Accu-Chek TenderLink User manual

03692051001/O Last update: 2018-06
ACCU-CHEK, ACCU-CHEK TENDERLINK and АККУ-ЧЕК
are trademarks of Roche.
© 2019 Roche Diabetes Care
Made in Mexico
Distributed by:
Roche Diabetes Care GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
MUnomedical a/s
Aaholmvej 1–3, Osted
4320 Lejre, Denmark

Instructions for use
Infusion set

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45 6
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Instructions for use 4
Gebrauchsanweisung 20
Mode d’emploi 36
Istruzioni per l’uso 52
Instrucciones de uso 68
Gebruiksaanwijzing 84
Instruções de utilização 100
Návod k použití 116
Instrukcja obsługi 130
Brugsanvisning 146
Bruksanvisning 162
Bruksanvisning 178
Käyttöohje 192
Οδηγίες χρήσης 206
Kasutusjuhised 224
 255
Інструкція з використання 256
Használati útmutató 272
Naudojimo instrukcijos 288
Lietošanas instrukcija 304
Instrucţiuni de utilizare 320
Инструкции по использованию 336
Návod na používanie 352
Navodila za uporabo 368
 399

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fr
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fi
Instructions for use
Gebrauchsanweisung
Mode d’emploi
Istruzioni per l’uso
Instrucciones de uso
Gebruiksaanwijzing
Instruções de utilização
Návod k použití
Instrukcja obsługi
Brugsanvisning
Bruksanvisning
Bruksanvisning
Käyttöohje
Οδηγίες χρήσης

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Infusion set
transfer set
head set
A
B, C
D
E
F
G
H
I
J
K
L
N
M

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en
Intended use
The Accu-Chek TenderLink infusion set is intended for the subcutaneous infu-
sion of insulin, administered with microdosage insulin pumps.
Package 1:
Aprotective cover
Cintroducer needle
Eself-adhesive
Gback half of the adhesive backing
Itubing
Kside clips of the connector
Mdisconnect cover
Bsoft cannula
Dside clips of the introducer needle
Ffront half of the adhesive backing
Hcannula housing
Jconnector with connector needle
Lcircular protective cap
Nluer-lock connector
Package 2:
Components A–H + M from package 1.

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Contents of package I
Package 1 only.
Contents of the cannula package for the infusion set
Package 2 only.
wWARNING
Read the instructions carefully before use. It is recommended that you consult
your insulin pump manual for information regarding pump therapy.
• When using the infusion set for the first time, your doctor or healthcare team
must be present.
• This device remains sterile until the package is opened or damaged. Do not
use if the sterile package has been opened or damaged.
• Protect the product from excessive humidity, sunlight, and heat. Store at
room temperature.
• Discard your infusion set after use according to local regulations. Do not
clean or re-sterilize.

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• 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.
• The infusion set is for subcutaneous use only.
• Always screw the luer-lock connector firmly into the pump adapter. If this is
not done, a loose connection between the infusion set and the pump could
cause leakage. Avoid using any tools to screw the luer-lock connector into
place, otherwise damage could result to the luer-lock connector.
• Do not leave air bubbles in the infusion set. Prime thoroughly.
• A small percentage of the Accu-Chek TenderLink infusion sets using soft
cannulas can accidentally become crimped during insertion or displaced
while in use. If this should occur, use a new infusion set immediately.
• Check frequently to make sure the soft cannula remains firmly in place.
Because the cannula is so soft, you will not notice any pain if it is pulled out.
The soft cannula must always be completely inserted in order to receive the

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• full amount of insulin. Replace the infusion set as soon as the self-adhesive
loosens.
• Do not reinsert the introducer needle into the soft cannula. Reinsertion could
cause tearing of the soft cannula which would result in unpredictable insulin
flow.
• If you have to disconnect your infusion set, pay particular attention to hy-
giene.
• Never use a soft cannula for more than 72 hours (3 days). Never use the
transfer set for more than 6 days. When changing the cartridge, make sure
that the transfer set is completely primed before connecting to the head set.
• lf the infusion site becomes inflamed, replace the infusion set and use a new
site.
• Do not put disinfectants, perfumes, deodorants, or insect repellent on your
infusion set as these may aect the integrity of the infusion set.

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• Never prime the transfer set or attempt to free clogged tubing while the
transfer set is connected to the head set. You may accidentally infuse an
uncontrolled quantity of insulin.
• Avoid excessive stress on the infusion site and on the infusion set. Pay atten-
tion when carrying heavy weights.
• Before inserting the infusion set, prepare the infusion site in accordance with
the instructions of your healthcare professional.
• Check your blood glucose level 1 to 3 hours after inserting your infusion set
and inspect the infusion site on a regular basis. Do not insert a new infusion
set just prior to bedtime. Check blood glucose frequently (check with your
physician).
• lf there is an unexplained increase in your blood glucose level, causing it to
be too high, or if an occlusion alarm occurs, check for clogs and leaks. lf in
doubt, change your infusion set.

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Insert the infusion set
Picture 1
Choose a site away from the waistline, bones, scar tissue, belly button and
recent infusion sites. Wash your hands and clean the infusion site according to
the instructions from your healthcare professional.Allow the infusion site to dry
before the inserting the infusion set.
Remove the front half of the adhesive backing (F) from the self-adhesive (E) and
pull the protective cover (A) o the introducer needle (C). Grasp the infusion set
between the thumb and middle finger of one hand behind the side clips and
pull back the edge of the self-adhesive with the index finger.
wWARNING
Ensure clean application. Do not touch the soft cannula or the introducer needle.

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Picture 2
With your free hand, pinch together a bit of subcutaneous tissue at the disin-
fected site. Insert the introducer needle (C) under the skin at an angle of
20–45°, proceeding quickly and in one motion.Watch the soft cannula (B) while
inserting to assure that it goes in smoothly without kinking or crimping.
wWARNING
People with very small or large amounts of subcutaneous fatty tissue should take
care when choosing the angle of insertion or the cannula length. The cannula
could be lodged in the muscular tissue or epidermis, where absorption of the
insulin is limited or impossible.Ask your healthcare professional for more informa-
tion.
Make sure that the soft cannula is fully inserted into the subcutaneous tissue
and not kinked at the skin surface. Insert the introducer needle in a single,
smooth movement, otherwise the soft cannula may kink or crimp upon inser-
tion, causing reduced insulin delivery or a blockage.

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Picture 3
Press the self-adhesive (E) firmly onto the skin in order to ensure secure seat-
ing of the infusion set. Place one finger in front of the inspection window on the
infusion set to fix it. Press the side clips of the introducer needle (D) together
gently and at the same time pull the introducer needle (C) out of the skin.
wWARNING
Discard your introducer needle and infusion set after use according to local
regulations.

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Picture 4
Remove the back half of the adhesive backing (G) from the self-adhesive (E)
and press the self-adhesive firmly onto the skin.
Picture 5
Attach the luer-lock connector (N) to the pump by screwing it into the pump
adapter. Make sure there is a cartridge containing sucient insulin in the car-
tridge compartment. Remove the circular protective cap (L) by pressing the
side clips gently inwards. Follow the pump manufacturer’s User’s Manual to
prime the transfer set until insulin drips from the connector needle tip. Do not
leave air bubbles in either the cartridge or the transfer set.

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Picture 6
Connect the transfer set to the newly inserted head set with the bulging side
upwards. A click must be heard when the connection engages. Prime the
empty space of the cannula housing (H) with a bolus of 0.7 units of U100 insu-
lin (about 7μl). Start insulin delivery with the pump.
wWARNING
Change the head set every 2 to 3 days (max. 72 hours), otherwise you risk in-
sulin resistance or inflammation of the infusion site.
Never use the transfer set for more than 6 days.
You must prime the empty space of the newly inserted head set after connect-
ing the transfer set. Failure to do so results in missed insulin.
Always check your blood glucose level 1 to 3 hours after introducing the set.
If the coupling does not click noticeably and audibly together,use a new head set
and a new transfer set.
Do not use any tools to screw the luer-lock connector into place.