BodyCAP e Celsius - Material-Vigilance Declaration

42
P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN
Electromagnetic immunity, radio frequencies:
The e-Celsius® Medical System is intended for use in the magnetic and electromagnetic environment
described in the table below. The user and installer should ensure compliance with the electromagnetic
environment.
Immunity test Standards
Test level according to
IEC 60601
Level of compliance
Electromagnetic environ-
ment Remarks
WARNING: Portable RF communications devices (including peripherals such as antenna cables and external
antennas) should not be operated closer than 30cm (12 inches) to any part of the UNIT UNDER TEST, including
cables specied by the manufacturer. Failure to do so may result in impaired performance of these devices.
Interference is possible near equipment identied by the following symbol:
Radiated radio
frequency electro-
magnetic elds
NF EN 61000-4-3
10 V/m
80 MHz to 2.7 GHz
80 % MA at 1 kHz
10 V/m
80 MHz to 2.7 GHz
80 % MA at 1 kHz
Environment of a professio-
nal health care facility.
Radiated radio
frequency electro-
magnetic elds
NF EN 61000-4-3
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
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
Environment of a professio-
nal health care facility.
Conducted distur-
bances induced by
RF elds
NF EN 61000-4-6
3 V
150KHz to 80MHz
6 V in ISM band and
band between
0.15 MHz
3 V
150KHz to 80MHz
6 V in ISM band and
band between
0.15 MHz
Environment of a professio-
nal health care facility.
7. MATERIAL-VIGILANCE DECLARATION
Users of a device and third parties who are aware of an incident or risk of incident involving a device that
has resulted or may result in the death or serious deterioration of the state of health of a patient, user
or third party must report it without delay to the manufacturer BodyCAP or to the "Agence nationale de
sécurité du médicament et des produits de santé".
materiovigilance@ansm.sante.fr
Lien BodyCAP: www.bodycap-medical.com