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Bioness BITS - Radio Equipment Directive (RED) Declaration of Conformity Statement; Electromagnetic Emissions; Chest Strap Technical Specifications

Bioness BITS
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Chapter 23 - Technical Specifications
Radio Equipment Directive (RED) Declaration of Conformity Statement
Hereby, Bioness, Inc. declares that the radio equipment is in compliance with Directive 2014/53/EU. This
product operates at 2402-2480 MHz with the maximum RF output power not to exceed 4dBm.
Electromagnetic Emissions
The Bioness Integrated Therapy System is medical electrical equipment and applicable components were
tested for electromagnetic compatibility (EMC) in accordance with International Electrotechnical Committee
(IEC) 60601-1-2. The Bioness Integrated Therapy System should be configured and used in accordance
with the instructions provided in this guide.
Chest Strap Technical Specifications
Chest Strap Specifications
Sizes
XSmall – Small | 20 to 33 in. (50.0 - 83.8cm)
Medium – XLarge | 28 to 52 in. (71.1 - 132.1cm)
XXLarge – XXXLarge | 42 to 77 in. (106.7 - 195.6cm)
Material 65% Polyamide, 35% Spandex
Environmental Conditions
Transport & Storage Temperature:
-20°C (-4°F) to 55°C (+131°F)
Operating Temperature:
5°C (41°F) to 55°C (+131°F)
Relative Humidity:
25% to 85%
Atmospheric Pressure: 50 kPA to 106 kPA
Protection Against Ingress of Water: IP68 per IEC 60529
Cleaning
Spray the straps with Clorox
®
Hydrogen Peroxide
Disinfecting Cleaner. Wipe the straps throughly with a
cloth to clean and remove any remaining residue of the
solution.

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