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Tandem AutoSoft XC Instructions For Use Manual
Also see for AutoSoft XC: Instructions for use
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PREPARATION AND INSERTIONRead all instructions carefully before using the AutoSoft™ XCinfusion set. For information about pump therapy, possibleerrors, and potential risks and their causes, consult yourpump manufacturer’s instructions for use before connectingAutoSoft™ XC. When using AutoSoft™ XC‚ follow properhygiene procedures. Please see the corresponding illustrations.INSTRUCTIONS1. Wash your hands before inserting AutoSoft™ XC.2. Suggested insertion sites. Choose an insertion site asrecommended by your healthcare provider. Do not use anarea right next to your previous insertion site.3. Clean the area of insertion with a disinfectant as directedby your healthcare provider. Be sure the area is air drybefore inserting AutoSoft™ XC.4. Pull the red tape to remove the seal.5. Remove the sterile paper.6. Press the three raised dots on each side of the lid firmlywith one hand and lift up the lid with the other hand.CAUTION: Be careful not to bend or touch theAutoSoft™ XC introducer needle when preparing theinserter and infusion set.IMPORTANT NOTE: If the infusion set is not securelyplaced in the insertion device with the needle pointingstraight ahead prior to insertion, pain or minor injury mayoccur. To avoid this, please ensure that the followingsteps are taken gently so the infusion set is not loosened /removed by accident.7. Unwinding the tubing: Carefully twist the beginningof the tubing out of the slot. Pull up gently. Now unwindthe tubing from the insertion device by pulling it carefullyupwards.CAUTION: Do not touch the AutoSoft™ XC introducerneedle when unwinding the tubing. Be careful not to pulltoo hard when the tubing is fully released. You couldaccidentally remove the infusion set from the inserter.8. Connect AutoSoft™ XC to a cartridge and the pump.Prime infusion set. Ensure there are no air bubbles in thetubing. Consult pump manufacturer’s instructions for use.CAUTION: When priming the infusion set, holdAutoSoft™ XC with the needle pointing down to ensurethat medication does not come in contact with theadhesive backing paper.9. Pull up gently to remove the adhesive backing paper.10. Prepare the inserter: Place fingers on lined indentations.Press lined indentations on each side. Pull spring up untilyou hear a “click”.11. Carefully remove the needle guard by gently twistingand then pulling it. Check that the soft cannula does notexceed the introducer needle.CAUTION: Before positioning AutoSoft™ XC over aclean insertion site, place the tubing in the slot to ensurethat the tubing is not caught underneath the infusion setduring insertion.12. Insert Autosoft™ XC: Position AutoSoft™ XC over theinsertion site. Simultaneously press the round indentationson both sides of the insertion device to insert AutoSoft™XC.13. Push gently on the center of the inserter to secure theadhesive tape on the skin.14. Remove the inserter/introducer needle by grasping thecenter and pulling it gently back. Gently massage thetape onto the skin. Fill the empty space in the cannulawith the following amount of insulin:15. Push the lid back in place until you hear a “click.”U-100 insulin:6 mm: 0.3 units (0.003 ml)9 mm: 0.5 units (0.005 ml)DISCONNECTA. AutoSoft™ XC allows you to temporarily disconnect your pump without having to change theinfusion set. Hold the adhesive in place by placing a finger just in front of the cannula housing, andgently squeeze the sides of connector. Pull the connector needle straight out from the cannulahousing.B. Insert the disconnect cover into the cannula housing until you hear a “click”.RECONNECTC. If necessary, prime the infusion set until medication dispenses from the needle.CAUTION: When priming the infusion set, hold AutoSoft™ XC with the needlepointing down.D. Remove the disconnect cover from the cannula housing by pressing the grips. Place afinger on the adhesive tape just in front of the cannula housing.E. Push the connector needle straight in until you hear a “click”.Use-by (Expiry date) YYYY-MM-DDDo not re-useSterilized using ethylene oxideConsult instructions for useReference / model numberLot numberManufacturerTemperature limit for transportation:-20° C up to 55° CUnique Device IdentifierNon-pyrogenicOpen hereCountry of Manufacture: MexicoDate of Manufacture YYYY-MM-DDGlobal Trade Item NumberDo not use if package is damaged andconsult instructions for useKeep away from sunlightKeep DryMedical DeviceSingle sterile barrier systemPrescription required, does not apply in allgeographiesCaution: see instructions for useDistributor55°C-20°CMXMDCONTENTSA. LidB. Needle guardC. Soft cannulaD. Adhesive tapeE. Cannula housingF. Connector needleG. TubingH. Introducer needleI. Insertion deviceJ. Sterile paperK. Three raised dots – press here when lifting thelid off (see figure 6)L. Lined indentations – press here when loadingAutoSoft™ XC (see figure 10)M. Round indentations – press here simultaneouslywhen inserting AutoSoft™ XC (see figure 12)N. Disconnect cover (see figure B)INDICATIONS FOR USEThe AutoSoft™ XC infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set isindicated for single use.INTENDED USEThe infusion set is indicated for subcutaneous infusion of insulin in the treatment of diabetes. The infusion set has been tested to be compatiblewith insulin approved for subcutaneous infusion. Refer to the insulin pump user guide for a list of compatible insulins and infusion sets.PRODUCT DESCRIPTIONAutoSoft™ XC is an infusion device which combines an infusion set with an aid for insertion (inserter). As the infusion set is an integrated part ofthe inserter, AutoSoft™ XC is delivered assembled and ready for use as a single, sterile unit.CONTRAINDICATIONSAutoSoft™ XC is neither intended nor indicated for use in intravenous infusion of blood or blood products.CLINICAL BENEFITS• Continuous subcutaneous infusion of insulin in the treatment of diabetes.• Less injections (insertions) compared to multiple daily injection therapy.WARNINGS• Carefully examine the instructions for use before inserting AutoSoft™ XC. Failure to follow instructions may result in pain or injury.• AutoSoft™ XC infusion sets with t:lock™ tubing connectors should only be used with Tandem cartridges featuring the t:lock™ connector.• AutoSoft™ XC is only sterile and nonpyrogenic if the insertion device is undamaged and unopened. Do not use if the insertion device isalready opened or has been damaged. Ensure sterility by checking if the sterile paper and tamperproof seal are unbroken.• When using AutoSoft™ XC for the first time, do so in the presence of a healthcare provider. Since different individuals have varying amounts ofsubcutaneous layer, ensure that an appropriate cannula length is chosen to fit your needs.• Inaccurate medication delivery, site irritation or infection may result from improper insertion or maintenance of your infusion site.• Do not re-insert the introducer needle into the infusion set. This could cause a tearing or damage of the soft cannula and may lead tounpredictable medication flow.• Reuse of the infusion set may cause site irritation or infection and may lead to inaccurate medication delivery.• Be sure that the needle guard is removed before insertion is made.• If the soft cannula bends during insertion, apply a new AutoSoft™ XC immediately at a new site.PRECAUTIONS• Never try to fill or free a clogged tubing while the infusion set is inserted. This may result in unpredictable medication flow.• When unwinding, release the tubing with caution as a hard pull of the tubing can result in damage to the infusion device. Ensure that theinfusion set is properly in place in the inserter when the tubing is fully released (see figure 8).• Do not leave air in the infusion set. Make sure to fill the tubing completely. Consult pump manufacturer’s instructions for use.• AutoSoft™ XC is a single-use device and should be disposed of immediately after use. Do not clean or re-sterilize.• Do not in any way put disinfectants, perfumes, deodorants, cosmetics or other products containing disinfectants in contact with the connectoror the tubing. This may impact the integrity of the infusion set.• Replace the infusion set if the adhesive tape becomes loose or is displaced from its original site. Since the cannula is soft, it will not cause anypain if it becomes dislodged, and this may take place without notice. The soft cannula must always be completely inserted to receive the fullamount of medication.• The infusion set may be worn for a maximum of three days, or according to insulin labeling or healthcare provider’s instructions, whicheverduration is shorter.• If your insertion site becomes irritated or infected, replace the infusion set and use new site until the first site has healed.• Wash your hands before disconnecting and reconnecting the infusion set. Consult your healthcare provider on how to compensate for missedmedication when disconnected.• Never point a loaded insertion device towards any body part, where insertion is not desired.RECOMMENDATIONS• Check your blood glucose level one to three hours after insertion of the AutoSoft™ XC. Measure your blood glucose on a regular basis.Discuss this with your healthcare provider.• Do not change your infusion set just prior to bedtime, unless blood glucose can be checked one to two hours after insertion.• If your blood glucose level becomes unexplainably high or an occlusion alarm occurs, check for clogs and leaks. If in doubt, change yourinfusion set since the soft cannula could be dislodged or partially clogged. Discuss plan to bring down your blood glucose level with yourhealthcare provider should any of these problems arise. Test your blood glucose level to make sure the problem is corrected.• Carefully monitor your blood glucose level when disconnected and after reconnecting.• If, during the use of this device or as a result of its use a serious incident has occurred, please report it to the manufacturer and to yournational authority.STORAGE & DISPOSAL• Store infusion sets in a cool, dry location at room temperature (15-25 °C). Do not store infusion sets in direct sunlight, or in high humidity.• Store and handle insulin according to the manufacturer’s instructions.• Put the lid back on the insertion device and dispose in a proper sharp container according to local laws, to avoid risk of needle stick.• Dispose of a used infusion set according to local regulations for biohazardous waste.© 2023 Tandem Diabetes Care, Inc. All rights reserved. TandemDiabetes Care, AutoSoft and t:lock are either registered trademarksor trademarks of Tandem Diabetes Care, Inc. in the United Statesand/or other countries. AW-1001699_BUnomedical a/sAaholmvej 1-3, Osted4320 Lejre, Denmarkwww.infusion-set.comMXTandem Diabetes Care, Inc.12400 High BluffSan Diego, CA 92130 USAtandemdiabetes.comInstructions for use |
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