English - SOMATEX Marrow Cut Gebrauchsanweisung

INSTRUCTION FOR USE
Important Information
Make yourself familiar with the entire content of these instructions for use and read them carefully before using
the product.
Area of Use
The systems for bone marrow puncture Somatex
the puncture and histological extraction of tissue from the bone marrow in the area of pelvic bone.
Contraindications
•
Hemophilia or similar blood coagulation disorders
•
Infection at the site of puncture
Warnings and Precautions
•
The bone marrow puncture systems Somatex
for sternal aspiration.
•
For safe and effective application of bone marrow puncture systems, the physician must have relevant
knowledge, experience and training in the use of this technique in patients.
•
Data from clinical experiments indicates that it is absolutely necessary to follow Good Clinical Practice
and preventive measures. Deep wound infections may occur as severe subsequent complications
following application, and elimination thereof requires a major surgical procedure.
•
These instructions are not intended as a description of techniques used during the intervention or surgical
techniques. The performing physician is responsible for testing and considering the possibility of the safe
application of these products and techniques for each individual patient.
•
All components of the bone marrow puncture systems described herein remain sterile only until the first
opening of and/or any damage to the packaging.
•
The tools are intended explicitly for single use only. The product may not be re-used after a single
application. The quality of materials, coatings and adhesive joints may deteriorate. A secure application is
no longer guaranteed. The product is not designed for cleaning and sterilization processes after a single
use. The sterility of reprocessed single-use is therefore not guaranteed. The risk of unintentional injuries
and infections, especially cross-infection with a patient and medical personnel increases unmeasurably.
The firm Somatex
use of any tool.
•
Caution, injury hazard! The individual components of these products have very sharp edges and can
easily cause injury.
•
Never use the product after the sterility expiration date indicated on the packaging.
Complications
•
Additional bleeding and hematoma
•
Infection
•
Injury of the skin, soft tissues, nerves or adjacent organs
•
Disorder of breathing functions during the use of analgesics or sedatives
Preventive Measures
•
Bone marrow punctures should be performed in clinical settings only.
•
Sterile disposable gloves should be worn.
•
The area of puncture should be covered to create aseptic conditions.
•
Appropriate measures should be taken prior to the puncture to assure biopsy sample for
hemopathological evaluation.
Biopsy Application: (you should unconditionally follow the illustrations I and II on page 2)
1. Perform subcutaneous and periosteal local anesthesia at the puncture site.
2. When necessary, use a sharp scalpel to make an incision at the puncture site to facilitate penetration
through the skin.
3. Prior to the beginning of the puncture, you can adjust the insertion depth stopper (3) on the cannule shaft
as needed to ensure optical control of the penetration depth.
4. Insert the puncture needle (2) and advance it forward until you feel a noticeable resistance indicating that
you reached the bone tissue.
®
– Medical Technologies – has no liability in the case of re-sterilization and/or repeated
®
– Marrow Cut, Bone Marrow, and SAFE-CUT
®
, described in these instructions for use, are not intended
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english

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– are used for