BARD Biopsy EnCor Enspire Instrucciones De Uso página 3

E C E
Breast Biopsy System
ENGLISH
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 E Breast Biopsy System provides control operations for specialized biopsy
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instruments intended to acquire tissue samples of suspected breast abnormalities. The E
Breast Biopsy System is designed to recognize individual Biopsy Drivers, provide a user interface, and to
The E E Breast Biopsy System may be used with E
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E ® Foot Pedals, and E ® Probes. Reference Figures 1, 2 and 3. E
Figure 1 – E C Biopsy Probes
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Figure 3 – E C
Indications for Use
The ® 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.
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 E E ® 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 E C E ® 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 C
create potentially hazardous conditions.
4. Only use E C ® and E C ® MRI Drivers with script version 1.19 or greater with the E C
E Breast Biopsy System. The system is not compatible with earlier driver scripts.
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5. The E C E Breast Biopsy System console may not be placed in an MRI suite.
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Place the console outside of the MRI suite and use the appropriate E C
when performing a biopsy under MRI guidance.
Biopsy System housing. Removal of the housing may cause electrical shock.
7. The E C E ®
8. Do not use in the presence of infection.
9. 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
1. This device should only be used by physicians trained in percutaneous biopsy procedures.
if product damage is evident and/or needle is bent.
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and E MRI Drivers,
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® Biopsy Probes,
Figure 2 – E C ® Driver and Probe
Foot Pedal
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E
E Breast Biopsy System may
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MRI accessories
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C E Breast
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3. Locate the E E
equipment to minimize interference or degradation of performance of the
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.
proper vacuum levels are achieved and maintained during use.
7. Do not leave the E
damage may result.
9. Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at
increased risk of complications.
E
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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
sample notch orientation is correct for the image guidance being used.
13. Ensure that the E
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
Equipment Required
The following equipment is required for a biopsy procedure:
• E or E MRI Driver
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• E ® or E ® MRI Probe
• E E ®
• Surgical gloves and drapes
• Local anesthetic
• Scalpel
• Other equipment as necessary
Directions for Use
Unpacking Instructions
Thoroughly inspect the packaging materials and the E
Service for instructions on how to report shipping damage.
The E E ® Breast Biopsy System is delivered assembled with the exception of the touch
from the packaging. Unlock the release knob on the touch screen as illustrated in Figure 4
connecting track on the back of the display screen and slide into place on the arm of the main body as
illustrated in Figure 5
an illustration of proper communication and power cable installation locations.
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Figure 4 – Release knob on the touch screen
Figure 6 – Connecting the touch screen cables
Procedure Setup
Prior to transporting the system, unlock the system casters and lower the tray and monitor to their lowest
positioned as illustrated on the cover of this Instructions for Use. When transporting the system, push or
pull using the handles located on the front and back of the tray. Do not transport the system by pushing
or pulling sideways. To transport the system outside of normal hospital conditions (e.g. outdoors or to
1. Position the E E
casters as illustrated in Figure 7.
1
® Breast Biopsy System as far as possible from other electronic
E Breast Biopsy System powered on overnight. Damage may
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® and E ® MRI Probes, the orientation of the sample
E ® Breast Biopsy System is positioned in such a way that the Power
E E ® Vacuum and Rinse
E ® Breast Biopsy System for any
Figure 5 – Attaching the touch screen
to the main body
Breast Biopsy System as required for safe use and plug the Power
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Breast
Figure 6 for