INDICATIONS FOR USE
The AutoSoft
™
30 infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump.
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 inserter and the separate tubing are sterile.
CONTRAINDICATIONS
AutoSoft 30 is neither intended nor indicated for use with blood, blood products or intravenous infusion (IV).
WARNINGS
• 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 unopened and undamaged. Do not use it if the sterile paper
or red seal has been broken.
• Go through instructions for use carefully before inserting AutoSoft 30, as failure to follow instructions may result in pain
or injury.
• Use AutoSoft 30 for the first time in the presence of your healthcare provider. When possible, stand or sit upright when
using AutoSoft 30.
• Do not put perfumes, deodorants, cosmetics or other products containing alcohol or disinfectants in contact with the
connector or the tubing. This may affect the integrity of the infusion set.
• AutoSoft 30 is a single-use device. Do not clean or re-sterilize.
• Put the lid back on the insertion device for safe disposal. For available sharps containers please consult your local pharmacy.
• Remove the needle protector before use.
• When priming, make sure there are no air bubbles in the tube.
• Inaccurate insulin delivery, infection and/or site irritation may result from improper insertion or maintenance of the
infusion site.
• Replace the infusion set every 48-72 hours, or per your healthcare provider’s instructions.
• If the soft cannula bends during insertion, apply a new AutoSoft 30.
• Replace the infusion set if the adhesive tape comes loose.
• Check the infusion set frequently to ensure that the soft cannula remains firmly in place. Replace with new set, if the 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.
• If your infusion site becomes red or inflamed, replace the infusion set and use a new site until the first site has healed.
• Do not re-insert the introducer needle into the infusion set. This could cause 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.
• Wash your hands before disconnecting and reconnecting the infusion set. Consult your healthcare provider on how to
compensate for missed medication while disconnected.
• Protect AutoSoft 30 from direct sunlight and 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
• For use with insulin: Check your blood glucose level 1-2 hours after insertion to ensure correct insertion/flow.
• Check the infusion site several times a day.
• Do not change your infusion set just before bedtime, unless your blood glucose can be checked 1-2 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.
• Carefully monitor your blood glucose levels when disconnected and after reconnecting.
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.
INSTRUCTIONS
1.
Wash your hands before inserting AutoSoft 30.
2.
Recommended insertion areas. Do not use an
area right next to your previous place of insertion.
Please refer to your healthcare provider for infusion
site rotation.
3.
Clean the area of insertion with a disinfectant as
directed by your healthcare provider. Be sure the
area is dry before inserting AutoSoft 30.
CAUTION:
Check the tamper-proof seal and sterile
paper. Do not use if the seal or paper 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 needle.
8.
Immediately before insertion, carefully remove the
needle protector. Be sure the tape is not stuck on
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.
Massage the adhesive thoroughly onto the skin.
IMPORTANT:
Do not attempt to straighten the
adhesive if curled.
13.
Put the lid back on for disposal.
14.
Remove the circular protective cap. Prime the
infusion set until medication dispenses from the
tip. Ensure there are no air bubbles in the tubing
or AutoSoft 30. Consult your pump manufacturer’s
instructions for use for proper priming procedures.
15.
Place a finger in front of the cannula housing and
insert the connector needle. Make sure the
connector locks with a “click”. Fill the empty space
in the cannula with the following prime:
U-100 insulin:
0.7 units (0.007 ml)
DISCONNECT
A.
AutoSoft 30 allows you to temporarily disconnect from your pump. Place a finger
just in front of the cannula housing and gently squeeze the sides of AutoSoft 30.
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. Prime the infusion set until medication
dispenses from the needle.
CAUTION:
When priming, hold AutoSoft 30 with the needle pointing down.
E.
Remove the disconnect cover from the cannula housing.
F.
Place a finger in front of the cannula housing. Push the connector needle
straight in until you hear a “click”.
Instructions for Use
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-1000220_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
CONTENTS
A.
Lid
B.
Needle protector
C.
Soft cannula
D.
Adhesive
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
