GI Dynamics EndoBarrier Instrucciones De Uso página 6

approximately 60 cc of air through the same port to
further separate the inner catheter from the liner.
15. Remove the inner catheter from the outer catheter while
watching fluoroscopy to determine if the implant is
bunching backward.
16. Remove the gastroscope from the patient.
17. Remove the outer catheter from the patient.
18. Re-introduce the gastroscope into the patient to
examine the GI liner in the duodenal bulb.
19. Flush 60 cc of 20% Gastrografin solution through the
working channel of the gastroscope into the GI liner to
confirm patency of the liner and also to stretch out the
sleeve section of the GI liner.
Note: If the GI liner does not appear to be fully
expanded, remove it and insert another liner.
MR Conditional
The EndoBarrier GI liner has been determined to be MR-conditional. Non-clinical testing has demonstrated that
the GI liner is MR-conditional. A patient with this device can be scanned safely immediately after placement
under the following conditions:
Static Magnetic Field
-Static magnetic field of 3-Tesla or less
-Maximum spatial gradient magnetic field of 720-Gauss/cm or less
MRI-related Heating
In non-clinical testing, the EndoBarrier GI liner produced the following temperature rise during MRI performed for 15 min of
scanning (i.e., per pulse sequence) in the 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric
Healthcare, Milwaukee, WI).
Highest temperature change +1.5°C
Therefore, the MRI-related heating experiments for the EndoBarrier GI liner at 3-Tesla using a transmit/receive RF body coil at
an MR system reported whole body averaged SAR of 2.9 -W/kg (i.e., associated with a calorimetry measured whole body
averaged value of 2.7-W/kg) indicated that the greatest amount of heating that occurred in association with these specific
conditions was equal to or less than +1.5°C.
Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the
EndoBarrier GI liner. Therefore, optimization of MR imaging parameters to compensate for the presence of the liner may be
necessary.
Pulse Sequence
Signal Void Size
Plane Orientation
T1-SE T1-SE
2
3.555 mm 3.374 mm
Parallel Perpendicular
6
20. Remove the gastroscope.
Notes and Precautions:

If anchor tips are crossed, use an endoscopic
forceps to lift one leg off the other.

If the anchor is incorrectly positioned, remove the
GI liner; do not try to reposition. Remove the
gastroscope and then remove the GI liner using the
EndoBarrier Gastrointestinal Retrieval System
following the Retrieval System Instructions for Use.

If the retrieval drawstring is wrapped around the
anchor or barbs, remove the GI liner using the
EndoBarrier Gastrointestinal Retrieval System
following the Retrieval System Instructions for Use.
GRE
2 2
7.399 mm
Parallel
GRE
2
5.582 mm
Perpendicular