Intragastric air balloon fornon surgical treatment

of Obesity

heliosphere®

DC-0

64-0

2 .04/11/2008

Procedure of introduction of the intragastric balloon

heliosphere®: Reminder of some important points

This document can not replace the instruction for use : see the latter for more informations.

Step I : Implantation of the intragastric balloon

1/Visuallycheckwiththeendoscope.

2/Ifnocountraindications:

• Cover the balloon with surgical gel (white cover + catheter).• Introduce the balloon in the mouth of the patient while guiding it with your finger.• Slowy push the balloon with the catheter with your hand always close to the mouth in

order not to bend the catheter.

3/ In the meantime, introduce the endoscope in order to visually check the progression of the balloon.

Inordertoopentheballoonyouneedtobe3or4cmunderthecardia.

4/ Cover opening: Cut the blue safety cable.

Slowly pull the Helioscopie label in order to open the cover. Check with the endoscope that the cover is completely removed.

Step II : Balloon inflation

Step III : Balloon dropping

5/ Removethetap.

6/Connectthe60ccsyringewiththecheckvalve.

7/Slowlyinflatetheballoon:BAG 10 syringes of 60 cc.BAG PreOp 12 syringes of 60 cc.

Warning : do not exceed the number of syringes required.

8/Once the balloon is fullyinflated, unscrew thecanulainordertoretractthe needle, you need topullitallthewayuntilyouseeablackmark.

9/Gently pull the catheterwhich will drop theballoon into the stomach.Visually check with theendoscopethattheballooniscorrectlyplaced.

3 à 4 cm

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Intragastric air balloonfor non surgical treatment

of Obesity

heliosphere®

Procedure of extraction of the intragastric balloon

heliosphere® : Reminder of some important points

DC-0

64-0

2 .04/11/2008

This document cannot replace the instruction for use : See the latter for more information.

Positionthepatientinleftlateraldecubitus.

Step I : Deflating balloon1/ Cover the endoscope with a large quantity of surgical gel (white cover + catheter). 2/ Introduce the aspiration needle.3/ Locatethevalveandpositiontheneedlecatheterasperpendicular aspossibletothesurfaceofthe

balloon.

PuncturesPuncturetheballoonateachpoleandallaroundthe«equator»,withoutsuckingtheair.

Aspiration

1/ Make the last puncture around the black valve and let the needle inside the balloon.2/ Screw the blue part on the grey part of the needle to be sure it stays inside the balloon.

Connect to the suction hose with the connector.3/ The aspiration of the balloon must be 5 minutes long at least.4/ Oncetheairissucked,retracttheneedleinsidethecatheter.5/ Removetheneedlefromtheendoscope.

Step II : Balloon catching (take your time in order to be sure that the position of the grasper is correct).

1/ Afterhavingverifieditswellfunctionning,insertthegrasperintotheendoscope.

2/ Chose a crease on the balloon to pull the balloon on its longitudinal axe (as near as possible to the black valve, open the grasper fully and close it by pushing.

3/ Once the ballon is correctly caught, move the balloon next to the endoscope.

4/ Hold firmly the grasper at the entrance of the channel operator so as to make them move all together at the same time.

Step III : Extraction of the balloonPassage of the cardiaKeepacontinuetractionontheendoscope,beingsurethatthegrasperisalwaysrightnexttotheextremityoftheendoscope;thiscontinueandmoderatetractionpermitstothecardiatobeprogressivelyexpandedandtoevacuatetheresidualairintheballoon.

Full extractionRemovetheballonthroughtheoesophagus,with a constant and moderate traction up to the killian.Forthekillianpassage,repeattheprotocolusedforthecardia.

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