42
43
Type BF: Device is not protected against
the effects of de
fi
bril-lators
Classi
fi
cation: Europe: Class 2a (EC directive
93/42/EWG, Medical devices)
USA: Device class 2
This device meets the regulations of EC
directive 93/42/EWG (directive for medical
devices) and is developed and manu-
factured according to the regulations of the
21CFR 820.
The requirements of the following standards
are met:
-
IEC 60601-1 Medical electrical devices –
General safety regulations
-
IEC 60601-1-2 General safety
regulations – Standard supplement:
Electromagnetic compatibility –
Requirements and tests
-
EN 1060 : 1995 Non-invasive blood
pressure meters Part 1: General
requirements
-
EN 1060 : 1997 Non-invasive blood
pressure meters Part 3:
Supplementary requirements for
electromechanical blood pressure
meters
-
ANSI/AAMI SP10:2002 /A1:2003
The wireless module integrated in this
device (BPM105 only) ful
fi
lls the
regulations of EC directive 1999/5/EC
(Radio and telecommunication terminal
equipment, R&TTE).
The requirements of the following
standards are met:
-
ETSI EN 301 489-17 Electromagnetic
Compatibility and Radio Spectrum
Matters (ERM); Electromagnetic
Compatibility (EMC) Standard for
Radio Equipment and Services; Part 17:
Specific Conditions for 2,4 GHz
Wideband Transmission Systems
-
EN 300328-2 V1.2.1 Electromagnetic
compatibility and radio spectrum
-
FCC Class B Part 15
9 EMC Information
(Electromagnetic
Compatibility)
This device complies with part 15 of
the FCC Rules. Operation is subject to
the following two conditions:
(1)This device may not cause harmful
interference and (2) this device must
accept any interference received,
including interference that may cause
undesired operation.
This equipment has been tested and
found to comply with the limits for a
Class B digital device, pursuant to Part
15 of the FCC Rules. These limits are
designed to provide reasonable
protection against harmful interference
in a residential installation. This
equipment generates, uses and can
radiate radio frequency energy and, if
not installed and used in accordance
with the manufacturer’ instructions,
may cause interference harmful to
radio communications. There is no
guarantee, however, that interference
will not occur in a particular
installation.
If this equipment does cause harmful
interference to radio or television
reception, which can be determined
by turning the equipment off and on,
the user is encouraged to try to
correct the interference by one or
more of the following measures:
-
Reorient or relocate the receiving
antenna.
-
Increase the separation between the
equipment and receiver
-
Connect the equipment to an outlet
on a circuit different from that to
which the receiver is connected.
-
Consult the dealer or an
experienced radio or TV technician
for help.
Not authorized changes or
modifications could void authority to
use this equipment.
