Accu-Chek TenderLink User manual

03692051001/Q
ACCU-CHEK, ACCU-CHEK TENDERLINK and АККУ-ЧЕК
are trademarks of Roche.
© 2020 Roche Diabetes Care
Made in Mexico
MUnomedical a/s
Aaholmvej 1–3, Osted
4320 Lejre, Denmark
www.infusion-set.com
Last update: 2020-06
Infusion set
Instructions for Use
Distributed by:
Roche Diabetes Care GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
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minevam - Jun 18, 2020
minevam - Jun 18, 2020
LAN
holeckos - Jun 18, 2020
hoffmm28 - Jun 19, 2020

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Instructions for use 4
Gebrauchsanweisung 20
Instructions d’utilisation 36
Istruzioni per l’uso 52
Instrucciones de uso 68
Instruções de utilização 84
Gebruiksaanwijzing 100
Brugsanvisning 116
Bruksanvisning 132
Bruksanvisning 148
Käyttöohje 164
Οδηγίες χρήσης 180
Instrukcja obsługi 196
Návod k použití 212
Návod na použitie 230
 261
Használati útmutató 262
Navodila za uporabo 278
Instrucțiuni de utilizare 294
Инструкции по использованию 310
Iнструкція із застосування 326
Kasutusjuhend 342
Lietošanas pamācība 358
Naudojimo taisyklės 374
 405
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Instructions for use
Gebrauchsanweisung
Instructions d’utilisation
Istruzioni per l’uso
Instrucciones de uso
Instruções de utilização
Gebruiksaanwijzing
Brugsanvisning
Bruksanvisning
Bruksanvisning
Käyttöohje
Οδηγίες χρήσης
Instrukcja obsługi
Návod k použití
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Infusion set
Indications for use
The Accu-Chek TenderLink infusion set is indicated for subcutaneous infusion
of insulin administered by an external pump. The infusion set is indicated for
single use.
Intended use
The infusion set is indicated for subcutaneous infusion of insulin in the
treatment of diabetes. The infusion set has been tested to be compatible with
insulin approved for subcutaneous infusion.
Product description
The Accu-Chek TenderLink infusion set consists of a cannula and tubing, i.e.
cannula (head set, picture 1a) and tubing (transfer set, picture 1b).
Instructions for use
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Contraindications
Accu-Chek TenderLink infusion set is neither intended nor indicated for use
with blood or blood products (I.V. infusion).
W WARNINGS
• Carefully examine the instructions for use before inserting Accu-Chek
TenderLink infusion set. Failure to follow instructions may result in pain or
injury.
• The Accu-Chek TenderLink infusion set is only sterile and non-pyrogenic if
the packaging is undamaged and unopened. Do not use it if the packaging
is already open or is damaged.
• When using Accu-Chek TenderLink infusion set for the first time, do so in
the presence of a healthcare professional.
• Inaccurate medication delivery, site irritation or infection may result from
improper insertion and maintenance of infusion site.
• Do not re-insert the introducer needle into the infusion set. This could cause
a tearing or damage of the soft cannula and may lead to unpredictable
medication flow.
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• Reuse of the infusion set may cause site irritation or infection and may lead
to inaccurate medication delivery.
• Be sure that the needle cover is removed before insertion is made.
W PRECAUTIONS
• Never try to fill or free a clogged tubing while the infusion set is inserted.
This may result in unpredictable medication flow.
• Do not leave air in the infusion set. Make sure to fill the tubing completely.
Consult pump manufacturer's instructions for use.
• Accu-Chek TenderLink infusion set is a single use item, which must be
disposed of after usage. Do not clean or re-sterilise.
• Check the infusion set frequently to ensure that the soft cannula remains
firmly in place. Replace with a new infusion set at a new site, if the infusion
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.
• Do not in any way put disinfectants, perfumes, deodorants or other products
containing disinfectants in contact with the luer lock connector or the
tubing. This may impact the integrity of the infusion set.
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• Replace the infusion set if the adhesive pad becomes loose.
• Replace the infusion set every two to three days, or per your healthcare
professional’s instructions.
• If the infusion site becomes irritated or infected, replace the infusion set and
use a new site until the first site has healed.
• Use aseptic techniques when temporarily disconnecting Accu-Chek
TenderLink infusion set. Consult with healthcare professional on how to
compensate for missed medication when disconnected.
• 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 which may lead to unpredictable medication
delivery. Normal insertion angle is between 20–45°. Consult your
healthcare professional concerning this matter.
Recommendations
• Check your blood glucose level one to three hours after insertion of the
Accu-Chek TenderLink infusion set. Measure your blood glucose on a regular
basis. Discuss this with your healthcare professional.
• Do not change infusion set just prior to bedtime, unless blood glucose can be
checked one to three hours after insertion.
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• If your 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. Discuss plan to bring down your blood glucose
level with your healthcare professional should any of these problems arise.
Test blood glucose level to make sure problem is corrected.
• Carefully monitor blood glucose levels when disconnected and after
reconnecting.
• If, during the use of this device or as a result of its use a serious incident has
occurred, please report it to the manufacturer and to your national authority.
Storage & disposal
• Store infusion sets in a cool, dry location at room temperature. Do not store
infusion sets in direct sunlight, or in high humidity.
• Store and handle insulin according to the manufacturer’s instructions.
• Dispose of the introducer needle in a proper sharp container according to
local laws, to avoid risk of needle stick.
• Dispose of a used infusion set according to local regulations for
biohazardous waste.
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