Definitions - aptus Heli-FX Instrucciones De Uso

EN
Abdominal Radiographs
The integrity of EndoAnchors placed in conjunction with AAA endografts is best assessed via abdominal
radiograph. The following abdominal X-ray views are recommended for optimal visualization of the
EndoAnchors and for assessing the position of the EndoAnchors relative to the endograft.
• Supine-frontal (AP)
• Lateral
• 30 degree LPO
• 30 degree RPO
Thoracic Radiographs
The integrity of EndoAnchors placed in conjunction with TAA endografts is best assessed via
chest x-ray. The following thoracic X-ray views are recommended for optimal visualization of the
EndoAnchors and for assessing the position of the EndoAnchors relative to the endograft.
• Supine-frontal (AP)
• Lateral
Ensure the entire area of interest in the device is captured on each single image. For the EndoAnchor,
this includes the aortic neck region(s) of the endograft. Other areas may be of interest to examine
for overall endograft performance; refer to the endograft manufacturer's guidelines for endograft
imaging. Aptus recommends imaging via abdominal or thoracic radiographs as appropriate at each
normally scheduled imaging follow-up interval.
MRI Safety and Compatibility
The Aptus EndoAnchor has been determined to be MR Conditional. Refer to Section 4.
Additional Surveillance and Treatment
Additional surveillance and possible treatment is recommended for patients whose follow-up
imaging indicates EndoAnchor movement or loss of integrity. Patients exhibiting Type I endoleak
and endograft migration should be considered for urgent treatment.

11.0 DEFINITIONS

CAUTION:
CONTRAINDICATION:
NOTE:
WARNING:
19
A CAUTION indicates that particular service procedures or precautions
must be followed to avoid possible damage to the product.
A CONTRAINDICATION identifies a condition under which the device
should not be used because the risk of use clearly outweighs any
possible benefit.
A NOTE indicates special information to facilitate use of the product,
or to clarify important information.
A WARNING indicates that the personal safety of the patient or
physician may be involved. Disregarding a WARNING could result in
injury to the patient or physician.