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

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

Contents

Blood pressure manual

© Copyright 2007 BodyMedia, Inc.BT-2.4-BP-LIT Rev.1®4 Smithfi eld Street11th FloorPittsburgh, PA 15222USAP.412.288.9901F.412.288.9902www.bodymedia.comBodyMedia International SrlVia G. Balzaretti, 1520133 Milan, Italy P.+39-02-2774121F.+39-02-27741250www.bodymedia.eubiotransceiver Operating Manualfor use with Omron® HEM705 Blood Pressure Monitor
2Important Information About the SenseWear® biotransceiver . . . . . . . . . . . . . . . . . . . . . . .02Taking a Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Sending a Reading to SenseWear® armband . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Sending a Reading to SenseWear® wireless gateway . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Copyright, Patent and Trademark Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11FCC Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12NOTE:Read these instructions and the Warnings and Cautions on pages 2-4 before using the Body Monitoring System.Intended UseThe 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® biotransceiverTABLE OF CONTENTS WARNINGSThis 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 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.
3 4 WARNINGSImportant Information About the SenseWear® biotransceiver CAUTIONSImportant Information About the SenseWear® biotransceiverThe 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 6FlickerIEC 6100-3-3 CompliesRF EmissionsCISPR 11 Class B 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.RF Emissions CISPR 11 Group 1 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 (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specifi ed below. The customer or user of the BT-2.4-BP should ensure that it is used in such an environment. Guidance and Manufacturer’s Declaration - EmissionsEmissions Test Compliance Electromagnetic Environment - GuidanceImportant Information About the SenseWear® biotransceiverComputer and Wireless Communicator1.5mDiagram not to scale.1.5m 1.5m2.5mPatient Environment Class A 3A/m Power frequency magnetic fi elds should be that of a typical commercial or hospital environment.Power Frequency 50/60HzMagnetic FieldIEC 61000-4-83A/mN/A N/AVoltage Dips/DropoutIEC 61000-4-11>95% Dip for0.5 Cycles60% Dip for 5 Cycles30% Dip for 25 Cycles>95% Dip for 5 SecondsN/ASurgeIEC 61000-4-5 ±1kV Differential±2kV CommonN/AN/AN/AEFTIEC 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%.ESDIEC 61000-4-2 ±6kV Contact±8kV AirThe BT-2.4-BP (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specifi ed below. The customer or user of the BT-2.4-BP should ensure that it is used in such an environment. Guidance and Manufacturer’s Declaration - ImmunityImmunity Test IEC 60601Test Level ComplianceLevel ElectromagneticEnvironment - GuidanceImportant Information About the SenseWear® biotransceiverHarmonics IEC 6100-3-2
7 8Important Information About the SenseWear® biotransceiver3 Vrms 150 kHz to 80 MHz3 V/m80 MHz to 2.5 GHzN/A3 V/mPortable and mobile communications equipment should be separated from BT-2.4-BP by no less than the distances calculated/listed below:D=(3.5/V1)(Sqrt P)D=(3.5/E1)(Sqrt P) 80 to 800 MHzD=(7/EI)(Sqrt P) 800 MHz to 2.5 GHzwhere 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 RFIEC 61000-4-6Radiated RFIEC 61000-4-3The BT-2.4-BP (SenseWear® biotransceiver) is intended for use in the electromagnetic environment specifi ed below. The customer or user of the BT-2.4-BP should ensure that it is used in such an environment. Guidance and Manufacturer’s Declaration - EmissionsIEC 60601Test Level ComplianceLevel ElectromagneticEnvironment - GuidanceImmunity TestNOTE 1 At 80 MHz and 800 MHz, the higher frequency range appliesNOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from structures, objects and people100 11.6666 11.6666 23.333310 3.6893 3.6893 7.37861 1.1666 1.1666 2.3333Important Information About the SenseWear® biotransceiver0.1 0.3689 0.3689 0.7378The 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. Recommended Separations Distances for the BT-2.4-BP0.01 0.1166 0.1166 0.2333Separation (m)150kHz to 80MHzD=(3.5/V1)(Sqrt P)Separation (m)80 to 800MHzD=(3.5/V1)(Sqrt P)Separation (m)800MHz to 2.5GHzD=(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-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, 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 10Taking a ReadingAfter you have read and understand the manufacturer’s manual for taking readings, the follow-ing 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.Locate the blood pressure monitor and 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.Sending a Reading to SenseWear® armbandfi gure 1 fi gure 2Ensure the biotransceiver is plugged into the printer port of the blood pressure monitor (fi gure 2).Turn the power on to the blood pressure monitor.3.4.Important Information About the SenseWear® biotransceiverFollow 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: 00512.400 - 2.483 GHzTransmit Power Class 8 - Less than 10mW output powerDuty Cycle Class 4 - permitted to operate at 100% duty cycle Receiver Class 3 - Standard reliable SRD communication mediaConforms to UL STD 60950Certifi ed to CSA C22.2 No. 950EMC Alert Mark for non-ionizing radiation .
11 12Sending a Reading to SenseWear® armbandSending a Reading to SenseWear® wireless gatewayPlace the blood pressure monitor and SenseWear® biotransceiver within 5 meters (15 feet) of the SenseWear® wireless gateway.Ensure the biotransceiver is plugged into the printer port of the blood pressure monitor (fi gure 2).Please consult the SenseWear® wireless gateway Operating Manual for further instructionsTurn the power on to the blood pressure monitor.Once the blood pressure monitor displays zero, follow Omron’s procedures for taking a reading.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 gate-way. The LED on the biotransceiver will blink green when successful and red if the transfer failed.1.2.3.4.5.6.Copyright, Patent and Trademark NoticesPatents 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.FCC StatementNOTE: 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 TestFCC 47CFR 15B clA - 47 CFR Part 15 Subpart B Unin-tentional Radiators Class A Verifi cationUL 60601-1 - UL Standard for Safety Medical Electri-cal Equipment, Part 1: General Requirements for Safety First EditionCENELEC 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: 2001CENELEC 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-M90ETSI 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 V1.3.1ETSI 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 rangeOnce the blood pressure monitor displays zero, follow Omron’s procedures for taking a reading.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. The armband will also beep and vibrate once the transfer is successfully completed.5.6.7.

Navigation menu