Bard E-Luminexx Vascular Stent Operating instructions

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For use in the iliac and femoral arteries
À utiliser dans les artères iliaques et fémorales
Zur Anwendung in A. iliaca und A. femoralis
Per uso nelle arterie iliache e femorali
Para uso en las arterias ilíaca y femoral
Voor gebruik in de arteriae iliaca en femoralis
Para utilização nas artérias ilíaca e femoral
Για χρήση στις λαγόνιες και στις μηριαίες αρτηρίες
Til brug i arteria iliaca og femoralis
För användning i höft- och lårbensartärer
Käytetään lonkka- ja reisivaltimoissa
Til bruk i bekken- og lårarteriene
Do stosowania w tętnicach biodrowej i udowej
Az arteria iliacaban és femoralisban való használatra
Pro použití v ilických a femorálních tepnách
Kalça ve uyluk atardamarlarında kullanmak için
Určené na použitie v iliakálných a femorálných tepnách
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BARD® ELUMINEXX® Vascular Stent
Delivery System Diagrams
BARD S.A.F.E.® Delivery System
with the PERFoRMAXX® Grip
S.A.F.E. designates Secure Adhesive FreE Tip Design
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BARD® ELUMINEXX® Vascular Stent
Delivery System Diagrams
BARD S.A.F.E.® Delivery System
after removal of the PERFoRMAXX® Grip
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BARD® ELUMINEXX® Vascular Stent
Table of contents
Table des matières • Inhaltsverzeichnis
Indice • Indice • Inhoudsopgave • Índice
Πίνακας Περιεχομένον • Indholdsfortegnelse
Innehållsförteckning • Sisällysluettelo
Innholdsfortegnelse • Spis treści
Tartalomjegyzék • obsah • İçindekiler • obsah
English
Page 5
Page 9
Seite 13
Italiano
Pagina 18
Página 22
Pagina 27
Página 31
Dansk
Side 40
Sida 44
Suomi
Sivu 49
Norsk
Side 53
Strona 57
oldal 61
Čeština
Strana 65
Sayfa 70
Slovenčina
Strana 74
4
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English
INFoRMATIoN FoR USE
Read the BARD® ELU MINEXX® Vascular Stent IFU thoroughly.
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.
1.0 DEVICE NAME
• The brand name of the device is BARD® ELUMINEXX® Vascular Stent.
• The Stent (Implant) is equipped with four highly visible radiopaque PUZZLE® Tantalum Markers on both the proximal and distal end.
• The BARD® ELUMINEXX® Vascular Stent is loaded on the BARD S.A.F.E.® Delivery System with the PERFoRMAXX® Grip.
2.0 PRoDUCT DIAGRAMS (PLEASE REFER To PAGE 2 AND 3)
A
Stent (implant)
E
K
Safety clip
B1
4 Distal PUZZLE® Tantalum Markers
F
Distal T-Luer adapter
L
Safety clip tabs
B2
4 Proximal PUZZLE® Tantalum Markers
G
PERFoRMAXX® Grip
M
Conversion tab
C
A single radiopaque marker on the outer catheter
H
D
Flexible catheter tip
J
Slide mechanism
3.0 DEVICE DESCRIPTIoN
3.1 Stent (Implant):
The BARD® ELUMINEXX® Vascular Stent 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 PUZZLE® Tantalum Markers to facilitate accurate stent placement (see Figure
A1). Before deployment, the stent (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 (B1 and B2). The stent MUST NoT be balloon expanded beyond its labeled diameter.
A single radiopaque marker (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 (B1) 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.
Table2: BARD® ELU MINEXX® Vascular Stent Length Change Information
Unconstrained Stent Diameter
(mm)
Average Length Change
at Recommended oversizing (%)
4
3
0.0
5
4
0.0
6
5
3.0
7
8
9
10
6
7
8
9
1.5
-0.5
-2.5
0.5
12
10
-3.0
12
11
-2.0
14
12
-1.5
14
13
-3.0
3.2 Delivery System:
The BARD S.A.F.E.® 6F Delivery System requires a minimum 8F guiding catheter or a minimum 6F introducer sheath. The delivery
system has a soft and flexible catheter tip (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) and the second is found within the T-Luer adapter (F). The
BARD S.A.F.E.® Delivery System also features a next generation STENTLoC™ Mechanism that uses compression along the entire length
of the stent to prevent unintentional movement or misplacement during deployment.
3.3 Deployment Methods:
The BARD S.A.F.E.® Delivery System with the PERFoRMAXX® Grip (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”
3.3.1 The Trigger Method
Stent deployment can be accomplished using “The Trigger Method” by pumping the trigger (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. (See Figure 1)
3.3.2 The Slide Method
Using “The Slide Method”, the stent can be deployed by pulling back the slide mechanism (J). (See Figure 2)
3.3.3 The Combination (Trigger/Slide) Method
“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. (See Fig ures 1 & 2)
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3.3.4 The Conven tional Method
“The Conventional Method" requires the user to remove the white conversion tab (M) before snapping the catheter out of the
PERFoRMAXX® Grip. The stent can then be deployed by using the conventional “pin & pull-back” technique by pulling back the T-Luer
adapter (F). (See Figure 3)
Figure 1:
Figu re 2:
Conventional Method
A removable red Safety Clip (K) prevents accidental or premature stent release. Do NoT remove the Safety Clip (K) until you are ready
to deploy the stent. Just prior to deploying the stent, the Safety Clip (K) must be removed by pressing the two red tabs (L) together and
removing the clip from the grip.
3.4 Radiopaque Markers and Verification of Positioning:
There are four radiopaque tantalum markers on each end of the stent and an additional radiopaque marker band on the outer catheter
of the deployment system. In its compressed stage, the tantalum markers appear like a contiguous band at each end of the stent:
• Four radiopaque tantalum markers on each end of the stent indicate the location of the distal (B1) and proximal end of the
compressed stent (B2)
• one radiopaque marker band is attached to the outer catheter (C, same position as B1) and overlaps the four distal markers on the
stent prior to deployment. This moving marker indicates the amount of stent deployed during the procedure.
During stent deployment, the radiopaque markers on the stent (B1 and B2) should not move. The marker band (C) on the outer catheter
will retract with the outer catheter during stent deployment. When the moving marker is past the proximal marker (B2) by 2 cm, the
stent is fully released.
4.0 INDICATIoNS FoR USE
The BARD® ELUMINEXX® Vascular Stent is indicated for:
• Residual stenoses with impaired perfusion (pressure gradient) following balloon dilatation, especially in stages III and IV according
to Fontaine
• Dissection
• Detached arteriosclerotic plaque material and luminal obstruction following balloon dilatation
• occlusion after thrombolysis or after aspiration and before dilatation
• Restenosis or reocclusion
5.0 CoNT RAINDICATIoNS
Contraindications for the BARD® ELUMINEXX® Vascular Stent include, but may not be limited to:
•
•
•
•
•
Uncorrected coagulopathies
Functionally relevant obstruction of the inflow path, poor outflow or no distal runoff
Fresh, soft thrombotic or embolic material
Placement in the distal superficial femoral artery
Placement in the popliteal artery
6.0 WARNINGS
6.1 General Warnings:
• Should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and
stent delivery system) should be removed as a single unit.
• Patients with known hypersensitivity to nickel-titanium may suffer an allergic reaction to this implant.
• Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.
• overstretching the artery may result in spasm, dissection, and/or perforation that may result in serious complications.
6.2 Device Warnin gs:
• Visually inspect the packaging to verify that the sterile barrier is intact. Do NoT use if the sterile barrier is open or damaged.
• Do NoT use the device after the “Use By” date specified on the label.
• Visually inspect the BARD® ELUMINEXX® Vascular Stent to verify that the device has not been damaged due to shipping or improper
storage. Do NoT use damaged equipment.
• Take care to avoid unnecessary handling, which may kink or damage the delivery system. Do NoT use if device is kinked.
• If the red safety clip has been removed or becomes inadvertently detached from the grip, Do NoT use the device.
• The delivery system catheter is intended for stent deployment only and not for any other use.
• During system flushing, Do NoT use the system if fluid is not observed exiting the catheter at the distal tip.
• If placing two overlapping stents, both stents must have identical diameters and similar metal composition.
• once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should not be dragged or
repositioned in the lumen.
• once stent deployment has been initiated, the stent cannot be recaptured using the stent delivery system.
• If the PER FoRMAXX® Grip is removed from the stent delivery system, it MUST NoT be reattached. In this event, the stent MUST be
deployed using “The Conventional Method” of deployment. (See instructions for “The Conventional Method”.)
• This product has been designed for single patient use only. Do NoT reuse. Do NoT resterilize.
• After use, the stent delivery system is a potential biohazard. Handle and dispose of this product in accordance with accepted medical
practice and with applicable local, state and federal laws and regulations.
7.0 PRECAUTIoNS
This device is intended for use only by physicians who are familiar with the principles, clinical applications, complications, side effects,
and risks commonly associated with vascular stenting. It is strongly recommended that physician operators adhere to all applicable
institutional, local, state, and federal guidelines and protocols regarding adequate procedural training.
7.1 System Handling Precautions:
• Non-compliance with sterility precautions may lead to infectious complications.
• An appropriate guidewire is required before introducing the stent deployment system into the body, and must remain in place during
the introduction, manipulation and eventual removal of the stent deployment system.
• The BARD® ELUMINEXX® Vascular Stent is only compatible with a 0.035“ (0.89 mm) guidewire.
• When catheters are in the body, they should be manipulated only under fluoroscopy with radiographic equipment that produces high
quality images.
• Read and understand the IFU for any interventional device to be used in conjunction with the BARD® ELUMINEXX® Vascular Stent.
• The delivery system is not designed for use with power injection systems.
• Faulty placement techniques could lead to stent deployment failure.
• Do not kink the delivery system.
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• The delivery system will not function properly until the Safety Clip (K) is removed (See Figure A2). As a precaution against accidental
stent deployment, the Safety Clip should not be removed until the stent is ready to be deployed.
• Store in a cool, dry, dark place.
7.2 Stent Placement Precautions:
The stent experiences minimal length changes during deployment. (See Table 2)
Appropriate diameter sizing of the stent to the target lesion is required to reduce the possibility of stent migration.
Prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement.
Do NoT remove the white conversion tab (M) unless you have selected "The Conventional Method" for stent deployment.
Do NoT remove the Safety Clip (K) until you are ready to deploy the stent.
Do NoT hold the delivery system catheter during stent deployment. (See Figure A3/A4)
Do NoT overlap more than two stents.
The BARD® ELUMINEXX® Vascular Stent is a self-expanding nitinol stent that MUST NoT be expanded beyond its labeled diameter by
dilatation with a PTA balloon.
• As with all self-expanding nitinol stents, careful attention during stent deployment is warranted to mitigate the potential for movement
of the stent.
• If more than one stent is required to cover the lesion, the distal lesion should be stented first, followed by stenting of the proximal
lesion. Stenting in this order obviates the need to cross the proximal stent for placement of the distal stent, and reduces the potential
to dislodge stents that have already been placed.
• To maximize stent placement accuracy, slowly and deliberately deploy the distal portion of the stent until you have visual confirmation
of wall apposition before steadily deploying the remaining length of the stent.
•
•
•
•
•
•
•
•
7.3 Post-Implant Precautions:
• Caution should be used when crossing a deployed stent with any adjunctive device.
8.0 PoTENTIAL CoMPLICATIoNS
Potential adverse events associated with the use of the BARD® ELUMINEXX® Vascular Sten t include, but may not be limited to the usual
complications reported for vascular procedures such as:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Adverse and / or allergic reactions to antiplatelet agents / contrast medium / drugs / implant material
Aneurysm
Arrhythmia
Arterial occlusion / thrombosis at puncture site or remote site
Ateriovenous fistula
Bacteremia or septicemia
Bleeding from anticoagulant or antiplatelet medications
Detachment of a component of the system
Embolization, distal (air, tissue or thrombotic emboli)
Emergent surgery to remove stent
Fever
Groin hematoma, with or without surgical repair
Hemorrhage, with or without transfusion
Hyperperfusion syndrome
Hypotension / hypertension
Infection and pain at insertion site
Ischemia / infarction of tissue / organ
Pseudoaneurysm
Restenosis, recurrent narrowing or occlusion of stented segment
Stent embolization
Stent fracture
Stent malposition (failure to deliver the stent to the intended site)
Stent migration
Stent thrombosis / occlusion
Vasospasm
Vessel spasm or recoil
Vessel tear, dissection, perforation, or rupture
Vessel total occlusion
9.0 DIRECTIoNS FoR USE
9.1 Procedural Access:
• Gain access to the treatment site utilizing appropriate accessory equipment compatible with the 6F BARD® ELUMINEXX® Vascular Stent
System.
• The working lengths of the BARD S.A.F.E.® 6F Delivery System are indicated on the labels and on the device itself. In order to allow
complete stent deployment, Do NoT use an introducer sheath or guiding catheter longer than the indicated working length.
• The BARD S.A.F.E.® 6F Delivery System requires a minimum 8F guiding catheter, or a minimum 6F introducer sheath.
• Via the femoral route, insert a 0.035“ (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath
or guiding catheter and pass the lesion. (See Figure A5, A6, A7 and A8)
9.2 Stent Selection:
• Appropriate diameter sizing of the stent to the target lesion is required to reduce the possibility of stent migration.
• Evaluate and mark the stricture. Measure the length of the stricture and the diameter of the target lumen to assist in stent selection.
• Use the following guidelines for proper stent diameter selection. For target lumens ranging from 3 mm to 9 mm, select a stent with
an unconstrained diameter of 1 mm larger than the target lumen. For target lumens ranging from 9 mm to 13 mm, select a stent
with an unconstrained diameter of 1 to 2 mm larger than the target lumen.
• Select the appropriate length of stent to traverse the stricture.
• Allow approximately 5 – 10 mm of the stent to extend beyond each end of the stricture. This will allow for adequate stent coverage
at either end of the stenosis.
• If placing two overlapping stents, both stents must have identical diameters.
• Stents should overlap by at least 5 mm to include the flared ends. Do NoT overlap more than two stents.
9.3 General Directions:
• Administration of adjunctive drug therapy before and after the procedure is left to the discretion of the treating physician.
• Pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician.
9.4 Preparation of the Stent Delivery System:
• Visually inspect the packaging to verify that the sterile barrier is intact. Do NoT use if the sterile barrier is open or damaged.
• Do NoT use the device after the “Use By” date specified on the label.
• Visually inspect the BARD® ELUMINEXX® Vascular Stent System to verify that the device has not been damaged due to shipping or
improper storage. Do NoT use damaged equipment.
• The delivery system catheter is intended for stent deployment only and not for any other use.
• Flush the stent delivery system with sterile saline using a small volume (e.g., 5 – 10 cc) syringe. Attach the saline filled syringe to
the two female Luer ports, the first of which is located at the proximal end of the device (E) and the second of which is found within
the T-Luer adapter (F). Continue flushing until saline drips from the distal tip of the catheter (D) after flushing each Luer port.
• During system flushing, Do NoT use the system if fluid is not observed exiting the catheter at the distal tip (D) after each Luer port
is flushed.
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• During delivery system preparation, ensure that the red safety clip remains in place until the stent is ready to be deployed. If the red
safety clip has been removed or becomes inadvertently detached from the grip, Do NoT use the device.
9.5 Selection of Deployment Method:
• Determine whether you will use the PERFoRMAXX® Grip for stent deployment. (See instructions for “Stent Deployment with the
PERFoRMAXX® Grip”, Section 9.8.)
• If selecting “The Conventional Method” of stent deployment, this option must be selected at the beginning of the procedure. (See
instructions for “The Conventional Method”, Section 9.9).
• If the PER FoRMAXX® Grip is removed from the stent delivery system, it MUST NoT be reattached. In this event, the stent MUST be
deployed using “The Conventional Method” of deployment.
• A removable red Safety Clip (K) prevents accidental or premature stent release.
• Do NoT remove the Safety Clip (K) until you are ready to deploy the stent.
• Just prior to deploying the stent, the Safety Clip (K) must be removed by pressing the two red tabs (L) together and removing the
clip from the grip. (See Figure A2)
9.6 Introduction of the Stent Delivery System:
• Insert the guidewire into the distal tip of the catheter until it exits the catheter at the proximal end of the device.
• Advance the delivery catheter over the guidewire into the target lumen. (See Figure A5, A6, A7 and A8)
• Under fluoroscopic visualization, advance the stent delivery system across the stricture using the radiopaque markers to center the
stent across the lesion. (See Figure A1)
• It is recommended to advance the delivery system past the stricture and then to pull back slightly on the entire system to achieve
the correct positioning of the markers and to help insure that slack has been removed and that the delivery catheter is straight.
• Prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement.
• Do NoT hold the delivery system catheter during stent deployment. (See Figure A3/A4)
9.7 Stent Placement:
• During stent deployment, the entire length of the catheter system should be kept as straight as possible. Maintaining a straight
catheter under slight tension during stent deployment is recommended to improve placement accuracy.
• Center the proximal stent markers (SSee Figure A1, “B2”) and both overlapping distal markers (SSee Figure A1, stent markers “B1”
and marker band on the outer catheter “C”) across the stricture. The radiopaque markers on the stent indicate the ends of the
compressed stent and the length of the expanded stent.
• By initially advancing the catheter beyond the stricture, micro-adjustments of the stent can be made by pulling the entire system
back toward the stricture to improve placement accuracy.
• once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should NoT be dragged or
repositioned in the lumen.
• once stent deployment has been initiated, the stent CANNoT be recaptured using the stent delivery system.
• once the moving marker has passed the proximal end of the stent by approximately 2 cm, the stent is completely deployed.
• Complete stent deployment can be fluoroscopically visualized when the radiopaque markers at the proximal and distal ends of the
stent are fully expanded.
9.8 Stent Deployment With the PE RFoRMAXX® Grip:
• There are three different stent deployment options with the PERFoRMAXX® Grip:
– “The Trigger Method” (See Section 3.3, Figure 1)
– “The Slide Method” (See Section 3.3, Figure 2)
– “The Combination Method (Trigger/Slide)”
• Switching from “The Trigger Method” to “The Slide Method” can be done at any time during stent deployment; however, switching
from “The Slide Method” to “The Trigger Method” MUST be avoided.
• Do NoT remove the Safety Clip (K) until you are ready to deploy the stent.
• Just prior to stent deployment, remove the red Safety Clip (K) by pressing the two red tabs (L) together and removing the clip from
the grip. (See Figure A2)
• Under fluoroscopic visualization, deploy the stent utilizing your chosen method of deployment until the stent is fully deployed and
the slide mechanism has reached the proximal end of the handle. (See Figure A9 – A11)
• During stent deployment (See Figure A12), the moving radiopaque marker (C) on the outer catheter moves backwards toward the
proximal markers on the stent (B2). The radiopaque markers on the stent (B1, B2) MUST NoT move during stent deployment.
• After stent deployment, carefully withdraw the delivery system from the patient over the guidewire. After removing the delivery
system, visually confirm that the entire stent delivery system has been removed. (See Figure A13)
(a) inner catheter
(b) outer catheter
(c) moving distal marker (C) on outer catheter
• Final radiological evaluation of the implanted stent should be conducted by angiogram.
9.9 Stent Deployment Using The Conventional Method:
• In addition to the three deployment options outlined in Section 9.8 there is also an option to release the stent WITHoUT the
PERFoRMAXX® Grip:
– “The Conventional Method” (See Section 3.3, Figure 3)
• To allow "The Conventional Method" of deployment, remove the white conversion tab (M) from the back of the grip. (See Figure A14)
• Separate the PERFoRMAXX® Grip from the delivery system catheter by grasping the Luer lock (E) at the back end of the handle and
gently twisting to snap the catheter out of the back of the grip. (See Figure A15) Then grasp the deployment system at the front T-Luer
adapter (F) and snap the deployment system completely out of the grip. (See Figure A16) Use caution not to bend the metal portion
of the catheter during removal from the grip.
• Do NoT remove the Safety Clip (K) until you are ready to deploy the stent.
• Just prior to stent deployment, remove the red Safety Clip (K) by pressing the two red tabs (L) together and removing the clip from
the grip. (See Figure A17)
• Under fluoroscopic visualization, deploy the stent using the conventional “pin & pull-back” technique by slowly pulling back the T-Luer
adapter (F) towards the hand that is pinned in place. Pulling back on the T-Luer adapter (F) directly retracts the outer catheter and
deploys a corresponding portion of the stent. (See Figure A18)
• Full stent deployment is ensured when the T-Luer adapter (F) reaches the metal handle. (See Figure A19)
• During stent deployment (See Figure A12), the moving radiopaque marker (C) on the outer catheter moves backwards toward the
proximal markers on the stent (B2). The radiopaque markers on the stent (B1, B2) MUST NoT move during stent deployment.
• After stent deployment, carefully withdraw the delivery system from the patient over the guidewire. After removing the delivery
system, visually confirm that the entire stent delivery system has been removed. (See Figure A13)
(a) inner catheter
(b) outer catheter
(c) moving distal marker (C) on outer catheter
• Final radiological evaluation of the implanted stent should be conducted by angiogram.
9.10 Post-Stent Placemen t:
• Post-dilatation of the stent with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician.
• The BARD® ELUMINEXX® Vascular Stent is a self-expanding, nitinol stent that MUST NoT be expanded beyond its labeled diameter by
dilatation with a PTA balloon.
• This product has been designed for single patient use only. Do NoT reuse. Do NoT resterilize.
• After use, the stent delivery system is a potential biohazard. Handle and dispose of this product in accordance with accepted medical
practice and with applicable local, state and federal laws and regulations.
10.0 PATIENT IMPLANT INFoRMATIoN CARDS
• A Patient IMPLANT Information Card is provided in the back of the IFU for your convenience.
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• The Patient IMPLANT Information Card should be carefully folded along the perforations and removed from the IFU after the completion
of the procedure.
• The Patient Data, Implant Data, and Hospital Data should be carefully recorded on the card and given to the patient.
• Apply one of the peel-off stickers found in the IFU to the indicated area on the Patient IMPLANT Information Card. This peel-off sticker
contains important information about the patient's stent implant.
• The patient should carry this card with them and provide to any medical personnel caring for the patient in the future.
11.0 MAGNETIC RESoNANCE IMAGING (MRI) INFoRMATIoN
Non-clinical testing demonstrated that the BARD® ELUMINEXX® Vascular Stent is MR Conditional. A patient with the BARD® ELUMINEXX®
Vascular Stent can be scanned safely, immediately after placement of this implant, under the following conditions:
• Static magnetic field of 3.0 Tesla or less
• Spatial gradient field of 720 Gauss/cm or less
• Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of scanning.
In non-clinical testing, the BARD® ELUMINE XX® Vascular Stent produced a temperature rise of less than or equal to 0.8°C at a maximum
MR system-reported whole body averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of MR scanning in a 3.0 Tesla MR
system (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI).
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the BA RD ®
ELUMINEXX® Vascular Stent. optimization of MR imaging parameters is recommended.
The effect of heating in the MR environment for overlapping stents or stents with fractured struts has not been evaluated.
12.0 HoW SUPPLIE D
The BARD® ELUMINEXX® Vascular Stent is supplied sterile (by ethylene oxide gas) unless the package has been opened or damaged. This
product has been designed for single patient use only.
Do NoT reuse. Do NoT resteriliz e. Store in a cool, dry, dark place.
MoDE D’EMPLoI
A
Stent (implant)
E
K
B1
F
L
B2
G
M
C
H
D
J
4
3
0.0
5
6
7
8
4
5
6
7
0.0
3.0
1.5
-0.5
9
10
12
12
14
14
8
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(mm)
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(%)
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Traditionelle Methode
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Fig. 2:
Fig. 3:
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MANUAL DE INSTRUCCIoNES
A
Stent (endoprótesis)
E
K
B1
F
Adaptador T-Luer distal
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B2
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M
C
H
D
J
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A
E
Proximale Luer-poort
K
B1
4 distale PUZZLE® tantalum markeringsbanden
F
Distale T-Luer-adapter
L
B2
4 proximale PUZZLE® tantalum markeringen
G
PERFoRMAXX® greep
M
C
Een enkele radiopake markering op de uitwendige
katheter
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Flexibele kathetertip
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Afbeelding 2:
Afbeelding 3:
Conventionele methode
Reststenose met belemmerde perfusie (drukgradiënt) na ballondilatatie, met name in de Fontaine-stadia III en IV
Dissectie
Losgeraakt arteriosclerotisch plaquemateriaal en obstructie van het lumen na ballondilatatie
occlusie na trombolyse of na aspiratie en voor dilatatie
Restenose of reocclusie
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INSTRUÇŐES PARA UTILIZAÇĂo
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Mecanismo de Deslize
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Figura 3:
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Dansk
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Stent (implantat)
E
Proksimal luerport
B1
B2
K
F
Distal T-lueradapter
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G
M
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H
D
Fleksibel kateterspids
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Stent (implantat)
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K
B1
4 distala PUZZLE® tantalmarkörer
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Distal T-lueradapter
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B2
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Glidmekanism
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Figur3:
Glidmetod
Konventionell metod
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Suomi
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Distaalinen T-Luer-sovitin
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Liukumekanismi
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Kuva 2:
Kuva 3:
Perinteinen menetelmä
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11.0 MAGNEETTIKUVANTAMISTIEDoT (MRI)
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Norsk
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Stent (implantat)
E
K
B1
4 distale PUZZLE® tantalmarkører
F
Distal T-lueradapter
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B2
4 proximala PUZZLE® tantalmarkörer
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Figur 2:
Figur 3:
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Csúsztató mechanizmus
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Čeština
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Rukojeť PERFoRMAXX®
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Stent (implant)
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Proksimal Luer portu
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Distal T-Luer adaptörü
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PERFoRMAXX® Sap
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Şekil 1:
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Slovenčina
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Symbols used on labelling • Symboles utilisés sur l'étiquetage • Erklärung der Symbole auf der Verpackung •
Simboli utilizzati nell'etichettatura • Símbolos usados en el etiquetado • Symbolen op de etiketten • Símbolos
utilizados na etiquetagem • Σύμβολα που χρησιμοποιούνται στην επισήμανση • Symboler anvendt på mærkater •
Symboler som används på etiketten • Myyntipäällysmerkinnöissä käytettävät merkit • Symboler som brukes på
merking • Symbole stosowane na etykietach • Címkéken használt szimbólumok • Symboly používané na značení •
Etiketlemede kullanılan simgeler • Symboly používané na označeniach
Consult instructions for u se • Voir les instructions d’utilisation • Gebrauchsanweisung
beachten • Leggere le istruzioni per l’uso • Consultar las instrucciones de uso • Raadpleeg de
gebruiksaanwijzing • Consulte as instruções de utilização • Συμβουλευτείτε τις οδηγίες χρήσης
• Se brugsanvisningen • Läs bruksanvisningen för användningen • Lue käyttöohjeet • Se
bruksanvisningen • Sprawdzić w instrukcji użycia • olvassa el a használati útmutatót • Viz
návod k použití • Kullanım yönergeleri’ne Başvurun • Pozri návod na použitie
Keep away from sunlight • À conserver à l'abri du rayonnement solaire • Vor Sonnenlicht
geschützt aufbewahren • Tenere al riparo dalla luce diretta • Manténgase alejado de la luz solar •
Niet bewaren in direct zonlicht • Manter afastado da luz solar • Διατηρείται μακριά από το
ηλιακό φως • Holdes borte fra sollys • Skyddas från ljus • Pidettävä poissa auringonvalosta •
Holdes unna sollys • Chronić przed światłem słonecznym • Napfénytől távol tartandó • Chraňte
před přímým slunečním světlem • Güneş ışığından uzak tutunuz • Chráňte pred slnečným svetlom
Keep dry • À conserver à l'abri de l'humidité • Trocken aufbewahren • Mantenere asciutto •
Manténgase seco • Droog bewaren • Manter seco • Διατηρείται στεγνό • Holdes tørt • Förvaras
torrt • Pidettävä kuivana • Hold tørr • Przechowywać w suchym miejscu • Szárazon tartandó •
Chraňte před vlhkem • Kuru yerde saklayınız • Uchovávajte v suchu
Do not use if package is damaged • Ne pas utiliser si l'emballage est endommagé. • Bei
beschädigter Verpackung nicht verwenden • Non usare se la confezione è danneggiata. • No
utilice el dispositivo si el embalaje está dañado. • Niet gebruiken als de verpakking beschadigd
is. • Não utilizar se a embalagem estiver danificada. • Μην το χρησιμοποιήσετε εάν η
συσκευασία έχει υποστεί ζημιά. • Må ikke bruges hvis emballagen er beskadiget. • Använd inte
om förpackningen är skadad. • Älä käytä, jos pakkaus on vaurioitunut. • Ikke bruk dersom
pakken er skadet. • Nie należy używać, jeśli opakowanie jest uszkodzone. • Ne használja, ha
a csomagolás sérült! • V případě porušení obalu zařízení nepoužívejte. • Ambalaj hasarlıysa
kullanmayın. • Nepoužívať, ak je balenie otvorené alebo poškodené.
Single use • Ne pas réutiliser • Nur zum Einmalgebrauch • Monouso • Para un solo uso • Enkel
voor eenmalig gebruik • Utilizar apenas uma vez • Μιας Χρήσης Μόνον • Kun til engangsbrug •
Endast för engångsbruk • Kun til engangsbruk • Vain kertakäyttöinen • Tylko do jednorazowego
użytku • Egyszeri használatra • Pouze pro jednorázové použití • Sadece Tek Kullanımlık • Na
jedno použitie
Do not res terilize • Ne pas restériliser • Nicht erneut sterilisieren • Non risterilizzare • No
reesterilizar • Niet opnieuw steriliseren • Não reesterilizar • Μην επαναποστειρώνετε • Må ikke
resteriliseres • Får ej återsteriliseras • Ei saa steriloida uudestaan • Må ikke resteriliseres • Nie
nadaje się do ponownej sterylizacji • Újrasterilizása tilos • Nesterilizovat opakovaně • yeniden
sterilize etmeyiniz • Neresterilizujte
Units • Unités • Stück • Unità • Unidades • Eenheden • Unidades • Μονάδες • Enheder •
Innehåll • yksiköt • Enheter • Ilość • Egységek • Počet jednotek • Birim • Jednotky
MR Conditional • Compatibilité conditionnelle à la résonance magnétique • Bedingt für MRI
geeignet • Condizioni per la RM • Condicional con respecto a RM • MR Conditional • Condicional
a RM • Υπό προϋποθέσεις κατάλληλο για μαγνητική τομογραφία • MR m/forbehold • MRT-säker •
Soveltuvuus magneettikuvaukseen • MR-betinget • Warunkowe stosowanie z MRI • MR-vizsgálattal
csak feltételesen kompatibilis • Podmíněná bezpečnost pro magnetickou rezonanci (MR) • MR
Şartlı • ovplyvňované poľom MR
Does not contain Natural Rubber Latex • Ne contient pas de latex d'élastomère-caoutchouc
naturel • Enthält keinen Naturkautschuklatex • Non contiene Lattice di Gomma Naturale • No contiene látex de caucho natural • Bevat geen natuurlijk rubberlatex • Não contém Látex de
Borracha Natural • Δεν περιέχει φυσικό ελαστικό κόμμι • Indeholder ikke naturlig gummilatex •
Innehåller inte naturgummi • Ei sisällä luonnonkumilateksia • Inneholder ikke naturlig gummilatex • Nie zawiera naturalnej gumy lateksowej • Természetes latex gumit nem tartalmaz •
Neobsahuje přírodní latex • Doğal Kauçuk Lateks İçermez • Neobsahuje prírodný gumový latex
Catalogue number • Numéro de catalogue • Bestellnummer • Numero di catalogo •
Número de catálogo • Catalogus-nummer • Número do catálogo • Αριθμός καταλόγου •
Katalognummer • Katalognummer • Luettelonumero • Katalognummer • Numer
katalogowy • Katalógusszám • Katalogové číslo • Katalog Numarası• Katalógové číslo
Lot number • Numéro de lot • Chargenbezeichnung • Numero di lotto • Número de
lote • Partijnummer • Número de lote • Αριθμός παρτίδας • Batchnummer •
Satsnummer • Eränumero • Lot nummer • Numer partii • Gyártási tétel szám • Číslo
šarže • Lot Numarası • Číslo šarže
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Sterilized using ethylene oxide • Stérilisé à l’oxyde d’éthylène • Sterilisation mit
Ethylenoxid • Sterilizzato ad ossido di etilene • Esterilizado con óxido de etileno •
Gesteriliseerd met ethyleenoxide • Esterilizado com óxido de Etileno • Αποστειρωμένο
με οξείδιο του αιθυλενίου • Ethylenoxid-steriliseret • Steriliserad med etylenoxid •
Steriloitu etyleenioksidilla • Sterilisert med etylenoksid • Sterylizowane tlenkiem etylenu
• Etilén-oxiddal sterilizálva • Sterilizováno etylénoxidem • Etilen oksitle Sterilize
Edilmiştir • Sterilizované etylénoxidom
Use by • À utiliser avant • Verwendbar bis • Utilizzare entro • Usar antes de • Te gebruiken voor
• Validade • Χρησιμοποιήστε μέχρι • Anvendes før • Utgångsdatum • Käyt. ennen • Bruk før •
Termin ważności • Lejárati dátum • Použitelné do • Son Kullanma Tarihi • Naudoti iki
Manufacturer • Fabricant • Hersteller • Fabbricante • Fabricante • Fabrikant • Fabricante •
Κατασκευαστής • Fremstillet af • Tillverkare • Valmistaja • Tilvirker • Producent • Gyártó •
Výrobce • Üretici • Výrobca
Date of manufacture • Date de fabrication • Herstellungsdatum • Data di fabbricazione • Fecha
de fabricación • Fabricagedatum • Data de fabrico • Ημερομηνία Κατασκευής •
Fremstillingsdato • Tillverkningsdatum • Valmistuspäivämäärä • Produksjonsdato • Data
produkcji • Gyártás dátuma • Datum výroby • Üretim tarihi • Dátum výroby
Min imum in troduc er si ze • Taille minimale de l’introducteur • Mindestgröße des
Einführbestecks • Misura minima dell’introduttor • Tamaño de introductor mínimo • Minimum
introducergrootte • Tamanho mínimo do introdutor • Ελάχιστο Μέγεθος Εισαγωγέα • Minimum
introducerstørrelse • Minsta storlek på introducern • Paikalleenasetuslaitteen pienin koko •
Minimal innførerstørrelse • Minimalny rozmiar prowadnika • Bevezetőhüvely minimális mérete •
Minimální velikost zaváděče • Minimum İntroduser Büyüklüğü • Minimálna veľkosť zavádzača
Gu idew ire c omp atib ility • Compatibilité de guide métallique •
Führungsdrahtkompatibilität • Compatibilità guida angiografica • Compatible con
guías de • Voerdraad-compatibiliteit • Compatibilidade do fio-guia • Συμβατότητα με
οδηγούς σύρματος • Guidewire-kompatibilitet • Ledar-kompatibilitet • ohjauslangan
yhteensopivuus • Ledetrådkompatibilitet • Kompatybilność prowadnika • Vezetődrót
kompatibilitása • Kompatibilita vodícího drátu • Kılavuz Tel Uyumluluğu •
Kompatibilita s vodiacim drôtom
Working Length • Longueur opérationnelle • Arbeitslänge • Lunghezza utile • Longitud de trabajo • Werklengte •
Comprimento de trabalho • έχει μήκος • Funktionslængde • Arbetslängd • Käyttöpituus • Arbeidslengde • Długość
robocza • Hasznos hossz • Pracovní délka • yerleştirilen yerin uzunluğu • Pracovná dĺžka
Stent Diameter • Diamètre du stent • Stent Durchmesser • Diametro dello stent • Diámetro del stent • Diameter
van de stent • Diâmetro do stent • Διάμετρος του stent • Diameter af den stent • Stentdiameter • Stentin halkaisija •
Stentdiameter • Średnica stentu • Stent átmérője • Průměr stentu • Stent çapı • Priemer stentu
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Manufacturer:
Bard and ELuminexx are trademarks and/or registered
trademarks of C. R. Bard, Inc.
This Device is classified as MR Conditional.
For further details please consult the Instructions for Use.
MR Conditional
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08.03.2010
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Carry this card with you. Prior to any treatment, please show it to all medical
personnel caring for you.
BARD® ELUMINEXX® Vascular Stent
Patient IMPLANT Information Card
English
Stent vasculaire BARD® ELUMINEXX®
Patient IMPLANT Information Card
Fiche d'informations patient RECEVEUR D’IMPLANT
BARD® ELUMINEXX® Vascular Stent
IMPLANTAT-Patienteninfokarte
IMPLANTAT-Patienteninfokarte
Patient Data:
Name:
Address:
Date of birth:
Implant Data:
Product:
Implantation site:
Date of implantation:
Follow up:
Implant Material:
Implantationsmaterial:
Arzt:
Telefon-Nr. :
Apply “Patient/Inv. chart” sticker here
Physician:
Phone:
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Fabrikant:
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
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08.03.2010
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Italiano
Stent vascular BARD® ELUMINEXX®
BARD® ELUMINEXX® vasculaire stent
IMPLANTAAT patiënten-informatiekaart
Implantatiemateriaal:
Arts:
Telefoonnr.:
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
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Stent Vascular BARD® ELUMINEXX®
BARD® ELUMINEXX® vaskulær stent
Patientinfo-kort for IMPLANTAT
Dansk
Patientdata:
Navn:
Adresse:
Fødselsdato:
Implantatmateriale:
Implantatdata:
Produkt:
Implantationssted:
Implantationsdato:
opfølgning:
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
MR Conditional
IMPLANTAT Patient Info-kort
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
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15:52
Suomi
08.03.2010
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Implanttimateriaali:
Dane szpitala:
Nazwa:
Adres:
Materiał implantu:
Lekarz:
Telefon:
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Tel: ++ 49 721 9445 - 0
Fax: ++ 49 721 9445 - 111
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
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Čeština
Údaje o implantátu:
Výrobek:
Místo implantace:
Datum implantace:
Kontrola:
Materiál implantátu:
Zde umístěte nálepku se schématem "Patient/Inv. chart"
Lékař:
Telefon:
orvos:
Telefon:
Produktdaten
Physician’s Record
Name:
Date of implantation:
Implantation site:
Follow up:
Manufacturer: Angiomed GmbH & Co. Medizintechnik KG •
Wachhausstraße 6 • 76227 Karlsruhe • Germany
apply “Patient/Inv. chart” sticker here
Name:
Date of implantation:
Implantation site:
Follow up:
apply “Patient/Inv. chart” sticker here
Product Data
Product Data
REMoVE THESE LABELS To CoMPLETE yoUR PATIENT FILE
English
15:52
Name:
Implantationsdatum:
Implantationsstelle:
Verlaufskontrolle:
ENLEVER CES éTIQUETTES PoUR REMPLIR LE DoSSIER DE VoTRE PATIENT
08.03.2010
Produktdaten
08.03.2010
15:52
Seite 94
Solicite aqui la pegatina “Patient/Inv. Chart”
Solicite aqui la pegatina “Patient/Inv. Chart”
Dati zul
paziente:
Applicare qui l’etichetta “Patient/Inv. Chart”
Dati zul
paziente:
Applicare qui l’etichetta “Patient/Inv. Chart”
PER CoMPLETARE LA CARTELLA DEL PAZIENTE, STACCARE QUESTE ETICHETTE
Italiano
15:52
Registro del médico
QUITE ESTAS ETIQUETAS PARA CoMPLETAR SU FICHA DEL PACIENTE
08.03.2010
VERWIJDER DEZE ETIKETTEN oM HET DoSSIER VAN DE PATIëNT TE VoLTooIEN
08.03.2010
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Seite 96
Navn:
Implantationsdato:
Implantationssted:
opfølgning:
Produktdata
15:52
Navn:
Implantationsdato:
Implantationssted:
opfølgning:
08.03.2010
Journal
Produktdata
Dansk
08.03.2010
15:52
Seite 98
Potilastiedot:
Potilastiedot:
IRRoTA NÄMÄ TARRAT JA KIINNITÄ NE SAIRASKERToMUKSEEN
Suomi
Namn:
Datum for implantation:
Implantationsställe:
Uppföljning:
Tillverkad av: Angiomed GmbH & Co. Medizintechnik KG •
Wachhausstraße 6 • 76227 Karlsruhe • Germany
15:52
Dane produktu
08.03.2010
08.03.2010
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Seite 100
Hasta Verileri:
Údaje o výrobku
Údaje o výrobku
15:52
oDSTRAŇTE TyTo ŠTÍTKy, DoPLNÍTE TAK SPIS VAŠEHo PACIENTA
Čeština
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Hasta Verileri:
08.03.2010
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Seite 102
08.03.2010
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Seite 103
C. R. Bard, Inc.
730 Central Avenue
Murray Hill, NJ 07974
U.S.A.
Bard S.p.A.
Via Cina 444
00144 Roma
Italy
Bard Norden AB
Karbingatan 22
Box 22210
250 24 Helsingborg
Sweden
Bard Shannon Limited
Earlsfort Center
Dublin 2
Ireland
Bard Hellas S.A.
72, Vouliagmenis Ave. & 22, Alkiviadou Str.
16675 Glyfada
Greece
Bard Medica S.A.
Thaliastrasse 125 a/1/5
1160 Wien
Austria
Bard Singapore Private Limited
51 Goldhill Plaza, # 20-05
Singapore 308900
Republic of Singapore
Bard Australia PTy LTD.
69-71 Waterloo Street
North Ryde, N.S.W. 2113
Australia
Bard India Healthcare Pvt. Ltd.
Krishna Bhavan,
Nehru Road
Vile Parle East
Mumbai - 400 057
India
Bard KoREA
Medical Devices Limited #201
2nd Floor Daenong Building
33-1 Mapo-Dong
Mapu-Ku, Seoul
Korea
Bard Limited
Forest House
Tilgate Forest Business Park
Brighton Road, Crawley
West Sussex, RH11 9BP
England
Bard Canada, Inc.
2715 Bristol Circle, Unit 1
oakville, oN
Canada L6H 6X5
08.03.2010
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Seite 104
For use in the iliac and femoral arteries
Bard, BARD S.A.F.E., ELuminexx, Luminexx, PerforMAXX, Puzzle and StentLoc are
trademarks and/or registered trademarks of C. R. Bard, Inc.
Manufacturer:
Angiomed GmbH & Co.
Medizintechnik KG
Subsidiary of C. R. Bard, Inc.
Wachhausstraße 6
76227 Karlsruhe
Germany
Tel.: ++49 721 9445 - 0
Fax: ++49 721 9445 - 111
Copyright © 2009 Angiomed GmbH & Co. Medizintechnik KG
All Rights Reserved
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