Roche Accu-Chek Ultraflex User manual

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
© 2015 Roche Diabetes Care
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

1
en
es
fr
Instructions for use
Instrucciones de uso
Mode d’emploi

2
transfer-set head-set
J
I
H
A
E
F
G
K
D
C
B
M
L
INFUSION SET

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en
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.

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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 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.

5
en
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-

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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.

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en
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.

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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 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.