ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: 800-927-4669;
Tel: +1 903-675-9321
www.argonmedical.com
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
+31 70 345 8570
Argon Medical Devices UK Ltd
Eastgate Business Centre
Eastern Avenue
Burton-on-Trent
Staffordshire
DE13 0AT
https://www.argonmedical.com/resources/product-information
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ENGLISH
Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.
INTENDED USE/PURPOSE: The SuperCore™ Biopsy Instrument is a semi-automatic biopsy
instrument used to obtain soft tissue biopsies.
DEVICE DESCRIPTION: The SuperCore™ Biopsy Instrument is composed of an echogenic
spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen
collection. The position of the needle may be visualized by x-ray, CT or ultrasound. The needle
has numerically ordered centimeter markings to facilitate precise depth placement. The
adjustable instrument allows for a throw of 1.2cm or 2.2cm exposing the specimen notch either
19mm or 9.5mm, providing clinical flexibility.
The SuperCore™ Biopsy Instrument packaged with a co-axial introducer needle has a
supplemental male/female Luer adapter to allow for length adjustment through the coaxial
introducer when the instrument is used at the 1.2cm throw.
INDICATIONS FOR USE: Disposable guillotine soft tissue instrument for obtaining percutaneous
or surgical histological samples, (e.g. lung, liver, spleen, kidney, prostate, lymph nodes, breast,
thyroid, and pancreas).
CONTRAINDICATIONS: These needles should be used by a physician familiar with the possible
side effects, typical findings, limitations, indications and contraindications of soft tissue biopsy.
Physician judgment is required when considering biopsy on patients with bleeding disorder or
receiving anti-coagulant medications.
Side Effect/Risk
• It is not uncommon for patients to experience bleeding, infection at insertion site, fever, pain
at the biopsy site, swelling at the biopsy site, adjacent tissue injury and hematoma after the
biopsy. When used as intended by a physician, the benefits of using the SuperCore Biopsy
Instrument outweigh the risks associated with the use of the device.
WARNINGS
• Contents are supplied sterile and are intended for single use only. Do not reuse, reprocess
or re-sterilize this device.
• Reuse or reprocessing
patient illness, infection or other injury.
• Inspect the package integrity before use.
• Do not use if package is open or damaged and if the expiry date has been exceeded.
• Do not continue to use if any of the component are damaged during the procedure.
• Functional tests are performed during manufacture. Do not try to "dry fire" the device.
PRECAUTIONS
• The device should be used by a qualified, licensed physician.
• Handle in a manner that will prevent accidental puncture.
• This instrument can be used with an appropriate Co-Axial Introducer Needle.
Caution: Other manufacturer's co-axial introducer needles have not been tested for
compatibility with the SuperCore™ Biopsy Instrument.
NOTE: These instructions are NOT meant to define or suggest any medical or surgical technique.
The individual practitioner is responsible for the proper procedure and techniques to be used with this
device.
PREPARATION AND DIRECTION FOR USE
1. Optional use of co-axial introducer needle with biopsy instrument: Advance the co-axial
introducer needle, using standard technique, to a position proximal to the lesion. Position
the adjustable needle stop proximal to the skin. Remove the stylet from the co-axial
introducer needle, leaving the cannula in position.
2. Cock the SuperCore™ biopsy instrument by pulling back on the plunger as in fig. 1 until a firm
click is felt at either the 1.2cm or 2.2cm position. (User selectable.)
1
2.1. If using the 1.2cm position with a co-axial introducer needle, install the male/female Luer
adapter onto the co-axial cannula as in fig 2. before proceeding.
2
1
©2013-2017 Argon Medical Devices, Inc. All rights Reserved
SuperCore™ is a trademark of Argon Medical Devices, Inc.
SuperCore™ Biopsy Instrument
has
not been evaluated and may lead to its failure and subsequent
X9585762/1120A