BodyMedia WG24 User manual

© Copyright 2006 BodyMedia, Inc.WG-2.4-LIT Rev.1
®
4 Smithfield 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
wireless gateway
Operating Manual

2
Important Information About the SenseWear biotransceiver . . . . . . . . . . . . . . . . . . . . . . . .02
Setting up SenseWear® wireless gateway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
SenseWear®wireless gateway Interface Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
FCC Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Intended Use
The SenseWear®wireless gateway can be used to remotely retrieve data from SenseWear®
armbands or OEM biometric monitors with SenseWear®biotransceivers 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®wireless gateway
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®wireless gateway should not be used for life critical applications; improper usage
may result in harm or even death to the wearer.
This product is non-defibrillation 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 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®wireless gateway
CAUTIONS
Important Information About the SenseWear®wireless gateway
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 configuration in which it will be used.
The SenseWear®wireless gateway should not be used in airplanes, hospitals or locations where
cellular telephones or electronic devices are prohibited.
Keep the SenseWear®wireless gateway out of reach of children. The product contains smaller,
removable parts which can become chocking hazards.
Water resistance
DO NOT IMMERSE THE WIRELESS GATEWAY IN WATER. The wireless gateway 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 clas-
sified.
Ordinary Protection, not protected against ingress to moisture.
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 specific regulations.
Maintenance
Changes or modifications to this equipment not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
If the wireless gateway is dropped, ensure that it is working properly and not physically dam-
aged before relying on readings.
Cleaning
Moisten a soft cloth or towel with mild disinfectant soap and water. Wipe and dry the wireless
gateway. Never use solvents to clean the wireless gateway, only for disinfecting (see below).
Disinfecting
Wipe wireless gateway with soft cloth dampened with 70% isopropyl alcohol. Allow wireless gate-
way 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 WG-2.4 is suitable for use in all establishments, including domestic, and those directly connected to the public low-volt-
age power supply network that supplies buildings used for
domestic purposes.
RF Emissions
CISPR 11 Group 1 The WG-2.4 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 WG-2.4 (SenseWear®wireless gateway) is intended for use in the electromagnetic environment specified below.
The customer or user of the WG-2.4 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 fields 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 floors are synthetic, the r/h should be at
least 30%.
ESD
IEC 61000-4-2 ±6kV Contact
±8kV Air
The WG-2.4 (SenseWear®wireless gateway) is intended for use in the electromagnetic environment specified below.
The customer or user of the WG-2.4 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 WG-2.4 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 fixed 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 WG-2.4 (SenseWear®wireless gateway) is intended for use in the electromagnetic environment specified below.
The customer or user of the WG-2.4 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
reflection 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 WG-2.4 (SenseWear®wireless gateway) is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the WG-2.4 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF Communications Equipment and the WG-2.4 as
recommended below, according to the maximum output power of the communications equipment.
Recommended Separations Distances for the WG-2.4
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 fixed 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 fixed RF transmitters, and electromagnetic site survey should be considered. If the
measured field strength in the location in which the WG-2.4 is used exceeds the applicable RF compliance level above, the
WG-2.4 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocationg the WG-2.4.
Over the frequency range 150 kHz to 80 MHz, field 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
reflection from structures, objects and people.

9 10
Setting up SenseWear®wireless gateway
TIP: In many homes, the kitchen may be an optimal location for your wireless gateway.
Typically, there are multiple electrical outlets, a phone jack, and a hard floor surface
(required to perform daily weight tests using a weight scale).
Locate an area in your home where a telephone jack and electrical outlet are in close
proximity. Keep in mind that the wireless gateway needs to be within 5 meters (15 feet) of
an area where you can take your daily readings.
1.
Plug one end of the power adapter into the wireless gateway and the other end into the
electrical outlet.
Plug one end of the telephone cable into one PHONE jack on the wireless gateway and the
other end into your home telephone jack. The other PHONE jack is for the optional cable
from your telephone.
2.
3.
TIP: The wireless gateway end data upload immediately will hang up immediately by sim-
ply lifting the handset of any phone on the same telephone cable as the wireless gateway.
Check the LED status indicators on the wireless gateway. If it is correctly set up and ready
to receive readings, the POWER light will glow a solid green.
Please leave the wireless gateway plugged into the electrical outlet and telphone cable at all
times to ensure timely delivery of your data to the monitoring service. To turn off the wireless
gateway, simply unplug the power adapter from the wall.
4.
TIP: To maximize tranceiver reception range, avoid placing anything on top of the wireless
gateway.
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.
Identification code of Notified Body involved: 0051.
Classification of the device, as per 93/42 directives : IIa (rule 10)
Certification procedure : 93/42/EEC, Annex VI, VII.
Identification code of Notified 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
Certified to CSA C22.2 No. 950
EMC Alert Mark for non-ionizing radiation .

11 12
SenseWear®wireless gateway Interface Key
Power: Wireless gateway is on and ready
Receive: Data in queue and ready to upload. If light is blinking,
the data was recently retrieved successfully.
Upload: Data being transferred over phone line.
Error: Please contact support
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
Certification Test
FCC 47CFR 15B clA - 47 CFR Part 15 Subpart B Unin-
tentional Radiators Class A Verification
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: Specific 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