Accu-Chek FlexLink User manual

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
42
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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4
transfer-set head-set
J
I
H
A
E
F
G
K
D
C
B
M
L
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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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 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
Filling volume head-set:
approx. 1.0 units* approx. 10 μl
*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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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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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
[email protected]
www.accu-chek.co.uk
www.accu-chek.ie
Australia
Accu-Chek Enquiry Line: 1800 251 816
Pump Support: 1800 633 457
www.accu-chek.com.au
New Zealand
Accu-Chek Enquiry Line: 0800 80 22 99
Pump Hotline: [phone]
www.accu-chek.co.nz
South Africa
Accu-Chek Customer Care Centre:
080-DIABETES (Dial 080-34-22-38-37)
www.diabetes.co.za
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σετ κεφαλής
Ι
Θ
H
A
E
ΣΤ
Ζ
ΙΑ
∆
Γ
B
ΙΓ
ΙΒ
σετ µεταφοράς
(ινσουλίνης)
ΣΕΤ ΕΓΧΥΣΗΣ
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Ενδείξεις χρήσης
Το Accu-Chek FlexLink είναι ένα σετ έγχυσης
για την υποδόρια έγχυση ινσουλίνης, η οποία
χορηγείται µε αντλίες ινσουλίνης.
Περιεχόµενα των συσκευασιών
Accu-Chek FlexLink
Συσκευασία 1 σετ κεφαλής και σετ
µεταφοράς (ινσουλίνης)
A λαβή βελόνας εισαγωγής
B προστατευτικό κάλυµµα
Γ βελόνα εισαγωγής
∆ εύκαµπτος καθετήρας
E αυτοκόλλητο επίθεµα
ΣT αυτοκόλλητο
Ζ περίβληµα του καθετήρα
H σύνδεσµος
Θ πλαϊνοί συνδετήρες του συνδέσµου
Ι σωλήνωση
ΙΑ σύνδεσµος τύπου luer-lock
ΙΒ κάλυµµα αποσύνδεσης
ΙΓ µπλε καπάκι στήριξης
Συσκευασία 2 σετ κεφαλής
Εξαρτήµατα A–Ζ, ΙΒ και ΙΓ της συσκευασίας 1.
Μπορούν να χρησιµοποιηθούν µόνο µαζί
µε το σετ µεταφοράς (ινσουλίνης) από τη
συσκευασία 1.
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ΠΡΟΕΙ∆ΟΠΟΙΗΣΕΙΣ
∆ιαβάστε προσεκτικά τις οδηγίες πριν από τη
χρήση. Συνιστάται να συµβουλευτείτε το
εγχειρίδιο της αντλίας ινσουλίνης για
πληροφορίες σχετικά µε τη θεραπεία µε
αντλία.
Όταν χρησιµοποιήσετε το σετ έγχυσης για
πρώτη φορά, η τοποθέτησή του πρέπει να
γίνει παρουσία ενός νοσηλευτή.
•Το σετ έγχυσης παραµένει αποστειρωµένο
µέχρι να ανοιχτεί ή να υποστεί ζηµιά η
συσκευασία. Μην το χρησιµοποιήσετε εάν η
αποστειρωµένη συσκευασία έχει ανοιχτεί ή
έχει υποστεί ζηµιά.
•Προστατέψτε το προϊόν από υπερβολική
υγρασία, ηλιακό φως και ζέστη. Αποθηκεύστε
το σε θερµοκρασία δωµατίου.
•Απορρίψτε το σετ ύστερα από κάθε χρήση.
Μην καθαρίζετε ή αποστειρώνετε εκ νέου.
•Το Accu-Chek FlexLink είναι για υποδόρια
χρήση µόνο.
•Να σφίγγετε πάντα το σύνδεσµο τύπου
luer-lock σταθερά στον προσαρµογέα
αντλίας. Εάν δεν γίνει αυτό, µπορεί να
υπάρξει κίνδυνος διαρροής ινσουλίνης,
εξαιτίας της χαλαρής σύνδεσης µεταξύ του
σετ έγχυσης και της αντλίας. Αποφεύγετε τη
χρήση εργαλείων για να βιδώσετε το
σύνδεσµο τύπου luer-lock στη θέση του.
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