Novy CORNUAL CANNULATION SET, Руководство пользователя

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ENGLISH
NOVY CORNUAL CANNULATION SET
The Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope
or other uterine access device, for hysteroscopic or fluoroscopic selective catheterization and cannulation
of the proximal fallopian tube(s), followed by the introduction of chromotubation solution or contrast
medium, in the evaluation of tubal patency. Intended for one-time use.
The wire guide in the Novy Cornual Cannulation Set is intended only to facilitate placement of the
inner catheter. It is not intended for tubal recanalization and should not be advanced beyond the
tubal isthmus.
WARNING: This device should not be used in the presence of hemorrhage, active pelvic infection,
profuse bleeding, or pregnancy.
NOTE: The Novy Cornual Cannulation Set is not intended for complete catheterization of the
fallopian tube or tubal recanalization.
CAUTION: Sterile if the package is unopened or undamaged. Do not use if package is broken.
INDICATION STATEMENT
Selective catheterization/cannulation of the fallopian tubes for injection of dye or contrast medium in order
to evaluate proximal tubal occlusion and/or patency under fluoroscopy or hysteroscopy/laparoscopy.
WARNING STATEMENTS
• This catheter system is only designed to access the fallopian tube from the uterine cavity. It should
only be advanced as far as necessary to achieve a meaningful diagnostic study. Possible adverse
effects of more distal advancement have not yet been determined. The catheter system is not
intended for tubal recanalization, and there is no data available, to date, showing any clinical
benefit when used this way.
• This catheter system is not designed nor intended for embryo transfer or other assisted
reproduction procedures.
• This device should only be used by an experienced clinician.
CONTRAINDICATIONS
• Pregnancy or suspected pregnancy
• Active or recent pelvic infection
• Unexplained or severe uterine bleeding
• Gynecologic malignancy (suspected or known)
• Known allergy to dye or contrast medium
POSSIBLE ADVERSE EFFECTS
The following adverse effects have been reported or are of concern with the use of this type of device.
Patients must be advised of the following risks.
1. Ectopic Pregnancy. Patients who have previously blocked fallopian tubes may be at increased risk for
ectopic (tubal) pregnancy after the tubes are opened. The magnitude of the increased risk is unknown.
2. Damage to Normal Tubes. It is unknown whether this procedure may damage normal fallopian tubes or
put the patient who has normal tubes at any increased risk for subsequent ectopic (tubal) pregnancy.
3. Tubal Dissection. It is possible that this catheter may dissect into the wall of the tube, under the
epithelial lining and cause blockage or narrowing of the lumen of the fallopian tube. This may result in
sterility, infertility, or increased risk of ectopic (tubal) pregnancy.
4. Pain or Discomfort. Some patients may experience cramping or other abdominal pain.