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

The frequency of positioning the pump is the physician's decision. Some physicians
have their patients position the pump several times daily.
To position the pump in the scrotum, the patient should be told to:
1. Locate the pump in the scrotum.
2. Grasp the pump firmly and carefully pull the pump down in the scrotum. The patient
should gently pull the pump into a position close to the outer scrotal wall.
After three to six weeks, the physician may instruct the patient to begin cycling the
device for the first time. To cycle the device, the patient inflates and deflates the
prosthesis several times. The cylinders must be fully inflated before they can be deflated.
It may be painful for the patient the first few times that he inflates and deflates the device.
However, after the postoperative healing period, the pain should subside. Instruct the
patient to inflate and deflate the prosthesis several times daily.
Four to six weeks postoperatively determine if the patient is ready to use the device:
1. Check the incision site to be sure that it has healed properly. There should be no
redness, swelling, or drainage. Any of these findings may indicate that an infection
is present and it should be treated promptly with antibiotics.
2. Ask the patient about pain when cycling the device and observe the patient inflating
and deflating the device.
After determining that the patient knows how to operate the device and that the device
is functioning correctly, inform the patient that it is possible to have gentle intercourse.
Advise the patient not to inflate the device for long periods of time when not in use.
If the patient is familiar with injection therapies for erectile dysfunction, remind the
patient that such therapies can cause damage to the penile prosthesis and should not
be used.
Evaluating Long-Term Function and Placement
After the postoperative healing period, continue to have contact with the patient at least
on an annual basis to evaluate the function of the device and to check for signs of
infection or erosion. Ask the patient how the device is functioning and if he has noticed
any changes in the function, for example, the cylinders losing rigidity. If the patient is
having mechanical difficulty with the device, or if there is infection or erosion present,
revision surgery may be necessary.

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.
Black (K) ∆E ≤5.0
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