Roche ACCU-CHEK LinkAssist User manual

Made in Switzerland
ACCU-CHEK, ACCU-CHEK FLEXLINK, ACCU-CHEK LINKASSIST and АККУ-ЧЕК
are trademarks of Roche.
© 2019 Roche Diabetes Care
In US, distributed by:
Roche Diabetes Care, Inc.
Indianapolis, IN 46256, USA
Toll Free 1-800-280-7801
MRoche Diabetes Care GmbH Sandhofer Strasse 116
68305 Mannheim, Germany
www.accu-chek.com 04818300001/K Last update: 2019-09
Insertion device
Instructions for Use

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E Instructions for Use 4
D Gebrauchsanweisung 12
F Instructions d’utilisation 20
I Istruzioni per l’uso 28
e Instrucciones de uso 34
P Instruções de utilização 42
N Gebruiksaanwijzing 50
d Brugsanvisning 56
n Bruksanvisning 62
V Bruksanvisning 68
f Käyttöohje 74
G Οδηγίες χρήσης 80
p Instrukcja obsługi 88
C Návod kpoužití 94
k Návod na použitie 100
j  111
H Használati útmutató 112
s Navodila za uporabo 118
R Instrucțiuni de utilizare 126
r Инструкции по использованию 132
U Інструкція із застосування 140
€ Kasutusjuhend 148
L Lietošanas pamācība 154
l Naudojimo taisyklės 160
A  173
Warranty 174
US

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3
Instructions for Use 4
Gebrauchsanweisung 12
Instructions d’utilisation 20
Istruzioni per l’uso 28
Instrucciones de uso 34
Instruções de utilização 42
Gebruiksaanwijzing 50
Brugsanvisning 56
Bruksanvisning 62
Bruksanvisning 68
Käyttöohje 74
Οδηγίες χρήσης 80
Instrukcja obsługi 88
Návod kpoužití 94
Návod na použitie 100
 111
Használati útmutató 112
Navodila za uporabo 118
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B
C
D
E
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A Release button
B Safety catch
C Pretensioning element
D Base
E Contact areas
Overview
E Instructions for Use

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Intended Use
The Accu-Chek LinkAssist insertion device is intended for the insertion of the head set of the
Accu-Chek FlexLink infusion set (USA: Accu-Chek Ultraflex infusion set) into the skin. The
insertion device can be reused multiple times. The insertion device is intended to be used by one
person only and must not be used by other people.
Before You Get Started
Read these instructions for use and the instructions for use of the Accu-Chek FlexLink infusion
set (USA: Accu-Chek Ultraflex infusion set) before using the insertion device.
If the insertion device was dropped or exposed to other mechanical stress, check it for damages,
e.g. cracks. Do not use the insertion device if it is damaged.
Information describing a situation for which there is a foreseeable serious hazard with the use of
the device, is preceded by the following heading:
W WARNING
Information regarding any special care you should exercise for the safe and effective use of the
device, or to avoid damage to the device that could occur as a result of use, including misuse, is
preceded by the following heading:
W PRECAUTION

6
Inserting the Cannula into the Skin
W PRECAUTION
Risk of injury
If a head set is inserted into the insertion device, the head set could be released accidentally.
Do not point the inserted head set at your face or other people.
1
• Push the pretensioning element of the insertion device into the base.
2
• Remove the head set of the infusion set from the packaging.
• Hold the head set by the needle cover.
• Insert the head set, with the blue handling aid pointing upwards, into the insertion device, until
you feel the head set click into place.
3
W WARNING
Risk of infection or injury
If you remove the needle cover, the introducer needle of head set is not protected anymore.
Take care and do not touch the introducer needle.
• Remove the needle cover.
Tip: The small tab on the protective film of the adhesive pad indicates the side of the head set to
which you will later connect the transfer set. See illustration A.

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4
• Remove both parts of the protective film from the adhesive pad.
5
• Pull the pretensioning element upwards, away from the base, as far as it will go.
W PRECAUTION
Risk of injury
If the safety catch is in the position, the insertion device is no longer locked. The head set
could be released accidentally.
Do not slide the safety catch to the position, until you have the insertion device placed on your
skin.
6
• Place the insertion device onto the chosen infusion site, holding it horizontally. It must be
positioned in such a way that the whole surface of each contact area on the base of the
insertion device is resting on the skin.
Tip: You should be able to comfortably reach the side of the head set which had the small tab on
the protective film. That is where you will later connect the transfer set.
• Slide the safety catch to the position. The insertion device is now unlocked.
7
• Press the release button. The cannula is inserted under the skin.
• Remove the insertion device.
If the head set of the infusion set is still in the insertion device, push the pretensioning element
back into the base. Continue with step 5.
If the cannula is not properly positioned under the skin, remove the adhesive pad from the skin

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and pull out the cannula. Start at step 1with a new head set.
8
• Press the adhesive pad onto the skin.
9
• Continue with removing the handling aid of the head set. Follow the instructions for use of the
infusion set.
Cleaning the Insertion Device
• Moisten a cloth with water, with a mild hand soap or with a standard disinfectant (for example,
70 % ethanol).
• Wipe the outside of the insertion device. Do not dip the insertion device into the cleaning
fluids.
• Allow the insertion device to dry completely.
Storing the Insertion Device
Keep the product dry and away from sunlight.
Store the insertion device with the pretensioning element retracted and without tension. See
illustration B.
• Pull the pretensioning element upwards, away from the base, as far as it will go.
• Slide the safety catch to the position.
• Press the release button.