Pulse oximeter MySign
®
S
16 EMC Declaration
Manufacturer`s Declaration – Electromagnetic Emissions IEC 60601-1-2
for the Equipment or System MYSIGN S
General information requirements of IEC 60601-1-2 sect. 5.2 Instructions for use:
5.2.1.1) Requirements applicable to all EQUIPMENT and SYSTEMS: Instructions for use shall include the
following:
a) a statement that MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in the
ACCOMPANYING DOCUMENTS;
b) a statement that portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
EQUIPMENT.
Table 1: Guidance and manufacturer`s declaration - electromagnetic emissions
Guidance and manufacturer`s declaration electromagnetic emissions
The MYSIGN S is intended for use in the electromagnetic environment specified below. The customer or the
user of the MYSIGN S should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
function. Therefore, RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
CISPR 11
Class B
The MYSIGN S is suitable 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.
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