User manual

Blackrock Microsystems CereStim R96 - User Manual
Rev. 2.00 Page iv
LB-0314
Electromagnetic Compatibility
The following tables document compliance levels and guidance from the IEC 60601-1-2 2007 Standard, for
the electromagnetic environment in which the CereStim R96 should be used. Medical Electrical Equipment
requires special precautions regarding EMC and should be installed and put into service according to the
guidelines provided in the tables below.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The CereStim R96 is intended for use in the electromagnetic environment specified below. The
customer or the user of the CereStim R96 should assure that it is used in such an environment
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Group 1
The CereStim R96 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF Emissions
CISRP 11
Class A
The CereStim R96 is suitable for use in all
establishments other than domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Not Applicable
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Not Applicable
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The CereStim R96 is intended for use in the electromagnetic environment specified below. The
customer or the user of the CereStim R96 should assure that it is used in such an environment
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6kV Contact
±8kV Air
Not Applicable
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
± 2kV for power
supply lines
±2 kV for input/output
Lines
± 2kV for power
supply lines
±2 kV for
input/output
Lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1kV line(s) to line(s)
±2kV line(s) to earth
Not Applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
Not Applicable
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the CereStim R96
requires continued operation
during power mains
interruptions, it is
recommended that the