Roche Accu-Chek TenderLink I User manual

INFUSION SET
Made in Denmark
ACCU-CHEK and ACCU-CHEK TENDERLINK
are trademarks of Roche.
Distributed by:
Disetronic Medical Systems AG
3401 Burgdorf, Switzerland
Unomedical a/s
4000 Roskilde, Denmark
03692051001/V03/07.07

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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 uso 100
Návod k použití 116
Instrukcja użytkowania 130
Bruksanvisning 146
Bruksanvisning 162
Käyttöohjeet 176
Brugsanvisning 190
Οδηγίεςχρήσης206
Kasutusjuhised 224
שומיש תוארוה
240
Upute za uporabu 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
Uputstvo za upotrebu 384
Kullanım talimatları 398
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428

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Instructions for use
Gebrauchsanweisung
Mode d’emploi
Istruzioni per l’uso
Instrucciones de uso
Gebruiksaanwijzing
Instruções de uso
Návod k použití
Instrukcja użytkowania
Bruksanvisning
Bruksanvisning
Käyttöohjeet
Brugsanvisning
Οδηγίεςχρήσης

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INFUSION SET
transfer set
head set
L K J I N
F G DB M
HEA
C

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Description
Accu-Chek TenderLink is an infusion set for the subcutaneous infusion of
insulin administered with microdosage insulin pumps.
Contents of the package Accu-Chek TenderLink II
Inner packages 1 and 2.
Package 1 (complete set):
Aprotective cover
Bsoft cannula
Cintroducer needle
Dside clips of the introducer needle
Eself-adhesive
Ffront half of the the adhesive
backing
Gback side of the adhesive backing
Hcannula housing
Itubing
Jconnector with connector needle
Kside clips of the connector
Lcircular protective cap
Mdisconnect cover
Nluer-lock

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Package 2 (additional needle head): Components A–H from package 1.
Contents of the package Accu-Chek TenderLink I
Package 1 only.
Warning
Read the instructions carefully before use.
It is recommended that you consult your insulin pump manual for information
regarding pump therapy.
For first time use, setup must be performed in the presence of a health care
professional.
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.
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Discard the set after each use. Do not clean or re-sterilize.
The Accu-Chek TenderLink is for subcutaneous use only.
Always tighten the luer-lock firmly into the pump adapter. If this is not done,
danger of leakage can result, due to a loose connection between the infusion
set and the pump.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 Accu-Chek TenderLink. Prime thoroughly.
A small percentage of Accu-Chek TenderLink using soft cannulas can acci-
dentally get crimped during insertion or displaced while in use. If this should
occur you should immediately use a new Accu-Chek TenderLink.
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
full amount of medication. Replace the Accu-Chek TenderLink as soon as the
self-adhesive loosens.
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Do not reinsert the introducer needle into the soft cannula. Reinsertion could
cause tearing of the soft cannula which would result in unpredictable med-
ication flow.
If you have to disconnect your Accu-Chek TenderLink, pay particular atten-
tion to hygiene.
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 Accu-Chek TenderLink and
use a new site.
Do not put disinfectants, perfumes, deodorants or insect repellent on your
Accu-Chek TenderLink as these may affect the integrity of the set.
Never prime the transfer set or attempt to free a clogged line while the trans-
fer set is connected to the head-set. You may accidentally infuse an uncon-
trolled quantity of insulin.
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Avoid mechanical stress on the infusion site and on the Accu-Chek
TenderLink. Pay attention when carrying heavy weights.
Before inserting the Accu-Chek TenderLink, prepare the infusion site in
accordance with the instructions of your healthcare professional.
Check blood glucose level 1–3 hours after inserting your Accu-Chek
TenderLink and inspect the infusion site on a regular basis. Do not insert a
new soft cannula just prior to bedtime. Check blood glucose frequently
(check with your physician).
lf blood glucose level gets unexplainably too high, or an “occlusion” alarm
occurs, check for clogs and leaks. lf in doubt, change your Accu-Chek
TenderLink.
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Insert Accu-Chek TenderLink
Picture 1
Choose a site away from the waistline, bones, scar tissue, belly button and
recent infusion sites. Clean hands and the site according to the instructions
from your health care professional. Allow infusion site to dry before the soft
cannula is inserted.
Remove the front half of the adhesive backing (F) from the self-adhesive (E) and
pull the protective cover (A) off the introducer needle (C). Grasp the Accu-Chek
TenderLink 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.
Warning
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.
Warning
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
medication is limited or impossible.Ask the doctor who is treating you about this.
Make sure that the soft cannula is fully inserted into the subcutaneous tissue
and not kinked at the skin surface.
Once the introducer needle punctures the skin, the soft cannula must be quick-
ly pushed in the rest of the way, or it may kink upon insertion, causing reduced
or blocked medication delivery.

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Picture 3
Press the self-adhesive (E) firmly onto the skin in order to ensure secure seat-
ing of Accu-Chek TenderLink. Place one finger in front of the inspection window
on the Accu-Chek TenderLink 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.
Warning
Dispose of the introducer needle safely, so that nobody can prick or injure
themselves on it.
Picture 4
Remove the back side of the adhesive backing (G) from the self-adhesive (E)
and press the self-adhesive firmly onto the skin.

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Picture 5
Attach the luer-lock (N) to the pump by tightening it into the pump adapter.
Make sure there is a cartridge containing sufficient insulin in the cartridge
compartment. Remove the circular protective cap (L) by pressing the side clips
inwards gently. Follow the pump manufacturer’s user manual to prime the
transfer-set until medication drips from the connector needle tip. Do not leave
air bubbles in either the cartridge or the transfer-set.
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. Fill the empty
space of the cannula housing (H) with a bolus of 0.7 units of insulin U-100
(about 7μl). Start distribution with the pump.

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Warning
Change the head-set every 2–3 days (max. 72 hours). Otherwise you risk
insulin resistance or inflammation of the infusion site.
Never use the tube-set for more than 6 days.
You must fill the empty space of the newly inserted head-set after connecting
the transfer set. Failure to do so results in missed insulin.
Always check your blood glucose level 1–3 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.

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Filling volume:
30 cm/12” approx 7 units * approx 70 μl
60 cm/24” approx 10 units * approx 100 μl
80 cm/31” approx 13 units * approx 130 μl
110 cm/43” approx 18 units * approx 180 μl
*U100 insulin

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Disconnect Accu-Chek TenderLink
Accu-Chek TenderLink allows you to temporarily disconnect from your pump
for showering, swimming, etc., without changing your Accu-Chek TenderLink.
Warning
Please consult with your health care professional on how to compensate for
any missed insulin while you are disconnected. Carefully monitor blood glucose
level while disconnected from the pump and after you reconnect.
Step 1
Stop the pump. Hold the self-adhesive (E) in place, gently press the side clips
of the connector (K) and pull the connector (J) from the cannula housing (H).
Step 2
Put the disconnect cover (M) on the cannula housing.

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Reconnect Accu-Chek TenderLink
Warning
Before reconnecting, ensure that a drop of medication appears at the tip of the
connector needle.
Step 1
Fill the Accu-Chek TenderLink until medication comes out of the connector
needle.
Step 2
Hold the self-adhesive (E) in place and remove the disconnect cover (M) from
the cannula housing (H).
Reattach the connector (J) to the cannula housing. An audible “click” ensures
the connector is locked.

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Warning
It is not necessary to give an additional bolus.
Distributed in United Kingdom by:
Roche Diagnostics Ltd.
Charles Avenue
Burgess Hill
West Sussex, RH15 9 RY
United Kingdom
Phone [phone]
[email protected]
www.accu-chek.co.uk
Distributed in Australia by:
Roche Diagnostics Australia Pty. Ltd.
31 Victoria Avenue
Castle Hill, NSW 2154, Australia
Phone [phone]
(Techn. Support)
1800 802 409 (Orders)
Fax [phone] (Orders)
[e-mail]
www.rochediagnostics.com.au