Tandem AutoSoft XC Instructions For Use

INDICATIONS FOR USE
The AutoSoft
DESCRIPTION
AutoSoft XC is an infusion device which combines an infusion set (catheter) 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.
WARNINGS
• AutoSoft XC infusion sets with t:lock tubing connectors should only be used with Tandem cartridges featuring the t:lock
• AutoSoft XC is only sterile and non-pyrogenic if the insertion device is unopened and undamaged. Do not use if the
• Carefully examine the instructions for use before inserting AutoSoft XC. Failure to follow instructions may result in
• When using AutoSoft XC for the first time, do so in the presence of a healthcare provider. Since different individuals have
• Do not in any way put disinfectants, perfumes, deodorants, cosmetics or other products containing alcohol or disinfectants
Instructions for Use • AutoSoft XC is a single-use device and should be disposed of immediately after use. Do not clean or re-sterilize.
• AutoSoft XC can be disposed of safely after insertion if the lid has been placed back on. Please consult your local pharmacy
• Be sure that the needle guard is removed before insertion is made.
• Release the tubing with caution as a hard pull of the tubing can result in damage to the infusion set/introducer needle.
• Do not leave air in the infusion set. Make sure to fill AutoSoft XC completely.
• Inaccurate medication delivery, infection and/or site irritation may result from improper insertion or maintenance of
• Replace the infusion set every 48-72 hours, or per your healthcare provider's instructions.
Use by (year-month-day)
• If the soft cannula bends during insertion, discard and apply a new AutoSoft XC immediately.
• Replace the infusion set if the adhesive tape becomes loose or is displaced from its original site. Since the cannula is soft,
Do not re-use
Sterilized using ethylene oxide
• If your infusion site becomes inflamed, replace infusion set and use new site until the first site has healed.
• Do not re-insert the introducer needle into the infusion set. This could cause a tearing of the soft cannula and unpredictable
Attention: See accompanying documents
• Never try to fill or free clogged tubing while the infusion set is inserted. This may result in unpredictable medication flow.
See Instructions for Use
• Always clean the insertion site when temporarily disconnecting the infusion set. Consult your healthcare provider on how
Reference / model number
• Protect the AutoSoft XC infusion set from direct sunlight and atmospheric humidity. Store in a dry place at room temperature.
• Never point a loaded insertion device towards any body part, where insertion is not desired.
Lot number
• Reuse of the infusion set may cause infection, site irritation, or damage to the cannula/needle. A damaged cannula/needle
Manufacturer
RECOMMENDATIONS
• Check your blood glucose level 1-2 hours after introducing AutoSoft XC. Measure your blood glucose on a regular basis.
Distributed by: Legal manufacturer:
• When using insulin, do not change your infusion set just prior to bedtime, unless blood glucose can be checked 1-2 hours
11045 Roselle Street Unomedical a/s
• When you are infusing insulin and your blood glucose level becomes unexplainably high or an occlusion alarm occurs, check
San Diego, CA 92121, USA Aaholmvej 1-3, Osted
www.tandemdiabetes.com 4320 Lejre, Denmark
+1-858-255-6269
Made in Mexico
• Carefully monitor your blood glucose level when disconnected and after reconnecting.
© 2017 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care is a registered
trademark and AutoSoft is a trademark of Tandem Diabetes Care, Inc. AW-1001699_A
CONTENTS
A.
B. Needle guard
C. Soft cannula
D. Adhesive
E.
F.
G. Tubing
H. Introducer needle
I.
J.
K. Three raised dots – press here
L.
M. Round indentations – press here
N. Disconnect cover
™ XC infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump.
connector.
insertion device is already opened or has been damaged. Ensure sterility by checking if the sterile paper and tamper-proof
seal are undamaged.
pain or injury.
varying amounts of subcutaneous layer, ensure that an appropriate cannula length is chosen to fit your needs.
in contact with the connector or the tubing. These may affect the integrity of the infusion set.
for sharps containers.
Ensure that the infusion set is properly in place when the tubing is fully released (see figure 8).
your infusion site.
it will not cause any pain if it slips out, and this may take place without notice. The soft cannula must always be completely
inserted to receive the full amount of medication.
medication flow.
to compensate for missed medication when disconnected. Carefully monitor blood glucose levels when disconnected
and after reconnecting.
may lead to inaccurate medication delivery.
Discuss this with your healthcare provider.
after insertion.
for clogs and leaks. If in doubt, change your infusion set since the soft cannula could be dislodged, crimped or partially
clogged. Discuss a plan for rapid replacement of insulin with your healthcare provider should any of these problems arise.
Test your blood glucose level to make sure the problem is corrected.
Lid
Cannula housing
Connector needle
Insertion device
Sterile paper
when lifting the lid off (see figure 6)
Lined indentations – press here
when loading AutoSoft XC
(see figure 10)
when inserting AutoSoft XC
(see figure 12)
(see figure B)
PREPARATION AND INSERTION needle pointing straight ahead prior to insertion,
pain or minor injury may occur. To avoid this,
Read all instructions carefully before using the AutoSoft
please ensure that the following steps are taken
XC infusion set. For information about pump therapy,
gently so the infusion set is not loosened /
possible errors, and potential risks and their causes,
removed by accident.
consult your pump manufacturer's instructions for use
7. UNWINDING THE TUBING: Carefully twist the
before connecting AutoSoft XC. When using AutoSoft
beginning of the tubing out of the slot. Pull up
XC‚ follow proper hygiene procedures. Please see the
corresponding illustrations. gently. Now unwind the tubing from the insertion
device by pulling it carefully upwards.
INSTRUCTIONS
CAUTION: Do not touch the AutoSoft XC
introducer needle when unwinding the tubing.
1. Wash your hands before inserting AutoSoft XC.
Be careful not to pull too hard when the tubing is
2. Recommended insertion areas. Do not use an area
fully released. You could accidentally remove the
right next to your previous place of insertion.
infusion set from the introducer needle.
3. Clean the area of insertion with a disinfectant as
8. Connect AutoSoft XC to a reservoir/cartridge and
directed by your healthcare provider. Be sure the
the pump. Prime infusion set. Ensure there are no
area is dry before inserting AutoSoft XC.
air bubbles in the tubing or AutoSoft XC.
4. Pull the red tape to remove the seal.
CAUTION: When priming the infusion set, hold
5. Remove the sterile paper. AutoSoft XC with the needle pointing down to
ensure that medication does not come in contact
6. Press the three raised dots on each side of the lid
with the adhesive backing paper.
firmly with one hand and lift up with the other hand.
9. Pull up gently to remove the adhesive backing
CAUTION: Be careful not to bend or touch the
paper.
AutoSoft XC introducer needle when preparing the
inserter and infusion set.
10. PREPARE THE INSERTER: Place fingers on lined
indentations. Press lined indentations on each side.
IMPORTANT NOTE: If the infusion set is not
Pull spring up until you hear a "click".
securely placed in the insertion device with the
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 AutoSoft XC. 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.
CAUTION: Before positioning AutoSoft XC over
clean insertion site, place the tubing in the slot to
ensure that the tubing is not caught underneath
the device 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 on the skin.
14. Remove the inserter/introducer needle by grasping
the center and pulling it gently back. Massage the
tape thoroughly 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. 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. 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".