FlexLink - Medical Equipment Accu-Chek - Free user manual and instructions

Product type	Subcutaneous infusion set for insulin pump
Brand	Accu-Chek
Model	FlexLink
Intended use	Subcutaneous insulin infusion
Sterilization	Sterilized with ethylene oxide
Maximum cannula wear time	3 days
Maximum tubing wear time	6 days
Main components	Infusion set, cannula, tubing, disconnection cap
Available tubing lengths	30 cm, 60 cm, 80 cm, 110 cm
Tubing fill volume (30 cm)	Approximately 6 units (60 μL) for 100 U insulin
Tubing fill volume (60 cm)	Approximately 11 units (110 μL) for 100 U insulin
Tubing fill volume (80 cm)	Approximately 14 units (140 μL) for 100 U insulin
Tubing fill volume (110 cm)	Approximately 18 units (180 μL) for 100 U insulin
Storage conditions	Room temperature, protected from moisture, sunlight and heat
Important precautions	Avoid contact with disinfectants, perfumes, deodorants or insect repellents
Safety	Choking hazard from small parts; strangulation risk from tubing
Disposal	According to local regulations; do not clean or sterilize
After-sales service (France)	Roche Diabetes Care France SAS, 2 Avenue du Vercors, B.P. 59, 38240 Meylan Cedex

Frequently Asked Questions - FlexLink Accu-Chek

How often should I replace the cannula and tubing?

The cannula must be replaced at the latest after 3 days and the tubing set at the latest after 6 days. Beyond this time, you risk inflammation of the infusion site or reduced insulin effect.

What to do in case of infusion site inflammation?

Immediately replace the infusion set and select a different infusion site. Monitor your blood glucose.

How to correctly insert the cannula?

Form a skin fold, insert the guide needle quickly and vertically (90°) into the fold, apply the adhesive patch, then remove the guide needle while holding it vertically.

What to do if the occlusion alarm is triggered?

Check that the infusion set has no occlusion or leak. If in doubt about its function, replace the set immediately.

Can I bathe with the device?

Yes, you can disconnect the pump by pressing the side clips of the connector, then put the disconnection cap on the cannula housing. Then reconnect the pump by removing the cap and snapping the connector back in.

How to safely dispose of the used needle?

Put the guide needle back into the needle cap or dispose of it in a sharps container to avoid injuries.

What to do if the connector does not click audibly?

Replace the infusion set and the tubing set, as an audible and tactile click is necessary to ensure a correct connection.

Can I fill the tubing after connecting it to the cannula?

No, you must fully fill the tubing set before connecting it to the cannula. After connection, do not fill the cannula housing with insulin.

How to disconnect the insulin pump?

Hold the adhesive patch firmly, press the side clips (M) of the connector, remove the connector from the cannula housing, then snap on the disconnection cap.

What are the risks of a bent cannula?

A bent cannula can lead to insufficient insulin delivery. Regularly check that it is not bent and replace it immediately if necessary.

USER MANUAL FlexLink Accu-Chek

ACCU-CHEK and ACCU-CHEK FLEXLINK are trademarks of Roche.

© 2021 Roche Diabetes Care

Made in Mexico

Roche Diabetes Care GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

www.accu-chek.com

Instructions for use

Infusion set

Close-up of two metallic mechanical components with a textured base (no visible text or symbols)

ACCU-CHEK*

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

Instructions for use

Gebrauchsanweisung

Instructions d’utilisation

Istruzioni per l’uso

Instrucciones de uso

Instruções de utilização

Gebruiksaanwijzing

Brugsanvisning

Bruksanvisning

Bruksanvisning

Käyttöohje

Instrukcja obsługi

Návod k použití

ACCU-CHEK\* FlexLink

Infusion set

Disconnect cover
Head set Transfer set
A
B
C
D
E
F

H G

J K L M

Description

Head set

A Handling aid
B Side wings
C Adhesive pad
D Protective film
E Cannula
F Introducer needle
G Needle cover
H Cannula casing

Disconnect cover

I Disconnect cover

Transfer set

J Luer-lock connector
K Tubing
L Connector
M Side wings

Contents of the pack

There are two packages with different contents:

Infusion set Infusion set cannula

• Head set
• Head set
• Disconnect cover
• Disconnect cover
• Transfer set

The head set from the infusion set cannula package must be used with the transfer set from the infusion set package.

Intended use

The Accu-Chek FlexLink infusion set is intended for the subcutaneous infusion of insulin administered with an insulin pump.

These instructions for use feature the following symbol:

This symbol draws your attention to a warning. A warning must be heeded because it indicates a risk of injury or of damage to your health or the health of others. Not heeding the warnings can lead to life-threatening situations.

General warnings

• Read these instructions for use carefully before using the infusion set. Also read the information about insulin pump therapy contained in the User's Manual of the insulin pump.
• When you use the infusion set for the first time, your healthcare team must be present.
• Prepare the infusion site as instructed by your healthcare professional before you insert the cannula.
• This product is sterile packaged. Do not use the product if the package has already been opened or is damaged.

• Protect the product from excessive humidity, sunlight and heat. Store the product at room temperature.

• Do not allow the infusion set to come into contact with disinfectants, perfumes, deodorants or insect repellents.

• Dispose of the used product according to local regulations. Do not clean or sterilise the used product.
• Avoid mechanical stress on the infusion set and infusion site.
• The infusion set contains small parts. There is a risk of suffocation if small parts are swallowed. Keep all parts of the infusion set away from persons who may not be aware of the risks and may put small parts in their mouth, for example, small children.
• 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.

Product-specific warnings

• Change the cannula at least every 3 days and the transfer set at least every 6 days. Otherwise, there is a risk that the infusion site may become inflamed or the insulin may not be as effective.
• If the infusion site is inflamed, replace the infusion set immediately and choose another infusion site.
• Check your blood glucose level at least four times a day and at least once within 1 to 3 hours of replacing the transfer set or cannula.

• Do not replace the cannula or transfer set immediately before going to bed.

• If your blood glucose level should unexpectedly increase, or if an occlusion alarm occurs, check the infusion set for occlusions or leaks. If you are not sure whether the infusion set is working properly, replace it immediately.

• Never fill the tubing or attempt to remove an occlusion in the tubing while the infusion set is connected to your body as you may deliver an uncontrolled quantity of insulin.
• The soft cannula can kink while you are inserting it or when you are wearing it. Check regularly that the cannula is not kinked and that it is completely under the skin. If the cannula is kinked or has slipped out, replace it immediately.
• Check the connection between the luer-lock connector and the tubing every 3 hours

and before you go to bed. If the connection is damaged, replace the transfer set immediately.

- Do not insert the removed introducer needle back into the cannula as this may damage the cannula.

Attaching the infusion set

▶Choose an infusion site away from your waistline, any scar tissue, bones, navel and recent infusion sites.
▶Wash your hands.
▶Disinfect the chosen infusion site as instructed by your healthcare team.
▶Let your skin dry completely.

1

▶Hold the head set by the handling aid (A). Remove the needle cover (G).

To avoid contamination or injury, do not touch the introducer needle or cannula after removing the needle cover.

Keep the needle cover. You will need it later to safely dispose of the introducer needle.

2

Remove both parts of the protective film (D) from the adhesive pad (C).

3

Form a skin fold at the chosen infusion site.
Insert the introducer needle quickly and vertically (at a 90° angle) into the skin fold. Ensure that the cannula does not kink.

Make sure you insert the introducer needle into the skin quickly and in a single motion. Otherwise, the cannula may kink and you may receive a reduced amount of insulin or no insulin at all.

4

▶Press the adhesive pad (C) onto the skin.

5

▶Hold the adhesive pad (C) in place.
▶Press the side wings (B) of the handling aid (A) together.
Remove the handling aid (A) in the direction of the arrow.

6

▶Hold the cannula casing (H) in place.

Remove the introducer needle straight upwards.
▶Dispose of the introducer needle in such a way that it will not cause injury to anyone. Place the introducer needle back into the needle cover or into a cannula disposal container.

7

Screw the luer-lock connector (J) into the insulin pump adapter.

Do not use any tools to screw the luer-lock connector into the insulin pump adapter as this may damage the luer-lock connector.

8

Fill the transfer set as described in the User's Manual of the insulin pump until insulin drips from the needle inside the connector (L). There must not be any air bubbles in the cartridge or transfer set.

Fill volume of the transfer set (U100 insulin)

Length Units Volume

30 cm / 12” approx. 6 U approx. 60 μL

60 cm / 24” approx. 11 U approx. 110 μL

80 cm / 31” approx. 14 U approx. 140 μL

110 cm / 43” approx. 18 U approx. 180 μL

You must fill up the transfer set completely before you connect it to the cannula. The transfer set must not contain any air bubbles.

▶Hold the cannula casing (H) in place.
▶Push the connector (L) onto the cannula casing (H). You must hear and feel the connector click into place.

If you do not hear and feel the connector click into place, replace the head set and the transfer set.

Fill the cannula casing (H) with a U100 insulin bolus of 1.0 U (10 μL).

If you do not fill the cannula casing with an insulin bolus, you will receive too little insulin.

Connecting and disconnecting the insulin pump

This infusion set allows you to disconnect and remove the insulin pump for showering and swimming, for example. You can reconnect the insulin pump without having to replace the infusion set.

Consult your healthcare team on how to compensate for any missed insulin while you are disconnected from the insulin pump.

Disconnecting the insulin pump

▶Hold the adhesive pad (C) in place.
▶Press the side wings (M) of the connector (L) together.
Remove the connector (L) from the cannula casing (H).
▶Push the disconnect cover (I) onto the cannula casing (H).

Connecting the insulin pump

▶Hold the adhesive pad (C) in place.
Press the side wings of the disconnect cover (I) together.
Remove the disconnect cover (I) from the cannula casing (H).
Push the connector (L) onto the cannula casing (H). You must hear and feel the connector click into place.

After connecting the insulin pump, you do not need to fill the cannula casing with an insulin bolus.

Replacing the head set or transfer set

▶Disconnect the transfer set from the cannula casing (H); see section “Disconnecting the insulin pump”.

Replacing the head set

Insert a new cannula. Start with step 1 in the section "Attaching the infusion set".

Replacing the transfer set

Connect the new transfer set to the insulin pump. Start with step 7 in the section "Attaching the infusion set".

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Customer support

Australia

Roche Diabetes Care Australia Pty. Limited

Insulin Pump Support: 1800 633 457

[e-mail]

www.accu-chek.com.au

Roche Diabetes Care South Africa (Pty) Ltd.

Hertford Office Park, 90 Bekker Road

Vorna Valley, 1686

South Africa

Tel: [phone]

Email: [e-mail]

www.accu-chek.co.za

Singapore

Accu-Chek ExtraCare line: 6272 9200

www.accu-chek.com.sg

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.

[e-mail]

www.accu-chek.co.uk

www.accu-chek.ie

ACCU-CHEK\* FlexLink Infusionsset

Verschluss-kappe

Kanüle Schlauch

A B C D E F H G

J K L M

Beschreibung

Kanüle

Accu-Chek Kundenservice:

Kostenfreie Telefonnummer 0800 4466800

A B C D E F H G

J K L M

Description

Dispositif cutané

A B C D E F H G

J K L M

Descrizione

Agocannula

30 cm / 12" circa 6 U circa 60 μL

60 cm / 24" circa 11 U circa 110 μL

80 cm / 31" circa 14 U circa 140 μL

110 cm / 43" circa 18 U circa 180 μL

A B C D E F H G

I J K L M

Descripción

Cabezal

A B C D E F G H

J K L M

Descrição

Cânula de infusão

A B C D E F G H

J K L M

Beskrivelse

Hovedsæt

Skru luerlåsen (J) ind i insulinpumpens adapter.

A B C D E F H G

Two transparent cylindrical electronic components labeled I and J, shown from different angles (no text or symbols beyond labels)

J K L M

Beskrivelse

Kanyle

Kanyldel Slang A B C D E F H G I J K L M

Beskrivning

Kanyldel

A B C D E F G H

Liitososan suojus

Two transparent mechanical components labeled I and J, shown from different angles (no text or symbols beyond labels)

J K L M

Kuvaus

Kanyyliosa

A B C D E F H G

Zatyczka

J K L M

Opis

Zestaw główny

Caution, refer to safety-related notes in the instructions for use accompanying this product.

Do not use if package is damaged

Keep away from sunlight

Sterilized using ethylene oxide

This product fulfils the requirements of the European Directive 93/42/EEC on medical devices.