Warning; Device Description; System Description - Boston Scientific AMS 700 Mode D'emploi

AMS 700™
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 patient 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

System Description

The AMS 700 Inflatable Penile Prostheses are totally implantable, closed, fluid-filled
systems (Figure 1) consisting of:
• Two cylinders with optional Rear Tip Extenders (RTEs)
• One Momentary Squeeze (MS) Pump
• One reservoir
Figure 1. AMS 700 Inflatable Penile Prosthesis
The reservoir stores the fluid that fills and expands the penile cylinders. The patient
operates the pump to inflate or deflate the system. The cylinders are inflated by
multiple squeezes of the pump, which transfers fluid from the reservoir to the cylinders
making the penis erect (Figure 2). The cylinders are deflated by squeezing the deflation
button for 2-4 seconds. This transfers fluid back into the reservoir making the penis
flaccid (Figure 3). The penis can be made more flaccid by squeezing the cylinders,
transferring additional fluid to the reservoir. All components are connected by kink
resistant tubing. The AMS 700 Penile Prosthesis components are also available
with InhibiZone™, an antibiotic treatment of rifampin (rifampicin) and minocycline
hydrochloride (minocycline HCl) . For more information, please refer to the InhibiZone
1
Antibiotic Treatment section.
InhibiZone Antibiotic Treatment is not available in all markets.
1
Reservoir
Cylinder
Pump Bulb
Figure 2. AMS 700 System inflation
Figure 3. AMS 700 System deflation
The AMS 700 Penile Prosthesis Product line includes the following products: AMS 700
CX, AMS 700 CXR, and AMS 700 LGX™. The AMS 700 Penile Prostheses are available
with or without preconnected cylinders and pump and for either an infrapubic or peno-
scrotal approach. The available configurations are shown in Table 1.
3
Deflation
Button
Black (K) ∆E ≤5.0