Annex - GERATHERM UniqueResc+ Instruction Manual

Annex

Annex from EN 60601-1-2:2001 and A1:2006
Information on the essential performance characteristics:
Essential performance characteristics:
Characteristics those were necessary in order to keep
the residual risk level within acceptable limits.
During the insensitivity test, each function of the de-
vice and/or system shall be tested in the mode that, in
respect of the result, is most critical for the patient on
the basis of a risk analysis, using device options, cable
arrangement and accessories in a typical configuration
as in normal use. This risk analysis is not necessary if
all modes of the device and/or system are tested. If the
device and/or system are not intended for continuous
operation, the operating mode can be selected in such
a way that reliable operation is achieved for the respec-
tive duration of the test.
6.8.2.201 Operating instructions
a) Requirements for all devices and/or systems
The operating instructions must contain the following:
1.) A declaration that medical electrical devices re-
quire special precautions as regards elec romagne-
tic compatibility (EMC) and must be installed and
operated in compliance with the EMC information
included in the accompanying documentation.
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2.) A statement that portable and mobile HF communi-
cation equipment may affect the function of medi-
cal electrical devices.
6.8.3.201 Technical description
a1) Cables, maximum lengths of cables and accessories:
A list of all cables and the maximum length of ca-
bles (if applicable), transducers and other acces-
sories with which the manufacturer of the device or
system claims compliance with the requirements
of sub-clauses 36.201, Emissions, and 36.202, In-
sensitivity. Accessories which do not affect com-
pliance with the requirements of these sub-clauses
do not need to be listed.
a2) Warning concerning the use of accessories A
warning that the use of other accessories, other
transducers and other cables than the specified
ones – except transducers and cables sold via the
manufacturer of the device or system – as replace-
ment parts for internal components can lead to hig-
her emissions and/or reduced insensitivity of the
device or system.
a3) Advice on electromagnetic compatibility - Emission
In the following the Geratherm UniqueResc
signated as a device or system.
is des-
+