US endoscopy Baleen Gebrauchsanleitung Seite 2

This device is not made with natural rubber latex.
Intended use:
The single use Baleen™ polyp trap is used for suction retrieval of endoscopically removed polyps.
Warnings and Precautions:
•
Consult the medical literature relative to techniques, complications and hazards prior to the performance of any endoscopic
procedure.
•
Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic
techniques and polyp retrieval.
•
Polyps less than or equal to 2mm may get suctioned through the mesh.
•
Do not attempt to reuse, reprocess, refurbish, remanufacture or resterilize this device. US Endoscopy did not design this
device nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on
this disposable medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination,
infection).
•
Inspect the package for shipping or handling damage. If damage is evident, do not use this device, save it for return, and
contact your local Product Specialist.
•
When removing a specimen from the trap, make sure that the entire net is grasped prior to removing trap from suction tubing
to prevent the loss of specimen.
Contraindications:
•
Contraindications include, but are not limited to, those specific to any endoscopic procedure.
Prior to Use:
1. Inspect and familiarize yourself with the device.
2. Read the Instructions for Use.
3. If there is evidence of damage (i.e. deformed, ripped, missing component, or damaged packaging), do not use this product
and contact your local Product Specialist.
Directions for Use:
1. Install the Baleen™ polyp trap just prior to suctioning a polyp through the endoscope.
2. Remove the Baleen™ polyp trap from the holding tray.
3. Disconnect the suction tubing from the suction connector (barb) located on the umbilical section of the endoscope.
4. Insert the narrow tip end of the Baleen™ polyp trap into the suction tubing until you meet resistance (See Fig. 1).
5. Fold the excess netting protruding from the end of the suction tubing back over the end of the suction tubing (See Fig 2).
6. Grab the flange-end of the Baleen™ polyp trap applicator and remove the applicator from the end of the suction tubing leaving
the netting in place (See Fig 3).
7. Discard the applicator after use.
8. Attach the suction tubing with the intact Baleen™ polyp trap to the suction connector (barb) of the endoscope (See Fig 4).
9. The Baleen™ polyp trap is now in place and ready for use.
10. After the polyp has been suctioned into the Baleen™ trap, disconnect the suction tubing from the umbilicus of the endoscope
(holding onto the netting) (See Fig. 5).
11. To remove the polyp, grasp all the exposed netting and pull the netting out of the suction tubing.
Caution: Not grasping all the netting could potentially allow the polyp to fall out of netting.
12. Reattach suction line to the suction connector (barb) on the endoscope.
13. Check to confirm polyp is retrieved by carefully opening the netting.
14. Place the polyp (and netting-if allowed per facility guidelines) into the pathology specimen container.
15. Specimens should be prepared for histologic evaluation per institutional guidelines.
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