INDICATIONS FOR USE
The VariSoft
™
infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The VariSoft
cannula and tubing make up the infusion set.
CONTRAINDICATIONS
VariSoft is neither intended nor indicated for use with blood or blood products (I.V. infusion).
WARNINGS
• VariSoft infusion sets with t:lock tubing connectors should only be used with Tandem cartridges featuring the t:lock
connector.
• The VariSoft infusion set is only sterile and non pyrogenic if the packaging is unopened and undamaged. Do not use it if the
packaging is already opened or is damaged.
• Go through instructions for use carefully before inserting VariSoft, as failure to follow instructions may result in pain or injury.
• Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of
infusion site.
• When using VariSoft for the first time, do so in the presence of a healthcare provider.
• VariSoft is a single-use item, which must be disposed of after usage. Do not clean or re-sterilize.
• Be sure that the needle guard is removed before insertion.
• People with small or large amounts of subcutaneous fat should choose the insertion angle carefully, as the cannula could
be placed in underlying muscle or dermal layer and hereby cause reduced or blocked medication delivery. Normal insertion
angle between 20-45°. Consult your healthcare provider concerning this matter.
• Do not leave air in the infusion set. Make sure to fill VariSoft completely.
• Do not in any way put disinfectants, perfumes, deodorants or other products containing alcohol or disinfectants in contact
with the tubing connector and the tubing, as these may affect the integrity of the infusion set.
• Replace the infusion set if the adhesive tape becomes loose.
• Check the infusion set frequently to ensure that the soft cannula remains firmly in place, and replace if it is not secured. Since
the cannula is soft, it will not cause any pain if the soft cannula becomes fully or partially dislodged from the skin, and this
may take place without notice. The soft cannula must always be completely inserted to receive full amount of medication.
• Replace the infusion set every 48-72 hours, or per your healthcare provider’s instructions.
• If infusion site becomes inflamed, replace set and use new site until the first site has healed.
• Do not re-insert introducer needle into infusion set. Re-insertion could cause tearing of soft cannula which would result in
unpredictable medication flow.
• Never prime the infusion set or attempt to free a clogged tubing while set is inserted. You may accidentally inject too
much medication.
• Use aseptic techniques when temporarily disconnecting VariSoft, and seal the cannula housing with the cover provided.
Consult with healthcare provider on how to compensate for missed medication when disconnected.
• Protect VariSoft from direct sunlight. Store at room temperature.
• 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.
• When infusing insulin, carefully monitor blood glucose levels when disconnected and after reconnecting.
• When infusing insulin, and blood glucose level becomes unexplainably high, or occlusion alarm occurs, check for clogs and
leaks. If in doubt, change infusion set since soft cannula could be dislodged, crimped or partially clogged. Discuss plan for
rapid replacement of insulin with healthcare provider should any of these problems arise. Test blood glucose level to make
sure problem is corrected.
• When infusing insulin, check the blood glucose level 1-2 hours after introducing VariSoft and check the infusion site several
times a day, and measure your blood glucose regularly.
• When infusing insulin, do not change infusion set just prior to bedtime, unless blood glucose can be checked 1-2 hours
after insertion.
RECONNECTING
DISCONNECTING
Consult pump
manufacturer’s
instructions for use
when connecting
infusion set to
insulin pump.
CONTENTS
A.
Needle guard
B.
Soft cannula
C.
Adhesive tape
D.
Introducer needle
E.
Cannula housing
F.
Tubing
G.
Connector needle
H.
Circular protective cap
I.
Disconnect cover
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 VariSoft is a trademark of Tandem Diabetes Care, Inc. AW-1000226_A
Unomedical a/s
Aaholmvej 1-3, Osted
4320 Lejre, Denmark
Made in Denmark
Legal manufacturer:
Distributed by:
11045 Roselle Street
San Diego, CA 92121, USA
www.tandemdiabetes.com
+1-858-255-6269
Fill the empty space in
the cannula with the
following prime:
U-100 insulin:
0.7 units (0.007 ml)
Instructions for Use
