Accu-Chek FlexLink Manual de usuario

04881192001/F Last update: 2015-03

INFUSION SET

ACCU-CHEK and ACCU-CHEK FLEXLINK

are trademarks of Roche.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

www.accu-chek.com

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1234

5678

Sterilized using Ethylene Oxide

Αποστειρώθηκε με αιθυλενοξείδιο

Steriliseeritud etüleenoksiidiga

דיסקוא ןליתא םע אטוחמ

Sterilizirano etilen-oksidom

Etilén-oxiddal sterilizálva

Sterilizuotas etileno oksido dujomis

Sterilizēts ar etilēna oksīdu.

Sterilizat cu oxid de etilenă

Стерилизовано с использованием

этиленоксида

Sterilizované etylénoxidom.

Sterilizirano z etilen oksidom



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Instructions for use 4

Οδηγίες χρήσης 16

Kasutusjuhised 30

שומיש תוארוה

Upute za uporabu 52

Használati útmutató 64

Naudojimo instrukcijos 76

Lietošanas instrukcija 88

Instrucţiuni de utilizare 102

Инструкции по использованию 114

Návod na používanie 128

Navodila za uporabo 140

152

162



183

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Instructions for use

Οδηγίες χρήσης

Kasutusjuhised

שומיש תוארוה

Upute za uporabu

Használati útmutató

Naudojimo instrukcijos

Lietošanas instrukcija

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transfer-set head-set

INFUSION SET

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Indications for use

Accu-Chek FlexLink is an infusion set for the

subcutaneous infusion of insulin administered

with microdosage insulin pumps.

Contents of the Accu-Chek FlexLink

packages

Package 1 head-set and transfer-set

Aintroducer needle handle

Bprotective cover

Cintroducer needle

Dsoft cannula

Eadhesive backing

Fself-adhesive

Gcannula housing

Hconnector

I side clips of the connector

Jtubing

K luer-lock

L disconnect cover

Mblue holder cap

Package 2 head-set

Components A–G, L and M from package 1.

May only be used together with the transfer-set

from package 1.

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WARNINGS

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.

•Discard the set after each use. Do not clean or

re-sterilize.

•The Accu-Chek FlexLink 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 connec-

tor into place. Otherwise damage could result

to the luer-lock connector.

•Do not leave air bubbles in the Accu-Chek

FlexLink. Prime thoroughly.

•A small percentage of Accu-Chek FlexLink us-

ing soft cannulas can accidentally get crimped

during insertion or displaced while in use.

If this should occur you should immediately

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use a new Accu-Chek FlexLink.

•Check the infusion site 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 insulin.

Replace the Accu-Chek FlexLink 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 un-

predictable medication ﬂow.

•If you have to disconnect your Accu-Chek

FlexLink pay particular attention to hygiene.

•Never use a soft cannula for more than 72

hours (3 days). Never use the tubing 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

your Accu-Chek FlexLink and use a new site.

•Do not put disinfectants, perfumes, deo-

dorants or insect repellent on your Accu-Chek

FlexLink as these may affect the integrity of

the set.

•Never prime the transfer-set or attempt to free

a clogged line while the transfer-set is con-

nected to the head-set. You may accidentally

infuse an uncontrolled quantity of insulin.

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•Avoid mechanical stress on the infusion site

and on the Accu-Chek FlexLink. Pay attention

when carrying heavy weights.

•Before inserting the Accu-Chek FlexLink,

prepare the infusion site in accordance with

the instructions of your healthcare profes-

sional.

•Check blood glucose level 1–3 hours after in-

serting your Accu-Chek FlexLink and inspect

the infusion site on a regular basis. Do not in-

sert a new soft cannula just prior to bedtime.

Check blood glucose frequently (check with

your physician).

•Check your infusion set at the luer-lock to tube

connection periodically (every 3 hours during

the day and before going to sleep) during use.

A break may result in leakage, causing inter-

ruption of insulin delivery. If you notice a break,

change your infusion set immediately and

check your blood glucose.

•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 FlexLink.

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