Cook Medical G17870 - CATHETER, SILICONE, BALLOON, 7FRENCH, 10/BX

Cook Medical G17870 - CATHETER, SILICONE, BALLOON, 7FRENCH, 10/BX

Cook Silicone Balloon HSG Catheter

The Cook Silicone Balloon HSG Catheter is used to access the uterine cavity for saline infusion sonohysterography or to inject contrast medium into the uterine cavity and fallopian tubes for evaluation of tubal patency. Cook Medical-Developing simple solutions for reproductive health.

• Silicone construction; contains no latex.
• Available with or without sideport.
• Includes an appropriately sized syringe.

Open Tip

Intended Use

Used to access the uterine cavity for saline infusion sonohysterography or for injection of contrast medium into the uterine cavity and fallopian tubes for evaluation of tubal patency.

• A syringe is included.
• The small diameter allows passage through the cervix.

Contraindications

This device should not be used in the presence of hemorrhage, active pelvic infection, sexually transmitted disease, profuse bleeding, or pregnancy.

Warnings

• Always inflate the balloon with a sterile liquid. Never inflate with air, carbon dioxide or any other gas.

Precautions

• Do not overinflate. Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.
• Refer to product label or the inflation check valve on the balloon device for appropriate balloon volume.
• This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease.

Instructions for Using Cook Silicone Balloon HSG Catheter

HYSTEROSALPINGOGRAPHY

• If desired, connect balloon catheter to a disposable connecting tube (order number: J-DET-115000).
• Position a vaginal speculum within the vagina so the external cervical os can be visualized during catheter insertion.
• Cleanse the cervix with an appropriate cleansing solution.
• Catheter tip is inserted through cervix and into uterus.
• Fill the syringe with sterile saline solution. Eliminate air from the syringe.
• To inflate the balloon, instill sterile saline solution.
• Inject a small amount of contrast medium to check the position of the balloon.
• If desired, deflate the balloon and using fluoroscopic control, advance the catheter along the course of the residual cervical contrast into the uterine cavity. When the catheters position in the uterus is confirmed, reinflate balloon with sterile saline solution to the maximum volume.
• Pull back gently on the catheter shaft to seat the inflated balloon against the internal cervical os.
• Inject sufficient contrast medium to fluoroscopically visualize the uterine cavity and the fallopian tubes.
• Deflate the balloon when the examination is complete and remove the catheter from the cervix.

SALINE INFUSION SONOHYSTEROGRAPHY

• If desired, connect balloon catheter to a disposable connecting tube (order number: J-DET-115000).
• Pre-fill catheter with saline and remove syringe prior to placement. (Syringe is reattached after catheter is positioned.)
• Position a vaginal speculum within the vagina so the external cervical os can be visualized during catheter insertion.
• Cleanse the cervix with an appropriate cleansing solution.
• Catheter tip is inserted through cervix and into uterus.
• Fill the syringe with sterile saline solution. Eliminate air from the syringe.
• To inflate the balloon, instill sterile saline solution.
• Pull back gently on the catheter shaft to seat the inflated balloon against the internal cervical os.
• Inject saline through catheter into uterus.
• Deflate the balloon when the examination is complete and remove the catheter from the cervix.

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from the package, inspect the product to ensure no damage has occurred.