Bard EnCor Enspire

Date of Manufacture is 5/8/2020

INDICATIONS FOR USE
The EnCor Enspire™ 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.

In instances when a patient presents with a palpable abnormality
that has been classified as benign through clinical and/or radiological criteria
(e.g. fibroadenoma, fibrocystic lesion), the EnCor Enspire™ 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
This device is not intended for use except as indicated.
The EnCor Enspire™ 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
The EnCor Enspire™ 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.
To minimize interference with other equipment, cables should be positioned
in such a manner to prevent contact with other cables.
Use of accessories not compatible with the EnCor Enspire™ Breast Biopsy System
may create potentially hazardous conditions.
Only use EnCor™ and EnCor™ MRI Drivers with script version 1.19 or greater
with the EnCor Enspire™ Breast Biopsy System.
The system is not compatible with earlier driver scripts.
The script version is identified on the touch screen display during system initialization.
EnCor Enspire™ Breast Biopsy System console may not be placed in an MRI suite.
Place the console outside of the MRI suite and use
the appropriate EnCor™ MRI accessories when performing a biopsy under MRI guidance.
No modification of this equipment is allowed. Do not remove the EnCor Enspire™
Breast Biopsy System housing. Removal of the housing may cause electrical shock.
The EnCor Enspire™ Breast Biopsy System is not classified as an AP or APG classified device. The system is not suitable for use in the presence flammable anesthetic.
Do not use in the presence of infection.
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.

PRECAUTIONS
This device should only be used by physicians trained in percutaneous biopsy procedures.
Carefully inspect the device prior to use to verify that the device has
not been damaged. Do not use if product damage is evident and/or needle is bent.
Locate the EnCor Enspire™ Breast Biopsy System as far as possible
from other electronic equipment to minimize interference or degradation
of performance of the EnCor Enspire™ Breast Biopsy System.
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.
Inspect tubing connection to the Vacuum Canister and the Vacuum Tubing Cassette
to ensure proper vacuum levels are achieved and maintained during use.
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.
Do not leave the EnCor Enspire™ Breast Biopsy System powered on overnight.
Damage may occur to the Vacuum or the Vacuum and Rinse Tubing Cassette.
Connect the Power Cord to a hospital grade wall outlet having the correct voltage
or product damage may result.
Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at increased risk of complications.
As with any biopsy instrument, there is a potential for infection.
All breast biopsies should be performed under imaging guidance to confirm that Probe position relative to the target region to be sampled and to help mitigate the occurrence of a false negative biopsy.
When performing a biopsy with the EnCor™ and EnCor™ MRI Probes,
the orientation of the sample notch is dictated by the image guidance selected.
Prior to initiating the procedure, confirm that the sample notch orientation is correct
for the image guidance being used.
Ensure that the EnCor Enspire™ 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.