Spatz 3 Mode D'emploi page 5

severe underlying medical problems); Digestive tract injury or
perforation; Upper digestive tract bleeding.
How Supplied
Each Spatz3 Adjustable Balloon System® Insertion Kit contains a
balloon attached to an extension tube with a 3-way stopcock at its
proximal end and a 50 ml or 60 ml Balloon Syringe. The white cap
for closure of the inflation valve is provided within the packaging
in a separate pouch. A device insertion facilitator is provided
within the packaging.
A patient card that identifies the Spatz3 balloon, is supplied in
each package and is to be carried by the patient at all times during
the period of balloon implantation.
Spatz3 Adjustable Balloon System adjustment/extraction Kit
contains extension tubes with 3-way stopcock and are separately
available.
The Spatz3 adjustable balloon Insertion Kit contains:
Spatz3 Adjustable Balloon System® in a non-sterile state, and
the Balloon Syringe in a sterile state
All are supplied FOR SINGLE USE ONLY and none should be re-
used or sterilized. The risk of infection, incorrect function and
patient harm are possible should these devices be re-used or
sterilized.
STORE AT ROOM TEMPERATURE (15°-30° C).
Safe Disposal
Dispose of used device/parts in accordance with institution's
standard protocol for disposal of biohazard materials
Cleaning Instructions
In the event that the product becomes contaminated prior to use,
it should not be used but should be returned to the manufacturer.
CAUTION: DO NOT SOAK THE PRODUCT IN A DISINFECTANT.
The silicone elastomer may absorb some of the solution which
could subsequently leach out and cause tissue reaction.
Instructions for use
Use of this device requires a working knowledge of endoscopic
techniques and equipment and oral- gastric intubation. The
instructions for use of the Spatz3 Adjustable Balloon System®
do not obviate the need for formal training in these methods.
Formal training in the Spatz3 Balloon insertion, down/up
adjustment and removal procedures are required and should be
performed by a Spatz-authorized instructor.
for tutorials movies see Spatzmedical.com
The inflation tube is delicate - please inflate cautiously, since
continued inflation while the tube is kinked can result in inflation
tube tear. The balloon should not be used if any damage is noted.
A stand by Spatz3 Adjustable Balloon System® should be
available at the time of placement.
Insertion Instructions:
1. Conscious sedation as per standard endoscopy.
2. Perform endoscopy and assess for findings that
contraindicate device implantation.
3. Remove the endoscope.
4. Remove the Spatz3 Adjustable Balloon System® from the
package.
5. Pull the "band-off" to remove ALL of the bands.
6. Dry the endoscope thoroughly.
7. Place the insertion facilitator on the distal end of the
endoscope and roll it over the distal edge of the balloon. The
tip of the balloon should be within 3 mm of the proximal
hole of the insertion facilitator-as shown in photos.
Push the Valve Hold snugly into the cap of the white
catheter (see figures below)
WARNING-Skipping this step can result in an inflation
tube tear which will require removal of the balloon.
WARNING: Do not twist the valve during this step it may
cause a kink in the inflation tube and failure to inflate.
Connect the valve firmly to the extension tube. Lubricate
the device generously over the length of the balloon,
and the inflation valve, using medical grade jelly or
equivalent. Pass the endoscope and device in one hand
as one unit, into the throat and advance to the esophagus
and stomach as per usual endoscopic insertion. Once in
the gastric antrum, retroflex and confirm that the balloon
has passed into the stomach, connect one opening of the
3-way stopcock to the large syringe and a second opening
to the solution bag and inflate the balloon with 500 ml.
During inflation, if there is any resistance to inflation,
reposition the endoscope until the inflation flows easily.
1. place condom
3. pull the other side
Spatz3 Adjustable Balloon System | 5
2. pull proximally
4. until edge is at the
tip of scope
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