Intended Use - Steris Padlock Clip C910001 Instrucciones De Uso

Not made with natural rubber latex.

Intended Use:

The Padlock Clip ® is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis
or for treating lesions of the wall of the gastrointestinal organs. The Padlock Clip
(GI) tract for the purpose of:
Endoscopic marking of lesions
•
• Hemostasis for:
o Mucosal/Submucosal defects
o Bleeding Ulcers
o Arteries <2mm
o Polyps <1.5cm in diameter
o Diverticula in the Colon
Closure of GI tract luminal perforations <20mm that can be treated conservatively
•
Device Descriptions:
The Padlock Clip ® defect closure system consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a
mechanical delivery system. The Padlock Clip
Clip defect closure system is mounted and secured at the distal tip on the outside surface of a flexible endoscope. The clip is deployed
®
using an independent hand control. The Linking Cable to the hand control rests along the outside of the endoscope's insertion tube. The
Padlock Clip ® defect closure system's delivery system includes a central "tissue chamber" that resides on the distal tip of the endoscope.
Clinically efficacious tissue manipulation techniques may be used to pull target tissue into this "tissue chamber" to approximate a larger
volume of tissue than would otherwise be approximated by deploying the clip alone. The Padlock Clip
Housing is compatible with flexible endoscopes with distal tip outer diameters ranging from 9.5mm to 14mm.
Each product code is specific to a size range of flexible endoscopes, see compatibility chart below.
o A more detailed endoscope reference chart is available (through your local Product Specialist or online at
www.usendoscopy.com), please refer to that for specific endoscope compatibility.
Product Description
Number
C910001 Padlock Clip ® defect closure device
Padlock Clip Pro Select
C913131
closure device
732380 Rev. K
® defect closure system is a onetime, single use tissue approximation device. The Padlock
Length Endoscope
(cm)
diameter (mm)
162
® defect
162
® is indicated for clip placement within the gastrointestinal
Tissue
distal tip chamber depth
(cm)
9.5-11 1.0
11.3 0.4
12.0 0.8
12.5 1.1
13.0 1.3
13.5 1.5
14.0 1.9
defect closure system's Delivery
®
Tissue Housing
chamber inner Outer diameter
diameter (cm) (mm)
1.1 16
1.1 19
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