Argon Medical Devices T-LOK Produktinformationen / Technische Daten

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1 800-927-4669;
Tel: +1 903-675-9321
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
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Bone Marrow
Biopsy/Aspiration Needle
https://www.argonmedical.com/resources/product-information
X9585768/0321A
ENGLISH
Intended Use/Purpose :
Bone Marrow Biopsy Needles are designed to provide biopsies by entrapping bone
marrow in the needle without altering the sample.
Device Descipriotn :
Bone Marrow Biopsy product features a unique cannula design, ergonomic handle,
and double-diamond stylet to facilitate penetration through hard bone.
Indications for Use: Intended for the purpose of harvesting bone and/or bone
marrow specimens.
Contraindications: For use only for biopsies of bone/bone marrow as determined by
a licensed physician. These needles should be used by a physician familiar with the
possible side effects, typical findings, limitations, indications and contraindications of
bone biopsy. Physician judgment is required when considering biopsy on patients with
bleeding disorder, or receiving anti-coagulant medications.
Potential Complications/Risks: It is not uncommon for patients to experience the
following :
• Nerve injury including puncture of the spinal cord or nerve roots potentially
resulting in radiculopathy, paresis or paralysis.
• Thrombus or other materials resulting in symptomatic pulmonary embolism or other
clinical sequelae.
• Hemothorax or pneumothorax.
• Deep or superficial wound infection.
• Unintended puncture wounds including vascular puncture and dural tear.
• Bleeding or hemorrhage
• Hematoma
• Pain
When use as intended by a physician, the benefits of using the Bone Marrow Biopsy
Needle outweigh the risks associated with the use of the device.
Warning
• Inspect the package integrity before use.
• Do not use if package is open or damaged and if the expiry date has been
exceeded.
• Do not continue to use if any of the component are damaged during procedure.
• Do not bend the needle excessively, it may result damage/breakage to the device.
• This device was designed, tested and manufactured for single patient 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.
• Reconditioning, refurbishing, repair, modification, of the device to enable further
use is expressly prohibited.
Precaution
• This device should be manipulated only while under fluoroscopic observation with
radiographic equipment that provides high quality images.
• Access to the vertebral body via pedicle requires a minimum pedicle width of 5mm.
• Knowledge of the dimensions of the site of insertion should be assessed by MRI,
CT, or other imaging method.
Note: These instructions 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.
Aspiration Procedure:
1. Place the patient in a right or left lateral position, with the back comfortably flexed
and the top knee drawn toward the chest.
2. Locate the posterior superior iliac spine and mark.
3. Using sterile technique, prepare the skin with antiseptic and drape.
______________________________
Bone Marrow Biopsy Needle
T•Lok™ Bone Marrow Biopsy Needle
T•Lok™ Bone Marrow
Biopsy Needle