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Electromagnetic Compatibility Guide
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones,
medical devices in use may be susceptible to electromagnetic interference from other devices.
Electromagnetic interference may result in incorrect operation of the medical device and create a
potentially unsafe situation.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to
prevent unsafe product situation, the IEC60601-1-2 standard has been implemented. This standard
defines the levels of immunity to electromagnetic interferences as well as maximum levels of
electromagnetic emissions for medical devices.
This medical device manufactured by pump conforms to this IEC60601-1-2:2007 standard for both
immunity and emissions.
Nevertheless, special precautions need to be observed:
·
Do not use mobile (cellular) telephones and other devices, which generate strong electrical or
electromagnetic fields, near the medical device. This may result in incorrect operation of the unit
and create a potentially unsafe situation. Recommendation is to keep a minimum distance of 7 m.
Verify correct operation of the device in case the distance is shorter.
Further documentation in accordance with IEC60601-1-2:2007 is available at pump at the address
mentioned in this user manual.
Guidance and manufacturer’s declaration Guidance and manufacturer’s declaration –
electromagnetic emissions
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment
specified below. The customer or the user of the [EQUIPMENT or SYSTEM] should assure
that it is used in such an environment.
Emissions test
Compliance
Electromagnetic
environment - guidance
RF emissions
CISPR 11
Group 1
The [EQUIPMENT or
SYSTEM] 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
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Not applicable
