Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 4
1.
General Safety Statements
WARNING The
neXus Ultrasonic Surgical Aspirator System is
an electro-mechanical device, which under certain
circumstances could present an electrical shock hazard to the operator and/or patient. Please read manual
thoroughly and follow directions stated herein to assure maximum safety during operation. This manual
shall be kept in close proximity to the system for easy referral when needed.
WARNING The
neXus Ultrasonic Surgical Aspirator System is
intended to be used in various types of invasive, surgical
procedures. There may be indirect danger to the patient should the device fail during the procedure. It is
recommended that the facility follows its back-up equipment protocols.
CAUTION Special Skills Training Requirements
1.
U.S. federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
2.
The neXus system is to be used by an appropriately trained and licensed healthcare practitioner.
3.
Prior to using the neXus system, all healthcare practitioners are to be trained in the institution’s
procedures for blood borne pathogen (BBP) universal precautions, including the use of appropriate
personal protection equipment (PPE).
1.1.
EMC Statement
The
neXus Ultrasonic Surgical Aspirator System is
designed and tested to comply with FCC regulations for conducted and
radiated emissions under 47 Part 18 Subchapter J and to comply with IEC60601-1-2: 2014 for emissions and immunity.
CAUTION This device is considered medical electrical equipment. Medical electrical equipment needs special
precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service
according to the EMC information provided in this operator’s manual.
WARNING Portable and mobile RF communication equipment (including peripherals such as antennas) should be no
closer than 30 cm (12 inches) to any part of the neXus, including the cables supplied with the neXus
Otherwise degradation of the performance of this equipment could result.
WARNING The use of accessories, handpieces and cables other than those specified or provided by Misonix may result
in increased electromagnetic emissions
or decreased immunity of the device and may result in improper
operation. Use only Misonix branded equipment and accessories.
WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
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