11
Stent Graft
Proximal
Diameter
Stent Graft
Distal
Diameter
Catheter
Working
Length
Delivery
System
Outer
Profile
Covered
Stent Graft
Length
18 mm
80 mm
18 mm
100 mm
18 mm
120 mm
18 mm
140 mm
22 mm
15 F
80 mm
22 mm
100 mm
22 mm
120 mm
22 mm
140 mm
Table 4.
Ovation Iliac Extension sizes
Stent Graft
Proximal and
Distal Diameter
Catheter
Working
Length
Delivery
System Outer
Profile
Covered Stent
Graft Length
10 mm
53 cm
13 F
45 mm
12 mm
14 mm
16 mm
18 mm
14 F
22 mm
8.1. Ovation Stent Graft & Delivery Systems
Contents are supplied STERILE and non-pyrogenic using an ethylene oxide (EO)
process.
•
Inspect the device and packaging to verify that no damage has occurred as
a result of shipping. Do not use this device if damaged or if the sterilization
barrier has been damaged or broken.
•
Do not use after the expiration date printed on the label.
•
Store in a cool, dry place.
•
For single patient use only.
Do not reuse, reprocess or re-sterilize. Reuse,
reprocessing or re-sterilization may compromise the structural integrity of the
device and/or lead to device failure that may result in patient injury, illness or
death. Reuse, reprocessing or re-sterilization may also create a risk of
contamination of the device and/or cause patient infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to
another. Contamination of the device may lead to injury, illness or death of
the patient.
•
After use, dispose of the product and packaging in accordance with hospital,
administrative and/or local government policy.
8.2. Fill Polymer Kit & Autoinjector
Contents are supplied STERILE using an E-beam sterilization process. The Fill
Polymer Kit is non-pyrogenic.
•
Inspect the device and packaging to verify that no damage has occurred as
a result of shipping. Do not use this device if damaged or if the sterilization
barrier has been damaged or broken.
•
Do not use after the expiration date printed on the label.
