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Instructions for use of this Bone Marrow Aspiration Needle
A. INTENDED USE
The Bone Marrow Aspiration Needle is intended for use in aspirating
bone marrow specimen.
B. CONTRAINDICATIONS
For use only for bone marrow aspiration as determined by a li-
censed physician. The device is intended to be used by a physician
familiar with the possible side effects, typical findings, limitations,
indications and contraindications of bone marrow aspiration. The
procedure should be performed on patients that are suitable for
such procedure only.
Caution:
For single patient use only. Do not attempt to clean or
resterilize this product. The design of this device may not perform
as intended by the manufacturer if it is reused. The manufacturer
cannot guarantee the performance, safety and reliability of a repro-
cessed device.
After use, this product may be a potential biohazard. Handle in a
manner which will prevent accidental puncture. Dispose in ac-
cordance with applicable laws and regulations. Carefully place the
used needle in a sharps biohazard container after the procedure is
completed.
Note:
These instructions are NOT meant to define or suggest any
medical or surgical technique. The individual practitioner is respon-
sible for the proper procedure and techniques to be used with this
device.
C. DIRECTIONS FOR USE
1. Inspect the package for proper integrity. If undamaged, open
the package using aseptic technique.
2. Remove the needle from the pouch and inspect the cutting
edge of both cannula and stylet for any damage or other imper-
fections that would prevent the proper operation of the needle.
3.
Following proper placing technique, locate the needle adjacent
to the biopsy site.
4.
Using gentle (but firm) pressure, advance the needle by
rotating in an alternating clockwise-counterclockwise mo-
tion. Entrance into the marrow cavity is generally detected by
decreased resistance.
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