US endoscopy Roth Net Instrucciones De Uso página 2

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.
Description
®
Roth Net retriever - select
Warnings and Precautions:
 The endoscopic retrieval of foreign objects, food bolus, or polyps 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.
If reference information for endoscopic techniques utilizing the Roth Net

US Endoscopy or refer to www.usendoscopy.com. Case reports and videos describing and demonstrating techniques are
available.
 Care should be exercised when grasping the targeted object, material, or polyp to be retrieved to avoid inadvertently grasping
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.
 The technique for using the Roth Net
personnel attempting the retrieval.
 These devices are not recommended for the retrieval of sharp foreign objects.
 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. Ensure the accessory channel diameter of the endoscope is compatible with the outer diameter of the device catheter prior to
insertion (refer to chart above).
2. Inspect and familiarize yourself with the device and review the diagrams. If there is evidence of damage to the device
(i.e. cracked/kinked catheter, deformed net), do not use this product and contact your local US Endoscopy representative.
3. Remove the device from the package.
4. Uncoil the entire device and drape in a "U" shaped configuration.
5. Hold the Proximal End of the catheter in one hand and the Distal End in the opposite hand.
6. Retract and deploy the handle several times and observe that the device functions properly.
7. Retract the handle until the net is completely withdrawn into its sheath (see Fig. 3).
Directions for Use:
1. Once the object has been endoscopically identified, advance the retracted device into the accessory channel of the endoscope
using short strokes (1" – 1.5" in length) until the distal end of the sheath is endoscopically visualized.
2. Advance the distal end of the sheath slightly past the object, bolus, or polyp to be retrieved. Avoid blindly passing the device
past any object, bolus, or polyp if the entire lumen is blocked.
3. Open the device by advancing the handle forward until it stops. Confirm the net is fully open via endoscopic observation
(see Fig.1).
4. 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.

Actuating the device in an extremely coiled position.

Actuating the device when the handle is at an acute angle in relation to the sheath.
00732305 Rev B
Product Number
00711169
® retriever, as described in any document or publication, is at the discretion of the medical
Sheath Diameter Minimum Scope
Channel required
2.5mm
® retriever product line is desired/needed, contact
Sheath Length
2.8mm 230cm
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