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Idiomas disponibles
Idiomas disponibles
Caution:
Pressing the Thumb Actuator on the Control Handle can deploy the clip at any time during procedure.
o
Press Thumb Actuator only when properly positioned over the target/desired lesion and AFTER Handle
Stay has been removed.
o
The clip resides within the Delivery Housing and is completely shielded from any endoscopic manipulation.
o
The Linking Cable connected to the Delivery Housing should run along the outside of the endoscopic retroflexion curve.
o
Care should be taken when positioning the Control Handle Body during the endoscope's insertion to ensure that the Linking
Cable is loose and flexible along the insertion tube.
o
Avoid bending the Linking Cable too aggressively or using a grasping/clamping device on the linking cable as it can create
a "kink" and/or disable device function.
Procedure for Use (once Padlock Clip
1.
Pull target tissue into the "Tissue Chamber" using clinically efficacious tissue manipulation techniques.
a.
This can be accomplished by using:
i. Varying degrees of endoscopic suction (adjusted by suction button depth of depression on endoscope)
ii. A grasping device to grab ahold of and pull tissue.
iii. Rotating and adjusting the distal tip of the scope to potentiate ease of tissue manipulation.
Note:
o
When using suction to pull target tissue into the cap, there is a risk of capturing tissue/organs outside of the lumen
and adjacent to the target treatment area.
o
Use of a grasping device is recommended to acquire the target tissue and minimize the risk of capturing tissue/
organs adjacent to the treatment area.
Caution:
o
If using a separate device to secure tissue, confirm that the device is completely retracted into the Tissue Chamber
of the Delivery Housing prior to, and until after, deployment of the clip to prevent the device from being locked into
the deployed clip and tissue.
2.
Gently remove Handle Stay making sure not to prematurely depress the Thumb Actuator. See Figure 9.
732380 Rev. K
®
defect closure system is at desired location):
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