Warning; Device Description; User Information; Contents - Boston Scientific AMS Ambicor Mode D'emploi

AMS Ambicor
Inflatable Penile Prosthesis
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

WARNING

Contents supplied STERILE using steam or an ethylene oxide (EO) process. Do not use if
sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead
to device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
After use, dispose of the product and packaging in accordance with hospital,
administrative and/or local government policy.

DEVICE DESCRIPTION

The AMS Ambicor Inflatable Penile Prosthesis is a closed, fluid-filled system consisting
of a pair of cylinders, which are implanted in the corpora cavernosa, and a pump which is
implanted in the scrotum (Figure 1). Rear Tip Extenders (RTEs) are provided for additional
length, if needed. All components are preconnected by kink-resistant tubing and prefilled
with normal saline. The cylinders are inflated as fluid is pumped from the reservoirs, which
are located in the proximal ends of the cylinders, into the main cylinder body, creating an
erection. They are deflated as fluid is transferred back to the reservoirs, making the penis
flaccid once again.
Figure 1. AMS Ambicor Inflatable Penile Prosthesis
The AMS Ambicor Penile Prosthesis cylinder specifications are shown in Table 1.
Table 1. AMS Ambicor Cylinder Specifications
Cylinder Diameter Cylinder Length
12.5 mm
14 mm
15.5 mm
™
Kink-Resistant
Tubing Length
14 cm
16 cm
18 cm
16 cm
18 cm 9 cm
20 cm
18 cm
20 cm
22 cm
Device Function
Inflation
The inflation pump is placed in the scrotum. To inflate the cylinders, the patient stabilizes
the pump with one hand and uses the other hand to squeeze and release the pump bulb
several times to make the cylinders stiff (Figure 2). When the cylinders are fully inflated,
the pump bulb will be hard and can no longer be compressed.
Figure 2. Inflating the AMS Ambicor Cylinders
Deflation
To deflate the cylinders, the patient places his thumb under the shaft of the penis
to act as a fulcrum and places his fingers on top of the shaft of the penis. Using the
fingers of the same or opposite hand, the patient bends his penis down over his thumb
(fulcrum) towards his scrotum at an approximate 65 degree angle, making sure that both
cylinders are bent (Figure 3). The cylinders are held in this position for approximately
10-12 seconds and then released. This opens the valves allowing the fluid to flow back
into the reservoirs and pump. The patient may also deflate the cylinders by bending
them upwards; this can be done by placing his thumb on top of the shaft of his penis and
following the same instructions as above.
Figure 3. Deflating the AMS Ambicor Cylinders

User Information

The implantation of this device is to be performed only by physicians who are
knowledgeable and have received appropriate training regarding the use of inflatable
penile prostheses. This manual is not intended to be a complete reference.

Contents

(2) Cylinders
(1) Pump
(2) 0.5 cm RTE
(2) 1 cm Stackable RTE
(2) 2 cm Stackable RTE
(2) 3 cm Stackable RTE
(2) Keith Needles

Material of Animal Origin

An internal component of the Ambicor Penile Prosthesis cylinders contains a non-viable
tallow derivative. The component does not contact blood or tissue.

INTENDED USE

The AMS Ambicor Penile Prosthesis is designed to provide the patient with control over
the erect and flaccid states of his penis.

INDICATIONS FOR USE

The AMS Ambicor Penile Prosthesis is intended for use in the treatment of chronic,
organic, male erectile dysfunction (impotence).
3
Black (K) ∆E ≤5.0