Bard EnCor Gebrauchsanweisung

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E C Introducer Set
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ENGLISH
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for use with E C MRI Probes
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Contains Trocar, Cannula, V L
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INSTRUCTIONS FOR USE
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
CANNULA STOP (D)
CANNULA (B)
TROCAR TIP
PROTECTOR (E)
NEEDLE GUIDE
BLOCK (C)
Figure 1 – Introducer Set
DESCRIPTION
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The E C Introducer Set consists of a:
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• Trocar
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• V L Obturator
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• Cannula
• Needle Guide Block
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The Trocar, V L Obturator, and E
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axially with the Cannula. When inserted in the cannula, the tip of the Obturator
approximates the center of the sample aperture of the E
Markings on the Cannula indicate the distance to the center of the E
probe sample aperture.
When the half-sample option is selected, the tip of the V
represent the proximal edge of the half-sample.
The Cannula fits through the Needle Guide Block and is locked into place with a
clockwise rotation (if present).
The Guide Blocks:
• 10 Ga block - has 4 holes which allow targeting from 13 positions, based on
rotation of the Block within the Grid.
• 7 Ga block - has 4 holes which allow targeting from 5 positions, based on
rotation of the block within the grid.
• The Block has a locking feature that helps to stabilize the Block within the
Grid after installation.
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The s r Introducer Set is also compatible with the Aurora
Eno x
Breast MRI System using the Aurora Needle Guide Insert (supplied separately).
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The s r Introducer Set is compatible with pillar/post localization systems
Eno x
as well.
INTENDED USE
The 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.
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Obturator and Needle Guide Block
TROCAR (A)
OBTURATOR (F)
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C MRI Probes can be used co-
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®
C MRI Probe.
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L obturator will
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Dedicated
WARNINGS
• The Introducer Set is not recommended for use in patients with breast
implants.
• Do not use in the presence of infection.
PRECAUTIONS
• The Introducer Set should only be used by physicians trained
in percutaneous breast biopsy procedures.
• Do not use this product if the sterile barrier has been previously opened or
if the package is damaged.
• Do not resterilize.
• Do not use if Trocar is bent and/or tip is damaged.
• Exercise caution in proximity to the magnet by maintaining control of the
Trocar and Biopsy Probe, which may accelerate in a strong magnetic field.
• Verify that the Cannula does not move when inserting or removing the
trocar/V L
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COMPLICATIONS
Complications that may be associated with the use of the Introducer Set are the
same as those associated with the use of other localization devices. These may
include injury to the skin, blood vessels, muscles, organs, bleeding, hematoma
and infection.
HOW SUPPLIED
The Introducer Set is provided sterile, and is intended for single use only.
DIRECTIONS FOR USE (Refer To Figure 1)
Use of the Introducer with a grid localization method
1. Inspect the package to insure that the package integrity has not been
compromised.
2. Using standard aseptic technique, remove Trocar (A) from the package,
remove the tip protector (E), and inspect the Trocar tip for signs of damage.
3. Remove the Cannula (B) from the package. Insert the Trocar into
the Cannula.
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° (Figure 2).
6. Anesthetize the area and make a skin nick.
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C MRI
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7. Using the 0.5 cm depth markings, position the Cannula Stop (D) on the
Cannula to the desired depth. Note: the leading (distal) edge of the depth
stop indicates the desired depth. Insert the Trocar and Cannula assembly
through the targeted hole in the Block into the breast, advancing the Trocar
tip to the target site.
10 Ga
7 Ga
8. Orient the small tab (located on the leading edge of the cannula stop)
toward any adjacent hole of the block and rotate clockwise to stabilize the
cannula within the block.
9. Support the cannula while replacing the Trocar with the V
(F). Re-image the breast to verify placement of the V
the target site. Modify position, if needed.
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Obturator.
UNLOCKED
Figure 2 – Needle Guide Block
LOCKED
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L Obturator
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L Obturator tip at
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