Hologic eviva Mode D'emploi page 8

• As with any medical procedure, please ensure that users wear appropriate personal
protective equipment to guard against potential contact with bodily fluids.
• The Eviva device is not recommended for use with MRI and ultrasound.
• The Eviva device biopsy procedure should be performed only by persons having
adequate training and familiarity with this procedure. Consult medical literature
relative to techniques, complications and hazards prior to performance of any
minimally invasive procedure.
• The Eviva device should be used only by physicians trained in percutaneous biopsy
procedures. The Eviva breast biopsy device is not recommended for use with MRI.
• Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician.
• Sound professional judgment should be used when the Eviva device is used on
patients with breast implants.
• Avoid operator or instrument contact with the sheathed needle portion of the Eviva
device.
• Minimally invasive instruments and accessories manufactured or distributed by
companies not authorized by Hologic, Inc. may not be compatible with the Eviva
device. Use of such products may lead to unanticipated results and possible injury to
the user or patient.
• Instruments or devices which come into contact with bodily fluids may require special
disposal handling to prevent biological contamination.
• Dispose of all opened instruments whether used or unused.
• Do not resterilize and/or reuse the Eviva device and/or introducer. Resterilization and/
or reuse may compromise the integrity of the instrument. This may lead to potential
risks of failure of the device to perform as intended and/or cross-contamination
associated with using inadequately cleaned and sterilized devices.
• A complete and comprehensive preoperative medical history and physical
examination are suggested. Radiographic evaluation and laboratory tests may be
included.
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