8.5 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:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment.
• 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:
• Have the interfering equipment repaired or replaced.
• Reorient or relocate the interfering equipment.
• Increase the separation between the equipment and the possible source of the interference.
• 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 PCs 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. On 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
VENTURI
conforms to this IEC60601-1-2 standard for immunity and emission. Nevertheless,
special precautions need to be observed:
• The
VENTURI
needs to be installed and put into service according to the EMC information below.
• The
VENTURI
is intended for use in the electromagnetic environment specified in the tables below. The user of
the
VENTURI
should assure that it is used in such environment.
• In general, although the
VENTURI
complies to the EMC standards, it can be affected by portable and mobile RF
communications equipment (such as mobile telephones).
• The
VENTURI
should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use
is necessary, the
VENTURI
should be observed to verify normal operation.
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