LeMaitre AlboGraft Gebrauchsanweisung Seite 3

This value indicates the internal diameter of the prosthesis when exposed to an internal pressure
of 120 mmHg; it equals the average natural pressure on the prosthesis when unclamped. The
diameter is higher than the nominal value as a result of two diff erent concomitant factors:
• distention of the pleated folds;
• radial dilation caused by blood fl ow pressure (its eff ect on a knitted prosthesis is more
sensible due to the high fl exibility and elasticity of the device).
AlboGraft ASC Models*: The external spiral support ensures the radial dilation of the prosthesis
remains negligible.
Water Permeability
Permeability is a chief property of the polyester fabric and depends on the porosity of the material
and impregnation process. The permeability is expressed as the amount of water that can pass
through 1 cm of the prosthesis at 120 mmHg over one minute. The table below compares the
2
maximum claimed permeability (ml x cm x min
-2
Type Double Velour Knitted Fabric
with Collagen
ml x cm -2 min -1 0.1
3-digit code AMC/ASC
Usable Length
This measurement indicates the minimum length of the prosthesis under tension during implantation. The
minimum useable length is determined under tension with the applied weight for each type (see table below).
Type
Double Velour Knitted Fabric With Collagen (ASC)*
Double Velour Knitted Fabric with Collagen (AMC)
Double Velour Woven Fabric with Collagen (ATC)
Double Velour Woven Fabric with Collagen (ATC)
Packaging
AlboGraft Vascular Grafts are supplied sterile through a double sterile barrier. The internal container is exter-
nally sterile provided that the external container has been neither damaged nor opened. The external container
is only internally sterile: it must not be brought into a sterile environment.
Warning: The collagen-impregnated AlboGraft Vascular Graft (AMC, ATC, and ASC*) double con-
tainer is provided in a vacuum sealed foil pouch. This pouch protects the graft during storage and
should be opened only immediately prior to use.
The labeling is color coded to identify the fabric characteristics and collagen impregnation of the model
contained inside (see table within "Available Models").
Indications
The AlboGraft Knitted and Woven Polyester Grafts are indicated for use in the replacement or repair of arteries
aff ected with aneurismal or occlusive disease.
Instruction For Use
Choice and Preparation of the Graft
Choose the graft type and size best suited to the vascular section to be replaced or supplied through a bypass.
* Not available for sale in the United States or Canada.
) for each graft type.
-1
Double Velour Woven Fabric
with Collagen
0.1
ATC
Diameter Weight (g)
ALL
ALL
<24 mm
≥24 mm
3
125
500
500
750