BodyMedia WG24 SenseWear (R) wireless gateway User Manual WG 2 4 LIT indd
BodyMedia, Inc. SenseWear (R) wireless gateway WG 2 4 LIT indd
User manual
wireless gateway Operating Manual ® 4 Smithfield Street 11th Floor Pittsburgh, PA 15222 USA P.412.288.9901 F.412.288.9902 www.bodymedia.com WG-2.4-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 2006 BodyMedia, Inc. TABLE OF CONTENTS Important Information About the SenseWear biotransceiver . . . . . . . . . . . . . . . . . . . . . . . . 02 Setting up SenseWear® wireless gateway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 SenseWear® wireless gateway Interface Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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® wireless gateway 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. 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. Important Information About the SenseWear® wireless gateway WARNINGS 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. Important Information About the SenseWear® wireless gateway CAUTIONS If the wireless gateway 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 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 gateway to dry for 5-10 minutes before using DO NOT STERILIZE THIS UNIT. 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 classified. Ordinary Protection, not protected against ingress to moisture. CAUTIONS 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. Important Information About the SenseWear® biotransceiver Important Information About the SenseWear® biotransceiver Patient Environment Guidance and Manufacturer’s Declaration - Immunity 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. 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 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. 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 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 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 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. 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 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. Portable and mobile communications equipment should be separated from WG-2.4 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 WG-2.4 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. 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 Tested to applicable safety standards. The Waste Electrical and Electronic Equipment Regulations indicates separate collection for electrical and electronic equipment. Setting up SenseWear® wireless gateway 1. 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. 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). 2. Plug one end of the power adapter into the wireless gateway and the other end into the electrical outlet. 3. 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. Identification code of Notified Body involved: 0051. EMC Alert Mark for non-ionizing radiation . TIP: The wireless gateway end data upload immediately will hang up immediately by simply lifting the handset of any phone on the same telephone cable as the wireless gateway. 4. 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. 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 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. TIP: To maximize tranceiver reception range, avoid placing anything on top of the wireless gateway. Conforms to UL STD 60950 Certified to CSA C22.2 No. 950 10 SenseWear® wireless gateway Interface Key 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: 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. • 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 Error: Please contact support 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. 11 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
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