Idiomas disponibles
Idiomas disponibles
This product is not made with natural rubber latex.
Intended Use:
®
The Roth Net
retriever product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during
flexible and rigid endoscopy procedures.
Description
®
Roth Net
retriever– mini
polyp
Warnings and Precautions:
The endoscopic retrieval of foreign bodies should only be performed by individuals 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.
Avoid blindly passing the Roth Net
Care should be exercised when grasping the object to be retrieved as not to inadvertently grasp tissue or organs not intended for retrieval.
Keep gentle traction on the device during retrieval so that the retrieved object does not become loosened, dislodged or aspirated into
the trachea.
This device is not recommended for the retrieval of sharp foreign objects.
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 catheter
It is recommended to use short strokes, 1"-1.5" (2.5 cm – 3.8 cm) in length, throughout device passage to avoid catheter kinking.
Do not attempt to reuse, reprocess, refurbish, remanufacture, or resterilize this device. STERIS 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).
This device has not been designed nor is it intended to be used with electrosurgical devices or their accessories.
Contraindications:
Contraindications include, but are not limited to, those specific to any endoscopic procedure.
Prior to Use:
Prior to clinical use, inspect and familiarize yourself with the device and review the diagrams. If there is evidence of damage, do
1.
not use this product and contact your local STERIS Endoscopy representative.
Remove the device from the package and uncoil the entire device and drape in a "U" shaped configuration, holding the Proximal
2.
End of the catheter in one hand and the Distal End in the opposite hand.
Retract the handle until the Roth Net
3.
Ensure the accessory channel diameter of the endoscope is compatible with the diameter of the Roth Net
4.
catheter prior to insertion. (channel diameter must be 3.0 mm or greater)
Directions for Use:
1.
Once the object has been endoscopically identified, insert device into the biopsy valve of accessory channel, then advance the
device through the accessory channel of the endoscope using short strokes (1" – 1.5" in length) until the distal end of the catheter
is endoscopically visualized.
2.
Advance the distal end of the catheter slightly past the object to be retrieved. Avoid passing the device past any object if the
entire lumen is blocked. Open the device by advancing the handle forward until it stops. Confirm the net is fully open via
endoscopic observation. (see Fig. 2)
3.
The following conditions may cause the device to function improperly:
advancing the handle to the open position with too much speed or force
attempting to pass or open the device in an extremely articulated endoscope
attempting to actuate the device in an extremely coiled position
actuating the device when the handle is at an acute angle in relation to the catheter
4.
Endoscopically position the Roth Net
proximal within the net prior to closure.
5.
Once entrapment is accomplished, retract the handle until it stops. (see Fig. 3) Continuous gentle traction should be applied on
the handle to keep the Roth Net
6.
Grasp and retract the proximal end of the catheter to bring the encapsulated object close to the tip of the endoscope without
obscuring the endoscopic
7.
When the object is secure in the net, slowly withdraw the object together with the endoscope from the patient.
8.
Do not retract the device and the object into the endoscope, this could cause damage to the endoscope and the device.
9.
Once the endoscope and the Roth Net
removed from the net by advancing the handle forward to open the Roth Net
should be prepared according to facility policy or protocol and standard technique for histologic evaluation.
10. If removing additional objects from the patient is required, confirm that the Roth Net
00732052 Rev. C
Product #
Catheter Diameter
00711158
2.8 mm
®
retriever – mini polyp past any foreign object, particularly if the entire lumen is blocked.
®
retriever – mini polyp is completely withdrawn into its catheter. (see Fig. 1)
®
retriever – mini polyp over the object. For best results, the object should be centered and
®
retriever – mini polyp closed. Excess force may cause the net to rupture or tear.
view.
®
retriever – mini polyp have been withdrawn from the patient, the retrieved object can be
Catheter Length
Approximate Net
230 cm
3.5 cm x 2.5 cm
®
retriever – mini polyp. (see Fig. 2) Specimens
®
retriever – mini polyp opens and closes
Size
®
retriever – mini polyp's
