Roche ACCU-CHEK TenderLink Bedienungsanleitung

Infusion set

Instructions for Use

Instructions for use 4

Gebrauchsanweisung 20

Instructions d’utilisation 36

Istruzioni per l’uso 52

Instrucciones de uso 68

Instruções de utilização 84

Gebruiksaanwijzing 100

Brugsanvisning 116

Bruksanvisning 132

Bruksanvisning 148

Käyttöohje 164

Οδηγίες χρήσης 180

Instrukcja obsługi 196

Návod k použití 212

Návod na použitie 230

 261

Használati útmutató 262

Navodila za uporabo 278

Instrucțiuni de utilizare 294

Инструкции по использованию 310

Iнструкція із застосування 326

Kasutusjuhend 342

Lietošanas pamācība 358

Naudojimo taisyklės 374

 405

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Instructions for use

Gebrauchsanweisung

Instructions d’utilisation

Istruzioni per l’uso

Instrucciones de uso

Instruções de utilização

Gebruiksaanwijzing

Brugsanvisning

Bruksanvisning

Käyttöohje

Οδηγίες χρήσης

Instrukcja obsługi

Návod k použití

Infusion set

Indications for use

The Accu-Chek TenderLink infusion set is indicated for subcutaneous infusion

of insulin administered by an external pump. The infusion set is indicated for

single use.

Intended use

The infusion set is indicated for subcutaneous infusion of insulin in the

treatment of diabetes. The infusion set has been tested to be compatible with

insulin approved for subcutaneous infusion.

Product description

The Accu-Chek TenderLink infusion set consists of a cannula and tubing, i.e.

cannula (head set, picture 1a) and tubing (transfer set, picture 1b).

Instructions for use

Contraindications

Accu-Chek TenderLink infusion set is neither intended nor indicated for use

with blood or blood products (I.V. infusion).

W WARNINGS

• Carefully examine the instructions for use before inserting Accu-Chek

TenderLink infusion set. Failure to follow instructions may result in pain or

injury.

• The Accu-Chek TenderLink infusion set is only sterile and non-pyrogenic if

the packaging is undamaged and unopened. Do not use it if the packaging

is already open or is damaged.

• When using Accu-Chek TenderLink infusion set for the first time, do so in

the presence of a healthcare professional.

• Inaccurate medication delivery, site irritation or infection may result from

improper insertion and maintenance of infusion site.

• Do not re-insert the introducer needle into the infusion set. This could cause

a tearing or damage of the soft cannula and may lead to unpredictable

medication flow.

• Reuse of the infusion set may cause site irritation or infection and may lead

to inaccurate medication delivery.

• Be sure that the needle cover is removed before insertion is made.

W PRECAUTIONS

• Never try to fill or free a clogged tubing while the infusion set is inserted.

This may result in unpredictable medication flow.

• Do not leave air in the infusion set. Make sure to fill the tubing completely.

Consult pump manufacturer's instructions for use.

• Accu-Chek TenderLink infusion set is a single use item, which must be

disposed of after usage. Do not clean or re-sterilise.

• Check the infusion set frequently to ensure that the soft cannula remains

firmly in place. Replace with a new infusion set at a new site, if the infusion

set is not in place. Since the cannula is soft, it will not cause any pain if

it slips out, and this may happen without notice. The soft cannula must

always be completely inserted to receive the full amount of medication.

• Do not in any way put disinfectants, perfumes, deodorants or other products

containing disinfectants in contact with the luer lock connector or the

tubing. This may impact the integrity of the infusion set.

• Replace the infusion set if the adhesive pad becomes loose.

• Replace the infusion set every two to three days, or per your healthcare

professional’s instructions.

• If the infusion site becomes irritated or infected, replace the infusion set and

use a new site until the first site has healed.

• Use aseptic techniques when temporarily disconnecting Accu-Chek

TenderLink infusion set. Consult with healthcare professional on how to

compensate for missed medication when disconnected.

• People with small or large amounts of subcutaneous fat should choose

the insertion angle carefully, as the cannula could be placed in underlying

muscle or dermal layer which may lead to unpredictable medication

delivery. Normal insertion angle is between 20–45°. Consult your

healthcare professional concerning this matter.

Recommendations

• Check your blood glucose level one to three hours after insertion of the

Accu-Chek TenderLink infusion set. Measure your blood glucose on a regular

basis. Discuss this with your healthcare professional.

• Do not change infusion set just prior to bedtime, unless blood glucose can be

checked one to three hours after insertion.

• If your blood glucose level becomes unexplainably high, or occlusion alarm

occurs, check for clogs and leaks. If in doubt, change infusion set since soft

cannula could be dislodged. Discuss plan to bring down your blood glucose

level with your healthcare professional should any of these problems arise.

Test blood glucose level to make sure problem is corrected.

• Carefully monitor blood glucose levels when disconnected and after

reconnecting.

• If, during the use of this device or as a result of its use a serious incident has

occurred, please report it to the manufacturer and to your national authority.

Storage & disposal

• Store infusion sets in a cool, dry location at room temperature. Do not store

infusion sets in direct sunlight, or in high humidity.

• Store and handle insulin according to the manufacturer’s instructions.

• Dispose of the introducer needle in a proper sharp container according to

local laws, to avoid risk of needle stick.

• Dispose of a used infusion set according to local regulations for

biohazardous waste.

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