INDICATIONS FOR USE
The AutoSoft
™
90 infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump.
DESCRIPTION
AutoSoft 90 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 90 is delivered assembled and ready for use as a single, sterile unit.
CONTRAINDICATIONS
AutoSoft 90 is neither intended nor indicated for use in intravenous infusion of blood or blood products.
WARNINGS
• AutoSoft 90 infusion sets with t:lock tubing connectors should only be used with Tandem cartridges featuring the t:lock
connector.
• AutoSoft 90 is only sterile and non-pyrogenic if the insertion device is unopened and undamaged. Do not use if the
insertion device is already opened or has been damaged. Ensure sterility by checking if the sterile paper and tamper-proof
seal are undamaged.
• Carefully examine the instructions for use before inserting AutoSoft 90. Failure to follow instructions may result in
pain or injury.
• When using AutoSoft 90 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.
• Do not in any way put disinfectants, perfumes, deodorants, cosmetics or other products containing alcohol or disinfectants
in contact with the connector or the tubing. These may affect the integrity of the infusion set.
• AutoSoft 90 is a single-use device and should be disposed of immediately after use. Do not clean or re-sterilize.
• AutoSoft 90 can be disposed of safely after insertion if the lid has been placed back on. Please consult your local pharmacy
for sharps containers.
• 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.
Ensure that the infusion set is properly in place when the tubing is fully released
(see figure 8)
.
• Do not leave air in the infusion set. Make sure to fill AutoSoft 90 completely.
• Inaccurate medication delivery, infection and/or site irritation may result from improper insertion or maintenance of
your infusion site.
• Replace the infusion set every 48-72 hours, or per your healthcare provider’s instructions.
• If the soft cannula bends during insertion, discard and apply a new AutoSoft 90 immediately.
• 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 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.
• 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
medication flow.
• Never try to fill or free clogged tubing while the infusion set is inserted. This may result in unpredictable medication flow.
• Always clean the insertion site when temporarily disconnecting the infusion set. Consult your healthcare provider on how
to compensate for missed medication when disconnected. Carefully monitor blood glucose levels when disconnected
and after reconnecting.
• Protect the AutoSoft 90 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.
• Reuse of the infusion set may cause infection, site irritation, or damage to the cannula/needle. A damaged cannula/needle
may lead to inaccurate medication delivery.
RECOMMENDATIONS
• Check your blood glucose level 1-2 hours after introducing AutoSoft 90. Measure your blood glucose on a regular basis.
Discuss this with your healthcare provider.
• When using insulin, do not change your infusion set just prior to bedtime, unless blood glucose can be checked 1-2 hours
after insertion.
• When you are infusing insulin and 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, 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.
• Carefully monitor your blood glucose level when disconnected and after reconnecting.
PREPARATION AND INSERTION
Read all instructions carefully before using the AutoSoft
90 infusion set. For information about pump therapy,
possible errors, and potential risks and their causes,
consult your pump manufacturer’s instructions for use
before connecting AutoSoft 90. When using AutoSoft
90‚ follow proper hygiene procedures. Please see the
corresponding illustrations.
INSTRUCTIONS
1.
Wash your hands before inserting AutoSoft 90.
2.
Recommended insertion areas. Do not use an area
right next to your previous place of insertion.
3.
Clean the area of insertion with a disinfectant as
directed by your healthcare provider. Be sure the
area is dry before inserting AutoSoft 90.
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
firmly with one hand and lift up with the other hand.
CAUTION:
Be careful not to bend or touch the
AutoSoft 90 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 steps are taken
gently so the infusion set is not loosened /
removed by accident.
7. UNWINDING THE TUBING:
Carefully twist the
beginning of the tubing out of the slot. Pull up
gently. Now unwind the tubing from the insertion
device by pulling it carefully upwards.
CAUTION:
Do not touch the AutoSoft 90
introducer needle when unwinding the tubing.
Be careful not to pull too hard when the tubing is
fully released. You could accidentally remove the
infusion set from the introducer needle.
8.
Connect AutoSoft 90 to a reservoir/cartridge and
the pump. Prime infusion set. Ensure there are no
air bubbles in the tubing or AutoSoft 90.
CAUTION:
When priming the infusion set, hold
AutoSoft 90 with the needle pointing down to
ensure that medication does not come in contact
with the adhesive 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 until you hear a “click”.
11.
Carefully remove the needle guard by gently
twisting and then pulling it.
CAUTION:
Before positioning AutoSoft 90 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 90:
Position AutoSoft 90 over
the insertion site. Simultaneously press the round
indentations on both sides of the insertion device
to insert AutoSoft 90.
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:
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)
DISCONNECT
A.
AutoSoft 90 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 90. Pull the connector
needle straight out from the cannula housing.
B.
Insert the disconnect cover into the cannula housing 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 90 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”.
Use by (year-month-day)
Do not re-use
Sterilized using ethylene oxide
Attention: See accompanying documents
See Instructions for Use
Reference / model number
Lot number
Manufacturer
© 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-1000184_A
Unomedical a/s
Aaholmvej 1-3, Osted
4320 Lejre, Denmark
Made in Mexico
Legal manufacturer:
Distributed by:
11045 Roselle Street
San Diego, CA 92121, USA
www.tandemdiabetes.com
+1-858-255-6269
Instructions for Use
CONTENTS
A.
Lid
B.
Needle guard
C.
Soft cannula
D.
Adhesive
E.
Cannula housing
F.
Connector needle
G.
Tubing
H.
Introducer needle
I.
Insertion device
J.
Sterile paper
K.
Three raised dots – press here
when lifting the lid off
(see figure 6)
L.
Lined indentations – press here
when loading AutoSoft 90
(see figure 10)
M.
Round indentations – press here
when inserting AutoSoft 90
(see figure 12)
N.
Disconnect cover
(see figure B)
