Path medical Senti, User Manual

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10 Electromagnetic Compatibility Information
Electromagnetic compatibility (EMC) as stated by standard DIN EN 60601-1-2
(Medical electrical
equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests)
and 60601-2-40
(Medical electrical equipment - Part 2-40:
Particular requirements for the safety of electromyographs and evoked response equipment)
was certified by an
accredited laboratory. Requirements from DIN EN 60601-1-2:2016-05 (see tables below, see also
section
8.4: Electromagnetic Compatibility ) are applicable to all devices delivered from 01/2019
(Handheld: PCB Rev. ≥ 70 with connector board, Desktop: PCB Rev. ≥ 333; for previous PCB versions
please refer to the previous manual version or contact PATH MEDICAL). Information on the full
report is available from PATH MEDICAL upon request.
The user must take care that the device is used in an environment with electromagnetic
radiation as specified in
Table 5 and in Table 6 .
Emitted interference
measurement
Compliance Electromagnetic environment
High-frequency emission according
to CISPR11 Group 1 The medical electric device uses high-frequency (HF)
energy only for internal operation. Hence, its HF
emissions are very low and it is unlikely that adjacent
electronic devices are disturbed.
Class B The medical electric device may be used in all
establishments, including those in residential
environments and those that are directly connected to
a public power network that also supplies buildings
used for residential purposes.
Emission of harmonic components
according to IEC 61000-3-2 Class A ---
Emission of voltage fluctuation /
flicker according to IEC 61000-3-3 Compliant ---
Table 5: Compliance with electromagnetic emission guidelines and resulting requirements for
electromagnetic environment
Tests for immunity
to interference
IEC 60601 test level Concurrent level Electromagnetic environment
Electrostatic discharge
(ESD) according to IEC
61000-4-2 ± 8 kV contact
discharge
± 15 kV air discharge
± 8 kV contact
discharge
± 15 kV air discharge
To reduce ESD effects, the ground
floor shall consist of wood,
concrete or ceramic tiles.
Fast transient electric
disturbance; bursts
according to IEC
61000-4-4 ± 2 kV for power lines
± 1 kV for input and
output lines
± 2 kV for power lines
± 1 kV for input and
output lines
The quality of supply voltage shall
correspond to typical hospital or
commercial environment.
Impulse voltage,
surges according to
IEC 61000-4-5 ± 1 kV voltage
outer conductor –
outer conductor ± 1 kV voltage
outer conductor –
outer conductor The quality of supply voltage shall
correspond to typical hospital or
commercial environment.