Argon Medical Devices X9585760 ProMag Instrucciones De Uso

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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Pro-Mag™ Ultra Automatic Biopsy Instrument
Figure 1
X9585760/1020A
Figure 2
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EN - English
Pro-Mag™ Ultra Automatic Biopsy Instrument
Intended Use/Purpose
Pro-Mag™ Ultra Automatic Biopsy Instrument is a reusable device that utilizes disposable
needles to harvest high quality histological specimens.
Device Description
Pro-Mag™ Ultra Automatic Biopsy Instrument features a built-in safety button to prevent
accidental firing, easy to trigger from the front or rear of the instrument and easy specimen
retrieval without removing the needle from the instrument. This device also provides automatic
sequential firing of a stylet and subsequent firing of a cannula after cocking the handle twice and
releasing the safety mechanism.
The Pro-Mag™ Ultra Automatic Biopsy Instrument are available in three (3) models:

Pro-Mag™ Ultra Automatic Biopsy Instrument has a throw (advancement) of 25mm and
used in conjunction with Pro-Mag™ Biopsy Needle Sets.

Pro-Mag™ Ultra ST Automatic Biopsy Instrument has a throw (advancement) of 14mm
and used in conjunction with Pro-Mag™ "Short Throw" Biopsy Needle.

Pro-Mag™ Ultra 2.2 Automatic Biopsy Instrument has a throw (advancement) of 22mm
and used in conjunction with ACN™ Biopsy Needle.
Note: The Pro-Mag Ultra Automatic Biopsy Instrument is designed to be compatible with listed
Biopsy Needles, sold separately. Compatibility of the instrument with other manufacturer's needle
has not been tested.
Indication for Use
The Pro-Mag™ Ultra Automatic Biopsy Instrument is indicated to obtain core samples from soft
tissue such as the liver, kidney, prostate, breast and various soft tissue lesions for examinations
and diagnosis.
Caution: Changes in the indication for use may result a new intended uses if new
questions of safety and effectiveness are raised.
Contra-indications for Use
For use only for core biopsies of soft tissue as determined by a licensed physician. The instrument
should be used by a physician familiar with the possible side effects, typical findings, limitations,
indications and contraindications of core needle biopsy. Physician judgement is required when
considering biopsy on patients with bleeding disorder or receiving anti-coagulant medications.
Warnings

The instrument is reusable and is supplied non-sterile.

The instrument is intended to be cleaned, disinfected and sterilized by the user as defined
in the reprocessing instruction.

Do not continue to use if any of the component are damaged during the procedure.

Hard tissue biopsy is considered an off-label misuse of the instrument.
Precautions

The product must only be used by licensed, knowledgeable physician and qualified
personnel who are familiar with possible side effects, typical findings, limitations,
indications and contraindications of this device and biopsy sampling.

These instructions for the Pro-Mag™ Ultra Automatic Biopsy Instrument 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 the device.

The device will typically be utilized in an outpatient clinical environment and in the following
clinical areas:
 Urology – Transrectal or transperineal biopsy of the prostate.
 Radiology – Percutaneous kidney, liver and breast biopsy
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