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This product has been manufactured not to include 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.
Warnings and Precautions:
Do not use this device if there is any apparent shipping or handling damage.
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" (2.5cm – 3.8cm) in length, throughout device passage to avoid catheter 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 disposable medical device is not intended for reuse. Any institution, practitioner, or third party who reprocesses, refurbishes, remanufactures, resterilizes,
and/or reuses this disposable medical device must bear full responsibility for their safety and effectiveness.
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:
1.
Prior to clinical use, inspect and familiarize yourself with the device and review the diagrams. If there is evidence of damage, do not use this product and
contact your local US Endoscopy representative.
Remove the device from the package and uncoil the entire device and drape in a "U" shaped configuration, holding the Proximal End of the catheter in one
2.
hand and the Distal End in the opposite hand.
3.
Remove the RED Handle Stay from the device. (see Fig. 1)
4.
Retract the handle until the Roth Net
5.
Ensure the accessory channel diameter of the endoscope is compatible with the diameter of the Roth Net
(channel diameter must be 2.0mm 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. 3)
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
to closure.
5.
Once entrapment is accomplished, retract the handle until it stops. (see Fig. 4) Continuous gentle traction should be applied on the handle to keep the Roth
– foreign body – mini closed. Excess force may cause the net to rupture or tear.
®
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
advancing the handle forward to open the Roth Net
and standard technique for histologic evaluation.
10. If removing additional objects from the patient is required, confirm that the Roth Net
into the patient. Rinsing the net in sterile water may be required if debris needs to be removed.
11. Repeat steps 1-10 as needed.
12. Once the object or objects have been retrieved and removed from net, retract the net into the catheter and remove the device from the endoscope.
(see Fig. 2)
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: April 2015
Warning:
An issued or revision date for these instructions is included for the user's information. In the event that two years have elapsed between this date and product use, the user should contact US Endoscopy to
determine if additional information is available.
Listening...and delivering solutions
, the US Endoscopy listening...and delivering solutions design, and all marks denoted with
®
US Endoscopy, a wholly owned subsidiary of STERIS Corporation.
Made in the U.S.A.
00730608 Rev. K
– foreign body – mini past any foreign object, particularly if the entire lumen is blocked.
®
– foreign body – mini is completely withdrawn into its catheter. (see Fig. 2)
®
– foreign body – mini over the object. For best results, the object should be centered and proximal within the net prior
®
– foreign body – mini have been withdrawn from the patient, the retrieved object can be removed from the net by
®
– foreign body – mini. (see Fig. 3) Specimens should be prepared according to facility policy or protocol
®
– foreign body – mini's catheter prior to insertion.
®
– foreign body – mini opens and closes smoothly prior to reinsertion
®
or ™ are registered with the U.S. Patent and Trademark Office, or trademarks owned by US Endoscopy.
®
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