BARD Biopsy STARCHMARK ULTRACOR STMK14GSS Gebrauchsanweisungen

®
S M U
Breast Tissue Marker
ENGLISH
INSTRUCTIONS FOR USE
CAUTION: Federal (USA) law restricts this device to sale by or on the order
of a physician.
Device Description
The S M U C
® ®
TARCH ARK LTRA OR
applicator containing 4 resorbable polysaccharide (starch) pellets, and
1 polyethylene glycol pellet with an embedded 316L stainless steel "V" shaped
radiopaque wireform. The wireform is intended for long-term radiographic
to help in the control and management of bleeding. The pellets are essentially
resorbed in approximately 2 weeks.
Table 1. Product Information
Product Code Gauge x Length
STMK14GSS 14G x 13 cm
The syringe like applicator is intended to be used with various introducers listed
in Figure 2.
Indications For Use
The S M ® U C ® Breast Tissue Marker is intended to radiographically
TARCH ARK LTRA OR
mark breast tissue during a percutaneous breast biopsy procedure.
Contraindications
Do not use this device in patients with a known hypersensitivity to the materials
listed in the device description as they may suffer an allergic reaction to this implant.
Warnings
• This device is not recommended for use in patients with breast implants.
• Avoid the use of excessive force during removal of the Applicator to
prevent breakage of the Applicator tip.
• 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.
• Patients with a known hypersensitivity to the materials listed in the
device description may suffer an allergic reaction to this implant.
• 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,
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.
• 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
and/or mechanical changes.
Precautions
• This device should only be used by physicians trained in percutaneous
biopsy procedures.
• Do not use if Temperature Indicator is black.
• 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.
• Published studies with comparably sized 316L stainless steel biopsy markers
• Although polysaccharide (starch) has known hemostatic properties, the
user should continue to employ standard methods for obtaining hemostasis
following the biopsy procedure.
®
C
Breast Tissue Marker is a sterile, disposable
Wireform Material Wireform Shape
316L Stainless Steel
Potential Complications
Potential complications may include, but are not limited to hematoma, hemorrhage,
infection, adjacent tissue injury, pain, allergic reaction, and migration.
How Supplied / Stored
• This product is provided sterile and is intended for single use only.
Do not resterilize.
• Store at temperatures below 25°C (77°F). Do not use if Temperature
Indicator is black.
Equipment Required
The following equipment is required to place the breast tissue marker:
• Appropriate imaging modality and accessories
• Surgical gloves and drapes
• Local anesthetic
• Other equipment as necessary
Directions For Use
Refer to Figures 1, 2, 3, 4 and 5.
Applicator (B)
Needle (C)
Tip Protector (D)
Figure 1. S M
TARCH ARK
Table 2. Compatible Introducers and Length Adapters
Compatible Introducers
7G & 10G E C MRI Introducer Models
®
N OR
ECMRINTLOC
ECMRINTLOC7G
E C Ultrasound Stylet and Coaxial
®
N OR
ECSTUS0110G
ECSTUS0112G
Eviva™ Biopsy Probe Cannula
Insert to First Step
Figure 2. E C MRI Introducer - Use with MRI Length Adapter
®
N OR
Figure 3. E C ® Ultrasound Introducer - Use with Ultrasound
N OR
Figure 4. Eviva™ Biopsy probe Cannula - Use with Eviva™
1
Plunger (A)
U C ® Logo (E)
LTRA OR
® U C ® Breast Tissue Marker
LTRA OR
Length Adapter Used
MRI Length Adapter
First Step
Ultrasound Length Adapter
Eviva™ Length Adapter
Length Adapter
Length Adapter (Stereo)
Adapter Color
White
Black
Beige