Roche Accu-Chek Tender User manual

04536517001/G Status: 05-2013
Made in Denmark
Fabricado en Dinamarca
Fabriqué au Danemark
ACCU-CHEK is a trademark of Roche.
ACCU-CHEK es una marca registrada de Roche.
ACCU-CHEK est une marque de Roche.
Distributed in USA by:
Distribuido en EE.UU. por:
Distribué aux États-Unis par:
Roche Health Solutions Inc.
Fishers, IN 46037, USA
Toll Free / Teléfono atención / Sans frais 1-800-280-7801
INFUSION SET / SET DE INFUSIÓN /
DISPOSITIF DE PERFUSION
Legal Manufacturer: / Fabricante legal: / Fabricant légal:
Unomedical a/s
Aaholmvej 1–3, Osted
4320 Lejre, Denmark

Manufacturer (Legal)
Fabricante (legal)
Fabricant (légal)
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Instructions for use
Instrucciones de uso
Mode d’emploi
en
es
fr

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INFUSION SET
L K J I N
M
F
B
C
G D
AEH
transfer set
head set

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Description
Accu-Chek Tender is an infusion set for the subcutaneous infusion of insulin
administered with microdosage insulin pumps.
Contents of the package Accu-Chek Tender II
Inner packages 1 and 2.
Package 1 (complete set):
A protective cover
B soft cannula
C introducer needle
D side clips of the introducer needle
E self-adhesive
F front half of the adhesive backing
G back side of the adhesive backing
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H cannula housing
I tubing
J connector with connector needle
K side clips of the connector
L circular protective cap
M disconnect cover
N luer-lock

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Package 2 (additional needle head): Components A–H from package 1.
Contents of the package Accu-Chek Tender I
Package 1 only.
Warning
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.

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• Discard the set after each use. Do not clean or re-sterilize.
• Reuse of the infusion set may cause infection, site irritation, or damage
to the cannula/needle. A damaged cannula/needle may lead to inaccurate
medication delivery.
• The Accu-Chek Tender 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 connector into
place. Otherwise damage could result to the luer-lock connector.
• Do not leave air bubbles in the Accu-Chek Tender. Prime thoroughly.
• A small percentage of Accu-Chek Tender using soft cannulas can accidental-
ly get crimped during insertion or displaced while in use. If this should occur
you should immediately use a new Accu-Chek Tender.
• Check 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
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full amount of medication. Replace the Accu-Chek Tender 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 unpredictable med-
ication ow.
• If you have to disconnect your Accu-Chek Tender, pay particular attention
to hygiene.
• Never use a soft cannula for more than 72 hours (3 days). Never use the
transfer set 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 the Accu-Chek Tender and use
a new site.
• Do not put disinfectants, perfumes, deodorants or insect repellent on your
Accu-Chek Tender as these may affect the integrity of the set.
• Never prime the transfer set or attempt to free a clogged line while the trans-
fer set is connected to the head-set. You may accidentally infuse an uncon-
trolled quantity of insulin.

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• Avoid mechanical stress on the infusion site and on the Accu-Chek Tender.
Pay attention when carrying heavy weights.
• Prepare the infusion site before insertion according to CDC (Centers for
Disease Control and Prevention) guidelines or institutional protocol.
• Check blood glucose level 1–3 hours after inserting your Accu-Chek Tender
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).
• 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
Tender.
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Insert Accu-Chek Tender
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.
Remove the front half of the adhesive backing (F) from the self-adhesive (E) and
pull the protective cover (A) off the introducer needle (C). Grasp the Accu-Chek
Tender between the thumb and middle nger of one hand behind the side clips
and pull back the edge of the self-adhesive with the index nger.
Warning
Ensure clean application. Do not touch the soft cannula or the introducer needle.

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Picture 2
With your free hand, pinch together a bit of subcutaneous tissue at the dis-
infected site. Insert the introducer needle (C) under the skin at an angle of
20–45°, proceeding quickly and in one motion. Watch the soft cannula (B) while
inserting to assure that it goes in smoothly without kinking or crimping.
Warning
People with very small or large amounts of subcutaneous fatty tissue should take
care when choosing the angle of insertion or the cannula length. The cannula
could be lodged in the muscular tissue or epidermis, where absorption of the
medication is limited or impossible. Ask the doctor who is treating you about this.
Make sure that the soft cannula is fully inserted into the subcutaneous tissue
and not kinked at the skin surface.
Once the introducer needle punctures the skin, the soft cannula must be quick-
ly pushed in the rest of the way, or it may kink upon insertion, causing reduced
or blocked medication delivery.
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Picture 3
Press the self-adhesive (E) rmly onto the skin in order to ensure secure seat-
ing of Accu-Chek Tender. Place one nger in front of the inspection window on
the Accu-Chek Tender to x it. Press the side clips of the introducer needle (D)
together gently and at the same time pull the introducer needle (C) out of
the skin.
Warning
Dispose of the introducer needle safely, so that nobody can prick or injure
themselves on it.
Picture 4
Remove the back side of the adhesive backing (G) from the self-adhesive (E)
and press the self-adhesive rmly onto the skin.

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Picture 5
Attach the luer-lock (N) to the pump by tightening it into the pump adapter.
Make sure there is a cartridge containing sufcient insulin in the cartridge
compartment. Remove the circular protective cap (L) by pressing the side clips
inwards gently. Follow the pump manufacturer’s user manual to 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.
Picture 6
Connect the transfer-set to the newly inserted head-set with the bulging side
upwards. A click must be heard when the connection engages. Fill the empty
space of the cannula housing (H) with a bolus of 0.7 units of insulin U-100
(about 7µl). Start distribution with the pump.
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Warning
Change the head-set every 2–3 days (max. 72 hours). Otherwise you risk
insulin resistance or inammation of the infusion site.
Never use the tube-set for more than 6 days.
You must ll the empty space of the newly inserted head-set after connecting
the transfer set. Failure to do so results in missed insulin.
Always check your blood glucose level 1–3 hours after introducing the set.
If the coupling does not click noticeably and audibly together, use a new head set
and a new transfer set.
Do not use any tools to screw the luer-lock connector into place.
Filling volume:
60 cm/24” approx 10 units * approx 100 µl
80 cm/31” approx 13 units * approx 130 µl
110 cm/43” approx 18 units * approx 180 µl
* U100 insulin

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Disconnect Accu-Chek Tender
Accu-Chek Tender allows you to temporarily disconnect from your pump for
showering, swimming, etc., without changing your Accu-Chek Tender.
Warning
Please consult with your health care professional 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.
Step 1
Stop the pump. Hold the self-adhesive (E) in place, gently press the side clips
of the connector (K) and pull the connector (J) from the cannula housing (H).
Step 2
Put the disconnect cover (M) on the cannula housing.
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Reconnect Accu-Chek Tender
Warning
Before reconnecting, ensure that a drop of medication appears at the tip of the
connector needle.
Step 1
Fill the Accu-Chek Tender until medication comes out of the connector needle.
Step 2
Hold the self-adhesive (E) in place and remove the disconnect cover (M) from
the cannula housing (H).
Reattach the connector (J) to the cannula housing. An audible “click” ensures
the connector is locked.

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Warning
It is not necessary to give an additional bolus. en
Distributed in USA by:
Roche Health Solutions Inc.
11800 Exit 5 Parkway, Suite 120
Fishers, IN 46037, USA
Toll Free 1-800-280-7801
[email protected]
www.accu-chek.com
Distributed in Canada by:
Roche Diagnostics Canada
201 Armand-Frappier Blvd.
Laval, Quebec
Canada
H7V 4A2
Toll Free 1-800-280-7801
www.accu-chek.ca

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SET DE INFUSIÓN
L K J I N
M
F
B
C
G D
AEH
catéter
cabezal

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Descripción
Accu-Chek Tender es un set de infusión para la administración subcutánea de
insulina realizada con micro-infusoras de insulina.
Contenido del envase de Accu-Chek Tender II
Envases interiores 1 y 2.
Envase 1 (set completo):
A cubierta protectora
B cánula exible
C aguja guía
D clips laterales de la aguja guía
E adhesivo
F mitad anterior del protector del
adhesivo
es
G mitad posterior del protector
del adhesivo
H cuerpo de la cánula
I catéter
J conector con aguja del conector
K clips laterales del conector
L tapón protector circular
M tapón de desconexión
N cierre luer

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Envase 2 (cabezal de aguja adicional): Componentes A-H del envase 1.
Contenido del envase de Accu-Chek Tender I
Sólo envase 1.
Advertencia
Lea detenidamente las instrucciones antes de usarlo.
Es recomendable que consulte el manual de la micro-infusora de insulina para
obtener información acerca de esta terapia.
Si es la primera vez que lo utiliza, deberá colocarlo bajo la supervisión de un
profesional sanitario.
• Este dispositivo se conserva estéril hasta que se abre o se daña el envase.
No utilice el producto si el envase está abierto o ha sufrido algún daño.
• Proteja el producto de la humedad excesiva, de la luz solar y del calor.
Almacénelo a temperatura ambiente.