Spécifications Techniques Et Garantie - Idmed ToFscan Manuel Utilisateur

VI Spécifications techniques et garantie
Le ToFscan intègre un microcontrôleur et un écran LCD couleur lui permettant une lisibilité optimale
et une utilisation simplifiée.
Sécurité
• Matériau capteurs biocompatibles (élément en contact avec le patient). Sans Latex.
• Conforme à la directive européenne CEE 93/42. Dispositif de Classe 2A (CE 0459 LNE/G-MED)
• Conforme avec la norme IEC 60601-1 équipement de classe II.
• Conforme avec la norme IEC 60601-2-10
• CEM : IEC 60601-1-2
Les informations suivantes sur les émissions électromagnétiques ont été rédigées intentionnellement
en anglais.
EMC Emission
Emission test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonics IEC 61000-3-2
Voltage fluctuations
and flicker IEC 61000-3-3
EMC Immunity
Basic EMC
Phenomenon
standard
ELECTROSTATIC
DISCHARGE
61000-4-2
(ESD)
Radiated RF EM
Fields 61000-4-3
Proximity fields
from RF
wireless com-
61000-4-3
munications
equipment
Manuel Utilisateur ToFscan
Compliance
Group 1
Class B
Class A
Compliant
Professional
healthcare
facility
environment
Immunity Test
Levels
± 8 kV contact
IEC
± 2 kV, ± 4 kV,
± 8 kV,
± 15 kV air
3 V/m
80 MHz – 2,7
IEC
GHz
80 % AM at
1 kHz
Complies to
IEC table 9 of IEC
60601-1-2
(2014)
EMC Instructions/cautions
The ToFscan uses RF energy only for internal
functions. Therefore RF emissions are very low and
should not disturb other nearby devices.
The ToFscan must be use in professional healthcare
facility environment
The ToFscan can be connected to the public mains
network
Compliance
levels
± 8 kV contact
In order to reduce ESD, the device
must be used in a 35% humidity
± 2 kV, ± 4 kV,
environment or more
± 8 kV air
Use of this equipment adjacent to or
stacked with other equipment should
3 V/m
be avoided because it could result
80 MHz – 2,7
in improper operation. If such use is
GHz
necessary,
80 % AM at
the
1 kHz
observed to verify that they are operating
normally
Complies to In order to prevent electromagne-
table 9 of IEC tic
60601-1-2 separation from RF communication
(2014) equipment of 30cm
EMC
Instructions/precautions
this equipment
other equipment should
disturbance, keep
and
be
minimum
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