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While keeping the scope seated in the "C" shaped mounting feature, grasp the securing strap and loop it around the scope
3.
across the "C" shaped mounting feature opening and snap the strap into the open hook on the far side. See Figure 3.
a.
When the strap appears as shown and is in both hooks, the housing is now secured to the scope. See Figure 4.
4.
Carefully twist and remove the safety cap from the Padlock Clip™ defect closure system Housing. See Figure 5.
5.
Set-up is now complete.
Caution: Keep Hands and Fingers clear from the tip of the Padlock Clip™ defect closure system Housing while handling
the endoscope.
Device Insertion into patient:
1.
Using standard techniques and protocols for insertion and management of Gastroscopes and/or Colonoscopes in surgical
procedures, direct the endoscopic instrument with the mounted Padlock Clip™ defect closure system to the desired location
within the patient.
Note:
Liberal application of Surgical Lubricant on the Padlock Clip™ defect closure system housing tip area will assist
o
in ease of passage.
The Padlock Clip™ is ready to be deployed at any time during a procedure.
o
The Padlock Clip™ resides within the Padlock Clip™ defect closure system Housing and is completely shielded from any
o
inadvertent tangential pressure which may arise due to endoscope manipulation.
o
The control system for the Padlock Clip™ defect closure system Housing is on the outside of the endoscopic instrument.
▪
Care should be taken in locating the handle to ensure that the control cable is loose and flexible in relation to the
endoscopic instrument to allow for easy instrument manipulation and articulation.
Procedure for Use (once Padlock Clip™ defect closure system is at desired location):
1.
Deploy Padlock Clip™ by rapidly pushing the thumb actuator while holding the handle body. See Figure 6.
2.
The endoscope camera will record the clip deployment motion as the clip will be seen directly in the instrument field of view.
The Padlock Clip™ after deployment can be further inspected by moving the endoscopic instrument to visualize using the
3.
endoscope video camera.
Caution:
o
Lesions located in the esophagus and the lesser curvature of the stomach may be difficult to treat with a forward viewing
endoscope.
o
Clipping hard or severely fibrotic lesions to achieve hemostasis may be more difficult.
o
Re-bleeding may occur if clip detaches within 24 hours.
o
The use of clips in the presence of bacterial contamination may potentiate or prolong infection.
o
Although rates of occurrence are low, recurrent bleeding, ineffective clipping or endoscopic complications could result in
the need for surgery.
Padlock Clip™ defect closure system Removal and Disposal:
1.
Withdraw the endoscopic instrument completely from the patient.
2.
Remove the Padlock Clip™ defect closure system housing by cutting or removing the securing strap.
3.
After use, dispose of product and packaging in accordance with hospital administrative and/or local government policy.
732380 Rev. B
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