Contraindications - Bard Biopsy DS4001 Mode D'emploi

Vacuum and Rinse Tubing Cassette/
Vacuum Tubing Cassette
DS4001
DS4002
INSTRUCTIONS FOR USE
CAUTION: Federal (U.S.A.) law restricts this device to
sale by or on the order of a physician.
Device Description
Table 1. Product Information
Product Code Description
E
DS4001
Cassette Assembly
DS4002 E
The E C E Vacuum and Rinse Tubing Cassette
®
N OR NSPIRE
provides vacuum and the option for a saline rinse to be
delivered to the sample trap of an E
Probe during a biopsy procedure.
The E C E ® Vacuum Tubing Cassette provides
N OR NSPIRE
vacuum to an E C ® Breast Biopsy Probe during a
N OR
biopsy procedure.
Indications For Use
The E C E ® Breast Biopsy System is indicated to
N OR NSPIRE
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.
In instances when a patient presents with a palpable
lesion), the E C E
N OR NSPIRE
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 E C E Breast Biopsy System is
®
N OR NSPIRE
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. Do not resterilize. After resterilization, the sterility
of the product is not guaranteed because of an
indeterminable degree of potential microbial
contamination which may lead to infectious
complications. Cleaning, reprocessing and/or
resterilization of the present medical device increases
the probability that the device will malfunction due
to potential adverse effects on components that are
2. After use, this product may be a potential biohazard.
medical practice and applicable local, state, and
federal laws and regulations.
C E Vacuum and Rinse Tubing
®
N OR NSPIRE
C E Vacuum Tubing Cassette
®
N OR NSPIRE
C ® Breast Biopsy
N OR
® Breast Biopsy System may also
3. This device has been designed for single use
only. Reusing this medical device bears the risk of
cross-patient contamination as medical devices –
particularly those with long and small lumina, joints,
with potential pyrogenic or microbial contamination
have had contact with the medical device for an
indeterminable period of time. The residue of
biological material can promote the contamination of
the device with pyrogens or microorganisms which
may lead to infectious complications.
4. Use of accessories not compatible with the E
E ® Breast Biopsy System may create potentially
NSPIRE
hazardous conditions.
Precautions
1. Carefully inspect the device prior to use to verify that
device has not been damaged. Do not use if product
damage is evident.
2. Do not use if the product sterile barrier system or its
packaging is compromised.
3. Inspect tubing connections to the Vacuum Canister and the
Vacuum or Vacuum and Rinse Tubing Cassette to ensure
proper vacuum levels are achieved and maintained
during use.
4. 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.
5. This device should only be used by a physician trained in
percutaneous biopsy procedures.
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 adhering to the
stylet or coaxial while removing it from the breast).
Equipment Required
The following equipment is required for a biopsy procedure:
• E C E Breast Biopsy System
®
N OR NSPIRE
• E C ® Breast Biopsy Probe
N OR
• E C ® Breast Biopsy Driver
N OR
• Vacuum Canister
• Saline (when using optional saline rinse feature)
• Surgical gloves and drapes
• Local anesthetic
• Scalpel
• Other equipment as necessary
This product is provided sterile and is intended for single use
only. Do not resterilize.
Directions For Use
Refer to Figures 1, 2, 3, 4, and 5.
1. Open the doors on the E
System console.
2. Install Vacuum Canister in the Console. Ensure correct
onto the Vacuum Canister. Securely attach the Center Port
to the Vacuum Tubing. Verify all unused lid port caps are
Figure 1. Install the Vacuum Canister
1
N
C E Breast Biopsy
®
N OR NSPIRE
C
OR