COOK Medical Percutaneous Nephrostomy Set, Инструкция по эксплуатации

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ENGLISH
PERCUTANEOUS NEPHROSTOMY SET
CAUTION: U.S. federal law restricts this device to sale by or on the
order of a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Percutaneous Nephrostomy Set includes the following:
• 22 gage, 15 cm long Chiba needle
• 18 gage, 15 cm long trocar needle
• .038 inch (0.97 mm) wire guide, 60 cm long with 3 mm
Safe-T-J® tip
• 7, 8, and 9 French radiopaque dilators, 20 cm long
• 8.3 French radiopaque pigtail catheter, 30 cm long
• Fixation device with pull tie
• Connecting tube, 30 cm long with one-way stopcock and universal
connector
INTENDED USE
The Percutaneous Nephrostomy Set is intended for external urine drainage
from the renal pelvis.
CONTRAINDICATIONS
None known
WARNINGS
Manipulation of this product requires fluoroscopic or ultrasound guidance.
PRECAUTIONS
• The product is intended for use by physicians trained and experienced
in diagnostic and interventional techniques. Standard techniques for
placement of percutaneous drainage catheters should be employed.
• The potential effects of phthalates on pregnant/nursing women or
children have not been fully characterized and there may be concern
for reproductive and developmental effects.
INSTRUCTIONS FOR USE
1. With patient prone, preliminary localization of the renal pelvis by plain
film, delayed pyelogram, retrograde pyelogram, ultrasound or CT
should be performed.
Skinny Needle Antegrade Pyelogram
2. After prepping skin, under fluoroscopic control, a 22 gage needle
puncture is made two finger breadths lateral to the lateral margin of
the paraspinous muscles and under the 12th rib.
NOTE: The puncture should be made as straight down as possible.
NOTE: Ultrasound could be used to guide the puncture, then
fluoroscopy for contrast injection. Real-time ultrasound with the
patient on a fluoroscopy table is most convenient.
3. An antegrade pyelogram is performed to provide visualization of the
target collecting system, gauge depth, and distend the system for
subsequent puncture.
NOTE: A urine specimen may be taken directly from the renal pelvis
before contrast injection if desired.
4. The needle is withdrawn by grasping the needle at the skin so the
depth of the collecting system can then be gauged. Alternatively, in
the case of small, partially obstructed systems, the needle can be left
in place and contrast infused during the next step. Alternatively, if
needle position is suitable for nephrostomy, the 18 gage introducing
needle can be placed next to it to the same depth.
Introducing Needle
5. With rubber-shod forceps placed on the 18 gage needle at the depth
previously gauged, the renal pelvis is entered as before. Free flow of
urine indicates proper positioning.
6. A .038 inch, 3 mm Safe-T-J ® wire guide is introduced and advanced
under fluoroscopic control until it is well inside the renal pelvis or
down the ureter (3 inches).
Dilatation and Tube Placement
7. The introducing needle is withdrawn and the tract is dilated using
the appropriate sequence of dilators passed over the wire guide,
maintaining wire guide position utilizing fluoroscopic visualization.
8. Prior to introduction, the pigtail should be uncoiled. The nephrostomy
catheter is introduced over the wire guide to a point where the pigtail
portion is positioned in the renal pelvis, infundibulum or ureter as
appropriate. To prevent accidental advancement or withdrawal of the
wire guide, the location of its tip should be continuously monitored
fluoroscopically.
9. Once catheter is properly positioned, the wire guide should be
removed.