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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.
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
and in
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
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
±2 kV voltage outer
conductor
–
earth
± 1 kV voltage
outer conductor
–
outer conductor
The quality of supply voltage
shall correspond to typical
hospital or commercial
environment.
