Contrast And Non-Contrast Ct Recommendations; Chest Radiographs - COOK Medical Zenith TX2 Instrucciones De Uso

Table 2 Recommended Imaging Schedule for Endograft Patients
Pre-procedure
Procedural
Pre-discharge (within 7 days)
1 month
6 month
12 month (annually thereafter)
1
Imaging should be performed within 6 months before the procedure.
2
If Type I or III endoleak, prompt intervention and additional follow-up post-intervention recommended,
See Section 12.5, Additional Surveillance and Treatment.
12.2 Contrast and Non-Contrast CT Recommendations
• Film sets should include all sequential images
at lowest possible slice thickness (≤ 3 mm).
Do NOT perform large slice thickness (> 3
mm) and/or omit consecutive CT images/film
sets, as it prevents precise anatomical and
device comparisons over time.
• All images should include a scale for each
film/image. Images should be arranged no
smaller than 20:1 images on 14" x 17" sheets
if film is used.
• Both non-contrast and contrast runs are re-
quired, with matching or corresponding table
positions.
Table 3 Acceptable Imaging Protocols
IV contrast
Acceptable machines
Injection volume
Injection rate
Injection mode
Bolus timing
Coverage - start
Coverage - finish
Collimation
Reconstruction
Axial DFOV
Post-injection runs
12.3 Chest Radiographs
The following views are required:
• Two films: supine-frontal (AP) and cross-table
lateral.
• Record the table-to-film distance and use the
same distance at each subsequent examina-
tion.
Ensure entire device is captured on each single
image format lengthwise. Middle photo cell
should be used to fully penetrate the mediasti-
num and allow visualization of the device.
If there is any concern about the device integrity
(e.g., kinking, stent breaks, barb separation, rela-
tive component migration), it is recommended
to use magnified views. The attending physician
should evaluate films for device integrity (entire
device length, including components) using 2-4X
magnification visual aid.
12.4 MRI Information
Non-clinical testing has demonstrated that the
Zenith TX2 Endovascular Graft with the Z-Trak
Plus Introduction System is MR Conditional. It
can be scanned safely immediately after place-
ment under the following conditions.
Static Magnetic Field
• Static magnetic field of 3.0 Tesla or less.
• Highest spatial magnetic gradient field of 720
Gauss/cm
12 ENGLISH
Angiogram
X
Non-contrast
No
Spiral capable of > 40 seconds
n/a
n/a
n/a
n/a
Neck
Diaphragm
< 3 mm
2.5 mm throughout - soft algorithm
32 cm
None
CT
(contrast and non-contrast)
1
X
2
X
2
X
2
X
2
X
• Pre-contrast and contrast run slice thickness
and interval must match.
• DO NOT change patient orientation or re-
landmark patient between non-contrast and
contrast runs.
Non-contrast and contrast enhanced baseline
and follow-up imaging are important for optimal
patient surveillance. It is important to follow ac-
ceptable imaging protocols during the CT exam.
Table 3 lists examples of acceptable imaging
protocols.
Spiral capable of > 40 seconds
Test bolus: Smart Prep, C.A.R.E.
2.5 mm throughout - soft algorithm
Non-clinical evaluation was conducted in a 3
Tesla MR system (General Electric Excite) with a
maximum spatial magnetic gradient field of 720
Gauss/cm as measured with a gaussmeter in the
position of the static magnetic field pertinent to
the patient (i.e., outside of scanner covering, ac-
cessible to a patient or individual).
MRI-Related Heating
1.5 Tesla Systems:
• Static magnetic field of 1.5 Tesla
• Maximum whole body averaged specific ab-
sorption rate (SAR) of 2 W/kg for 15 minutes
of scanning (i.e., per scanning sequence)
In non-clinical testing, the Zenith TX2 TAA Endo-
vascular Graft with the Z-Trak Plus Introduction
System produced a temperature rise of less than
or equal to 1.4°C at a maximum whole body
averaged specific absorption rate (SAR) of 2.8
W/kg for 15 minutes of MR scanning in a 1.5
Tesla Magnetom, Siemens Medical Magnetom,
Numaris/4 Software, Version Syngo MR 2002B
DHHS MR Scanner. The maximum whole body
averaged specific absorption rate (SAR) was 2.8
W/kg, which corresponds to a calorimetry mea-
sured value of 1.5 W/kg.
Chest Radiographs
X
X
X
X
Contrast
Yes
150 cc
> 2.5 cc/sec
Power
or equivalent
Subclavian aorta
Profunda femoris origin
< 3 mm
32 cm
None
I-ZDEG-EU-1105-394-02