SAVI Dual™ Migraine Therapy Instructions for Use 23
EMC Compliance and Warning Statement
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1)
This device may not cause harmful interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
IEC 60601-1-2: 2014
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to
part 15 of the FCC Rules and with the limits of the standard for medical devices, IEC 60601-1-2, suitable for use
in all environments including domestic. The unit also complies with the requirements of EN 60601-1-2,
providing the presumption of compliance to the European Union’s Medical Device Directive2007/42/EC. The
limits are designed to provide reasonable protection against harmful interference in a typical medical
installation. This equipment generates, uses, and can radiate radio-frequency energy, (such as wireless home
networks, mobile phones, cordless telephones and their base stations, and walkie-talkies), and, if not installed
and used in accordance with the manufacturer’s instructions, may cause harmful interference to other devices
in the vicinity.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result
in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the SAVI Dual, including cables specified by the
manufacturer.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Avoid exposure to known sources of EMI (electromagnetic interference) such as diathermy, lithotripsy, electrocautery,
RFID (Radio Frequency Identification), and electromagnetic security systems such as anti-theft/electronic article
surveillance systems, metal detectors. Note that the presence of RFID devices may not be obvious. If such interference
is suspected, reposition the equipment if possible, to maximize distances.
Otherwise, degradation of the performance of this equipment could result. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment causes interference with other
devices, which may be determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
• Reorient or relocate the device receiving the interference.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.
• Consult the manufacturer or field service technician for help.
EMC Guidance
If other equipment interferes with normal SAVI Dual operation, which may be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the SAVI Dual device away from the equipment.
• Increase the separation between the SAVI Dual and the equipment.
• Connect the equipment into an outlet on a circuit different from that to which the
SAVI Dual is connected.
• Consult eNeura Customer Service for assistance.
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