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Idiomas disponibles
This product is manufactured not to contain latex.
Description
Infinity® ERCP
00711652
sampling device
Infinity® ERCP
00711653
sampling device
Intended Use:
®
The disposable Infinity
ERCP sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.
Warnings and Precautions:
Consult the medical literature relative to techniques, complications and hazards prior to the performance of any endoscopic
procedure.
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 these disposable medical devices must bear full responsibility for their
safety and effectiveness.
Do not force the brush through the endoscope's channel. Reduce angulation of the scope if resistance is met.
Do not use contrast injection with this device. Use of contrast will leak out of the short wire access hole.
Do not rapidly remove wires from this device. Scatter of bodily fluids and debris could occur.
When using a guide wire, hold the guidewire while brushing for cellular material. Otherwise the guidewire may move and
cause patient injury.
This device is not to be used for any purpose other than what it is intended. Use of this device for any other purpose than what
it is intended could cause patient harm (eg. Perforation, cross contamination, bleeding).
Contraindications:
Contraindications include those specific to any endoscopic procedure, as well as those specific to ERCP, and any techniques
associated with ductal brush cytology.
Prior to the procedure:
1.
Read all the Instructions for Use and familiarize yourself with the device.
2.
Open the sterile pouch and uncoil the brush.
Drape the catheter in a "U" shaped configuration.
3.
4.
Remove plastic brush protector.
5.
Tighten the luer lock between the white handle and the gray y-port.
6.
Hold the proximal device end in one hand, and the distal sheath end in the opposite hand.
7.
Rinse the brush with sterile water.
8.
Actuate the handle several times to be sure the brush functions properly. If the unit does not function properly, or there is
evidence of damage (e.g., bent brush, bent brush stem, kinked catheter), do not use this product and contact your local
Product Specialist.
Directions for Use (Long Guidewire technique):
1.
Carefully retract the brush into the catheter past the radiopaque band near the tip of the catheter.
2.
When using a guidewire, irrigate the guidewire lumen of the catheter with sterile water/saline.
3.
After selective cannulation of the desired duct is achieved and the guidewire is placed beyond the desired site for brushing:
a.
Advance the Infinity
b.
With your finger, cover the hole approximately 20 cm. from the tip of the catheter when performing long wire technique.
c.
Observe the guide wire as it advances past the hole approximately 20 cm. from the tip of the catheter and exits the luer
lock fitting.
4.
Advance the device into the accessory channel of the endoscope using short strokes (1"- 1.5") until the distal end of the
sheath is endoscopically visualized.
5.
Advance the brush catheter using fluoroscopic guidance to the desired location.
6.
Using the spool handle and thumb ring, slowly advance the brush out of the catheter and brush the desired area in order to
obtain adequate cellular material.
d.
Brushing of the desired area will be easier with the endoscope elevator open.
7.
When brushing is complete, retract the brush into the catheter and remove the Infinity
wire exchange technique.
8.
Properly prepare the specimen per institution guidelines for cytological evaluation. If salvage cytology is desired, see
Directions for Use (Salvage Cytology).
00732074 Rev. D
Product #
Sheath Diameter
3.0 mm
2.5 mm
®
ERCP sampling device over the guidewire.
Sheath Length
Approx. Brush Size
(Width x Length)
200 cm
4.75 mm x 29 mm
200 cm
3.0 mm x 24 mm
®
Max. Guide Wire
0.035in/0.89mm
0.035in/0.89mm
sampling device using accepted long
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