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Patient  motion  should  be  avoided  during  scan.  If  possible,  avoid  scanning  non-
patient objects in field of view. Do not change patient position, table height, or field of 
view during scan. If patient moves, repeat the study in its entirety. 

Table 7. 

Spiral CT requirements 

 

Minimum Protocol 

High Resolution 

Protocol 

(Recommended) 

Scan Mode 

Helical 

Helical 

Scan Parameters 

110-140 kVp, Auto mAs 
or 
170-400 mA scan time of 
0.5 sec 

110-140 kVp, Auto mAs 
or 
170-400 mA scan time of 
0.5 sec 

Slice Thickness 

3 mm 

0.625 – 2 mm 

Slice Interval 

3 mm 

0.625 – 2 mm 

Pitch 

0.984:1 

0.984:1 

Superior Extent 
AAA 

2 cm above celiac artery 
origin 

2 cm above celiac artery 
origin 

Inferior Extent 
AAA 

Pre-op: Lesser trochanter 
of femurs to include 
femoral bifurcations 
Post-op: At least 2 cm 
distal to the lowest 
hypogastric artery origin 

Pre-op: Lesser 
trochanter of femurs to 
include femoral 
bifurcations 
Post-op: At least 2 cm 
distal to the lowest 
hypogastric artery origin 

Contrast 

Standard per Radiology 
Department 

Standard per Radiology 
Department 

Volume 

80 ml contrast with 40 ml 
saline flush or Standard 
Contrast Volume with 
Saline Flush per 
Radiology Department 

80 ml contrast with 40 ml 
saline flush or Standard 
Contrast Volume with 
Saline Flush per 
Radiology Department 

Rate 

4 ml/sec 

4 ml/sec 

Scan Delay 

ROI – threshold 90-100 
HU in aorta 

ROI – threshold 90-100 
HU in aorta 

Field of View 

Large Body 

Large Body 

Reconstruction 
Algorithm 

Standard 

Standard 

Содержание TriVascular

Страница 1: ...810 0005 01 05 Rev B Instructions for Use 810 0005 01 05 EN 0 05 0 0 05 0...

Страница 2: ...ent Selection and Treatment 9 6 1 Individualization of Treatment 9 6 2 Specific Patient Populations 9 7 Patient Counseling Information 9 8 How Supplied 10 8 1 Ovation Stent Graft Delivery Systems 11 8...

Страница 3: ...of the graft and to provide support into which the iliac limbs are deployed the graft body contains a network of inflatable rings that are filled with a liquid polymer that solidifies during the depl...

Страница 4: ...tion Abdominal Stent Graft System is designed to accommodate various aortic anatomies including a range of proximal and distal aortic neck diameters and aneurysm lengths Refer to Table 1 for patient s...

Страница 5: ...ices and or accessories Non aneurysmal proximal aortic neck with a length of at least 7 mm proximal to the aneurysm with an inner wall diameter of no less than 16 mm and no greater than 30 mm and with...

Страница 6: ...d All patients treated with this device must undergo periodic imaging to evaluate the stent graft aneurysm size aneurysm pulsatility device migration leaks device integrity and occlusion of vessels in...

Страница 7: ...Events Adverse events that may occur include but are not limited to Acute and chronic renal failure renal microembolism renal insufficiency renal artery occlusion contrast toxicity Allergic reaction...

Страница 8: ...sible infection urinary tract systemic or localized endograft Pneumothorax Pulmonary respiratory events and subsequent attendant problems such as pulmonary insufficiency pneumonia respiratory depressi...

Страница 9: ...ions for patient selection include but are not limited to Patient s age and life expectancy Co morbidities e g cardiac pulmonary or renal insufficiency prior to surgery morbid obesity Patient morpholo...

Страница 10: ...delivery system the fill polymer kit and the autoinjector The stent grafts are available in the following sizes and configurations Table 2 Ovation Aortic Body Stent Graft sizes Stent Graft Proximal Di...

Страница 11: ...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 tha...

Страница 12: ...nal techniques and in the use of this device The recommended skill knowledge requirements for physicians using the Ovation Abdominal Stent Graft System are outlined below Patient Selection Knowledge o...

Страница 13: ...uoroscopy capability Digital Subtraction Angiography DSA capability Appropriate personnel protection equipment for fluoroscopy Video recorder Power injector with associated supplies Angiography and ex...

Страница 14: ...ated Heating In non clinical testing the Ovation Abdominal Stent Graft System produced the following temperature rises during MRI performed for 15 min of scanning i e per pulse sequence in 1 5 Tesla 6...

Страница 15: ...within the vasculature 10 2 Implant Procedure Do not kink the delivery catheters Doing so may cause damage to the delivery catheters and the TriVascular Ovation Abdominal Stent Graft System Systemic a...

Страница 16: ...ker is toward patient s ipsilateral side CAUTION Rotate entire delivery system as a unit Do not independently rotate catheter sheath or handle 6 Under fluoroscopic guidance retract delivery system out...

Страница 17: ...ill polymer kit Fill Polymer Injection WARNING DO NOT push or pull the delivery system after complete deployment of the proximal stent to avoid inadvertent disconnection of the polymer fill connector...

Страница 18: ...ng of the aortic body most proximal ring 7 Confirm distal iliac limb radiopaque markers are at the appropriate location and that the iliac limb is in the contralateral lumen 8 Retract sheath to deploy...

Страница 19: ...labeling Prepare balloon catheters and other adjunctive devices to be used according to the manufacturer s Instructions For Use Iliac limb aortic body junction The junction may be ballooned using a 12...

Страница 20: ...b Distal Diameter 1 0 X X X 1 2 X X X 1 4 X X X 1 6 X X X 1 8 X X 2 2 X 20 mm Maximum allowable extension 3 To use an iliac limb as an extension refer to the table below Based on the iliac limb distal...

Страница 21: ...paration and use of balloons 13 Re insert angiographic catheter and advance to the suprarenal aorta Perform deployment completion angiography as described above 11 Follow up Imaging Recommendations Tr...

Страница 22: ...n 2 cm above celiac artery origin Inferior Extent AAA Pre op Lesser trochanter of femurs to include femoral bifurcations Post op At least 2 cm distal to the lowest hypogastric artery origin Pre op Les...

Страница 23: ...mperature for excursions during transit only Do not reuse Do not resterilize Keep dry Do not use if package is damaged Sterilized using ethylene oxide STERILE R STERILE R Sterilized using irradiation...

Страница 24: ...ckway Blvd Santa Rosa CA 95403 USA 1 707 543 8800 Authorized Representative MediTech Strategic Consultants B V Maastrichterlaan 127 129 6291 EN Vaals NL T 31 43 306 3320 F 31 43 306 3338 2012 TriVascu...

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