Roche Accu-Chek Ultraflex Bedienungsanleitung

INFUSION SET / SET DE INFUSIÓN / DISPOSITIF DE PERFUSION

Made in Mexico

Fabricado en México

Fabriqué au Mexique

In US, distributed by:

En EE.UU., distribuido por:

Aux États-Unis, distribué par :

Roche Diabetes Care, Inc.

Indianapolis, IN 46256, USA

Toll Free / Teléfono atención / Sans frais 1-800-280-7801

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

ACCU-CHEK y ACCU-CHEK ULTRAFLEX son marcas registradas de Roche.

ACCU-CHEK et ACCU-CHEK ULTRAFLEX sont des marques de Roche.

Manufacturer: / Fabricante: / Fabricant :

Roche Diabetes Care GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

www.accu-chek.com

04626745001/G Last update: 2015-07

1234

5678

Manufacturer

Fabricante

Fabricant

Sterilized using ethylene oxide

Esterilizado utilizando óxido de etileno

Méthode de stérilisation utilisant de

l’oxyde d’éthylène

Keep dry

Proteger de la humedad

Garder à l’àbri de l’humidité

Do not use if package is damaged

No utilizar si el envase está dañado

Ne pas utiliser si l’emballage est endommagé

Global Trade Item Number

Número mundial de artículo

comercial

Code article international

Instructions for use

Instrucciones de uso

Mode d’emploi

transfer-set head-set

INFUSION SET

Indications for use

Accu-Chek Ultraex is an infusion set for the

subcutaneous infusion of insulin administered

with microdosage insulin pumps.

Contents of the

Accu-Chek Ultraex II package

Inner packages 1 and 2.

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.

Contents of the

Accu-Chek Ultraex I package.

Package 1 only.

WARNINGS

Read the instructions carefully before use.

It is recommended that you consult your insulin

pump manual for information regarding pump

therapy.

For rst 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 Ultraex is for subcutaneous

use only.

• Always tighten the luer-lock rmly 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

Ultraex. Prime thoroughly.

• A small percentage of Accu-Chek Ultraex us-

ing soft cannulas can accidentally get crimped

during insertion or displaced while in use.

If this should occur you should immediately

use a new Accu-Chek Ultraex.

• Check the infusion site frequently to make

sure the soft cannula remains rmly 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 Ultraex as soon as

the self-adhesive loosens.

• Do not reinsert the introducer needle into the

soft cannula. Reinsertion could cause tear-

ing of the soft cannula which would result in

unpredictable medication ow.

• If you have to disconnect your Accu-Chek

Ultraex 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 inamed, replace

your Accu-Chek Ultraex and use a new site.

• Do not put disinfectants, perfumes, deodorants

or insect repellent on your Accu-Chek Ultraex

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.

• Avoid mechanical stress on the infusion site

and on the Accu-Chek Ultraex. Pay attention

when carrying heavy weights.

• Prepare the infusion site before insertion ac-

cording to CDC (Centers for Disease Control

and Prevention) guidelines or institutional

protocol.

• Check blood glucose level 1–3 hours after

inserting your Accu-Chek Ultraex and inspect

the infusion site on a regular basis. Do not

insert 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) dur-

ing 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.

• 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 Ultraex.

Insert Accu-Chek Ultraex

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 Ultraex at the

blue holder cap (M) with thumb and forenger,

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 as-

sure that it goes in smoothly without kinking or

crimping.

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 ngers 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).

Picture 7

To remove the introducer needle (C) hold the

cannula housing (G) rmly to your body. Place

one nger 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 introduc-

er needle and infusion set after use according to

local regulations.

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