Tandem TruSteel Instructions For Use

INDICATIONS FOR USE
The TruSteel
DESCRIPTION
TruSteel is a 90-degree, stainless steel needle infusion set with a tubing connection.
CONTRAINDICATIONS
TruSteel is neither intended nor indicated for intravenous infusion (I.V.) of medication, including blood or blood products.
WARNINGS
• TruSteel infusion sets with t:lock tubing connectors should only be used with Tandem cartridges featuring the t:lock
connector.
• The TruSteel 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 TruSteel, 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 TruSteel for the first time, do so in the presence of a healthcare provider.
• 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.
• Carefully remove the needle guard before inserting the infusion set.
• Do not bend the needle prior to insertion, and do not use the infusion set if the needle is bent or has been damaged.
Instructions for Use
PRECAUTIONS
• Never prime the infusion set or attempt to free a clogged tubing while the infusion set is inserted. You may accidentally inject
too much medication.
• Check the infusion set frequently to ensure that the steel needle remains firmly in place. If the steel needle is not in place,
change to a new infusion set.
• TruSteel is a single-use item which must be disposed of after usage. For available sharps containers, please consult your
local pharmacy. Do not clean or re-sterilize.
• Choose insertion sites as recommended by your healthcare provider.
Use by (year-month-day)
• 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.
Do not re-use
• Replace with a new infusion set if the adhesive tape becomes loose.
• Change the infusion set every 24-48 hours, or as recommended by your healthcare provider.
Sterilized using ethylene oxide
• Dispose of used TruSteel safely, so that no one can prick or injure themselves with it.
• When removing the infusion set, make sure that the needle is still attached to the adhesive and pulled completely out of the
Attention: See accompanying documents subcutaneous tissue (skin). If the needle is missing, immediately contact your healthcare provider for assistance.
• If infusion site becomes inflamed, replace with a new infusion set and use new site until the first site has healed.
See Instructions for Use • Use aseptic techniques when temporarily disconnecting TruSteel, and seal the coupling housing with the cover provided.
Consult with healthcare provider on how to compensate for missed medication when disconnected.
• Protect the TruSteel from direct sunlight. Store at room temperature.
Reference / model number
RECOMMENDATIONS
Lot number
• If blood glucose level becomes unexplainably high, or occlusion alarm occurs, check for clogs and leaks. If in doubt, change
infusion set. Discuss plan for rapid replacement of insulin with healthcare provider should any of these problems arise. Test
Manufacturer
blood glucose level to make sure problem is corrected.
• Check the blood glucose level 1-2 hours after introducing TruSteel and check the infusion site several times a day, and
measure your blood glucose regularly.
Distributed by: Legal manufacturer:
• Do not change infusion set just prior to bedtime, unless blood glucose can be checked 1-2 hours after insertion.
• Carefully monitor blood glucose levels while disconnected and after reconnecting.
11045 Roselle Street Unomedical a/s
San Diego, CA 92121, USA
Aaholmvej 1-3, Osted
www.tandemdiabetes.com 4320 Lejre, Denmark
+1-858-255-6269
Made in Mexico
© 2017 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care is a registered
trademark and TruSteel is a trademark of Tandem Diabetes Care, Inc. AW-1000232_A
™ infusion set is indicated for subcutaneous infusion of insulin administered by an external pump.
CONTENTS
A. 90-degree steel needle
G. Connector needle
B. Needle guard
H. Tubing
C. Adhesive tape Connector
I.
D. Backing paper J. Circular protective cap
E. Retaining wings K. Disconnect cover
F. Coupling housing
Prime infusion set until medication dispenses from the
tip. Ensure there are no air bubbles in the tubing or
TruSteel. Consult your pump manufacturer's instructions
for use for proper priming procedures.
Massage the tape
thoroughly onto
the skin.
DISCONNECTING
RECONNECTING