® biotransceiver
CAUTIONS
Important Information About the SenseWear® biotransceiver
The equipment or system should not be used adjacent to or stacked with other equipment and
that 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® biotransceiver should not be used in airplanes, hospitals or locations where cel-
lular telephones or electronic devices are prohibited.
Keep the SenseWear® biotransceiver out of reach of children. The product contains smaller,
removable parts which can become chocking hazards.
Water resistance
DO NOT IMMERSE THE BIOTRANSCEIVER IN WATER. The biotransceiver 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 classi-
fi ed.
Ordinary Protection, not protected against ingress to moisture.
Batteries
Batteries may explode or leak and can cause burn injury if recharged, disposed of in fi re, or
disassembled. Dispose of properly. For further information about the disposal battery, please
following manufacturer’s instructions.
Batteries may present a choking hazard for small children.
Remove battery if biotransceiver will not be used for over 30 days.
Handling
Avoid exposing the biotransceiver to extreme temperatures, direct sunlight, moisture, sand,
dust, or mechanical shock.
Dispose of device in accordance with local, state, federal, or country specifi c regulations.
Maintenance
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 biotransceiver is dropped, ensure that it is working properly and not physically damaged
before relying on readings.
Cleaning
Moisten a soft cloth or towel with mild disinfectant soap and water. Wipe and dry the biotrans-
ceiver. Never use solvents to clean the biotransceiver, only for disinfecting (see below).
Disinfecting
Wipe biotransceiver with soft cloth dampened with 70% isopropyl alcohol. Allow biotransceiver
to dry for 5-10 minutes before using DO NOT STERILIZE THIS UNIT.
CAUTIONS
5 6
Flicker
IEC 6100-3-3 Complies
RF Emissions
CISPR 11 Class B The BT-2.4-WS is suitable for use in all establishments,
including domestic, and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
RF Emissions
CISPR 11 Group 1 The BT-2.4-WS 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.
The BT-2.4-WS (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specifi ed below.
The customer or user of the BT-2.4-WS should ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Emissions
Emissions Test Compliance Electromagnetic Environment - Guidance
Important Information About the SenseWear® biotransceiver
Computer and Wireless Communicator
1.5m
Diagram not to scale.
1.5m 1.5m
2.5m
Patient Environment
Harmonics
IEC 6100-3-2 Class A 3A/m Power frequency magnetic fi elds should be that
of a typical commercial or hospital environment.
Power
Frequency 50/60Hz
Magnetic Field
IEC 61000-4-8
3A/m
N/A N/A
Voltage Dips/
Dropout
IEC 61000-4-11
>95% Dip for
0.5 Cycles
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5
Seconds
N/ASurge
IEC 61000-4-5 ±1kV Differential
±2kV Common
N/A
N/A
N/AEFT
IEC 61000-4-4 ±2kV Mains
±1kV I/Os
±6kV Contact
±8kV Air Floors should be wood, concrete, or ceramic
tile. If fl oors are synthetic, the r/h should be at
least 30%.
ESD
IEC 61000-4-2 ±6kV Contact
±8kV Air
The BT-2.4-WS (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specifi ed below.
The customer or user of the BT-2.4-WS should ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Immunity
Immunity Test IEC 60601
Test Level Compliance
Level Electromagnetic
Environment - Guidance
Important Information About the SenseWear® biotransceiver
7 8
Important Information About the SenseWear® biotransceiver
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
N/A
3 V/m
Portable and mobile communications equipment
should be separated from BT-2.4-WS by no less
than the distances calculated/listed below:
D=(3.5/V1)(Sqrt P)
D=(3.5/E1)(Sqrt P) 80 to 800 MHz
D=(7/EI)(Sqrt P) 800 MHz to 2.5 GHz
where P is the max power in watts and D is the
recommended separation distance in meters.
FIeld strengths from fi xed transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equip-
ment containing a transmitter symbol:
•
•
•
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
The BT-2.4-WS (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specifi ed below.
The customer or user of the BT-2.4-WS should ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Emissions
IEC 60601
Test Level Compliance
Level Electromagnetic
Environment - Guidance
Immunity Test
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
refl ection from structures, objects and people
100 11.6666 11.6666 23.3333
10 3.6893 3.6893 7.3786
1 1.1666 1.1666 2.3333
Important Information About the SenseWear® biotransceiver
0.1 0.3689 0.3689 0.7378
The BT-2.4-WS (SenseWear® biotransceiver) is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the BT-2.4-WS can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF Communications Equipment and the BT-2.4-BG as
recommended below, according to the maximum output power of the communications equipment.
Recommended Separations Distances for the BT-2.4-WS
0.01 0.1166 0.1166 0.2333
Separation (m)
150kHz to 80MHz
D=(3.5/V1)(Sqrt P)
Separation (m)
80 to 800MHz
D=(3.5/V1)(Sqrt P)
Separation (m)
800MHz to 2.5GHz
D=(7/E1)(Sqrt P)
Max Output Power
(Watts)
Field strenghts from fi xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fi xed RF transmitters, and electromagnetic site survey should be considered. If the
measured fi eld strength in the location in which the BT-2.4-WS is used exceeds the applicable RF compliance level above,
the BT-2.4-WS should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocationg the BT-2.4-WS.
Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than 3 V/m.
For transmitters rated at a maximum output power not listed above, the recommended seperation distance d in meters (m)
can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the seperation distance for the higher frequency range applies.
NOTE 2 These guideleines may not apply in all situations. Electromagnetic propogation is affected by absorption and
refl ection from structures, objects and people.
9 10
Taking a Reading
After you have read and understood the manufacturer’s manual for taking readings, the follow-
ing instructions will tell you how to send a reading.
For more information about your weight scale device, please consult the Tanita® Operating
Instructions in the Tanita® Weight Scale box.
Make sure that the scale is on a hard, even surface. Do not place on carpet.
Locate the weight scale with built-in SenseWear® biotransceiver within 2 meters (6 feet)
of SenseWear® PRO3 armband.
Press the armband button (fi gure 1). Note: the armband must be on-body at time of button
press (indicated by a short vibration by the armband).
1.
2.
3.
Sending a Reading to SenseWear® armband
fi gure 1 fi gure 2
Important Information About the SenseWear® biotransceiver
Follow operating instructions.
Caution
The Waste Electrical and Electronic Equipment Regulations indicates
separate collection for electrical and electronic equipment.
Tested to applicable safety standards.
Identifi cation code of Notifi ed Body involved: 0051.
Classifi cation of the device, as per 93/42 directives : IIa (rule 10)
Certifi cation procedure : 93/42/EEC, Annex VI, VII.
Identifi cation code of Notifi ed Body involved: 0051
2.400 - 2.483 GHz
Transmit Power Class 8 - Less than 10mW output power
Duty Cycle Class 4 - permitted to operate at 100% duty cycle
Receiver Class 3 - Standard reliable SRD communication media
Conforms to UL STD 60950
Certifi ed to CSA C22.2 No. 950
EMC Alert Mark for non-ionizing radiation .
11 12
Sending a Reading to SenseWear® wireless gateway
Place the weight scale with SenseWear® biotransceiver within 5 meters (15 feet) of the
SenseWear® wireless gateway.
Press 1 on the weight scale (fi gure 2) and wait for 0.0 reading and a beep before stepping
on to scale. Before stepping off the scale, wait for another beep.
The biotransceiver will immediately retrieve data off the weight scale. As soon as retrieval
is complete, the biotransceiver will send data to the wireless gateway.
Please consult the SenseWear® wireless gateway Operating Manual for further details.
1.
2.
3.
4.
Sending a Reading to SenseWear® armband
Press 1 on the weight scale (fi gure 2) and wait for 0.0 reading and a beep before stepping
on to scale. Wait for another beep before stepping off the scale.
The biotransceiver will immediately retrieve data off the weight scale. As soon as retrieval
is complete, the biotransceiver will send data to the armband.
The armband will also beep and vibrate once the transfer is successfully completed.
4.
5.
6.
Patents and patents pending. The BodyMedia® biotransceiver is covered by one or more of the
following patents when used with a BodyMedia® armband (e.g., SenseWear® armbands and
bodybugg™ armbands): United States Pat. Nos.: 6,527,711, 6,595,929, 6,605,038, 7,020,508;
European Patent Nos.: 1,292,217, 1,292,218; and various worldwide patents pending.
SenseWear® and BodyMedia® are registered trademarks of BodyMedia, Inc. Accu-Chek Advantage
is a registered trademark of Roche Diagnostic Corporation.
Copyright, Patent and Trademark Notices
FCC Statement
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that interference will not occur
in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:
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.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two condi-
tions: (1) This device may not cause harmful interference, and (2) this device must accept any interfer-
ence received, including interference that may cause undesired operation.
•
•
•
•
FCC 47CFR 15C TCB - 47 CFR Part 15 Subpart C
Intentional Radiator
Certifi cation Test
FCC 47CFR 15B clA - 47 CFR Part 15 Subpart B Unin-
tentional Radiators Class A Verifi cation
UL 60601-1 - UL Standard for Safety Medical Electri-
cal Equipment, Part 1:
General Requirements for Safety First Edition
CENELEC EN 60601-1-2 - 2001 - Medical Electrical
Equipment Part 1-2: General Requirements for Safety
- Collateral Standard: Electromagnetic Compatibility
- Requirements and Tests IEC 60601-1-2: 2001
CENELEC EN 60601-1-1 - Medical Electrical Equip-
ment - Part 1: General Requirements for Safety -
Collateral Standard: Safety Requirements for Medical
Electrical Systems.
CAN/CSA-C22.2 No.606.1-M90
ETSI EN 301 489-1 - Electromagnetic Compatibility
and Radio Spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) Standard for Radio Equipment
and Services; Part 1: Common Technical Require-
ments V1.3.1
ETSI EN 301 489-3 - (Draft) Electromagnetic Compat.
and Radio Spectrum Matters (ERM); Harmonized EN
for ElectroMag. Compatibility (EMC) of Radio Comms.
Equip. & Srvs.; Pt. 3: Specifi c Conditions for Short-
Range Devices (SRD) Operating on Freqs Between 9
KHz and 40 GHz V1.3.1
ETSI EN 300 440-1 V1.3.1 (2001-07) Electromag-
netic compatibility and Radio spectrum Matters
(ERM);Short range devices; Radio equipment to be
used in the 1 GHz to 40 GHz frequency range

Navigation menu