EMI/EMC Statement and Manufacturer’s Declaration
This equipment has been tested and found to comply with the limits of EN 60601-1-2.
These limits are designed to provide reasonable protection against harmful interference in both a
medical and residential environment. This equipment generates, uses and can radiate radio frequency
energy and, if not used in accordance with manufacturer’s instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception or other
equipment, which can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one of the following measures:
l
Reorient or relocate the receiving antenna.
l
Increase the separation between the equipment.
l
Connect the equipment to an outlet on a circuit different from that to which the receiver or equipment
was connected.
The equipment having been tested to operate within the limits of electromagnetic compatibility.
(Immunity to interference from nearby sources radiating radio frequency energy). Sources exceeding
these limits may give rise to operation faults. Where possible the system will sense the interference and
if it is of short duration transparently take countermeasures whilst operating near normally, or failing
this will issue a warning and take measures for the continued safely of the user. Further increased levels
of energy may cause the system to stop operating, continuously generate random faults or continuous
resets.
Try to ascertain the source of the interference by turning nearby or suspect equipment off, and see if the
interference effects stop. In any such event the user is encouraged to try to correct the interference by
one of the following measures:
l
Have the interfering equipment repaired or replaced.
l
Reorient or relocate the interfering equipment.
l
Increase the separation between the equipment and the possible source of the interference.
l
Connect the equipment to an outlet on a circuit different from that to which the interfering equipment
was connected.
Information regarding Electro Magnetic Compatibility (EMC) according to IEC60601-1-2
With the increased number of electronic devices such as PC’s and mobile telephones, medical devices
in use may be susceptible to electromagnetic interference from other devices. The EMC (Electro
Magnetic Compatibility) standard IEC60601-1-2 defines the levels of immunity to these electromagnetic
interferences. From the other hand, medical devices must not interfere with other devices. IEC60601-
1-2 also defines the maximum levels of emissions for these medical devices. The ATTIVO
™
conforms to
this IEC60601-1-2 standard for immunity and emission. Nevertheless, special precautions need to be
observed:
l
The ATTIVO
™
needs to be installed and put into service according to the EMC information below.
l
The ATTIVO
™
is intended for use in the electromagnetic environment specified in the tables below.
The user of the ATTIVO
™
should assure that it is used in such environment.
l
In general, although the ATTIVO
™
complies too the EMC standards, it can be affected by portable and
mobile RF communications equipment (such as mobile telephones).
l
The ATTIVO
™
should not be used adjacent to or stacked with other equipment. In case adjacent or
stacked use is necessary, the ATTIVO
™
should be observed to verify normal operation.
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions (IEC 60601-1-2)
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Class B
The
ATTIVO
™
systems are suitable for use in all establishments,
including domestic establishments and those directly connected to
the public low-voltage pump supply network that supplies buildings
used for domestic purposes.
Harmonics emissions 61000-3-2
Class A
Voltage fluctuations / flicker emissions 61000-3-3
Complies
10
