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Beat2Phone ECG Instruction Manual
11
Regulatory Information
Compliant with the following:
EN 60601-1:2005
EN 60601-1-2:2015
EN 60601-1-6:2007
EN 60601-1-11:2015
EN 60601-2-47:2015
11.1
Classification
Classification
Sensor
Charging connector
Medical device classifi-
cation, MDD 93/42/EEC
IIa
IP
X7, not tested for protection
against dust ingress. Protected
from immersion between 15 centi-
meters and 1 meter in depth.
21, protected from touch by fingers and ob-
jects greater than 12 millimeters. Protected
from vertically dripping water.
Protection against elec-
tric shock
Internally Powered, Class II when
connected to charging connector
Class II
Applied parts
Type BF, Beat2Phone ECG Elec-
trode Strap
-
Mode of operation
Non-continuous 22h/2h ON/OFF
Non-continuous 2h/22h ON/OFF
Input voltage range
Charging cycles = 500
100-240 VAC, 50-60 Hz
Usage type
transit-operable, body-worn
portable
EMC (CISPR11:2009)
Class B, group 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The Beat2Phone ECG is intended for use in the electromagnetic environment specified below.
The customer or the user of the Beat2Phone ECG should ensure that it is used in an environment of the speci-
fied type.
Emissions test
Compliance
Electromagnetic environment
–
guidance
RF emissions below 1 GHz
CISPR 11, EN 55011
30-230 MHz at
10 m
30 dBuV/m
The Beat2Phone ECG must emit
electromagnetic energy (BLE 5) in
order to perform its intended func-
tion. Nearby electronic equipment
may be affected.
230-1000 MHz
at 10 m
37 dBuV/m
Harmonic emissions
IEC 61000-3-2
Class A
The Beat2Phone ECG is suitable
for use in a home healthcare envi-
ronment and in environments di-
rectly connected to the public low-
voltage power network that sup-
plies buildings used for domestic
purposes, provided the following
warning is heeded:
Warning:
This equipment/system
may cause radio interference or
may disrupt the operation of
nearby equipment. It may be nec-
essary to take measures to miti-
gate the effects, such as re-orient-
ing or relocating the Beat2Phone
ECG or shielding its location.
Average 50, Quasi-peak 60 dBuV
Conducted disturbance EN 55011
Class B, 150 kHz – 30 MHz
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliant
Guidance and manufacturer’s declaration – electromagnetic immunity
The Beat2Phone ECG is intended for use in the electromagnetic environment specified below.
The customer or the user of the Beat2Phone ECG should ensure that it is used in an environment of the speci-
fied type.