Argon Medical Devices Pro-Mag Manual Del Usuario

Figure 1 - Pro-Mag™ Needle
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
X9585761/1020A
Intended Use/Purpose
Pro-Mag™ Biopsy Needle, Pro-Mag™ Short Throw Biopsy Needle and ACN™ Biopsy
Needle are intended to be used in conjuction with Pro-Mag™ Ultra Automatic Biopsy
Instrument to harvest high quality histological specimens.
Device Description
This product features a high quality core biopsy needles that provide histological
specimens for diagnosis of suspect lesions. It has centimeter markings provide reference
for accurate depth placement, each needle has an echogenic tip for accurate placement
under ultrasound guidance, hubs are color coded for easy gauge size determination and
all needle types can be utilized with compatible echogenic Co-Axial introducer needles.
The device are used in conjuction with the following accessories:
Pro-Mag™ Biopsy Needle is used in conjunction with Pro-Mag™ Ultra Automatic

Biopsy Instrument or other compatible, commercially available biopsy instrument.
ACN™ Biopsy Needles is used in conjunction with Pro-Mag™ Ultra 2.2 Automatic

Biopsy Instrument or other compatible, commercially available biopsy instrument.
Pro-Mag™ Short Throw Biopsy Needle is used in conjunction with Pro-Mag™

Ultra Short Throw Automatic Biopsy Instrument or other compatible, commercially
available biopsy instrument.
Indication for Use
The Pro-Mag™ Biopsy Needle, Pro-Mag™ Short Throw Biopsy Needle and ACN™ Biopsy
Needle are indicated to obtain core samples from soft tissue such as the liver, kidney,
prostate, breast and various soft tissue lesions.
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
Contents are supplied sterile and are intended for single use only. Do not re-
•
sterilize.
• Reuse or reprocessing has not been evaluated and may lead to its failure and
subsequent patient illness, infection or other injury.
Inspect the package integrity before use.
•
Do not use if package is open or damaged and if the expiration date has passed.
•
Hard tissue biopsy is considered an off-label misuse of the device.
•
Figure 2 - ACN™ Neede
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yer almaktadır
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Pro-Mag™ Biopsy Needle,
Pro-Mag™ Short Throw Biopsy Needle,
ACN™ Biopsy Needle
‫ﯾﺗوﻓر ﻣﺳرد اﻟرﻣوز إﻟﻛﺗروﻧ ﯾ ً ﺎ ﻋﻠﻰ‬