TANDEM Diabetes Care AutoSoft 30 Infusion Set Instruction Manual

TANDEM Diabetes Care AutoSoft 30 Infusion Set

Product Information

1. The AutoSoftTM 30 infusion set is designed for the subcutaneous infusion of insulin using an external pump. It is intended for single use and has been tested to be compatible with insulin approved for subcutaneous infusion.
2. However, it is important to note that the AutoSoftTM 30 infusion set is not intended for use with blood, blood products, or intravenous infusion (IV).

Product Usage Instructions

1. Before inserting the AutoSoftTM 30, wash your hands thoroughly.
2. Choose a suitable insertion area, avoiding areas right next to previous insertion sites. Consult your healthcare provider for recommended insertion sites and rotation.
3. Clean the area of insertion with a disinfectant according to your healthcare provider’s instructions. Ensure that the area is completely dry before proceeding.
4. Check the tamper-proof seal and sterile paper. Do not use the infusion set if the sterile paper or red seal has been broken.
5. Follow the instructions provided by your pump manufacturer for connecting the AutoSoftTM 30 to your pump.
6. Refer to the illustrations on pages 84-85 of the user manual for visual guidance on releasing and inserting the AutoSoftTM 30.
7. After insertion, wait for three hours before measuring your blood glucose levels.
8. If you need to change the site, apply a new AutoSoftTM 30 at a new location.

Instructions for Use

• Do not re-use
• Caution: see instructions for use
• Consult instructions for use
• Prescription required, does not apply in all geographies

European Conformity
This symbol means that the device fully complies with applicable European Union Acts

• Manufacturer
• Non-pyrogenic
• Open here
• Use-by (Expiry date) YYYY-MM-DD
• Lot number
• Date of Manufacture YYYY-MM-DD
• Reference / model number
• Sterilized using ethylene oxide
• Global Trade Item Number
• Do not use if package is damaged
• Keep away from sunlight
• Keep Dry
• Medical Device
• Single sterile barrier system
• Authorized representative in the European Community

Indications for use

The AutoSoft™ 30 infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.

INTENDED USE
The infusion set is indicated for subcutaneous infusion of insulin in the treatment of diabetes.
The infusion set has been tested to be compatible with insulin approved for subcutaneous infusion.

PRODUCT DESCRIPTION
AutoSoft™ 30 is an angled infusion set with an integrated insertion device. The built-in legs support a 30° insertion angle. This product is delivered ready for use. Both the insertion device and the separate tubing are sterile.

CONTRAINDICATIONS
AutoSoft™ 30 is neither intended nor indicatedfor use with blood, blood products or intravenous infusion (IV).

WARNINGS

• Carefully examine the instructions for use before inserting AutoSoft™ 30. Failure to follow instructions may result in pain or injury.
• AutoSoft™ 30 infusion sets with t:lock™ tubing connectors should only be used with Tandem cartridges featuring the t:lock™ connector.
• AutoSoft™ 30 is only sterile and non-pyrogenic if the packaging is undamaged and unopened. Do not use it if the sterile paper or red seal has been broken.
• When using AutoSoft™ 30 for the first time, do so in the presence of a healthcare provider.
• 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 to unpredictable medication flow.
• Reuse of the infusion set may cause site irritation or infection and may lead to inaccurate medication delivery.
• If the soft cannula bends during insertion, apply a new AutoSoft™ 30 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 priming the infusion set, make sure there are no air bubbles in the tubing. Consult your pump manufacturer’s instructions for use.
• AutoSoft™ 30 is a single-use device and should be disposed of immediately after  use. Do not clean or re-sterilize.
• Check the infusion set frequently to ensure that the soft cannula remains firmly in place. Replace with a new infusion set at a new site, if the infusion set is not in place. Since the cannula is soft, it will not cause any pain if it slips out, and this may happen without notice. The soft cannula must always be completely inserted to receive the full amount of medication.
• Do not put perfumes, deodorants, cosmetics or other products containing disinfectants in contact with the connector or the tubing. This may impact the integrity of the infusion set.
• Replace the infusion set if the adhesive tape becomes loose or is dislodged from its original site.
• Replace the infusion set every two to three days, or per your healthcare provider’s instructions.
• If your insertion site becomes irritated or infected, replace the infusion set and use a 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 missed medication while 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™ 30. Measure your blood glucose on a regular basis. Discuss this with your healthcare provider.
• Do not change your infusion set just before bedtime, unless your blood glucose can be checked one to three 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 your infusion set since the soft cannula could be dislodged. Discuss plan to bring down your blood glucose level with your healthcare provider should any of these problems arise. Test your blood glucose level to ensure 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 your national authority

STORAGE & DISPOSAL

• Store infusion sets in a cool, dry location at room temperature. 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 the used infusion set according to local regulations for biohazardous waste.

Preparation and insertion

• Read all instructions carefully before using
• AutoSoft™ 30. Consult your pump manufacturer’s instructions for use before connecting
• AutoSoft™ 30 to your pump. Follow proper hygiene procedures. Please see the corresponding illustrations on pages 84-85.

CONTENTS

• A. Lid
• B. Needle protector
• C. Soft cannula
• D. Adhesive tape
• E. Cannula housing
• F. Connector
• G. Tubing
• H. Introducer needle
• I. Insertion device
• J. Sterile paper
• K. Lined indentations – hold here when loading AutoSoft™ 30 (see figure 7)
• L. Release buttons – press here when releasing AutoSoft™ 30 (see figure 9)
• M. Disconnect cover
• N. Circular protective cap

OVERVIEW

INSTRUCTIONS

Unfold the cover of this booklet to view images that correspond to the steps below.

1. Wash your hands before inserting AutoSoft™ 30.

2. Suggested insertion areas. Do not use an area right next to your previous site of insertion. Please consult your healthcare provider for recommended insertion site and rotation.

3. Clean the area of insertion with a disinfectant as directed by your healthcare provider. Be sure the area is air dry before insertingAutoSoft™ 30.
   CAUTION: Check the tamper-proof seal and sterile paper. Do not use if the sterile paper or red seal has been broken.

4. Pull the red tape to remove the seal.

5. Pull off the sterile paper. Do not touch the spring at this stage.

6. Hold on the lined indentations with one hand and pull the lid off with the other.
   CAUTION: Be careful not to bend or touch the AutoSoft™ 30 introducer needle.
   IMPORTANT NOTE: If the infusion set is not securely placed in the insertion device with the needle pointing straight ahead, pain or minor injury may occur during insertion.

7. Place your fingers on the lined indentations on each side. Pull back the spring softly until you hear a “click”. The needle protector will lift up or peel off. Do not touch or bend the introducer needle.

8. Immediately before insertion, carefully remove the needle protector. Be sure the tape is not stuck on the introducer needle. Check that the soft cannula does not exceed the introducer needle.

9. Insertion: Place your index finger on the top release button and your thumb on the bottom release button. Position AutoSoft™ 30 with its legs level (flat) on the skin to ensure an insertion angle of 30°. Make sure to maintain a 30° angle while inserting and gently squeeze once to insert AutoSoft™ 30.

10. Make sure that the cannula stays in place: Put your finger gently on the clear window while removing the insertion device and introducer needle. Pull it gently straight back.

11. Secure the cannula with one finger on the clear window

    • Carefully remove the backing paper under the cannula housing as shown .

12. Remove the backing paper under the front end

    • Gently massage the adhesive tape onto the skin .
      IMPORTANT: Do not attempt to straightenthe adhesive if curled

    • Start over with a new infusion set .

13. Put the lid back on for disposal .

14. TUBING: Remove paper from the tubing and the circular protective cap from the connector

    • Prime the tubing until medication dispenses from the tip
    • Ensure there are no air bubbles in the tubing
    • Consult your pump manufacturer’s instructions for use for proper priming procedures .

15. Place a finger in front of the cannula hous ing and insert the connector needle

    • Make sure the connector locks with a “click”
    • Fill the empty space in the cannula with the following prime:

DISCONNECT

• A. AutoSoft™ 30 allows you to temporarily disconnect from your pump
  • Place a finger  just in front of the cannula housing andgently squeeze the sides of the connector
  • Pull the connector needle straight out .
• B. Insert the circular protective cap into the connector needle until you hear a “click” .
• C. Insert the disconnect cover into the cannula housing until you hear a “click” .

RECONNECT

• D. Remove the circular protective cap

  • If necessary, prime the tubing until medication dispenses from the needle .
    CAUTION: When priming, hold the tubing with the needle pointing down .

• E. Remove the disconnect cover from the cannula housing .

• F. Place a finger in front of the cannula hous -ing

  • Push the connector needle straight in until you hear a “click” .

Contacts

• Contactos
• Distributor
• Made in Mexico
• Address: Unomedical a/s Aaholmvej 1-3, Osted 4320 Lejre, Denmark
• www.infusion-set.com

References

• Diabetes Care - Diabetes Set for Insulin Infusion - Convatec
• Diabetes Management | Insulin Pumps | Tandem Diabetes Care
• International Distribution Partners | Tandem Diabetes Care

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