Warnings And Precautions - Devicor Mammotome elite Manual Del Usuario

Warnings and Precautions

• Minimally invasive procedures should be performed only by persons having adequate training and familiarity with
minimally invasive techniques. Consult medical literature relative to techniques, complications, and hazards prior to
performance of any minimally invasive procedure.
• Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When minimally invasive
instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility
prior to initiation of the procedure.
• Do not autoclave device.
• Do not submerse device.
• Do not spray the Holster with any fluids.
• This instrument should only be used by physicians trained in percutaneous needle techniques for tissue collection.
• Special care should be taken to avoid bending or twisting the Probe.
• If Probe is bent, do not use. Dispose of the Probe in an appropriate container.
• The Probe is not designed for percutaneous skin puncture.
• As with any biopsy instrument, there may be a potential for infection.
• Do not use this instrument in conjunction with Magnetic Resonance Imaging (MRI).
• The Holster must only be used with Mammotome® elite Biopsy Probes.
• Products manufactured or distributed by companies not authorized by Devicor® Medical Products, Inc. may not be
compatible with the Mammotome® elite System. 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 disposable instruments whether used or unused.
• The Probe is packaged and sterilized for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing,
or resterilization may compromise the structural integrity of the device and/or lead to device failure that in turn may
result in patient injury, illness or death. Also, reprocessing or resterilization of single use devices may create a risk
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