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Instructions for Use
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
A.
General Information and Device Description:
The U
C
LIP ®
Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a
LTRA
metal implantable tissue marker with polyvinyl alcohol (PVA). The front and rear trigger buttons are color coded according to
the marker shape (e.g., Ice Blue = Ribbon, Yellow = Wing, Pink = Coil, Red = Heart, Violet = Venus). The introducer needle
has 1 cm reference marks and ultrasound enhancement on the distal end to aid in needle placement. The B
front trigger line up with the bevel of the needle to help with needle placement (See Figure 1).
5
The tissue marker, located inside the distal end of the introducer needle, is made of Titanium, Inconel
and contains a PVA polymer pellet interwoven with the marker to enhance viewing of the marker under ultrasound. Please
note this polymer is non-absorbable.
The metal and polymer marker may protrude from the needle and be visible as illustrated below.
Simulated use testing has demonstrated that when the metal and polymer marker protrude from the introducer needle, the
Product Code
863017D
863017DL
862017D
862017DL
864017D
864017DL
866017D
867017D
B.
How Supplied:
LIP ®
The U
C
Dual Trigger Breast Tissue Marker is supplied sterile and non-pyrogenic unless the package has been
LTRA
opened or damaged. Sterilized by using Ethylene Oxide. For single use only. Do not reuse. Do not resterilize.
C.
Indications for Use:
LIP ®
The U
C
LTRA
Dual Trigger breast tissue marker is intended for use to attach to soft breast tissue at the surgical site
during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy
procedure.
D.
Contraindications for Use:
None known.
E.
Warnings:
1.
Use caution when inserting near a breast implant to avoid puncture of the implant capsule.
2.
As with any foreign object implanted into the body, potential adverse reactions are possible. It is the
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, and/or crevices
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.
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
by thermal and/or mechanical changes.
Figure 1
1
2
1. 1 cm reference marks
2. Ultrasound enhancement
3. Front trigger
4. Rear trigger
5. Tissue marker
Gauge x Length
Marker Material
17g x 10cm
Titanium with PVA
17g x 12cm
Titanium with PVA
17g x 10cm
Inconel
17g x 12cm
Inconel
17g x 10cm
BioDur
17g x 12cm
BioDur
17g x 10cm
Titanium with PVA
17g x 10cm
BioDur
3
Ribbon
Ribbon
™
625 with PVA
Wing
™
625 with PVA
Wing
™
108
Coil
with PVA
™
108
Coil
with PVA
Heart
™
108
Venus
with PVA
1
ARD ®
logo and
4
™
™
625 or BioDur
Marker Shape
108
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