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Introducer Set
ENGLISH
ECMRINTLOC
ECMRINTLOC7G
For use with
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MRI Breast Biopsy Probes
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
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Introducer Set consists of the following:
•
Trocar
•
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™ Obturator
•
Cannula
• Needle Guide Block
The Trocar,
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Obturator, and
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MRI Breast Biopsy Probe can be used
co-axially with the Cannula. When inserted in the Cannula, the tip of the
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Obturator approximates the center of the sample aperture of the
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MRI Breast
Biopsy Probe.
Reference markings on the Cannula indicate the distance to the center of the
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MRI Breast Biopsy Probe sample aperture. When the half-sample option is selected,
the tip of the
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Obturator will represent the proximal edge of the half-sample.
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clockwise rotation (if present).
Needle Guide Blocks:
•
The 10G Needle Guide Block has 4 holes which allow targeting from 13 positions,
based on rotation of the Needle Guide Block within the grid.
•
The 7G Needle Guide Block has 4 holes which allow targeting from 5 positions,
based on rotation of the Needle Guide Block within the grid.
•
The Needle Guide Block has a locking feature that helps to stabilize the Needle
Guide Block within the grid after installation.
The
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Introducer Set is also compatible with the Aurora™
1
Dedicated Breast
MRI System using the Aurora™ Needle Guide Insert (supplied separately).
The
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Introducer Set is compatible with pillar/post localization systems as well.
Indications for Use
The
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Introducer Set is indicated for use to penetrate the breast under image
guidance and provide a passageway through which a diagnostic biopsy of the breast
may be performed.
Contraindications
This device is not intended for use except as indicated.
Warnings
• This device is not recommended for use in patients with breast implants.
• Do not use in the presence of infection.
•
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, and/or
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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.
•
Do not resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or 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
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mechanical changes.
•
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.
•
Do not use if the product sterile barrier system or its packaging is compromised.
•
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.
•
Exercise caution in proximity to the magnet by maintaining control of the Trocar
and
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MRI Breast Biopsy Probe, which may accelerate in a strong
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•
Verify that the Cannula does not move when inserting or removing the Trocar/
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Obturator.
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
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MRI Breast 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:
• Appropriate imaging modality and accessories
• Appropriate biopsy probe and system
• Breast Tissue Markers (if applicable)
• Surgical gloves and drapes
• Local anesthetic
•
Scalpel
• Other equipment as necessary
How Supplied / Stored
This product is provided sterile and is intended for single use only. Do not resterilize.
Store at temperatures above 0° C (32° F).
Directions For Use
Refer to Figures 1, 2, 3, and 4.
Trocar (A)
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Obturator (F)
Cannula Stop (D)
Trocar Tip
Protector (E)
Cannula (B)
Needle Guide
Block (C)
Figure 1.
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Introducer Set
Use of the Introducer with a Grid Localization Method:
1. Inspect the package to ensure that the package integrity has not been
compromised. Do not use the product if the sterility has been compromised.
2. Using standard aseptic technique, remove the Trocar (A) from the package,
remove the Trocar Tip Protector (E), and inspect the Trocar (A) tip for signs
of damage.
3. Remove the Cannula (B) from the package. Insert the Trocar (A) into
the Cannula (B).
4. Identify the target lesion or site in the breast.
5. The Needle Guide Block (C) is used with grid localization systems. Insert the
Needle Guide Block (C) into the grid and lock by rotating the lever clockwise
approximately 90°. Refer to Figure 2.
6. Anesthetize the area and make a skin nick.
7. Using the 0.5cm depth reference markings, position the Cannula Stop (D) on the
Cannula (B) to the desired depth.
Note:
The leading (distal) edge of the depth stop indicates the desired depth.
8. Insert the Trocar (A) and Cannula (B) assembly through the targeted hole in the
Needle Guide Block (C) into the breast, advancing the Trocar (A) tip to the
target site.
Unlocked
Locked
10G
7G
Figure 2. Needle Guide Block
9.
Orient the small tab (located on the leading edge of the Cannula Stop (D)) toward
any adjacent hole of the Needle Guide Block (C) and rotate clockwise to stabilize
the Cannula (B) within the Needle Guide Block (C).
10. Support the Cannula (B) while replacing the Trocar (A) with the
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Obturator (F). Re-image the breast to verify placement of the
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Obturator
(F) tip at the target site. Modify position, if needed.
