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Breast Biopsy System
INSTRUCTIONS FOR USE
CAUTION: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
Device Description
The E
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Breast Biopsy System provides control operations for specialized biopsy
instruments intended to acquire tissue samples of suspected breast abnormalities.
The
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Breast Biopsy System may be used with the
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Breast Biopsy Driver,
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Foot Pedal, and
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Breast Biopsy Probes. Reference
Figures 1, 2 and 3
.
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Breast Biopsy Probes and
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Vacuum Tubing and Canisters are available separately.
Figure 3 – E
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Foot Pedal
Indications For Use
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Breast Biopsy System is indicated to provide breast tissue samples for
diagnostic sampling of breast abnormalities.
• It is intended to provide breast tissue for histologic examination with partial or complete
removal of the imaged abnormality.
• It is intended to provide breast tissue for histologic examination with partial removal of a
palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or
imaged appearance. Therefore, the extent of removal of the palpated or 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.
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Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever
breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.
Contraindications
1.
This device is not intended for use except as indicated.
2. The
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Breast Biopsy System is contraindicated for those patients where,
in the physician’s judgment, there is an increased risk of complications associated with
percutaneous removal of tissue samples.
Warnings
1. The
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Breast Biopsy System must be properly grounded to ensure patient
safety. The system is supplied with a medical grade Power Cord with AC plug. Do
not connect the included Power Cord to extension cords or three-prong to two-prong
adapters. To avoid the risk of electric shock, this equipment must only be connected
to supply mains with protective earth.
2.
To minimize interference with other equipment, cables should be positioned in such a
manner to prevent contact with other cables.
3.
Use of accessories not compatible with the E
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Breast Biopsy System may
create potentially hazardous conditions.
4. Only
use
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Breast Biopsy Drivers with script version 1.23 or greater, with the
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Breast Biopsy System. The system is not compatible with earlier driver
scripts.
5. The
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Breast Biopsy System console may not be placed in an MRI suite.
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Breast
Biopsy System housing. Removal of the housing may cause electrical shock. Contact
Bard for service.
7. The
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8.
After use, this product may be a potential biohazard. Handle and dispose of in
accordance with acceptable medical practice and applicable local, state, and federal
laws and regulations.
9.
Do not use in the presence of infection.
Precautions
1.
This device should only be used by physicians trained in percutaneous biopsy procedures.
2.
Carefully inspect the device prior to use to verify that device has not been damaged. Do not
use if product damage is evident and/or needle is bent.
3.
Locate the E
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Breast Biopsy System as far as possible (no closer than 30 cm or
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of performance of the
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Breast Biopsy System.
4.
Inspect accessories and cords for breaks, cracks, nicks, or other damage before every use.
If damaged, do not use. Failure to observe this precaution may result in injury or electrical
shock to the patient or to the operator.
5.
Inspect tubing connections to the Vacuum Canister and the Vacuum Tubing to ensure proper
vacuum levels are achieved and maintained during use.
6.
Inspect the Vacuum Canister to ensure the lid is secure and that no damage has occurred
during shipping or installation. A heavily scratched canister can break during use.
7.
Do not leave the E
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Breast Biopsy System powered on overnight. Damage may
occur to the Vacuum Tubing.
8.
Connect the Power Cord to a hospital grade wall outlet having the correct voltage or product
damage may result.
9.
Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may
be at increased risk of complications.
10.
As with any biopsy instrument, there is a potential for infection.
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position relative to the target region to be sampled and to help mitigate the occurrence of a
false negative biopsy.
12.
When performing a biopsy with E
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Breast Biopsy Probes, the orientation of the sample
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that the sample notch orientation is correct for the image guidance being used.
13.
Ensure that the E
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Breast Biopsy System is positioned in such a way that the
Power Cord and retainer are accessible. In the event that the system Power Switch is
inoperable, release retainer and remove cord to shut off system power.
Potential Complications
Potential complications may include, but are not limited to hematoma, hemorrhage, infection,
adjacent tissue injury, pain, allergic reaction, and tissue adherence to the biopsy probe during
removal from the breast (as per routine biopsy procedures, it may be necessary to cut tissue
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Equipment Required
The following equipment is required for a biopsy procedure:
• Appropriate imaging modality and accessories
•
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Breast Biopsy Driver
• E
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Breast Biopsy Probe
• E
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Vacuum Tubing and Canister
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• Surgical gloves and drapes
• Local anesthetic
• Scalpel
• Other equipment as necessary
Directions For Use
Unpacking Instructions
Carefully remove the
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Breast Biopsy System from the packaging. Thoroughly inspect
the packaging materials and the system for any signs of transit damage. Do not use the unit if it
appears to have any damage. Contact Bard Customer Service for instructions on how to report
shipping damage.
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Figure 4 –
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System
with Handle
Figure 5 –
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System
with Optional Tray
Figure 1 – E
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Breast Biopsy Probes
Figure 2 – E
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Breast Biopsy Driver
and E
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Breast Biopsy Probe
