body monitoring system Instructions For Use SenseWear® software SenseWear® Professional software SenseWear® armband and data collection
TABLE OF CONTENTS Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Important Information About the SenseWear® armband. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Retrieving armband Data to Your Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Viewing and Analyzing the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Introduction This manual will instruct you in the use of the SenseWear® Body Monitoring System™. It covers the routine operations and frequently-used features of the SenseWear® software, SenseWear® Professional software and the SenseWear® armband. If you have not done so already, please refer to the Getting Started Guide included in the System box to install the SenseWear software or SenseWear Professional software and configure the 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. The SenseWear® armband should not be used for life critical applications; improper usage may result in harm or even death to the wearer.
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 constriction or loss of circulation, simply loosen the adjustable strap and re-fasten it to a more comfortable setting. Be sure that both your arm and the sensors on the back of the armband are cleaned daily. To clean the sensors, wipe with a soft, damp cloth.
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). IPX0 classified. Ordinary Protection, not protected against ingress to moisture.
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.
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.
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.
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.
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.
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. Retrieve Armband Data will already be selected. Connect the USB cable to the armband and to one of your computer’s USB ports.
Retrieving armband Data to Your Computer If the armband was not configured prior to wearing, you will receive a pop up window (figure 3) after the data has been retrieved. The window will prompt you to enter the wearer’s Subject Info and other important information needed to derive accurate lifestyle information. The subject information MUST be entered to ensure that the software can accurately analyze the raw data collected by the armband. (see Getting Started Guide, Step 2, Configuration).
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 previously saved data file, go to File on your menu bar and select Open Data File. A window (figure 5) will open up to your default directory. Double click on the data file you wish to open. IMPORTANT SenseWear® software and SenseWear® Professional software v. 6.0 are designed to work with SenseWear Pro2 and Pro3 armbands.
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. Solid-colored areas show periods when the armband was on-body and collecting data. Thin horizontal grey lines show periods when the armband was off-body and not collecting data.
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 number, battery level, and memory capacity. figure 27 IMPORTANT If the armband clock is not synchronized with your PC clock, a message may suggest that you synchronize the clocks. If your PC clock time is the correct time, we recommend doing this by clicking the Apply button.
® SenseWear Professional software Using the Software to Configure an armband and display The SenseWear® Professional software includes the Data Channels tab (figure 22) feature. This tab lets you configure the data channels to be collected and the sampling rates used by each channel. If you are not familiar with the low-level physiological parameters the device collects, we strongly recommend not changing this section.
Features of the SenseWear® armband Battery The armband is powered by one AAA battery. During continuous use (24/7), it will last approximately 14 days. To check the status of the battery, remove the armband and press the Timestamp/Status button. The light above the word “battery” will turn on as follows: • Green (solid) = More than 24 hours of battery life remains. • Amber (flashing) = Less than 24 hours of battery life remains.
Features of the SenseWear® armband Memory Under default configurations, the armband has approximately 10 days of data collection memory. 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: • Green (solid) = More than 24 hours of memory remains. • Amber (flashing) = Less than 24 hours of memory life remains. • Red (flashing) = Available memory is low and the armband will not collect data.
Features of the SenseWear® armband Threading your adjustable strap Your SenseWear® armband comes with two identical adjustable straps. One strap comes attached 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. Follow these steps to thread your adjustable strap into your armband. 1. 2. 3. 4. 5. Hold the armband upright with the sensors facing you.
Features of the SenseWear® armband E C D B A A 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. B SenseWear® wireless communicator - Part No.100155 (US) and 100158 (Europe) • Directly connects to computer to wirelessly retrieve data off of armband. C USB Cable - Part No.
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.
Features of the SenseWear® armband Sensor Accuracy Accelerometer (2-axis) 37 • Absolute range is +/- 2.00g • The minimum resolution is 0.01g • A two-standard-deviation range of longitudinal axis • A two-standard-deviation range of otherwise on the longitudinal axis • A two-standard-deviation range of transverse axis • A two-standard-deviation range of otherwise on transverse axis. +/-0.05g, up to 1.00g on +/-12.00% of expected value +/-0.06g up to 1.00g on the +/-12.
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.
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. 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.
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); 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.
