Product Description

English Indications for use This product is indicated for the subcutaneous infusion of insulin from an infusion pump. Contraindications Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products. Warnings Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site. Before insertion, clean the insertion site with isopropyl alcohol. Remove the needle guard before inserting the infusion set. If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional. Do not leave air in the infusion set. Prime completely. Check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication. If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin. Replace the infusion set every **- *2 hours, or per your healthcare professionals instructions. Do not reinsert the introducer needle into the infusion set. Re-insertion may cause tearing of the soft cannula, which may result in unpredictable medication flow. Never prime the set or attempt to free a clogged line while the set is inserted. You may accidentally inject too much medication. Do not put disinfectants, perfumes, or deodorants on the infusion set as these may affect the integrity of the set. Dispose of the infusion set and introducer needle safely, in a sharps container, after a single use. Do not clean or re-sterilize. This device is sterile and non-pyrogenic unless the package has been opened or damaged. Do not use if the package has been opened or damaged. (For Paradigm users, do not use the infusion set if the tubing connector needle has been damaged.) Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle. Use aseptic techniques when temporarily disconnecting the set and consult your healthcare provider on how to compensate for missed medication when disconnected. If infusing insulin, carefully monitor your blood glucose levels when disconnected and after reconnecting. If infusing insulin, and your blood glucose level becomes unexplainably high, or an occlusion alarm occurs, check for clogs and/or leaks. If in doubt, change the infusion set because the soft cannula may be dislodged, crimped and/or partially clogged. Should any of these problems arise, make a plan with your healthcare professional for rapidly replacing insulin. Test your blood glucose level to make sure the problem is corrected. If infusing insulin, do not change the infusion set just before bedtime unless you can check your blood glucose **3 hours after insertion. Reuse of the infusion set may cause damage to the cannula/needle and lead to infection, site irritation, and/or inaccurate medication delivery. If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly prime the infusion set. This may result in the delivery of too little or too much insulin, which can cause hyperglycemia or hypoglycemia. If this occurs, start over with a new reservoir and infusion set.
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