Publicité
Les langues disponibles
Les langues disponibles
This device is not made with natural rubber latex.
Intended Use:
®
The Falcon
rotatable retrieval basket is intended for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the
gastrointestinal tract.
Warnings and Precautions:
Not intended for use in ERCP procedures.
The endoscopic retrieval of polyps or foreign bodies should only be performed by persons having adequate training and familiarity with endoscopic
techniques. Consult the medical literature relative to techniques, complications and hazards prior to the performance of any endoscopic procedure
Do not use this device if there is any apparent shipping or handling damage.
Care should be exercised when grasping the polyp/object to be retrieved as not to inadvertently grasp tissue or organs not intended for retrieval.
Keep gentle traction on the retrieval device so that the retrieved object does not become loosened, dislodged or aspirated into the trachea.
Use in conjunction with an overtube is recommended. Failure to use an overtube during foreign body or tissue retrieval may lead to complications.
The following conditions may not allow the device to function properly: (1) advancing the handle to the open position with too much speed or force, (2)
attempting to pass or open the device in an extremely articulated endoscope, (3) attempting to actuate the device in an extremely coiled position, (4)
actuating the device when the handle is at an acute angle in relation to the sheath and/or (5) rotating the basket loop multiple times in one direction.
Short strokes (1"-1.5" in length) are recommended throughout device passage to avoid sheath kinking.
US Endoscopy did not design this device to be reprocessed or reused, and therefore cannot verify that reprocessing can clean and/or sterilize or
maintain the structural integrity of the device to ensure patient and/or user safety.
This medical device is intended for single patient use only. Any institution, practitioner, or third party who reprocesses, refurbishes, remanufactures,
resterilizes, and/or reuses this disposable device must bear full responsibility for its safety and effectiveness.
Contraindications:
Contraindications include those specific to any endoscopic procedure, endoscopic procedures to remove a foreign body or food bolus, use of an
overtube, or any endoscopic procedure performed in conjunction with an overtube.
Pre-Use Instructions:
Prior to clinical use you should familiarize yourself with the device.
1.
Open package, remove and inspect device for damage. Uncoil the device, carefully remove the foam shipping restraint from the basket and activate the
handle to ensure proper opening and closing. Should there be evidence of damage or if the unit is not functioning properly, do not use the product.
2.
Completely uncoil the catheter prior to any manipulation of the handle.
Once the catheter is uncoiled, carefully retract the handle until the basket bullet tip bottoms out at the distal catheter end.
3.
The Rotatable Retrieval Basket should now be ready for introduction into an operating scope channel diameter of 2.8mm or greater.
4.
Directions for Use:
Prepare Rotatable Retrieval Basket for introduction into the endoscope.
1.
Once the polyp/object has been endoscopically identified, advance the retracted Retrieval Basket into the operating channel of the endoscope using
short strokes until the bullet tip and distal end of the sheath are endoscopically visualized.
2.
Advance the distal end of the sheath slightly past the polyp/object to be retrieved. Open the Retrieval Basket by advancing the handle forward until it
stops. Confirm the Retrieval Basket is fully open via endoscopic observation. The following conditions may cause the device to function
improperly: (1) advancing the handle to the open position with too much speed or force, (2) attempting to pass or open the device in an
extremely articulated endoscope, (3) attempting to actuate the device in an extremely coiled position, (4) actuating the device when the
handle is at an acute angle in relation to the sheath and/or (5) rotating the basket loop multiple times in one direction.
3.
When the polyp/object is endoscopically visualized, rotation may be accomplished by slowly twisting the hand holding the device in the direction of
desired movement. Rotation is best achieved with the basket in the center of the lumen and not lying against the lumen wall. Endoscopically
manipulate the Retrieval Basket around the object/polyp until entrapment is accomplished, then retract the handle. Continuous pressure should be
applied on the handle to keep the Retrieval Basket closed. Excess pressure may cause the basket to rupture or tear.
4.
Once the desired object is entrapped, retract the sheath retrograde toward the endoscope so the Retrieval Basket is endoscopically observed yet not
obscuring the endoscopic view. Endoscopic observation may be clinically necessary during the extubation as not to lose the polyp/object during
removal.
5.
Once the endoscope and the Retrieval Basket have been extubated, the retrieved object/polyp can be removed from the basket by advancing the
handle forward to open the Retrieval Basket. Specimens should be prepared according to standard technique for histologic evaluation.
6.
Once the endoscopic retrieval has been completed, remove the device from the endoscope.
Product Disposal:
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local,
state and federal laws and regulations.
Issued Date: September 2013
Note:
An issued or revision date for these instructions is included for the user's information. In the event that more instructions for use are desired, please go to
contact US Endoscopy directly.
Listening...and delivering solutions
®
, the US Endoscopy listening...and delivering solutions design, and all marks denoted with ® or ™ are registered with the U.S. Patent and Trademark
Office, or trademarks owned by US Endoscopy.
US Endoscopy, a wholly owned subsidiary of STERIS Corporation.
Made in the U.S.A.
00731999 Rev. C
www.usendoscopy.com
or
Publicité
