Enbrel SMARTCLIC APP-1000, Руководство пользователя

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Technical Information Technical Information
SMARTCLIC Injection Device is intended for use
in the home healthcare environment and has
been confirmed to conform to IEC 60601-1-2:2014
“Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests”.
Emissions test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Electromagnetic Emissions
Electromagnetic Immunity
Immunity test
IEC 60601-1-2
test level
Compliance
level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Rated power
frequency
magnetic field
(50 Hz/60 Hz)
IEC 61000-4-8
30 A/m* 30 A/m*
Radiated RF EM
fields
IEC 61000-4-3
10 V/m
80 MHz to
2.7 GHz
80 % AM at
1 kHz
10 V/m
80 MHz to
2.7 GHz
80 % AM at
1 kHz
Proximity fields
from RF wireless
communication
equipment
IEC 61000-4-3
See pages 72 - 73.
* SMARTCLIC Injection Device should be used
no closer than 15 cm to any AC power cable.
Otherwise, degradation of the performance of this
equipment could result.
EMC Relevant Information
Copyright © 2014, Kenneth MacKay. All rights
reserved.
Redistribution and use in source and binary forms,
with or without modification, are permitted
provided that the following conditions are met:
1. Redistributions of source code must retain the
above copyright notice, this list of conditions
and the following disclaimer.
2. Redistributions in binary form must reproduce
the above copyright notice, this list of
conditions and the following disclaimer in
the documentation and/or other materials
provided with the distribution.
THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT
HOLDERS AND CONTRIBUTORS “AS IS” AND ANY
EXPRESS OR IMPLIED WARRANTIES, INCLUDING,
BUT NOT LIMITED TO, THE IMPLIED WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE ARE DISCLAIMED. IN
NO EVENT SHALL THE COPYRIGHT HOLDER OR
CONTRIBUTORS BE LIABLE FOR ANY DIRECT,
INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR
CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT
LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS
OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED
AND ON ANY THEORY OF LIABILITY, WHETHER IN
CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING
NEGLIGENCE OR OTHERWISE) ARISING IN ANY
WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF
ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
BSD 2-Clause License