WARNINGS

Talk to your doctor if you have symptoms of erectile dysfunction (not being able to get or keep an erection that allows you to have sex) in order to prevent a delay in discovering and treating the cause.

  • Do not use this device if:

    • You have an abnormally formed penis

    • You have been advised not to have sexual activity

    • You have sickle cell anemia or trait, leukemia, tumor of the bone marrow or other conditions that change blood clotting and may result in bleeding or prolonged erections.

  • Do not leave the VenoSeal on your penis for more than 30 minutes.  Do not fall asleep wearing the device.  Leaving the VenoSeal on too long may cause permanent injury or damage to your penis.

  • Allow at least 60 minutes between uses of VenoSeal device.  Using Adjustable Constriction Loops too often may cause bruising at the base of the penis (where the penis is joined to the body).

  • Talk to your doctor if any complications occur in using this device.  Stop using the device if complications continue.

PRECATIONS

  • Ask your doctor about using the VenoSeal if you are taking anticoagulant (blood-thinning) medicine; if you have a penile implant; or if you have Peyronie’s disease, leukemia or other blood disorders where bleeding or clotting may be a problem.  The effects of the VenoSeal on the components of implanted penile prostheses have not been adequately investigated.  Therefore, if you have a penile prosthesis, consult your physician prior to use.

  • Do not use the VenoSeal under the influence of drugs or alcohol.  These substances may reduce your sensitivity to pain or impair your ability to follow directions properly.

  • Do not use VenoSeal if you cannot sense pain in the penis.  Pain may be a warning sign that the device is causing injury.

  • Do not use VenoSeal if you do not have adequate use of your hands to easily remove the device.

  • Tension rings (including the VenoSeal) are not a means of birth control.  Do not rely on tension rings to avoid pregnancy.

  • Always use the lowest amount of tension necessary to maintain the erection.  Do not over-tighten the VenoSeal ring.Too much tension can cause bruising at the base of the penis.

POSSIBLE SIDE EFFECTS

Prolonged Erection/Priapism:

  • Contact your doctor immediately if you experience an erection that lasts more than 4 hours.  Prolonged erection or Priapism is a serious condition that requires prompt medical attention to prevent permanent damage to the penis.

OTHER SIDE EFFECTS

  • Pain or redness of the penis can occur as a result of using this device

  • Permanent injury to the penis can result if the device is either worn too tight or for more than 30 minutes.

CARE AND REPLACEMENT OF THE VENOSEAL ADJUSTABLE CONSTRICTION LOOP

  • Care of VenoSeal.If you use lubricant for sexual activity, use only water based lubricants.  Oil based lubricants may decrease the performance of VenoSeal.

  • Venoseal can be used more than once.  Clean after use with warm water and ordinary hand soap.  Keep VenoSeal dry and store at room temperature after it is cleaned.

  • Replacement:  Repeated use of the VenoSeal device may result in wearing out the synthetic rubber loop.  Replace VenoSeal after 6 months of use or when it shows signs of wear such as cracking.