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

Download:
Mirror Download [FCC.gov]
Document ID	762353
Application ID	RN6rU+7i7F1nRDmHElTeiw==
Document Description	Blood pressure manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	13.9kB (173789 bits)
Date Submitted	2007-02-26 00:00:00
Date Available	2007-02-26 00:00:00
Creation Date	2007-01-11 10:13:24
Producing Software	Acrobat Distiller 5.0 (Windows)
Document Lastmod	2007-01-11 10:13:24
Document Title	BT-2.4-BP-LIT.indd
Document Creator	PScript5.dll Version 5.2
Document Author:	quang

biotransceiver
for use with Omron® HEM705 Blood Pressure Monitor
Operating Manual
®
4 Smithfield Street
11th Floor
Pittsburgh, PA 15222
USA
P.412.288.9901
F.412.288.9902
www.bodymedia.com
BT-2.4-BP-LIT Rev.1
BodyMedia International Srl
Via G. Balzaretti, 15
20133 Milan, Italy
P.+39-02-2774121
F.+39-02-27741250
www.bodymedia.eu
© Copyright 2007 BodyMedia, Inc.
TABLE OF CONTENTS
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
NOTE:
Read these instructions and the Warnings and Cautions on pages 2-4 before using the
Body Monitoring System.
Important Information About the SenseWear® biotransceiver
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.
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-defibrillation proof.
Do not place 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.
Important Information About the SenseWear® biotransceiver
WARNINGS
Important Information About the SenseWear® biotransceiver
CAUTIONS
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.
Handling
Avoid exposing the biotransceiver to extreme temperatures, direct sunlight, moisture, sand,
dust, or mechanical shock.
The SenseWear® biotransceiver should not be used in airplanes, hospitals or locations where cellular telephones or electronic devices are prohibited.
Dispose of device in accordance with local, state, federal, or country specific regulations.
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 classified.
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 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 biotransceiver. Never use solvents to clean the biotransceiver, only for disinfecting (see below).
Ordinary Protection, not protected against ingress to moisture.
CAUTIONS
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.
Batteries
Batteries may explode or leak and can cause burn injury if recharged, disposed of in fire, 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.
Important Information About the SenseWear® biotransceiver
Important Information About the SenseWear® biotransceiver
Patient Environment
Guidance and Manufacturer’s Declaration - Immunity
The BT-2.4-BP (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specified below.
The customer or user of the BT-2.4-BP should ensure that it is used in such an environment.
2.5m
1.5m
IEC 60601
Test Level
Immunity Test
1.5m
1.5m
Compliance
Level
Electromagnetic
Environment - Guidance
ESD
IEC 61000-4-2
±6kV Contact
±8kV Air
±6kV Contact
±8kV Air
Floors should be wood, concrete, or ceramic
tile. If floors are synthetic, the r/h should be at
least 30%.
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/Os
N/A
N/A
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
N/A
N/A
Voltage Dips/
Dropout
IEC 61000-4-11
>95% Dip for
0.5 Cycles
N/A
N/A
3A/m
Power frequency magnetic fields should be that
of a typical commercial or hospital environment.
Computer and Wireless Communicator
Diagram not to scale.
Guidance and Manufacturer’s Declaration - Emissions
The BT-2.4-BP (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specified below. The
customer or user of the BT-2.4-BP should ensure that it is used in such an environment.
Emissions Test
Compliance
RF Emissions
CISPR 11
Group 1
RF Emissions
CISPR 11
Class B
Harmonics
IEC 6100-3-2
Class A
Flicker
IEC 6100-3-3
Complies
Electromagnetic Environment - Guidance
60% Dip for 5 Cycles
The BT-2.4-BP 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-BP 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.
30% Dip for 25 Cycles
>95% Dip for 5
Seconds
Power
Frequency 50/60Hz
3A/m
Magnetic Field
IEC 61000-4-8
Important Information About the SenseWear® biotransceiver
Guidance and Manufacturer’s Declaration - Emissions
The BT-2.4-BP (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specified below.
The customer or user of the BT-2.4-BP should ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance
Important Information About the SenseWear® biotransceiver
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 BT-2.4-BP is used exceeds the applicable RF compliance level above, the
BT-2.4-BP 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-BP.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Portable and mobile communications equipment
should be separated from BT-2.4-BP by no less
than the distances calculated/listed below:
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
N/A
• D=(3.5/V1)(Sqrt P)
3 V/m
• 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 equipment containing a transmitter symbol:
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
Recommended Separations Distances for the BT-2.4-BP
The BT-2.4-BP (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-BP can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF Communications Equipment and the BT-2.4-BP as
recommended below, according to the maximum output power of the communications equipment.
Max Output Power
(Watts)
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)
0.01
0.1166
0.1166
0.2333
0.1
0.3689
0.3689
0.7378
2.3333
1.1666
1.1666
10
3.6893
3.6893
7.3786
100
11.6666
11.6666
23.3333
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.
Important Information About the SenseWear® biotransceiver
Follow operating instructions.
Caution
Taking a Reading
After you have read and understand the manufacturer’s manual for taking readings, the following instructions will tell you how to send a reading.
For more information about your blood pressure monitoing device, please consult the Omron®
Instruction Manual included in the Omron® Blood Pressure Monitoring box.
Tested to applicable safety standards.
Sending a Reading to SenseWear® armband
The Waste Electrical and Electronic Equipment Regulations indicates
separate collection for electrical and electronic equipment.
1. Locate the blood pressure monitor and SenseWear® biotransceiver within 2 meters (6 feet)
of SenseWear® PRO3 armband.
2. Press the armband button (figure 1). Note: the armband must be on-body at time of button
press (indicated by a short vibration by the armband).
Identification code of Notified Body involved: 0051.
EMC Alert Mark for non-ionizing radiation .
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
figure 1
figure 2
3. Ensure the biotransceiver is plugged into the printer port of the blood pressure monitor
(figure 2).
4. Turn the power on to the blood pressure monitor.
10
Sending a Reading to SenseWear® armband
5. Once the blood pressure monitor displays zero, follow Omron’s procedures for taking
a reading.
6. Turn the blood pressure monitor power off to send the reading to the biotransceiver. As
soon as retrieval is complete, the biotransceiver will send data to the armband. The LED
on the biotransceiver will blink green when successful and red if the transfer failed.
7. The armband will also beep and vibrate once the transfer is successfully completed.
Sending a Reading to SenseWear® wireless gateway
1. Place the blood pressure monitor and SenseWear® biotransceiver within 5 meters (15 feet)
of the SenseWear® wireless gateway.
2. Ensure the biotransceiver is plugged into the printer port of the blood pressure monitor
(figure 2).
3. Please consult the SenseWear® wireless gateway Operating Manual for further instructions
4. Turn the power on to the blood pressure monitor.
5. Once the blood pressure monitor displays zero, follow Omron’s procedures for taking
a reading.
6. Turn the blood pressure monitor power off to send the reading to the biotransceiver. As
soon as retrieval the is complete, the biotransceiver will send data to the wireless gateway. The LED on the biotransceiver will blink green when successful and red if the transfer
failed.
Copyright, Patent and Trademark Notices
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. Omron is a registered
trademark of Omron Tateishi Electronics Co.
11
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 conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference 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 Unintentional Radiators Class A Verification
UL 60601-1 - UL Standard for Safety Medical Electrical 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 Equipment - 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 Requirements 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 ShortRange Devices (SRD) Operating on Freqs Between 9
KHz and 40 GHz V1.3.1
ETSI EN 300 440-1 V1.3.1 (2001-07) Electromagnetic compatibility and Radio spectrum Matters
(ERM);Short range devices; Radio equipment to be
used in the 1 GHz to 40 GHz frequency range
12

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.2
Linearized                      : No
Create Date                     : 2007:01:11 10:13:24-05:00
Modify Date                     : 2007:01:11 10:13:24-05:00
Page Count                      : 7
Creation Date                   : 2007:01:11 15:13:24Z
Mod Date                        : 2007:01:11 15:13:24Z
Producer                        : Acrobat Distiller 5.0 (Windows)
Author                          : quang
Metadata Date                   : 2007:01:11 15:13:24Z
Creator                         : quang
Title                           : BT-2.4-BP-LIT.indd

EXIF Metadata provided by EXIF.tools