GI Dynamics EndoBarrier Instrucciones De Uso

The EndoBarrier
Sterile device for one time use only. Do not reuse or re-sterilize. Read instructions before using.
The EndoBarrier Gastrointestinal Liner System can be purchased only upon order of a physician and is intended for
use by qualified medical personnel who have received training by GI Dynamics or its designate.
NOT AVAILABLE FOR SALE OR DISTRIBUTION WITHIN THE UNITED STATES. FOR
EXPORT ONLY.
Note: The EndoBarrier
0.035 - 0.038-inch nitinol guidewire.
Product Description
The GI Dynamics' EndoBarrier
with BMI ≥ 30 kg/m 2 , or obese patients with BMI ≥ 30 kg/m
2
BMI > 35 kg/m . It is provided sterile and consists of a gastrointestinal (GI) liner (anchor and liner), preloaded in a
catheter that delivers the liner to the proximal intestine. The product is sterilized using ethylene oxide. The GI liner
is removed using the EndoBarrier Gastrointestinal Liner Retrieval System, consisting of a Grasper and Retrieval
Hoods, which are compatible with standard gastroscopes. The Retrieval System may be supplied either sterile or
non-sterile.
These instructions pertain only to the EndoBarrier Gastrointestinal Liner with Delivery System. For information
regarding the requirements for EndoBarrier removal, refer to the EndoBarrier
System Instructions for Use.
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Instructions for Use
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Gebruiksaanwijzing NL
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Mode d'emploi FR
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Istruzioni per l'uso IT
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Gebrauchsanweisung DE
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Instrucciones de uso SP (EU)
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Instrucciones de uso SP (LA)
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Brugsanvisning DA
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Návod k použití CZ
with Delivery System
Instructions for use
®
System requires use of a commercial gastroscope and exchange length,
®
Gastrointestinal Liner System is used for the treatment of obese type 2 diabetes
®
Gastrointestinal Liner
2 with ≥ 1 comorbidities, or obese patients with
1
9
17
25
33
41
49
57
65
1
®
Gastrointestinal Liner Retrieval