4
•
Do not use this instrument in conjunction with Magnetic Resonance Imaging
(MRI).
•
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, EMC issues
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.
•
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 of contamination and/or cause patient
infection or cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of the device
may lead to injury, illness, or death of the patient.
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.
•
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.
•
The Holster must only be used with Mammotome elite Biopsy Probes.
•
Dispose of all opened disposable instruments whether used or unused.
•
If the patient-contacting components of the sterile Probe (i.e., the needle
aperture, trocar shaft, or integrated coaxial cannula) should come in contact with
a non-sterile surface, the Probe shall be disposed of in an appropriate container.
