Withings Scan Monitor Gebrauchsanweisung Seite 7

Scan Monitor
classifiable recordings. These results reflect use in a controlled environment. Real world use of
the Scan Monitor may result in a greater number of strips being deemed inconclusive.
The waveform output from the software was tested in accordance with IEC 60601-2-47*
standard by a beat-to-beat QRS detection. This detection reaches a F1-score of at least 99,19%
on all the datasets with the exception of NSTDB (90,65% because of the digitally added noise).
*
*IEC 60601-2-47:2012 : Requirements for the Basic Safety and Essential Performance of Ambulatory
Electrocardiographic Systems.
6.1. RF Statement
Guidance and manufacturer's declaration-electromagnetic emissions
The Scan Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the Scan Monitor should assure that it is used in such an environment
Emissions test
CE emissions CISPR11
RE emissions CISPR11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ Flicker
emissions
IEC 61000-3-3
6.2. Declaration- electromagnetic emissions and immunity for equipment and systems that are
not life-supporting and are specified for use only in a shielded location
Declaration- Electromagnetic immunity
The Scan Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the Scan Monitor should assure that it is used in such an environment
Immunity test IEC 60601 Test Level
Conducted 3 Vrms
RF IEC 150kHz to 80MHz
61000-4-6
Rev. 1.7 - Sep 12, 2023
Compliance Electromagnetic environment-guidance
Group 1 The Scan Monitor uses RF energy only for its
internal function. Therefore, its RF emissions are
Class B
very low and are not likely to cause any
interference in nearby electronic equipment
Not The Scan Monitor is suitable for use in all
applicable establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Compliance
level
N/A
N/A
Electromagnetic
environment-guidance
N/A