Electromagnetic Compatibility Information - Spengler Neotens Neo300 Gebrauchsanweisung

ELECTROMAGNETIC COMPATIBILITY INFORMATION

The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The requirements are satisfied under the conditions described in the
table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the
instructions for use. Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunction with non-approved accessories
can affect the device negatively and alter the electromagnetic compatibility. The device should not be used directly adjacent to or between other electrical
equipment.
Table 1
The customer or the user of the device should assure that it is used in such an environment.
Emissions test
Radiated emission CISPR 11
Conducted emission CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Table 2
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should
IMMUNITY test
Electrostatic discharge (ESD) IEC
61000-4-2
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
assure that it is used in such an environment.
IEC 60601 test level
± 8 kV
contact
± 2 kV,±4 kV,
± 8 kV,
± 15 kV air
Compliance
Group 1, class B.
Group 1, class B.
Class A
Complies
± 8 kV
contact
± 2 kV,±4 kV,
± 8 kV,
± 15 kV air
USER MANUAL NEOTENS | WWW.SPENGLER.FR
EN
Compliance level
61