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Non-clinical testing demonstrated that the Padlock Clip™ defect closure system Clip is MRI conditional.
o
A patient can be scanned safely immediately after placement in a 3-Tesla or less magnetic field.
o
ASTM F2182-11a test for MRI heating demonstrated:
▪
Whole body SAR (Specific Rate of Absorption) of 2.4W/Kg at 3.0 Tesla Field, a maximum ∆T (change in
temperature) rise of less than 1.0°C in 15 minutes.
Contraindications:
1.
When hemostasis or closure cannot be verified with an endoscopic field of view.
2.
On arteries greater than 2mm.
3.
On polyps greater than 1.5cm in diameter.
4.
Mucosal/Submucosal defects greater than 3cm.
5.
Treatment of esophageal varices.
Storage:
o
Fragile! Handle all packaging with Care.
o
Do not expose to sunlight, ionizing radiation or ultraviolet light.
o
Keep all Packaging and Contents dry.
o
Do Not expose to organic solvents.
o
Rotate inventory so that products are used prior to the expiration date on the package box.
Prior to clinical use:
1.
Familiarize yourself with the device and read all the Instructions for Use.
The Padlock Clip™ defect closure system is supplied sterile. Carefully examine the unit to verify that neither the contents nor
2.
the package has been damaged in shipment. If the device shows any signs of damage DO NOT use this product and contact
your local Product Specialist or Customer Service Representative.
3.
Open pouch and remove device. See Figure 1.
4.
Inspect device for kink or damage. If the device shows any signs of damage DO NOT use this product and contact your local
Product Specialist or Customer Service Representative.
o
DO NOT attempt to repair non-functional or damaged devices.
Directions for Use:
Mounting the Padlock Clip™ defect closure system Housing onto a flexible endoscope:
1.
While holding the Padlock Clip™ defect closure system Housing (ensuring the Safety Cap in place) firmly insert the distal end
of the endoscopic instrument into the "C" shaped scope Mounting Feature until it stops. See Figure 2.
Note: The "C" shaped scope mounting feature is made of flexible material and will conform to the diameter of the instrument.
Seat the tip of the scope as far as possible into the "C" shaped mounting feature section. See Figure 3.
2.
a.
Check to ensure the distal tip of the instrument when inserted does NOT project beyond the distal end of the
Padlock Clip™ defect closure system Housing.
732380 Rev. B
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