Tandem T:90 Infusion Set Instuctions For Use

Instructions for Use
t:90 Infusion Set – Preparation and insertion
™
Read all instructions carefully before using the t:90
about pump therapy, possible errors, and potential risks and their causes,
consult your pump manufacturer's instructions for use before connecting the
infusion set. Follow proper hygiene procedures.
CONTENTS
A. Lid D. Adhesive
B. Needle guard E. Cannula housing
C. Soft cannula F. Connector needle
IMPORTANT NOTE!
K. Three raised dots – press here when lifting the lid off (see figure 6)
L. Lined indentations – press here when loading (see figure 10)
M. Round Indentations – press here when releasing (see figure 12)
N. Disconnect cover (see figure B)
Infusion Set. For information
™
G. Tubing J. Sterile paper
H. Introducer needle
I. Insertion device
INDICATIONS FOR USE
The t:90 Infusion Set is indicated for the subcu taneous
™
infusion of insulin administered by an external pump.
DESCRIPTION
This product is an infusion device which combines an
infusion set (catheter) with an aid for infusion (inserter). As the
infusion set is an integrated part of the inserter, this product is
delivered assembled and ready for use as a single, sterile unit.
CONTRAINDICATIONS
This product is neither intended nor indicated for use in
intravenous infusion of blood or blood products.
WARNINGS
• This product is only sterile and non-pyrogenic if the
insertion device is unopened and undamaged. Do not
use if the insertion device is already open 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
product. Failure to follow instructions may result in pain
or injury.
• When using product for the first time, do so in the pres-
ence of a healthcare provider. Since different individuals
have varying amounts of subcutaneous layer, ensure that
an appropriate can nula length is chosen to fit your needs.
• Do not in any way put disinfectants, perfumes, deodor-
ants, cosmetics or other products containing alcohol or
desinfectants in contact with the connector or the tubing.
These may affect the integrity of the infusion set.
• Product is a single use device and should be disposed of
immediately after use. Do not clean or re-sterilize.
• Product can be disposed of safely after insertion if the lid
has been placed back on. Please consult your local phar-
macy for sharp containers.
• Be sure that the needle guard is removed before insertion
is made.
• Release the tubing with caution as a hard pull of the tub-
ing 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 picture 8.
• Do not leave air in the infusion set. Make sure to fill tubing
and cannula completely.
• Inaccurate medication delivery, infection and/or site irrita-
tion may result from improper insertion or maintenance of
your infusion site.
Use by (year/month)
Do not re-use
Sterilized using ethylene oxide
Attention: See accompanying documents
See Instructions for Use
Reference / model number
Lot number
Manufacturer
• 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 product immediately.
• Replace the infusion set if the ad hesive tape becomes
loose or is displaced from its original site. Since the can-
nula 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 unpre-
dictable medication flow.
• Never try to fill or free clogged tubing while the infusion
set is inserted. This may result in unpredictable medica-
tion flow.
• Always clean the insertion site when temporarily discon-
necting the infusion set. Consult your healthcare provider
on how to com pen sate for missed medication when dis-
connected. Carefully monitor blood glucose levels when
disconnected and after re connecting.
• Protect the product 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 inserting
product. 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 infu-
sion 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.
Distributed by:
|
11045 Roselle Sreeet San Diego, CA 92121
|
1-877-801-6901 www.tandemdiabetes.com
Legal Manufacturer:
Unomedical a/s
|
Aaholmvej 1-3, Osted 4320 Lejre, Denmark
Made in Mexico
© 2015 Tandem Diabetes Care, Inc. All rights reserved.
Tandem Diabetes Care is a registered trademark, and t:90
is a trademark of Tandem Diabetes Care, Inc. 005866_B