19
Rev
：A1
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 regulat e 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
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.
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
