Technical Specifications; Compliance Information - Bellman & Symfon BE9159 Medical Device Information

Technical specifications

Neck loop diameter: 22 cm, 9"
Weight: BE9159: 62g, 2.2 oz
BE9161: 58g, 2 oz
Cable length: BE9159: 90cm, 3'
BE9161: 15cm, 6"
Connectors: 3.5mm tele plug (stereo) gold plated
connector, 90 degrees angle
(Break-away connector on cable)
Load impedance: 2 x 5 Ω
Magnetic output: 1500mA/m @ 15 cm, 6" distance
and 2 x 50mW input signal
In the box: BE9159 or BE9161 Neck loop
ISO Certification of legal manufacturer
Bellman is certified in accordance with SS-EN ISO
9001 and SS-EN ISO 13485.
SS-EN ISO 9001 Certification Number: CN19/42071
SS-EN ISO 13485 Certification Number: CN19/42070
Certification Body
SGS United Kingdom Ltd
Rossmore Business Park Ellesmere Port Cheshire
CH65 3EN UK
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Compliance information

Hereby Bellman & Symfon declares that, in Europe,
this product is in compliance with the essential
requirements of the Medical Device Regulation EU
2017/745 as well as the directives and regulations
listed below. The full text of the declaration of
conformity can be obtained from Bellman & Symfon
or your local Bellman & Symfon representative. Visit
bellman.com for contact information.
Radio Equipment Directive (RED)
Medical Device Regulation (MDR)
EC General Product Safety Directive
Electromagnetic Compatibility Directive (EMC)
Restriction of Hazardous Substances Directive (RoHS)
REACH Regulation
Waste Electrical & Electronic Equipment (WEEE)
EN
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