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English
I N S T R U C T I O N S F O R U S E
DEVICE DESCRIPTION
The Achieve Programmable Automatic Biopsy System is
a spring loaded, core needle biopsy system with delay or
automatic firing options. The automatic firing mode releases
the cannula and stylet in rapid sequence and captures a
tissue sample with the push of a button. The delay firing
method is used to verify the position of the sample notch
in the target area prior to depressing the A button, which
activates the cutting cannula, capturing the tissue sample.
Notched
Stylet
Cutting Cannula
Firing Buttons
Charging
Handle
Figure 1:
Achieve Programmable Automatic Biopsy System
INTENDED USE
Intended for use in obtaining core biopsy samples from soft
tissue such as breast, kidney, liver, prostate, spleen, lymph
nodes, and various soft tissue masses. Not intended for use
in bone.
The Pink Achieve Programmable Automatic Biopsy System is
also indicated to provide breast tissue samples for diagnostic
sampling of breast abnormalities. It is designed to provide
breast tissue for histologic examination with partial or
complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably
determined from its mammographic appearance. Therefore,
the extent of removal of the imaged evidence of an
abnormality does not predict the extent of removal of a
histologic abnormality (e.g., malignancy). When the sampled
abnormality is not histologically benign, it is essential that
the tissue margins be examined for completeness of removal
using standard surgical procedures.
WARNING:
Test firing the needle may damage the cutting
cannula and/or stylet tip and is not recommended. If test
firing is performed, the cutting cannula may be protected
by holding the cannula near the clear taper with moderate
pressure between the thumb and fingers during firing. Keep
fingers or other objects from in front of the needle as it will
advance 2.5 cm very rapidly when activated. Never test fire
the instrument in an unsafe direction.
In the automatic mode, the Achieve automatic biopsy device
is designed to fire the cannula and stylet in rapid succession.
Please exercise caution before proceeding as the device will
advance 2.5 cm when activated.
Ensure the device is fully discharged before disposing of the
device.
Only clinicians, who have been properly trained in
this procedure, including patient preparation, sample
preservation and the use of image guidance for percutaneous
biopsy, should use this device.
Good medical judgment should be exercised in considering
biopsy on patients who are receiving anticoagulant therapy
or who have bleeding disorders.
Post-biopsy care may vary with the biopsy technique
utilized and the individual patient’s physiological condition.
Observation of vital signs and other precautions should be
taken to avoid and/or treat potential complications that may
be associated with biopsy procedures.
