Roche Accu-Chek FlexLink User manual

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
04537246001/E Status: 04-2013

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Instructions for use 4
Gebrauchsanweisung 16
Mode d’emploi 28
Istruzioni per l’uso 40
Instrucciones de uso 52
Gebruiksaanwijzing 64
Instruções de uso 76
Návod k použití 88
Instrukcja użytkowania 100
Brugsanvisning 112
Bruksanvisning 122
Bruksanvisning 134
Käyttöohjeet 144

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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
Brugsanvisning
Bruksanvisning
Bruksanvisning
Käyttöohjeet

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transfer-set head-set
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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
A introducer needle handle
B protective cover
C introducer needle
D soft cannula
E adhesive backing
F self-adhesive
G cannula housing
H connector
I side clips of the connector
J tubing
K luer-lock
L disconnect cover
M blue 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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Insert Accu-Chek FlexLink
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.
Picture 2
While holding the Accu-Chek FlexLink at the blue
holder cap (M) with thumb and forefinger, remove
the transparent protective cover (B) by turning and
pulling. Keep the protective cover for later use in
order to safely dispose the introducer needle (C).
Picture 3
Remove both pieces of the adhesive backing (E)
from the self-adhesive (F).
Picture 4
Pinch the subcutaneous tissue. Insert the intro-
ducer needle (C) and soft cannula (D) quickly and
straight into the infusion site, at a 90° angle.
Watch the soft cannula while inserting to assure
that it goes in smoothly without kinking or
crimping.

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WARNING
Ensure clean application. Do not touch the soft
cannula or introducer needle. Make sure that the
soft cannula is fully inserted into the subcutane-
ous tissue and not kinked at the skin surface.
Once the introducer needle punctures the skin,
the soft cannula must be quickly pushed in the
rest of the way, or it may kink upon insertion,
causing reduced or blocked insulin delivery.
Picture 5
Carefully smooth out the self-adhesive (F) onto
the skin and run your fingers over the self-adhe-
sive to ensure good skin contact is achieved.
Picture 6
Hold the self-adhesive (F) in place, gently press
the side clips of the blue holder cap (M) and pull
it from the cannula housing (G).

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Picture 7
To remove the introducer needle (C) hold the
cannula housing (G) firmly to your body. Place
one finger on the top of the cannula housing and
withdraw the introducer needle in a straight
manner using the introducer needle handle (A).
Remember to dispose the introducer needle (C)
safely (needle container). Discard your intro-
ducer needle according to local regulations. If
you inserted the infusion set all by yourself and
no safe needle container is at hand, consider
using the protective cover to cover the needle.
Ensure to avoid needle injury of others with the
risk of infection.
Picture 8
Attach the luer-lock (K) to the pump by tightening
it into the pump adapter. Follow the pump manu-
facturer’s user manual to prime the transfer-set.
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.
Connect the transfer-set to the newly inserted
head-set and fill the empty space of the cannula
housing with a bolus of 1.0 units (U100 insulin).

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WARNING
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.
If the coupling does not click noticeably and au-
dibly together, use a new head-set and a new
transfer-set.
Do not use any tools to screw the luer-lock con-
nector into place.
Filling volume transfer-set:
12"/ 30 cm: approx. 6 units* approx. 60 l
24"/ 60 cm: approx. 11 units* approx. 110 l
31"/ 80 cm: approx. 14 units* approx. 140 l
43"/110 cm: approx. 18 units* approx. 180 l
Filling volume head-set:
approx. 1.0 units* approx. 10 l
*U 100 Insulin
WARNING
Change head-set every 2–3 days (max. 72
hours). Otherwise you risk insulin resistance or
inflammation of the infusion site. Never use the
transfer-set for more than 6 days.

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Disconnect Accu-Chek FlexLink
WARNING
Please consult with your health care profes-
sional 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.
Accu-Chek FlexLink allows you to tempora-
rily disconnect from your pump for show-
ering, swimming, etc., without changing your
Accu-Chek FlexLink.
Hold the self-adhesive (F) in place, gently press
the side clips of the connector (I) and pull the
connector (H) from the cannula housing (G).
Put the disconnect cover (L) on the cannula
housing.

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Distributed in the United Kingdom by:
Roche Diagnostics Limited
Charles Avenue, Burgess Hill,
West Sussex, RH15 9RY, United Kingdom
Accu-Chek Pump Care Line:
UK Freephone number: 0800 731 22 91*
ROI Freephone number: 1800 88 23 51*
[email protected]
www.accu-chek.co.uk
www.accu-chek.ie
*Calls may be recorded for training purposes
Reconnect Accu-Chek FlexLink
WARNING
Before reconnecting, ensure that a drop of med-
ication appears at the tip of the connector needle.
Fill the Accu-Chek FlexLink until medication
comes out of the connector needle. Hold the self-
adhesive (F) in place and remove the disconnect
cover (L) from the cannula housing (G). Reattach
the connector (H) to the cannula housing. An au-
dible «click» ensures the connector is locked.
WARNING
It is not necessary to give an additional bolus.

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Distributed in Australia by:
Roche Diagnostics Australia Pty. Ltd.
31 Victoria Avenue, Castle Hill,
NSW 2154, Australia
ABN 29 003 001 205
Phone: [phone] (Pump Hotline)
Phone: [phone] (Orders)
Fax: [phone] (Orders)
www.accu-chek.com.au
Distributed in New Zealand by:
Roche Diabetes Care NZ Ltd
15 Rakino Way, Mt. Wellington 1641
P O Box 62-089, Sylvia Park 1644
Auckland
New Zealand
Pump Hotline: [phone]
Accu-Chek Enquiry Line: [phone]
www.accu-chek.co.nz
Distributed in South Africa by:
Roche Products (Pty) Ltd.
Diagnostics Division
P.O. Box 1927, Randburg 2125
9 Will Scarlet Road, Ferndale
Randburg, South Africa
Accu-Chek Customer Care Centre:
080-DIABETES (Dial 080-34-22-38-37)
www.diabetes.co.za

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Schlauch Kanüle
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INFUSIONSSET

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Beschreibung
Accu-Chek FlexLink ist ein Infusionsset für die
subkutane Infusion von Insulin, welches mit In-
sulinpumpen verabreicht wird.
Packungsinhalt Accu-Chek FlexLink
Packung 1 Kanüle und Schlauch
A Haltegriff der Führungsnadel
B Schutzhülle
C Führungsnadel
D Biegsame Kanüle
E Schutzfolie der selbsthaftenden Auflage
F Selbsthaftende Auflage
G Kanülengehäuse
H Kupplungsteil
I Seitenclips des Kupplungsteils
J Schlauch
K Luer-Anschluss
L Verschlusskappe
M Blauer Adaptergriff (abnehmbar)
Packung 2 Kanüle
Bestandteile A-G, L und M von Packung 1.
Die Kanüle muss mit einem Schlauch aus
Packung 1 verwendet werden.

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WARNUNG
Lesen Sie die Anweisungen vor der Anwendung
sorgfältig durch. Es wird empfohlen, in der
Gebrauchsanweisung der Insulinpumpe für
Informationen über die Insulinpumpentherapie
nachzuschlagen.
Die erste Anwendung des Accu-Chek FlexLink
sollte in Gegenwart eines Arztes erfolgen.
• Dieses Produkt ist nur bei ungeöffneter und
unbeschädigter Verpackung steril. Nicht ver-
wenden, falls die Verpackung geöffnet oder
beschädigt ist.
• Packung vor Luftfeuchtigkeit, direkter Sonnen-
einstrahlung und Hitze schützen. Bei Raum-
temperatur lagern.
• Nach einmaligem Gebrauch wegwerfen. Nicht
reinigen oder erneut sterilisieren.
• Accu-Chek FlexLink ist nur für die subkutane
Anwendung.
• Schrauben Sie den Luer-Anschluss immer fest
in den Adapter der Insulinpumpe. Ansonsten
besteht die Gefahr, dass aufgrund einer zu lo-
ckeren Verbindung zwischen Infusionsset und
Insulinpumpe Flüssigkeit austritt. Verwenden
Sie keine Werkzeuge zum Einschrauben des
Luer-Anschlusses. Andernfalls könnte der
Luer-Anschluss beschädigt werden.