Merit Medical MADISON MINI Gebrauchsanweisung

PRODUCT DESCRIPTION
The Madison Mini™ Bone Biopsy System is designed for accessing bone, traversing bone when necessary, and
performing bone biopsies. The contents of the system are listed in Table 1. Component working lengths are
provided in Table 2.
A
Cutting (Access) Cannula
B
Stylet with Trocar Tip
C
Biopsy Needle
G
Sliding Stop (Depth Gauge)
Component
Cutting (Access) Cannula
Biopsy Needle
INTENDED PURPOSE
Bone access and biopsies of bone lesions.
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.
PATIENT POPULATION
For bone access and bone biopsies of lesions in adults.
USER(S)
The device must only be used by a physician trained to carry out biopsies or radiology interventions, or under his/
her supervision.
CLINICAL BENEFITS
The intended clinical benefit of the device is reduced morbidity and mortality compared to open surgical
procedures.
PERFORMANCE CHARACTERISTICS
• This direct access 13G system features a Cutting Access Cannula with removable handle. This minimizes
exterior weight and size and is extremely useful for small, rounded bones with little soft-tissue
surroundings.
• Accurate targeting of small lesions via tactile control & small gauge
• Optimized sample for sclerotic and blastic lesions (Hard bone lesions)
PRECAUTIONS
• The device is supplied in a sterile state and should be considered as such unless the packaging has been
opened or is damaged. Employ aseptic technique during removal from the package and use. Do not use if the
packaging is damaged.
• 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.
• In the event of changes in the performance of the device, exercise caution as this may indicate a change that
may affect the safety of the device.
• This device includes stainless-steel alloy components that contain Cobalt (EC No.: 231-158-0; CAS No.:
7440-48-4) defined as CMR 1B in a concentration above 0.1% weight by weight.
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.
POTENTIAL COMPLICATIONS
• Foreign Body Non- Vascular
• Bone Fracture
• Hemorrhage
• Infection
• Inflammation
• Soft Tissue Injury
• Biologic Exposure
Bone Biopsy System
I N S T R U C T I O N S F O R U S E
G
Table 1: List of components
D
E
F
Table 2: Component working length
Working length definition:
Distal tip of the cannula to the
proximal laser mark
Distal laser mark to the proximal
laser mark
G
Biopsy Handle (with Stiffener)
Ejector Pin
Cannula Handle (Removable)
Working length size and image:
KDP136: 60mm
KDP136:30.5mm
ENGLISH