Tandem AutoSoft XC Instructions For Use

INDICATIONS FOR USE
The AutoSoft™ XC infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is
indicated for single use.
Instructions for 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. Refer to the insulin pump user guide for a list of compatible insulins and infusion sets.
PRODUCT DESCRIPTION
AutoSoft™ XC is an infusion device which combines an infusion set with an aid for insertion (inserter). As the infusion set is an integrated part of
the inserter, AutoSoft™ XC is delivered assembled and ready for use as a single, sterile unit.
CONTRAINDICATIONS
AutoSoft™ 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 is
already 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 of
subcutaneous 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 to
unpredictable 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
Unomedical a/s
• Never try to fill or free a clogged tubing while the infusion set is inserted. This may result in unpredictable medication flow.
Tandem Diabetes Care, Inc.
Aaholmvej 1-3, Osted
12400 High Bluff
• When unwinding, release the tubing with caution as a hard pull of the tubing can result in damage to the infusion device. Ensure that the
4320 Lejre, Denmark
San Diego, CA 92130 USA infusion set is properly in place in the inserter when the tubing is fully released (see figure 8).
www.infusion-set.com
tandemdiabetes.com
• 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.
MX
• Do not in any way put disinfectants, perfumes, deodorants, cosmetics or other products containing disinfectants in contact with the connector
© 2023 Tandem Diabetes Care, Inc. All rights reserved. Tandem
or the tubing. This may impact the integrity of the infusion set.
Diabetes Care, AutoSoft and t:lock are either registered trademarks
• 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 any
or trademarks of Tandem Diabetes Care, Inc. in the United States
pain if it becomes dislodged, and this may take place without notice. The soft cannula must always be completely inserted to receive the full
and/or other countries. AW-1001699_B
amount of medication.
• The infusion set may be worn for a maximum of three days, or according to insulin labeling or healthcare provider's instructions, whichever
duration is shorter.
Use-by (Expiry date) YYYY-MM-DD
• 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 missed
medication when disconnected.
Do not re-use
• Never point a loaded insertion device towards any body part, where insertion is not desired.
Sterilized using ethylene oxide
RECOMMENDATIONS
• Check your blood glucose level one to three hours after insertion of the AutoSoft™ XC. Measure your blood glucose on a regular basis.
Consult instructions for use
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.
Reference / model number
• 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 or partially clogged. 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 make sure the problem is corrected.
Lot number
• 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
Manufacturer
national authority.
55°C Temperature limit for transportation:
STORAGE & DISPOSAL
-20°C -20° C up to 55° C
• 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.
Unique Device Identifier
• 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.
Non-pyrogenic
Open here
CONTENTS
Country of Manufacture: Mexico
A.
MX
B.
Date of Manufacture YYYY-MM-DD
C.
D.
Global Trade Item Number
E.
F.
Do not use if package is damaged and
G.
consult instructions for use
H.
Keep away from sunlight I.
J.
Keep Dry
K.
L.
MD Medical Device
M.
Single sterile barrier system
N.
Prescription required, does not apply in all
geographies
Caution: see instructions for use
Distributor
Lid
Needle guard
Soft cannula
Adhesive tape
Cannula housing
Connector needle
Tubing
Introducer needle
Insertion device
Sterile paper
Three raised dots – press here when lifting the
lid off (see figure 6)
Lined indentations – press here when loading
AutoSoft™ XC (see figure 10)
Round indentations – press here simultaneously
when inserting AutoSoft™ XC (see figure 12)
Disconnect cover (see figure B)
PREPARATION AND INSERTION steps are taken gently so the infusion set is not loosened /
removed by accident.
Read all instructions carefully before using the AutoSoft™ XC
Unwinding the tubing: Carefully twist the beginning
7.
infusion set. For information about pump therapy, possible
of the tubing out of the slot. Pull up gently. Now unwind
errors, and potential risks and their causes, consult your
the tubing from the insertion device by pulling it carefully
pump manufacturer's instructions for use before connecting
upwards.
AutoSoft™ XC. When using AutoSoft™ XC‚ follow proper
hygiene procedures. Please see the corresponding illustrations.
CAUTION: Do not touch the AutoSoft™ XC introducer
needle when unwinding the tubing. Be careful not to pull
INSTRUCTIONS
too hard when the tubing is fully released. You could
accidentally remove the infusion set from the inserter.
1. Wash your hands before inserting AutoSoft™ XC.
8. Connect AutoSoft™ XC to a cartridge and the pump.
2. Suggested insertion sites. Choose an insertion site as
Prime infusion set. Ensure there are no air bubbles in the
recommended by your healthcare provider. Do not use an
tubing. Consult pump manufacturer's instructions for use.
area right next to your previous insertion site.
CAUTION: When priming the infusion set, hold
3. Clean the area of insertion with a disinfectant as directed
AutoSoft™ XC with the needle pointing down to ensure
by your healthcare provider. Be sure the area is air dry
that medication does not come in contact with the
before inserting AutoSoft™ XC.
adhesive backing paper.
4. Pull the red tape to remove the seal.
9. Pull up gently to remove the adhesive backing paper.
5. Remove the sterile paper.
10. Prepare the inserter: Place fingers on lined indentations.
6. Press the three raised dots on each side of the lid firmly Press lined indentations on each side. Pull spring up until
with one hand and lift up the lid with the other hand. you hear a "click".
CAUTION: Be careful not to bend or touch the
AutoSoft™ XC introducer needle when preparing the
inserter and infusion set.
IMPORTANT NOTE: If the infusion set is not securely
placed in the insertion device with the needle pointing
straight ahead prior to insertion, pain or minor injury may
occur. To avoid this, please ensure that the following
DISCONNECT
A. AutoSoft™ XC allows you to temporarily disconnect your pump without having to change the
infusion set. Hold the adhesive in place by placing a finger just in front of the cannula housing, and
gently squeeze the sides of connector. Pull the connector needle straight out from the cannula
housing.
B. Insert the disconnect cover into the cannula housing until you hear a "click".
11. Carefully remove the needle guard by gently twisting
and then pulling it. Check that the soft cannula does not
exceed the introducer needle.
CAUTION: Before positioning AutoSoft™ XC over a
clean insertion site, place the tubing in the slot to ensure
that the tubing is not caught underneath the infusion set
during insertion.
12. Insert Autosoft™ XC: Position AutoSoft™ XC over the
insertion site. Simultaneously press the round indentations
on both sides of the insertion device to insert AutoSoft™
XC.
13. Push gently on the center of the inserter to secure the
adhesive tape on the skin.
14. Remove the inserter/introducer needle by grasping the
center and pulling it gently back. Gently massage the
tape onto the skin. Fill the empty space in the cannula
with the following amount of insulin:
U-100 insulin:
6 mm: 0.3 units (0.003 ml)
9 mm: 0.5 units (0.005 ml)
15. Push the lid back in place until you hear a "click."
RECONNECT
C. If necessary, prime the infusion set until medication dispenses from the needle.
CAUTION: When priming the infusion set, hold AutoSoft™ XC with the needle
pointing down.
D. Remove the disconnect cover from the cannula housing by pressing the grips. Place a
finger on the adhesive tape just in front of the cannula housing.
E. Push the connector needle straight in until you hear a "click".