Warnings And Precautions - Hologic celero Gebrauchsanleitung

Warnings and Precautions

• The Celero breast biopsy device is not recommended for use with MRI.
• The Celero breast biopsy procedure should be performed only by persons having ad-
equate training and familiarity with this procedure. Consult medical literature relative to
techniques, complications, and hazards prior to performance of any minimally invasive
procedure.
• The Celero breast biopsy device should be used only by physicians trained in percuta-
neous biopsy procedures.
• 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 Celero breast biopsy device is
used on patients with breast implants
• Avoid operator or instrument contact with the needle portion of the Celero.
• The Celero breast biopsy device should not be tested by "dry" firing the cutting can-
nula. Damage to the device may occur, dulling the cutting edge.
• In the event of changes in the performance of the device, please dispose of the
device and resume the procedure with a new device.
• Minimally invasive instruments and accessories manufactured or distributed by
companies not authorized by Hologic, Inc. may not be compatible with the Celero breast
biopsy 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 Celero breast biopsy device. 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.
• Potential complications are associated with any percutaneous removal/biopsy tech-
nique for tissue collection. Potential complications are limited to the region surrounding
the biopsy site and include hematoma, hemorrhage, infection, pain and tissue adher-
ence to the biopsy probe while removing it from the breast.