Argon Tru-Core II Manual Del Usuario

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road, Athens, Texas 75751 USA
Tel: 800-927-4669
Tel: +1 903-675-9321
www.argonmedical.com
ENGLISH
Tru-Core™II and Tru-Core™II URO
Automatic Biopsy Instrument
Product Description: The Tru-Core™ II Automatic Biopsy Instrument has a
22mm throw with a 19mm sample notch. The device includes a spring loaded
hand held unit which houses and fires a needle set under the user guidance of
two thumb knobs. It is available in various sizes (14, 16, 18 and 20ga) with
lengths varying from 10 cm to 25 cm. The 18gax20cm and 18gax25cm
instruments are also available in the URO configuration with the stylet notch
upside-down and is specifically for prostate biopsies.
The instrument can be used with a corresponding Co-Axial Introducer Needle
(packaged and sold separately).
Indications for use: The Tru-Core™ IIAutomatic Biopsy Instrument is used to
obtain multiple core samples from soft tissue such as liver, kidney, prostate,
breast, etc and not intended for bone.
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.
Caution:
 For Single Use Only. Do not attempt to clean or resterilize this product.
 After use, this product may be a potential biohazard. Handle in a manner,
which will prevent accidental puncture. Dispose in accordance with
applicable laws and regulations.
 Never test fire the Tru-Core™ II Automatic Biopsy Instrument.
 Verify integrity of needle before loading instrument and after firing(s). If
needle is damaged, replace the whole system (needle set and
instrument).
 This device was designed, tested and manufactured for single use
only. When used repeatedly in the same patient, the device should be
inspected for damage or wear after each core sample is taken. Reuse
or reprocessing has not been evaluated and may lead to its failure
and subsequent patient illness and/or injury. DO NOT reuse,
reprocess or re-sterilize this device.
Note:
 DO NOT ATTEMPT TO OPEN LID!
 These instructions for the Tru-Core™ II 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.
 The disposable needle/biopsy set is for Single Use Only. Do not attempt
to clean or resterilize. After use, this product may be a potential
biohazard. Handle in a manner, which will prevent accidental puncture.
Dispose of in accordance with applicable laws and regulations.
Storage : Store in a cool, dry area.
Instructions For Use
Slide the cannula knob (1) proximally until the mechanism "clicks" into
1.
place.
Slide the stylet knob (2) proximally until the mechanism "clicks" into
2.
place.
3. The device is now ready for use; insert needle proximal to area to be
sampled. Warning: Be careful not to push stylet thumb knob until needle is
inserted to desired location. Verify proper location of needle.
4. Slide stylet knob (2) forward until device fires.
5. Withdraw the needle from the biopsy site.
6. To remove the biopsy specimen from the needle, engage the cannula
knob (1) until the mechanism "clicks" into place.
7. If more samples are required, repeat steps 2 through 7.
STERILE EO
1
2
3
4
1
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands