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PRODUCT DESCRIPTION
The Kensington™ Guide Wire Bone Biopsy System is designed for accessing bone and performing bone biopsies.
The system has the following contents. For specific sizes, see Table #1.
A
B
C
D
INDICATIONS
Bone access and biopsies of bone lesions.
PRECAUTIONS
The device must only be used by a physician trained to carry out biopsies or radiology interventions, or under his/
her supervision. The device is supplied in a sterile state and should be considered as such unless the packaging has
been opened or is damaged. Do not use if the packaging is damaged. When using equipment from other suppliers,
check that their length and diameter are compatible with the components of the device. When in use, only apply
pressure with your fingers and ensure that you do not apply excessive axial pressure or bend the elements. After
use, this product may pose a potential biological risk. All products of this type must be handled and destroyed in
accordance with accepted medical practices, legislation and applicable provisions.
STORAGE
Store in a cool, dry place (below 26° C), away from humidity and direct heat. Do not use after the expiry date.
REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may
compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient
injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the
patient.
CONTRAINDICATIONS
Contraindicated for use on patients who are receiving heavy anticoagulant therapy or who have a severe bleeding
problem. Prior to procedure, patient's medical records should be carefully checked for any history of hemorrhagic
activity.
INSTRUCTIONS
The following is a suggested method for using the device. The approach should be accurately planned using
diagnostic imaging and clinically approved techniques. Disinfect the skin, make a small skin incision, and apply
local anesthetic.
FIG. 1 Introduce the Anesthesia Needle and its Stylet (A+B)
through the soft tissue until in contact with the bone.
Note: Perform additional anesthesia with the
Anesthesia Needle (A) to the periosteum if desired.
FIG. 2 Withdraw the Anesthesia Needle Stylet (B) and
introduce the Guide Wire (C) into the Anesthesia
Needle (A) until in contact with the bone.
FIG. 3 Withdraw the Anesthesia Needle (A) while holding the
Guide Wire (C) firmly against the bone.
FIG. 4 Place the assembled Cannula and Inner Stylet (D+E) by
sliding them over the Guide Wire (C) until in contact
with the bone.
FIG. 5 Withdraw the Guide Wire (C). Remove the Inner Stylet
(E) while holding the Cannula (D) firmly against the
bone.
Note: If you need to traverse hard bone to reach the
biopsy area, you must use the corresponding Merit
Preston™ Hard Bone Introducer (provided separately,
see Table #2). The blunt Cannula and Inner Stylet (D+E)
are not designed for piercing or traversing hard bone.
FIG. 6 Adjust the depth gauge on the Biopsy Needle (F) to the
appropriate centimeter marker and tighten to provide
a visual guide.
Note: The selected centimeter marker (see Fig. 6) will
represent the Biopsy Needle protrusion beyond the
Cannula (D).
FIG. 7 Insert the assembled Biopsy Needle and Handle (F+G)
through the Cannula (D). Carefully rotate the Biopsy
Needle and Handle (F+G) clockwise until desired
biopsy depth is achieved or until the depth gauge of
the Biopsy Needle (F) reaches the Cannula (D) luer end.
Then rotate Biopsy Needle and Handle (F+G)
counterclockwise and remove. Remove the Handle (G)
from the Biopsy Needle (F); insert the Ejector Pin (H)
through the Biopsy Needle (F) from the luer end and
eject the sample.
Note 1: Repeat process from Fig.6 if desired and
anatomically safe.
Note 2: A syringe can be connected to the luer end of
the Biopsy Needle (F) and light aspiration may be
applied during removal of the Biopsy Needle (F) if
desired.
Note 3: In the case of sclerotic lesions, taking several
incremental, smaller, samples are recommended to
avoid crushing tissue within Biopsy Needle (F).
Guide Wire Bone Biopsy System
I N S T R U C T I O N S F O R U S E
Anesthesia Needle
Anesthesia Needle Stylet
Guide Wire
Cannula (blunt)
E
Inner Stylet (blunt)
F
Biopsy needle with Clockwise Tip
G
Biopsy Handle (with Stiffener)
H
Ejector Pin
ENGLISH
1cm
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