Inspection Prior To Use; Materials Required; Device Diameter Sizing Guidelines; Directions For Use - COOK Medical Zenith TX2 Instrucciones De Uso

• Snare techniques
• Appropriate use of radiographic contrast ma-
terial
• Techniques to minimize radiation exposure
• Expertise in necessary patient follow-up mo-
dalities
10.2 Inspection Prior to Use
Inspect the device and packaging to verify that
no damage has occurred as a result of shipping.
Do not use this device if damage has occurred or
if the sterilization barrier has been damaged or
broken. If damage has occurred, do not use the
product and return to Cook Medical.
Prior to use, verify correct devices (quantity
and size) have been supplied for the patient by
matching the device to the order prescribed by
the physician for that particular patient.
10.3 Materials Required
(Not included with the Zenith TX2 Dissection
Endovascular Graft with Pro-Form and the Z-Trak
Plus Introduction System). For information on
the use of these products, refer to the individual
product's instructions for use.
• Fluoroscope with digital angiography capa-
bilities (C-arm or fixed unit)
• Contrast media
• Power injector
• Zenith Dissection Endovascular Stent with
the H&L-B One-Shot Introduction System
• Syringe
Table 1 Straight Component and Tapered Component Graft Diameter Sizing Guide
Intended Aortic
Vessel Diameter (mm)
1,2
20
21
22/23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
*
All dimensions are nominal.
1
Maximum diameter along the fixation site, measured outer wall to
outer wall.
11 DIRECTIONS FOR USE
The following instructions embody a basic guide-
line for device placement. Variations in the follow-
ing procedures may be necessary. These instruc-
tions are intended to help guide the physician and
do not take the place of physician judgement.
General Use Information
Standard techniques for placement of arterial
access sheaths, guiding catheters, angiographic
catheters and wire guides should be employed
during use of the Zenith TX2 Dissection Endo-
vascular Graft with Pro-Form and the Z-Trak Plus
Introduction System. The Zenith TX2 Dissection
Endovascular Graft with Pro-Form and the Z-Trak
Plus delivery system is compatible with .035 inch
diameter wire guides.
Pre-Implant Determinants
Verify from pre-implant planning that the correct
device has been selected. Determinants include:
1. Femoral artery selection for introduction of
the delivery system(s).
I-ZDEG-EU-1105-394-02
Overall Length of
Graft Diameter 3 Straight Compo-
(mm)
22
24
26
28
30
30
30
32
32
34
36
36
38
38
40
40
42
42
• Heparinized saline solution
• Sterile 4X4 gauze pads
• 0.035 inch (0.89 mm) extra stiff wire guide,
260/300 cm; for example:
• Cook Amplatz Ultra Stiff Wire Guides (AUS)
• Cook Lunderquist™ DC Extra Stiff Wire
Guides (LESDC)
• 0.035 inch (0.89 mm) standard wire guide; for
example:
• Cook .035 inch Wire Guides
• Cook .035 inch Bentson Wire Guide
• Cook Nimble
• Molding Balloons
• Introducer sets; for example:
• Cook Check-Flo
• Sizing catheter; for example:
• Cook Aurous
• Angiographic radiopaque marker catheters;
for example:
• Cook Beacon
• Cook Beacon
• Entry needles; for example:
• Cook Single Wall Entry Needles
10.4 Device Diameter Sizing Guidelines
The choice of diameter should be determined
from the outer wall to outer wall vessel diameter
and not the lumen diameter. Undersizing or
oversizing may result in incomplete sealing or
compromised flow.
Overall Length of
Tapered Component
nent (mm)
79/117
79/117
79/136
82/142/202
82/142/202
82/142/202
82/142/202
82/142/202
82/142/202 162/202
79/154/204 159/199
79/154/204 159/199
79/154/204 159/199
79/154/204 154/204
79/154/204 154/204
83/164/218 160/210
83/164/218 160/210
83/164/218 160/210
83/164/218 160/210
2
Round measured aortic diameter to nearest mm.
3
Additional considerations may affect choice of diameter.
2. Angulation of aorta, aneurysm and iliac arter-
ies.
3. Quality of the proximal and distal fixation
sites.
4. Diameters of proximal and distal fixation sites
and distal iliac arteries.
Patient Preparation
1. Refer to institutional protocols relating to
anesthesia, anticoagulation, and monitoring
of vital signs.
2. Position patient on imaging table allowing
fluoroscopic visualization from the aortic arch
to the femoral bifurcations.
3. Expose femoral artery using standard surgical
technique.
4. Establish adequate proximal and distal vascu-
lar control of femoral artery.
® Wire Guides
Introducer Sets
®
® Centimeter Sizing Catheters
Tip Angiographic Catheters
®
Tip Royal Flush
® ®
*
Introducer Sheath
(mm)
Catheters
(Fr)
20
20
20
20
20
20
20
20
20
20
22
22
22
22
22
22
22
22
ENGLISH 9