Apollo OverTube Mode D'emploi page 2

Single use only. Disposable. Do not resterilize.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Patent Pending.
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.
Table of Symbols
Description
Consult Instructions for Use
Do Not Re-use
Sterilized Using Ethylene Oxide
Reference Number
Authorized Representative in the
European Community
1. Instructions for Use
Carefully read all instructions prior to use. Observe all
contraindications and warnings in these instructions. Failure
to do so may result in complications.
Apollo Endosurgery recommends that the surgical team
carefully read and familiarize themselves with the instructions
before removing the device from its packaging.
10ml Syringe
Seal Valve
Aspiration Source
(Not Included)
Symbol Description
Manufacturer
Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician
Caution
Do Not Resterilize
2. Indications for Use
The OverTube is intended to be used in conjunction with
an endoscope for foreign body removal or endoscopic
procedures requiring multiple insertions of the endoscope
into the lower or upper gastrointestinal tract.
OPEN
Inflation Line
CLOSED
MAX MIN
16.0mm 10.0mm
Endoscope Size
Symbol
Cuff Seal
Hub
2
Description
Use By
Lot Number
Do not use if package is damaged
Non-Sterile
3. General System Description
The Apollo Endosurgery OverTube™ is comprised of a
polymer extrusion reinforced with a metallic coil. The Hub
located at the proximal end of the device contains a Cuff Seal
which can be inflated with air using a Syringe to prevent loss
of pressure when insufflation is used.
27cm
Symbol
Tip