DeRoyal Prospera PRO Series, Руководство пользователя, Страница: 38 / 44

38
7.3 EMC Information
ATTENTION!
Medical electrical equipment is subject to special precautionary measures
regarding electromagnetic compatibility and must be installed and
operated in accordance with the EMC information provided in the
accompanying documentation.
ATTENTION!
Portable and mobile RF communication equipment may affect medical
electrical equipment! Do not apply any 3 rd party device to unit without
proper testing performed by DeRoyal or by authorized professionals of
DeRoyal.
CAUTION!
The use of any accessories and/or spare parts (incl. transformers and
cables, non-permanent 3 rd party devices, etc.) not recommended by
DeRoyal may increase the emission of electromagnetic interference or
reduce the electromagnetic immunity of the devices. Damage caused by
using non-recommended accessories and/or spare parts or by improper
use is not covered by warranty in any case.
Only use original DeRoyal accessories and spare parts.
CAUTION!
Use of the recommended accessories and spare parts (incl. transformers
and cables) in devices other than the PRO-II ® and PRO-III ® devices may
increase the emission of electromagnetic interference or reduce the
electromagnetic immunity. Damage caused by using recommended
accessories and spare parts in other devices or by improper use is not
covered by warranty in any case.
Use the accessories and spare parts only with the PRO-II ® and PRO-III ®
devices.
WARNING!
The PRO-II ® and PRO-III ® devices must not be used directly adjacent to
or stacked with other devices. If operation adjacent to or stacked with
other devices is necessary, monitor the PRO-II
®
and PRO-III
®
devices in
this configuration to verify proper operation!
The PRO-II ® and PRO-III ® devices meet the requirements of IEC 60601-1-2/EN 60601-1-2
“Electromagnetic Compatibility – Medical Electrical Equipment.” Electromagnetic
interference is therefore reduced to a minimum.
39
Table 1
Guidance and Manufacturer ’ s Declaration – Electromagnetic Emissions
The PRO-II ® and PRO-III ® devices are intended for operation in the electromagnetic
environment specified below. The customer or the user of the PRO-II ® or PRO-III ® device
must ensure that it is operated in such an environment.
Emissions measurement
Compliance
Electromagnetic Environment
– Guidance
RF emissions CISPR 11 Group 1
The PRO-II ® and PRO-III ®
devices use RF energy for
their internal function only.
Their RF emissions are
therefore very low and not
likely to cause interference in
nearby electronic equipment.
RF emissions CISPR 11 Class B The PRO-II ® and PRO-III ®
devices are appropriate for
use in all facilities incl.
private residences and those
directly connected to the
public power supply network
that supplies buildings used
for residential purposes.
Harmonic emissions pursuant to
IEC 61000-3-2
Class A
Voltage fluctuations / Flicker
emissions pursuant to
IEC 61000-3-3
Complies
Table 2
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The PRO-II
® and PRO-III ® devices are intended for operation in the electromagnetic
environment specified below.
The customer or user of the PRO-II
®
or PRO-III
®
device must ensure that it is used in
such an environment.
Immunity test IEC 60601 test level Compliance level
Electromagnetic
Environment –
Guidance
Electrostatic
discharge (ESD)
pursuant to
IEC 61000-4-2
±6kV contact
discharge
±8kV air discharge
±6kV contact
discharge
±8kV air discharge
Floors should be
made of wood,
concrete or ceramic
tile. If floors are
covered with
synthetic material,
the relative
humidity must be at
least 30%.
Fast transient
electrical
disturbances /
bursts pursuant to
IEC 61000-4-4
±2kV for power
supply lines
±1kV for input and
output lines
±2kV for power supply
lines
±1kV for input and
output lines
Main supply voltage
should be of the
same quality as in a
typical commercial,
living or hospital
environment.