Argon Medical Devices Pro-Mag 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
The symbols glossary is located electronically at
www.argonmedical.com/symbols
Figure 1 / Figura 1 / Figure 1 / Figura 1 / Abb. 1 / Figuur 1 /
Figura 1 / Fig. 1 / Σχήμα 1 / Kuva 1 / Fig. 1 / Figur 1 / Şekil 1
Figure 2 / Figura 2 / Figure 2 / Figura 2 / Abb. 2 / Figuur 2 /
Figura 2 / Fig. 2 / Σχήμα 2 / Kuva 2 / Fig. 2 / Figur 2 / Şekil 2
Pro-Mag™ Ultra Automatic Biopsy Instrument
ENGLISH
Description: The Pro•Mag™ Ultra Automatic Biopsy Instrument is an automatic, reusable
system for histological core biopsies. Pro•Mag™ Ultra is available in two models:
•
Pro•Mag™ Ultra has a throw (advancement) of 25mm.
•
Pro•Mag™ Ultra ST has a throw (advancement) of 14mm.
Indications for Use: The Pro•Mag™ Ultra Automatic Biopsy Instrument is used to obtain
tissue core biopsy in the following clinical areas:
•
Urology - Transrectal or transperineal biopsy of the prostate.
•
Radiology – Percutaneous kidney, liver, lung and breast biopsy.
Contraindications: 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 judgment is required when considering biopsy on patients with bleeding disorder,
or receiving anti-coagulant medications.
Note: 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 this device.
Caution: The Pro•Mag™ Ultra Automatic Biopsy Instrument should be used by or under the
supervision of a physician who is completely familiar with the use and limitations of this
device and biopsy sampling.
Directions For Use:
1. Inspect the disposable needle set package for damage. If undamaged, open the
package using proper aseptic technique.
2. Remove the needle (1.3) from the pouch. Inspect the stylet for damage to the point, the
cannula for damage to the cutting edge, or other imperfections that would prevent
proper operation of the needle assembly.
3. Open the lid (1.1) of the biopsy device, load needle set (1.3) into the biopsy device,
close lid (1.1), and remove protective sheath.
4. Safety button (2.3) must be set in the position indicated by the arrow on the lid before
cocking.
5. Cock the actuator handle (1.6) twice in order to activate the device for firing (this
automatically sets the safety).
6. Release the safety by pushing the "Safety Release Button" (2.3) located on the side of
the device.
7. Firing the device can be achieved by pushing in on either the front trigger button (1.2) or
the rear trigger button (1.5). This action will trigger the spring mechanism, propelling the
needle forward for a core biopsy sample.
NOTE: The needle need not be removed from the biopsy device to retrieve the sample.
8. After removing the needle from the patient, reset safety button (2.3) and cock the
actuator handle once to expose the biopsy notch located at the distal end of the needle.
This action exposes the specimen for removal. Cocking the actuator handle a second
time will activate the device for a second biopsy.
REPROCESSING INSTRUCTIONS FOR THE PRO•MAG™ ULTRA AUTOMATIC BIOPSY
SYSTEM (Per ISO 17664-2004):
• Never place the device in bleach or bleach solution.
Warnings /
• Lubrication on the sides of the carrier blocks will slow the action
Precautions
of the device
After cleaning and sterilization, verify functionality prior to re-
Limitations
use.
INSTRUCTIONS
This product is provided non-sterile and must be cleaned and
Point of Use
sterilized before using.
Containment and
No particular requirements.
Transportation
Preparation for No particular requirements. Ultrasonic treatment of the device has
cleaning not been tested.
The Pro•Mag™ device has been validated for effective cleaning
using an automated washer/disinfector cycle of a minimum of 30
minutes total time, including a pre-wash, enzyme wash, main
wash, rinse and dry.
Cleaning: Automated
Immerse instrument, with lid open, in the washer-disinfector and
refer to the manufacturer's recommendations and instructions.
Examine device for any residual soil. Thoroughly dry the device or
it will not function properly.
The Pro•Mag™ device should be cleaned in a mild detergent (e.g.
ENZOL Enzymatic Detergent) and lukewarm water solution, per
manufacturer's recommendations.
Cleaning: Manual
Immerse instrument, with lid open, into solution and use a soft
brush to clean any residue left from the procedure. After washing
completely, rinse the device in hot water. Thoroughly dry the
device or it will not function properly.
A high level of disinfection can be achieved with CIDEX or
Disinfection ProCide NS; follow the manufacturer's recommended procedure.
Thouroughly dry the device or it will not function properly.
A standard, sterilization wrap may be used. In the US, an FDA
Packaging
approved surgical wrap must be used.
The instrument should first be cleaned, lubricated and packaged
prior to sterilization.
Sterilization
Cycle:
(Temperatures are
minimum required,
Temp.:
times are minimum
Time:
required)
Drying:
Washing detergents may eventually remove the lubricant originally
applied. Lubricate device with silicone free, steam sterilization
Maintenance, compatible lubrication (e.g., Aesculap
Inspection and prior to sterilization. Refer to the manufacturer's instructions for the
Testing use of the selected lubricating agent. Lubricate at the following
points as displayed on Figure 2 :
1
Gravity Gravity Pre-vac
250º F (121ºC) 270º F (132ºC) 270º F (132ºC)
40 - 50 min 10 - 25 min 4 min
20 min, or until visibly dry
® ®
Sterilit I Oilspray JG 600)