Product Description - Merit Medical MADISON MINI Instrucciones De Uso

PRODUCT DESCRIPTION

The Madison Mini™ Bone Biopsy System is designed for accessing bone, traversing bone when necessary, and
performing bone biopsies. The system has the following contents.
A Cutting (Access) Cannula 13G x 6cm
B Stylet with Trocar Tip Ø1.9mm x 10.2cm
C
Biopsy Needle with Clockwise Tip Ø1.85mm x 14cm
INDICATIONS FOR USE
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.
DIRECTIONS FOR USE
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 perform
anesthesia until in contact with bone.
FIG. 1 Depending on the depth of the bone to be reached,
adjust the depth gauge on the Cutting Cannula (A)
to the appropriate centimeter marker and tighten
to provide a visual guide. Introduce, rotating
counterclockwise, the assembled Cutting Cannula
and Stylet and Handle (A+B+F) until engaged with
the bone surface.
Note: To protect soft tissue, a counterclockwise
rotation must be applied during insertion through
the soft tissue.
FIG.2 Move the depth gauge forward until in contact
with the skin, then withdraw it by the desired
depth, using the centimeter markings on the
Cutting Cannula (A) to provide a visual guide.
With careful but firm turns, rotate the Cutting
Cannula and Stylet and Handle (A+B+F) clockwise
until the depth gauge reaches the skin and/or
desired position is obtained.
FIG. 3 Firmly hold the Cutting Cannula with Handle (A+F)
and unscrew and remove the Stylet (B).
If desired, the Handle (F) can be removed from the
Cutting Cannula (A) by placing two fingers under
the Handle (F) and pressing the luer end of the
Cutting Cannula (A) with the thumb.
Note: To replace the Stylet (B) in the Cutting
Cannula (A), place first the Handle (F) on the luer
end of the Cutting Cannula (A) by aligning tabs and
slots. Then insert the Stylet (B) at a right angle to the
assembled Cutting Cannula and Handle (A+F) and
screw it until it clicks into place.
FIG. 4 Adjust the depth gauge on the Biopsy Needle (C) to
the appropriate centimeter marker and tighten to
provide a visual guide.
Note: The selected centimeter marker will
represent the Biopsy Needle (C) protrusion beyond
Cutting Cannula (A).
Bone Biopsy System
I N S T R U C T I O N S F O R U S E
D Biopsy Handle (with stiffener)
E Ejector Pin Ø1.3mm x 17.4cm
F
Cannula Handle (Removable)
ENGLISH