Product Replacement Information; Warranty - Boston Scientific AMS 700 Mode D'emploi

Postsurgery
Problem
Pump bulb won't compress or fill
completely
Cylinders difficult to inflate or pump
won't inflate cylinders
Cylinders will not inflate
Kavoussi NL, Viers BR, VanDyke ME, et al. "Stiction Syndrome": Non-Operative Management of Patients With
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Difficult AMS 700™ Series Inflation. J Sex Med 2017;14:1079e1083.

PRODUCT REPLACEMENT INFORMATION

For more information about the replacement of a device, component or accessory,
please contact a Boston Scientific representative or local distributor. Replacement may
require the return of product to Boston Scientific in accordance with the applicable
Product Replacement Policy for Implanted Devices.

WARRANTY

Boston Scientific Corporation (BSC) warrants that reasonable care has been used in
the design and manufacture of this device. This warranty is in lieu of and excludes
all other warranties not expressly set forth herein, whether express or implied by
operation of law or otherwise, including, but not limited to, any implied warranties
of merchantability or fitness for a particular purpose. Handling and storage of this
device as well as other factors relating to the patient, diagnosis, treatment, surgical
procedures and other matters beyond BSC's control may directly affect the device
and the results obtained from its use. BSC's obligation under this warranty is limited
to the replacement of this device and BSC shall not be liable for any incidental or
consequential loss, damage or expense directly or indirectly arising from the use of
this device. BSC neither assumes, nor authorizes any other person to assume for it, any
other or additional liability or responsibility in connection with this device. BSC assumes
no liability with respect to devices that are reused, reprocessed or resterilized and
makes no warranties, express or implied, including but not limited to merchantability
or fitness for a particular purpose, with respect to such devices.
Tyvek is a trademark of E.I. DuPont De Nemours and Company Corporation.
What to Do
• Grasp the proximal penile shaft
with one hand and apply firm,
circumferential pressure on the
cylinders while simultaneously
squeezing the pump deflation button
with the other hand. After the pump
bulb refills, reactivate the pump with
a hard, quick squeeze of the pump
bulb. Inflate normally.
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• Squeeze the deflation button to
refill the pump bulb. Reactivate the
pump with a hard, quick pump bulb
squeeze. Inflate normally.
• If this does not resolve the problem,
squeeze the sides of the deflation
block to refill the pump bulb. Then,
squeeze the deflation button for
2-4 seconds to reset the lock-out
mechanism prior to attempting
inflation. Reactivate with a hard,
quick pump bulb squeeze. Inflate
normally. Do not squeeze the
deflation button and the pump bulb at
the same time.
• The tubing may be kinked. The
following pull-stretch technique
may modify the tubing placement
to optimize fluid flow and open the
lumens of the tubing to the cylinders:
The patient's penis is pulled-
stretched out, up, down, and side to
side 2-3 times.
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Black (K) ∆E ≤5.0