Bard E-Luminexx Vascular Stent, Инструкция по эксплуатации

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IIN NFFo oR RM MA AT TIIo oN N FFo oR R U US SE E
R Reeaad d tth hee B B
A AR RD D
®® E E LL
U UM MIIN NE EX XX X
®® V Vaassccu ullaarr S Stteen ntt IIFFU U tth hoorroou ug gh hllyy..
Also, thoroughly read the IFUs supplied with any other interventional devices to be used in conjunction with the system.
• Please use the product illustration at the beginning of this booklet to guide you through the device description.
• Please use the fold-out, step-by-step procedure illustrations at the end of this booklet to guide you through the procedure description.
1 1..0 0 D DE EV VIIC CE E N NA AM ME E
• The brand name of the device is B B
A AR RD D
®® E E LL
U UM MIIN NE EX XX X
®® V Vaassccu ullaarr S Stteen ntt.
• The Stent (Implant) is equipped with four highly visible radiopaque P P
U UZ ZZ ZLLE E
®® T Taan nttaallu um m M Maarrkkeerrss on both the proximal and distal end.
• The B B
A AR RD D
®® E E LL
U UM MIIN NE EX XX X
®® V Vaassccu ullaarr S Stteen ntt is loaded on the B BA AR RD D S S..A A..FF..E E..®® D Deelliivveerryy S Syysstteem m with the P P
E ER RFFo oR R
M MA AX XX X®® G Grriip p.
2 2..0 0 P PR Ro oD DU UC CT T D DIIA AG GR RA AM MS S ((P PLLE EA AS SE E R RE EFFE ER R T To o P PA AG GE E 2 2 A AN ND D 3 3))
3 3..0 0 D DE EV VIIC CE E D DE ES SC CR RIIP PT TIIo oN N
3 3..1 1 S Stteen ntt ((IIm mp pllaan ntt))::
The B B
A AR RD D
®® E E LL
U UM MIIN NE EX XX X
®® V Vaassccu ullaarr S Stteen ntt is a self-expanding, flexible, nitinol (nickel-titanium alloy) stent that expands to its preset diameter
upon exposure to body temperature. The stent has a segmental repeating pattern and an open cell geometry with flared ends to help
prevent dislocation or migration. Partial cuts around the circumference of the stent cylinder provide enhanced flexibility and allow
segment-by-segment expansion. The stent is available in a wide range of diameters and lengths.
Each end of the stent has four highly visible radiopaque P P
U UZ ZZ ZLLE E
®® T Taan nttaallu um m M Maarrkkeerrss to facilitate accurate stent placement ((sseeee FFiig gu urree
A A1 1)). Before deployment, the stent ((A A)) is compressed between the inner catheter and outer catheter at the distal end of the delivery
system. In this compressed configuration, the stent struts lie close together and the radiopaque markers appear as a contiguous band
at each end of the stent ((B
B1 1 aan nd d B B2 2)). The stent M MU US ST T N No oT T be balloon expanded beyond its labeled diameter.
A single radiopaque marker ((C C)) on the outer catheter of the delivery system is attached approximately 6 mm proximal to the distal end
of the delivery system. Prior to deployment, this radiopaque marker overlaps the distal markers ((B
B1 1)) on the stent.
The following information regarding stent length change may assist in proper stent length selection and may facilitate proper placement
in the body resulting in greater accuracy of stent placement. The information within the following table indicates the expected overall
stent length change (from its compressed condition within the catheter) when deployed at the recommended oversizing.
T Taab bllee2 2:: B B
A AR RD D
®® E E LL
U UM MIIN NE EX XX X
®® V Vaassccu ullaarr S Stteen ntt LLeen ng gtth h C Ch haan ng gee IIn nffoorrm maattiioon n
3 3..2 2 D Deelliivveerryy S Syysstteem m::
The B BA AR RD D S S..A A..FF..E E..®® 6 6FF D Deelliivveerryy S Syysstteem m requires a minimum 8F guiding catheter or a minimum 6F introducer sheath. The delivery
system has a soft and flexible catheter tip ((D D)) formed from the outer catheter. The catheter tip is tapered to accommodate a 0.035“
(0.89 mm) guidewire. The guidewire exit port is located at the proximal end of the delivery system. Prior to inserting the delivery catheter
over the guidewire, the system must be flushed with sterile saline at the two female Luer ports until saline drips from the distal tip of
the catheter. Flushing eliminates air bubbles from the inner catheter lumen and lubricates the surface between the inner and outer
catheters. The first Luer port is located at the proximal end of the device ((E
E)) and the second is found within the T-Luer adapter ((FF)). The
B BA AR RD D S S..A A..FF..E E..®® D Deelliivveerryy S Syysstteem m also features a next generation S S
T TE EN NT T
LL
o oC C
™ ™ M Meecch haan niissm m that uses compression along the entire length
of the stent to prevent unintentional movement or misplacement during deployment.
3 3..3 3 D Deep pllooyym meen ntt M Meetth hood dss::
The B
BA AR RD D S S..A A..FF..E E..®® D Deelliivveerryy S Syysstteem m with the P P
E ER RFFo oR R
M MA AX XX X®® G Grriip p ((G G)) is a multifunctional stent deployment system that offers four different
stent deployment options:
• “The Trigger Method”
• “The Slide Method”
• “The Combination Method (Trigger/Slide)”
• “The Conventional Method”
3 3..3 3..1 1 T Th hee T Trriig gg geerr M Meetth hood d
Stent deployment can be accomplished using “The Trigger Method” by pumping the trigger ((H H)) of the handle. ”The Trigger
Method” offers micro-clicks for ultimate control 2 mm at a time or full pumps for rapid, one-handed stent deployment. ((S Seeee FFiig gu urree 1 1))
3 3..3 3..2 2 T Th hee S Slliid dee M Meetth hood d
Using “The Slide Method”, the stent can be deployed by pulling back the slide mechanism ((JJ)). ((S Seeee FFiig gu urree 2 2))
3 3..3 3..3 3 T Th hee C Coom mb biin naattiioon n ((T Trriig gg geerr//S Slliid dee)) M Meetth hood d
“The Combination Method” utilizes “The Trigger Method” until the stent has achieved wall apposition and then switches to “The
Slide Method” to complete the deployment. ((S
Seeee FFiig gu urreess 1 1 & & 2 2))
T Taab bllee 1 1:: B B
A AR RD D
®® E E LL
U UM MIIN NE EX XX X
®® V Vaassccu ullaarr S Stteen ntt C Coom mp poon neen ntt IId deen nttiiffiiccaattiioon n C Cood deess
A Stent (implant) E Proximal Luer port K Safety clip
B1 4 Distal P
UZZLE
® Tantalum Markers F Distal T-Luer adapter L Safety clip tabs
B2 4 Proximal P
UZZLE
® Tantalum Markers G P
ERFoR
MAXX® Grip M Conversion tab
C A single radiopaque marker on the outer catheter H Trigger
D Flexible catheter tip J Slide mechanism
Unconstrained Stent Diameter Reference Lumen Diameter Average Length Change
(mm) (mm) at Recommended oversizing (%)
4 3 0.0
5 4 0.0
6 5 3.0
7 6 1.5
8 7 -0.5
9 8 -2.5
10 9 0.5
12 10 -3.0
12 11 -2.0
14 12 -1.5
14 13 -3.0
E En ng glliissh h
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