Hologic ATEC Mode D'emploi page 4

Instructions for Use
Refer to the "ATEC Breast Biopsy and Excision System Operator's Manual" for console
and handpiece instructions for use.
Warnings and Precautions
• Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician.
• The 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 ATEC breast biopsy device should be used only by physicians trained in
percutaneous biopsy procedures.
• Sound professional judgment should be used when the ATEC breast biopsy device is
used on patients with breast implants.
• A complete and comprehensive preoperative medical history and physical
examination are suggested. Radiographic evaluation and laboratory tests may be
included.
• The MRI ATEC breast biopsy device is intended for use only with an ATEC MRI
compatible console and footswitch.
• Prior to use of the ATEC breast biopsy device, inspect the protective packaging and
device to verify that neither has been damaged during shipment. If it appears that the
packaging has been compromised, do not use the device.
• As with any medical procedure, please ensure that users wear appropriate personal
protective equipment to guard against potential contact with bodily fluids.
• Avoid operator or instrument contact with the sheathed needle portion of the ATEC
breast biopsy device.
• Minimally invasive instruments and accessories manufactured or distributed by
companies not authorized by Hologic, Inc. may not be compatible with the ATEC
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.
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