Warnings And Precautions - Hologic ATEC Bedienungsanleitung

Warnings and Precautions

• Care should be taken when removing sharp objects from the patient, in order to
prevent needle stick injury.
• The ATEC introducer stylet is not recommended for use within the bore of an MRI
magnet.
• Breast biopsies using the ATEC ILS 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 open or percutaneous
biopsy procedures.
• Caution: Federal (USA) law restricts this device to sale by or on the
order of a physician.
• Minimally invasive instruments and accessories manufactured or distributed by
companies not authorized by Hologic, Inc. may not be compatible with the ATEC
ILS. 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 ATEC ILS. Resterilization and/or reuse may
compromise the integrity of the instruments. 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.
• The introducer sheath and connecting tubing of this device contain di-(2-
ethylhexyl) phthalate; DEHP. In accordance with European Commision Directive
67/548/EEC, it is noted here that DEHP may impair fertility; it also may cause
harm to the unborn child. This device is not contraindicated for use in nursing or
pregnant women or children, however residual risks may exist from use of DEHP in
these populations. Sound medical judgment should be used.
• Sound professional judgement should be used when performing biopsies on
patients with implants.
• The ATEC ILS has been tested up to 3 Tesla for acceptability of artifact and
magnetic draw safety. Use of the ATEC ILS in magnets beyond this strength is not
recommended.
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