Electromagnetic compatibility
Instructions for use • C-MAC
®
Pocket Monitor • DRE117_EN_V1.0_10-2020_IFU_CE-MDR
31
10 Electromagnetic compatibility
10.1 General notes on the operating environment
The product is suitable for use in professional healthcare settings. Professional healthcare
facilities include physician offices, dental offices, limited care facilities, freestanding surgical
centers, freestanding birth centers, multiple treatment facilities, hospitals (emergency rooms,
patient rooms, intensive care, surgical rooms, outside the HF-shielded room of an ME system
for MRT).
WARNING:
The use of this device next to or with other devices should be avoided, as this can
result in incorrect operation. If such use is necessary, this and the other devices should be
observed to ensure that they are operating correctly.
WARNING:
Portable HF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the device, including cables specified by the manufacturer. Otherwise, performance may be
impaired.
The emission characteristics of this product make it suitable for use in industrial areas as
well as in hospitals (CISPR 11 Class A) and other professional healthcare environments.
If it is used in a residential environment (for which CISPR 11 Class B is normally
required), the product may not offer sufficient protection for radio transmission operation.
The user might need to take mitigation measures, such as relocating or re-orienting the
product.
The emission characteristics of this product make it suitable for use in professional
healthcare facilities as well as in a residential environment (CISPR 11 Class B). This
product offers adequate protection to radio communication service. In the rare event of
interference to the radio transmission operation, the user might need to take mitigation
measures, such as relocating or re-orienting the product.
The product was tested for compatibility with HF surgical devices in accordance with IEC
60601-2-2 Appendix BB.
10.2 Table 1 – Compliance level for immunity tests
Guidelines and manufacturer’s declaration – electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user
of the product should make sure that it is used in such an environment.
Interference im-
munity tests
EN/IEC 60601 test
level
Compliance level
Electromagnetic envi-
ronment – guidelines
Electrostatic dis-
charge (ESD) acc.
to IEC 61000-4-2
± 8 kV contact dis-
charge
± 15 kV air discharge
± 8 kV contact dis-
charge
± 15 kV air discharge
Floors should be made
of wood, concrete, or
covered with ceramic
tiles. If floors are cov-
ered with synthetic ma-
terial, the relative hu-
midity must be at least
30%.
Electrical fast
transients/bursts
acc. 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 power supply qual-
ity should be that of a
typical commercial or
hospital environment.
