argon audio BIOPINCE 360-1080-01 Manual

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road Athens, Texas 75751 USA
Tel: +1 (903) 675-9321
Tel: +1 (800) 927-4669
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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EN - ENGLISH
X9585365/0221A
INTENDED USE/PURPOSE
Biopince™ Full Core Biopsy Instrument is intended to be used for harvesting multiple core
specimens from soft tissue for clinical diagnosis.
DEVICE DESCRIPTION:
The instruments are comprised of a lightweight handle with a pre-attached 16ga or 18ga
needle set. The device is designed to capture a full core specimen using tri-axial core cut
and capture system to harvest diagnostic quality specimens. The device also feature a
centimeter markings that provide reference for depth placement. It had a color-coded rear
trigger for gauge indentification, green ready indicator and forward trigger for flexibility
approach.
The variable throw lengths enhance clinical flexibility: 13mm throw yields 9mm specimen
length, 23mm throw yields 19mm specimen length, 33mm throw yields 29mm specimen
length.
INDICATIONS FOR USE: The disposable, automatic BioPince™ Full Core Biopsy
Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney,
abdominal masses, etc.
CONTRAINDICATIONS: Use only for core biopsies of soft tissue as determined by a
licensed
physician.
limitations, indications and contraindications of core needle biopsy. should use the
instrument. Physician judgement is required when considering biopsy on patients with
bleeding disorders,or receiving anticoagulant medications.
WARNINGS
• Reuse or reprocessing has not been evaluated and may lead to its failure and
subsequent patient illness, infection or other injury. Do not reuse, reprocess or re-sterilize
this device.
• Inspect the package integrity before use.
• Do not use if package is open or damaged or if the expiry date has been exceeded.
• The instrument should be used by a physician familiar with the possible side effects,
typical findings, limitations, indications and contraindications of core needle biopsy.
• Use only for core biopsies of soft tissue as determined by a licensed physician.
Attempting to biopsy hard tissue or masses may reduce the performance, causing
damage to the instrument or potentially harm the patient. This instrument is intended for
soft tissue biopsy only.
• Incorrect setting of stroke length on the device may cause a sample to be incorrectly
taken.
• Handle in a manner, which will prevent accidental puncture.
Note: These instructions for the BioPince Full Core Biopsy Instrument are NOT meant to
define or suggest any medical or surgical technique. The individual physician is responsible
for the proper procedure and techniques to be used with this product.
PRECAUTIONS
• The BioPince Full Core Biopsy Instrument is available in different needle lengths and
gauges. The appropriate length and gauge of the instrument must be selected for the
procedure, per physician judgment.
• Verify integrity of needle before cocking instrument and after firing(s). If needle is
damaged, appropriately discard the entire device (see disposal section) and prepare a
new instrument. Do not attempt to open the device.
• This instrument was designed, tested, and manufactured for single use only.
• The introduction of the needle into the body should be carried out under imaging control
(ultrasound, CT, etc.)
• This instrument can be used with an appropriate Argon Co-Axial Introducer Needle.
Other manufacturer's co-axial introducer needles have not been tested for compatibility
with the BioPince Full Core Biopsy Instrument.
• Do not bend the needle.
• Do not contact the needle tips to a hard surface while expelling a sample.
Note: Deliberate mis-use or off-label use in violation of this IFU may negatively impact the
safety of the patient and/or the effectiveness of the device.
DIRECTIONS FOR USE:
1. Prepare the biopsy site appropriately and locate the target area.
2. Advance a BioPince™ Co-axial Introducer Needle, using standard technique, to a
position proximal to the lesion. Position the adjustable needle stop proximal to the skin.
1
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‫ﺎ ﻋﻠﻰ‬ ً ‫ﯾﺗوﻓر ﻣﺳرد اﻟرﻣوز إﻟﻛﺗروﻧ ﯾ‬
BIOPINCE™ FULL CORE BIOPSY INSTRUMENT
A physician familiar with the possible side effects, typical findings,
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