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BodyMedia SenseWear 908901PROD2 Instructions For Use Manual

Body monitoring system

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body monitoring system
Instructions For Use
SenseWear ® software
SenseWear ® Professional software
SenseWear® armband
and data collection

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Summary of Contents for BodyMedia SenseWear 908901PROD2

  • Page 1 body monitoring system Instructions For Use SenseWear ® software SenseWear ® Professional software SenseWear® armband and data collection...
  • Page 2: Table Of Contents

    TABLE OF CONTENTS Introduction ............2 ®...
  • Page 3: Introduction

    Introduction This manual will instruct you in the use of the ® IMPORTANT SenseWear Body Monitoring System™. It covers the routine operations and frequently-used To run the SenseWear software or ® features of the SenseWear software, SenseWear Professional software, SenseWear® Professional software and the the minimum requirements for your ®...
  • Page 4: Important Information About The Sensewear Armband

    ® Important Information About the SenseWear armband WARNINGS side this age range or 2) engaged in alternate or obscure activities may see decreased accuracy in the data. Any decisions based on the data from this device should be made only by medical or paramedic personnel and should consider the condition and lifestyle of the subject tested.
  • Page 5 ® Important Information About the SenseWear armband WARNINGS Wear comfortably Be careful not to over-tighten the armband while on your arm. If, at any time, you feel constric- tion or loss of circulation, simply loosen the adjustable strap and re-fasten it to a more comfort- able setting.
  • Page 6 ® Important Information About the SenseWear armband WARNINGS Water resistance DO NOT IMMERSE THE ARMBAND IN WATER. The monitor 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).
  • Page 7 ® Important Information About the SenseWear armband CAUTIONS Dispose of device in accordance with local, state, federal, or country specific regulations. Maintenance Do not attempt to open the armband yourself. It contains no user-serviceable parts. Refer all servicing to qualified Service Personnel. Opening the armband yourself will void the warranty. 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.
  • Page 8 ® Important Information About the SenseWear armband Patient Environment 2.5m 1.5m 1.5m 1.5m Computer and Wireless Communicator Diagram not to scale. Guidance and Manufacturer’s Declaration - Emissions The 908901PROD2 (SenseWear ® armband) is intended for use in the electromagnetic environment specified below. The customer or user of the 908901PROD2 should ensure that it is used in such an environment.
  • Page 9 ® Important Information About the SenseWear armband Guidance and Manufacturer’s Declaration - Immunity ® The 908901PROD2 (SenseWear armband) is intended for use in the electromagnetic environment specified below. The customer or user of the 908901PROD2 should ensure that it is used in such an environment. IEC 60601 Compliance Electromagnetic...
  • Page 10 ® Important Information About the SenseWear armband Guidance and Manufacturer’s Declaration - Emissions ® The 908901PROD2 (SenseWear armband) is intended for use in the electromagnetic environment specified below. The customer or user of the 908901PROD2 should ensure that it is used in such an environment. IEC 60601 Compliance Electromagnetic...
  • Page 11 ® Important Information About the SenseWear armband Recommended Separations Distances for the 908901PROD2 ® The 908901PROD2 (SenseWear armband) is intended for use in the electromagnetic environment specified below. The customer or user of the 908901PROD2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the 908901PROD2 as recommended below, according to the maximum output power of the communications equipment.
  • Page 12: Retrieving Armband Data To Your Computer

    Retrieving armband Data to Your Computer ® ® To start the program, double-click on the SenseWear software or SenseWear Professional* software icon on your desktop. The main screen ( figure 1 ) will appear as shown. There are three buttons at the top under the menu bar: Retrieve Armband Data, View & Annotate Armband Data and Configure Armband.
  • Page 13 Retrieving armband Data to Your Computer If the armband was not configured prior to wearing, you will receive a pop up window ) after the data has been retrieved. figure 3 The window will prompt you to enter the wearer’s Subject Info and other important information needed to derive accurate lifestyle information.
  • Page 14: Viewing And Analyzing The Data

    Viewing & Analyzing the Data If you have just retrieved data from the armband, then the data file will already be displayed. If you would like to view a previ- ously saved data file, go to File on your menu bar and select Open Data File.
  • Page 15 Viewing & Analyzing the Data The date and time located to the left and right just above the selector indicate the total duration of the data file. Inside the rectangle itself, the beginning of each day (midnight) within this duration is marked by the date and a thin vertical white line.
  • Page 16: Using The Software To Configure An Armband And Display

    Using the Software to Configure an armband and display The armband Parameters tab ( figure 27 allows you to verify the date and time of the armband clock. It also allows you to check the hardware version, serial num- ber, battery level, and memory capacity. figure 27 IMPORTANT If the armband clock is not synchronized with your PC clock, a message may suggest that...
  • Page 17 29 IMPORTANT Do not select Reboot Armband unless instructed to do so by a BodyMedia representative or Technical Support Specialist. Unnecessary reboots of the device can result in data loss.
  • Page 18 ® Features of the SenseWear armband Battery The armband is powered by one AAA battery. During continuous use (24/7), it will last approxi- mately 14 days. To check the status of the battery, remove the armband and press the Timestamp/Status button. The light above the word “battery”...
  • Page 19: Features Of The Sensewear Armband

    ® Features of the SenseWear armband Memory Under default configurations, the armband has approximately 10 days of data collection mem- ory. To check the memory status, remove the armband and press the Timestamp/Status button. The light above the word “memory” will turn on as follows: •...
  • Page 20 ® Features of the SenseWear armband Threading your adjustable strap ® Your SenseWear armband comes with two identical adjustable straps. One strap comes at- tached to the armband and the other is a spare to be used if you’re cleaning the first one. See the Cleaning section (page 6) of this manual for information on cleaning your adjustable strap.
  • Page 21 ® Features of the SenseWear armband ® SenseWear armband - Part No.100156 (US), 100153 (Europe-Italian), 100154 (Europe-English). • Wearable body monitor with multi-sensor array collects data directly off skin of the wearer’s arm. ® SenseWear wireless communicator - Part No.100155 (US) and 100158 (Europe) •...
  • Page 22 ® Features of the SenseWear armband Armband features • Gathers raw physiological data, including movement, heat flux, skin temperature, near body temperature, and galvanic skin response. • Battery lasts approximately 14 days when worn continuously. • Stores approximately 10 days of continuous physiological and lifestyle data with default configuration.
  • Page 23 ® Features of the SenseWear armband Sensor Accuracy Accelerometer Absolute range is +/- 2.00g • The minimum resolution is 0.01g (2-axis) • A two-standard-deviation range of +/-0.05g, up to 1.00g on • longitudinal axis A two-standard-deviation range of +/-12.00% of expected value •...
  • Page 24 ® Features of the SenseWear armband Follow operating instructions. Caution Tested to applicable safety standards. TYPE B APPLIED PART The Waste Electrical and Electronic Equipment Regulations indicates separate collection for electrical and electronic equipment. 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.
  • Page 25 ® Features of the SenseWear armband 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.
  • Page 26 ® Features of the SenseWear armband 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); Elec- troMagnetic Compatibility (EMC) Standard for Radio Equipment and Services;...