40
41
Humidity limitation
Temperature limitation
Atmospheric
pressure for storage
CE marked product
Reference number
Sterilise at temperature
specified
Made in China
EU Importer
Distributor
Keep out of direct
sunlight
Unique device
identifier
Medical Device
Do not reuse
Warning
Authorised Representative in the EUROPEAN
COMMUNITY
12 Statement
All rights of modifying the product are reserved to the manufacturer
without further notice. The pictures are only for reference.
According to the EU Medical Devices Regulation, users / patients
are obliged to report serious events with a medical device to the
manufacturer and to the competent authority of the country in which they
occurred.
13 EMC-Declaration of conformity
The device has been tested and homologated in accordance with EN
60601-1-2 for EMC. This does not guarantee in any way that this device
will not be effected by electromagnetic interference Avoid using the
device in high electromagnetic environment.
Technical Description Concerning Electromagnetic Emission
Table 1: Declaration - electromagnetic emissions
Guidance and manufacturer’s declaration - electromagnetic emissions
The model BAE380R is intended for use in the electromagnetic environment specified below. The
customer or the user of the model BAE380R should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The model BAE380R 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
CISPR11
Class B
The model BAE380R is suitable for
used 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.
Harmonic emissions
lEC 61000-3-2
Class A
Voltage fluctuations / flicker
emissions
lEC 61000-3-3
Complies
Technical Description Concerning Electromagnetic Immunity
Table 2: Guidance & Declaration - electromagnetic immunity
Guidance & Declaration — electromagnetic immunity
The model BAE380R is intended for use in the electromagnetic environment specified below. The
customer or the user of the model BAE380R should assure that It is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic discharge
(ESD)
lEC 61000-4-2
±8kV contact
±2, ±4, ±8, ±15kV
air
±8kV contact
±2, ±4, ±8, ±15kV 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
±2kV for power
supply lines
±1kV for Input/
output lines
±2kV for power supply
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
lEC 61000-4-5
±0.5, ±1kV line to
line
±0.5, ±1, ±2kV line
to earth
±0.5, ±1kV line to line
±0.5, ±1, ±2kV line to
earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Summary of Contents for BA OPTIMA E+ BAE380R
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