Argon Medical Devices Pro-Mag Manual

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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

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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:

Inspect the disposable needle set package for damage. If undamaged, open the

package using proper aseptic technique.

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.

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.

Safety button (2.3) must be set in the position indicated by the arrow on the lid before

cocking.

Cock the actuator handle (1.6) twice in order to activate the device for firing (this

automatically sets the safety).

Release the safety by pushing the "Safety Release Button" (2.3) located on the side of

the device.

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.

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 :

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)