Accu-Chek FlexLink User manual

Infusion set
ACCU-CHEK and ACCU-CHEKFLEXLINK
are trademarks of Roche.
© 2016 Roche Diabetes Care
MRoche Diabetes Care GmbH Sandhofer Strasse 116
68305 Mannheim, Germany
www.accu-chek.com 04537246001/H Last update: 2016-03
PDF
LAY
LAB
LAN
Kat. 03
Approved according to
SOP 04.07.08 – Anl. A, Vers. 02
The Signature will not be printed!

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Instructions for use 4
Gebrauchsanweisung 16
Instructions d’utilisation 28
Istruzioni per l’uso 40
Instrucciones de uso 52
Gebruiksaanwijzing 64
Instruções de utilização 76
Návod k použití 88
Instrukcja obsługi 100
Brugsanvisning 112
Bruksanvisning 124
Bruksanvisning 136
Käyttöohje 148

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Instructions for use
Gebrauchsanweisung
Instructions d’utilisation
Istruzioni per l’uso
Instrucciones de uso
Gebruiksaanwijzing
Instruções de utilização
Návod k použití
Instrukcja obsługi
Brugsanvisning
Bruksanvisning
Bruksanvisning
Käyttöohje

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Infusion set
transfer set head set

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Indications for use
The Accu-ChekFlexLink infusion set is intended
for the subcutaneous infusion of insulin
administered with microdosage insulin pumps.
Contents of the infusion set
packages
Package 1: head set and transfer set
Aintroducer needle handle
Bprotective cover
Cintroducer needle
Dsoft cannula
Eadhesive backing
Fself-adhesive
Gcannula housing
Hconnector
Iside clips of the connector
Jtubing
Kluer-lock connector
Ldisconnect 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.
We recommend 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 becomes 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.
• Dispose of your infusion set after use
according to local regulations. Do not clean
or re-sterilize.
• 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 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.
Fill carefully.
• A small percentage of Accu-ChekFlexLink
infusion sets using soft cannulas can
accidentally become crimped during
insertion or displaced while in use. If

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this should occur, use a new infusion set
immediately.
• 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 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 delivery.
• If you have to disconnect your infusion set
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 filled before connecting it to the
head set.
• lf the infusion site becomes inflamed,
replace your 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.
• Never prime the transfer set or attempt
to free a clogged line while the transfer
set is connected to the head set. You may
accidentally infuse an uncontrolled quantity
of insulin.
• Avoid mechanical stress on the infusion site

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and on the infusion set. Pay attention 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 soft cannula just prior
to bedtime. Check your blood glucose
frequently (check with your healthcare
professional).
• Check your infusion set at the luer-lock
connector to tube connection periodically
(every 3 hours during the day and before
going to sleep) during use. A break may
result in leakage, causing interruption of
insulin delivery. If you notice a break,change
your infusion set immediately and check
your blood glucose.
• If 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.
• This product contains small parts. There is a
risk of suocation if small parts (e.g. covers,
caps or similar objects) are swallowed.
• Pay attention to the tubing of the infusion set
connected to your body. There is a risk of
strangulation if the tubing becomes wrapped
around your neck. In case of doubt, use the
shortest tubing length to minimise the risk of
strangulation.

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Insert the infusion set
Picture 1
Choose a site away from the waistline, bones,
scar tissue, navel 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 soft cannula is inserted.
Picture 2
While holding the infusion set 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 of 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
introducer 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
subcutaneous 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 the self-adhesive (F) onto the
skin and run your fingers over the self-adhesive
to ensure good contact with the skin.
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).
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 of the introducer needle
(C) safely (needle container). Dispose of your
introducer needle according to local regulations.
If you inserted the infusion set by yourself and no
safe needle container is at hand, consider using
the protective cover to cover the needle. Ensure

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that no one can injure themselves on the needle
to avoid risk of infection.
Picture 8
Attach the luer-lock connector (K) to the pump
by screwing it firmly into the pump adapter.
Follow the pump manufacturer’s User’s Manual
to prime the transfer set. 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. 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).
WARNING
You must fill the empty space of the newly
inserted head set after connecting the
transfer set. Failure to do so will result in
missed insulin.
If the coupling does not click noticeably and
audibly together, use a new head set and a
new transfer set.
Filling volume of transfer set:
12"/ 30cm: approx. 6units* approx. 60μl
24"/ 60cm: approx. 11units* approx. 110μl
31"/ 80cm: approx. 14units* approx. 140μl
43"/ 110cm: approx. 18units* approx. 180μl

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Filling volume of head set:
approx. 1.0units* approx. 10μl
* U100Insulin
WARNING
Change the head set every 2 to 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 the infusion set
WARNING
Consult your healthcare professional on how
to compensate for any missed insulin while
you are disconnected. Carefully monitor your
blood glucose level while disconnected from
the pump and after you reconnect.
The infusion set allows you to temporarily disconnect
from your pump for showering, swimming, etc.,
without changing it.
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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Reconnect the infusion set
WARNING
Before reconnecting, ensure that a drop of
insulin appears at the tip of the connector
needle.
Fill the infusion set until insulin comes out of the
connector needle. Hold the self-adhesive (F) in
place and remove the disconnect cover (L) from
the cannula housing (G). Re-attach the connector
(H) to the cannula housing. An audible “click”
ensures the connector is locked.
WARNING
It is not necessary to give an additional bolus.

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Australia
Accu-Chek Enquiry Line: 1800 251 816
Pump Support: 1800 633 457
www.accu-chek.com.au
United Kingdom
Distributed in the United Kingdom by:
Roche Diabetes Care Limited
Charles Avenue, Burgess Hill
West Sussex, RH15 9RY, United Kingdom
Accu-Chek Pump Careline 1):
UK Freephone number: 0800 731 22 91
ROI Freephone number: 1 800 88 23 51
1) calls may be recorded for training purposes
Some mobile operators may charge for calls to
these numbers.
[email protected]
www.accu-chek.co.uk
www.accu-chek.ie
New Zealand
Accu-Chek Enquiry Line: 0800 80 22 99
Pump Hotline: [phone]
www.accu-chek.co.nz
Roche Diabetes Care South Africa (Pty) Ltd
Hertford Oce Park, Building E
No 90 Bekker Street,
Vorna Valley
1686
South Africa
Accu-Chek Customer Care Centre:
080-DIABETES (Dial 080-34-22-38-37)
www.accu-chek.co.za
Singapore
Accu-Chek ExtraCare line: 6272 9200
www.accu-chek.com.sg

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Infusionsset
Schlauch Kanüle

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Beschreibung
Das Accu-Chek FlexLink Infusionsset dient zur
subkutanen Infusion von Insulin, welches mit
Insulinpumpen verabreicht wird.
Packungsinhalt des Infussionsets
Packung 1: Kanüle und Schlauch
AHaltegri der Führungsnadel
BSchutzhülle
CFührungsnadel
DBiegsame Kanüle
ESchutzfolie der selbsthaftenden Auflage
FSelbsthaftende Auflage
GKanülengehäuse
HKupplungsteil
ISeitenclips des Kupplungsteils
JSchlauch
KLuer-Anschluss
LVerschlusskappe
MBlauer Adaptergri (abnehmbar)
Packung 2: Kanüle
Bestandteile A-G, L und M von Packung 1.
Die Kanüle muss mit einem Schlauch aus
Packung 1 verwendet werden.