Warnings And Precautions - Hologic ATEC Bedienungsanleitung

Warnings and Precautions

• The ATEC ultrasound introducer is for diagnostic use only and is NOT indicated for
therapeutic use.
• The ATEC ultrasound introducer is NOT intended to be used outside the standards,
specifications, and limitations as outlined in this IFU and other related materials.
• The ATEC ultrasound introducer is not recommended for use with MRI.
• As with any medical procedure, please ensure that users wear appropriate personal
protective equipment to guard against potential contact with body fluids.
• Observe caution while handling sharp components.
• Breast biopsies using the ATEC ultrasound introducer 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.
• This device should be used only by physicians trained in percutaneous biopsy
procedures.
• Sound professional judgment should be used when the ATEC ultrasound introducer is
used on patients with breast implants.
• Avoid operator or instrument contact with the needle portion of the ATEC ultrasound
introducer.
• Minimally invasive instruments and accessories manufactured or distributed by
companies not authorized by Hologic, Inc. may not be compatible with the introducer
set. Use of such products may lead to unanticipated results and possible injury to the
user or patient.
• Dispose of all opened instruments whether used or unused.
• Do not resterilize the ATEC ultrasound introducer. Re-sterilization and/or reuse may
compromise the integrity of the instruments. This may lead to potential failure of
the device to perform as intended and/or cross-contamination associated with using
inadequately cleaned or sterilized devices.
• Instruments or devices which come into contact with bodily fluids may require special
disposal handling to prevent biological contamination.
• Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician.
English 4