Stim Switch User Manual
Rev. 2.00
®
Page iv
LB-0357
•
Redundant protective earth connection shall be made to either the medical
device or the other equipment.
•
The other equipment shall be powered from a medical grade (IEC 60601-1
compliant) separating transformer.
Cautions
•
Federal law restricts this device to sale, by or on the order of a physician.
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 Stim Switch 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 Stim Switch is intended for use in the electromagnetic environment specified below. The customer
or the user of the Stim Switch should assure that it is used in such an environment
Emissions Test
Compliance
Electromagnetic Environment -‐ Guidance
RF Emissions
CISPR 11
Group 1
The Stim Switch 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 B
The Stim Switch is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-‐voltage
power supply network that supplies buildings used for
domestic purposes.
Voltage Fluctuations/
Flicker Emissions
IEC 61000-‐3-‐3
Complies
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Stim Switch is intended for use in the electromagnetic environment specified below. The customer
or the user of the Stim Switch 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
±2, ±4, ±6kV Contact
±2, ±4, ±8kV Air
±2, ±4, ±6kV Contact
±2, ±4, ±8kV Air
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
AC-‐ ±2kV
DC, signal, control
lines -‐ ±1kV
Test both 50/60 Hz
AC-‐ ±2kV
DC, signal, control
lines -‐ ±1kV
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-‐4-‐5
Ac/dm -‐ ±0.5, ±1kV
Ac/cm -‐ ±0.5, ±1, ±2kV
Test both 50/50 Hz
Ac/dm -‐ ±0.5, ±1kV
Ac/cm -‐ ±0.5, ±1,
±2kV
Mains power quality should be
that of a typical commercial or
hospital environment.
Содержание STIM
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