Aktiia Bracelet Manual do utilizador - Página 12
Procurar online ou descarregar pdf Manual do utilizador para Monitor de tensão arterial Aktiia Bracelet. Aktiia Bracelet 14 páginas.
Imprimir página
This confidential document
is the property of Aktiia
Guidance and manufacturer's declaration - electromagnetic immunity
AKTIIA bracelet is intended for use in the electromagnetic environment specified below.
The user of AKTIIA bracelet should ensure that it is used in such an environment.
AKTIIA bracelet is suitable for use in "Home Healthcare
tic establishments and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Immunity test
Electrostatic discharge
IEC 61000-4-2
Radiated RF electromagnetic field
IEC 61000-4-3
Proximity fields from RF wireless
communications equipment
IEC 61000-4-3 (interim method)
Power frequency magnetic field
IEC 61000-4-8
17. CE compliance
This device complies with the following regulations and normative documents/standards:
2017/745 (EU) Regulation of the European Parliament and of the Council of 5 April 2017 on medical devices, re-
pealing Council Directives 93/42/EEC
2014/53/EU Directive of the European Parliament and of the council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making available on the market of radio equipment
FCC part B 15B:2013 Electromagnetic Compatibility
FCC Rule Part: 15.247 Cat: DSS (Bluetooth)
EN ISO 10993-1:2009/AC:2010: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a
risk management process
EN ISO 10993-5: 2009: Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
Printed copies are uncontrolled - Check you are using the latest version
P01_0020 - USER MANUAL
Table 2 : Immunity tests for all ME EQUIPMENT and ME SYSTEMS
60601-1-2 test levels
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV in air
10 V/m
80 MHz à 2.4 GHz
80 % MA à 1 kHz
9 V/m
710 MHz, 745 MHz,
780 MHZ, 5240 MHz, 5550 MHz, 5785
MHz
27 V/m
385 MHz
28 V/m
450 MHz, 810 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz, 1970 MHz,
2450 MHz
30 A/m
50 Hz
Environment", i.e.
all establishments, including domes-
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV in air
10 V/m
80 MHz à 2.4 GHz
80 % MA à 1 kHz
9 V/m
710 MHz, 745 MHz,
780 MHZ, 5240 MHz, 5550 MHz,
5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz, 810 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz, 1970 MHz,
2450 MHz
30 A/m
50 Hz
Version: 2
Compliance
Page 12 of 14