Bard 3DMax Light Mesh, Instructions For Use Manual

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en
3DMax
™
Light Mesh
Anatomically-shaped Large Pore Polypropylene Mesh
InstructIons for use
Product descrIPtIon:
The 3D M
ax
™ Light Mesh is
made from monofilament poly­
propylene and has a large pore
design. This construction allows
a prompt fibroblastic response
through the interstices of the
mesh. Its unique 3D design con ­
forms to the inguinal anatomy.
There is a blue monofilament ori ­
entation marker (M) and arrow on
the 3D M
ax
™ Light Mesh to facili­
tate ease of placement. The “M”
mark and arrow designate the
medial edge of the mesh.
IndIcatIons:
The 3D M
ax
™ Light Mesh is indicated for use in the reinforcement of soft tissue
where weakness exists, in the repair of inguinal hernias.
contraIndIcatIons:
1. Literature reports that there may be a possibility for adhesion formation
when polypropylene mesh is placed in direct contact with the bowel or
viscera.
2. Do not use polypropylene mesh in infants and children, whereby future
growth will be compromised by use of such material.
WarnIngs:
1. this device is supplied sterile. Inspect the packaging to be sure it is
intact and undamaged prior to use.
2. this device is for single use only. do not resterilize or reuse any por-
tion of the 3d M
ax
™ Light Mesh.
3. this device has been designed for single use only. reuse, repro-
cessing, resterilization or repackaging may compromise the structural
integrity and/or essential material and design characteristics
that are critical to the overall performance of the device and may
lead to device failure which may result in injury to the patient.
reuse, reprocessing, resterilization or repackaging 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 diseases from one patient to another. contamination of the
device may lead to injury, illness or death of the patient or end user.
4. the use of any permanent mesh or patch in a contaminated or
infected wound could lead to fistula formation and/or extrusion of the
prosthesis.
5. If an infection develops, treat the infection aggressively. consider-
ation should be given regarding the need to remove the mesh. an
unresolved infection may require removal of the device.
6. to prevent recurrences when repairing hernias, the prosthesis should
be large enough to extend beyond the margins of the defect.
7. to avoid injury, careful attention is required if fixating the mesh in the
presence of nerves and vessels.
PrecautIons:
1. Please read all instructions prior to use.
2. Only physicians qualified in appropriate surgical techniques should use this
prosthesis.
3. Do not cut or reshape the 3D M
ax
™ Light Mesh as this may affect its
effectiveness.