Warnings And Precautions; How Supplied - Hologic Atec Gebrauchsanweisung

9. Ensure the ATEC handpiece is advanced until handpiece hub is contacting the hub of the
introducer sheath. Then, follow the instructions for handpiece use in the ATEC console Operator's
Manual to perform the biopsy.
10. Once the biopsy is completed, remove the ATEC handpiece while leaving the introducer sheath in
place. Re-image the patient to confirm acquisition of the suspect target area.
11. If desired, place a biopsy site marker. Follow the instructions for use.
12. Take a final image of the target area to confirm marker location. Remove Introducer Sheath and
Needle Guide and dispose per standard procedures.

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.
• 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.

How Supplied

The ATEC ILS is sterilized by radiation and supplied packaged for single use. Discard into an
appropriate container after use.
As Identified on Labels:
Number of Devices Enclosed.
YYYY-MM-DD Expiration date is represented by the following:
YYYY represents the year
MM represents the month
DD represents the day
Product Complaints and Technical Support
Report any complaints or problems in the quality, reliability, safety, or performance of this product
to Hologic. If the device has caused or added to patient injury, immediately report the incident to
Hologic Authorized Representative and Competent authority of the respective member state or country.
The Competent Authorities, for medical devices, are usually the individual Member States' Ministry of
Health, or an agency within the Ministry of Health.
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