The i-port® is indicated for use by people requiring multiple daily subcutaneous injections of physician prescribed medications, including insulin.

The i-port® is suitable for use on adults and children in home use and healthcare facility environments for up to 72 hours.

If applying the i-port® for the first time, perform device application in the presence of a healthcare provider.

Do not use the i-port® for any purpose other than the indications specified by your healthcare provider.

Do not use the same i-port® for longer than 72 hours.

Do not use a needle longer than 5/16 in. (8 mm) and/or thicker than 28 gauge when injecting into the i-port®.

Do not attempt to reuse the i-port® after use.

DO NOT USE A NEEDLE LONGER THAN 5/16 in. or 8 mm (DO NOT attempt to use a 1/2 in. (12.7 mm) injection needle with the i-port®. Doing so may damage the device causing unnecessary punctures of the skin, or tearing or puncturing of the soft cannula which may result in unpredictable medication delivery).

DO NOT USE A NEEDLE THICKER THAN 28 GAUGE. Doing so may damage the device which may result in unpredictable medical delivery or increased risk of infection.

DO NOT ATTEMPT TO REUSE THE DEVICE AFTER USE. Properly dispose of the used i-port® and replace with a new device as needed.

Inaccurate medication delivery, infection, and/or site irritation may result from improper application to the body and/or maintenance of the i-port® application site.

If the insertion site becomes irritated or inflamed, remove and discard the i-port® and apply a new i-port® to a different location on the body.

The device’s soft cannula may crimp or bend when applying or while wearing the i-port®. A crimped or bent cannula may limit or prevent medication delivery through the i-port®. You should remove and discard any i-port® device you suspect has a crimped or bent cannula and apply a new i-port® to a different location on your body. Indications that your i-port® has a crimped or bent cannula include:

• Difficulty pressing down on the plunger of a syringe when injecting
• Injected medication escaping from the device onto the top of the septum
• Injected medication leaking onto the skin or saturating the adhesive
• Moisture present within the clear body of the device

If the adhesive becomes loose or if the soft cannula becomes fully or partially dislodged from under the skin, medication delivery may be limited or prevented. If this occurs, remove and discard the i-port® and apply a new i-port® to a different location on the body.

Remove the i-port® and replace with a new i-port® at a different location on the body every 72 hours according to Centers for Disease Control guidelines or per your healthcare provider’s instructions.

Do not reinsert the insertion needle into the i-port®. Reinsertion could cause puncturing or tearing of the soft cannula which would result in unpredictable medication delivery or injury.

Do not put perfumes or deodorants on the i-port® as these may affect the integrity of the device.

This device is sterile and non-pyrogenic unless package has been opened or damaged. Do not use device if the package has been opened or damaged.

Store the i-port® at room temperature.

Test blood glucose per your healthcare provider’s instructions to ensure that insulin delivery at the injection site is appropriate.

Test blood glucose 2 to 4 hours after using the i-port® to ensure insulin delivery performs as anticipated.

Avoid applying and using a new i-port® prior to bedtime unless blood glucose can be checked 2 to 4 hours after injection.

In the case of unexplainably high blood glucose, remove and discard the i-port® and apply a new i-port® to a different location on the body since the soft cannula could be dislodged, crimped or partially clogged.

Should suggested actions not provide a resolution to a problem or should your blood glucose remain high, contact your physician or healthcare provider.