apollo endosurgery BIB Bedienungsanleitung Seite 10

12.5 IGB REPLACEMENT
If an IGB needs to be replaced, then follow the instructions
for IGB Removal and IGB Placement and Filling.
Additionally, it is recommended that the same volume of
sterile saline that was used during the placement of the
previous IGB (i.e. initial fill volume) be used when filling the
replacement IGB.
CAUTION: A larger initial fill volume in the replacement IGB
may result in severe nausea, vomiting or ulcer formation.
13. MEDICAL IMAGING
The saline filled IGB is considered to be MR Safe.
14. DISCLAIMER OF WARRANTY AND LIMITATION
OF REMEDY
There is no express or implied warranty, including without
limitation any implied warranty of merchantability or fitness
for a particular purpose, on the Apollo Endosurgery, Inc.
product(s) described in this publication. To the fullest extent
permitted by applicable law, Apollo Endosurgery, Inc.
disclaims all liability for any indirect, special, incidental, or
consequential damages, regardless of whether such liability
is based on contract, tort, negligence, strict liability, products
liability or otherwise. The sole and entire maximum liability
of Apollo Endosurgery, Inc., for any reason, and buyer's sole
and exclusive remedy for any cause whatsoever, shall be
limited to the amount paid by the customer for the particular
items purchased. No person has the authority to bind Apollo
Endosurgery, Inc. to any representation or warranty except
as specifically set forth herein. Descriptions or specifications
in Apollo Endosurgery, Inc. printed matter, including this
publication, are meant solely to generally describe the
product at the time of manufacture and do not constitute any
express warranties or recommendations for use of the
product in specific circumstances. Apollo Endosurgery, Inc.
expressly disclaims any and all liability, including all liability
for any direct, indirect, special, incidental, or consequential
damages, resulting from reuse of the product.
Caution. See instructions for use
Manufacturer
Reference Number
Serial Number
Non-Sterile
Use By Year, Month & Date
1. Abu-Dayyeh B et al. A Randomized, Multi-Center Study
to Evaluate the Safety and Effectiveness of an Intragastric
Balloon As an Adjunct to a Behavioral Modification Program,
in Comparison With a Behavioral Modification Program
Alone in the Weight Management of Obese Subjects.
Gastrointestinal Endoscopy 2015: 81(5):AB147.
Single Use Only. Do Not Reuse
Authorised
Community
Do Not Use If Package Is Damaged
MR Safe (Filled Balloon Only)
Medical Device
Consult Instructions for Use
10
REFERENCES
Representative in the European