Warning; Device Description - Boston Scientific AMS 800 Mode D'emploi

AMS 800
Artificial Urinary Sphincter for Male
and Female Patients
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.
Figure 1. AMS 800 AUS implanted in a male patient
Figure 2. AMS 800 AUS implanted in a female patient

DEVICE DESCRIPTION

System Description
The AMS 800 Artificial Urinary Sphincter (AUS) is an implantable, fluid filled device
(Figures 1, 2). The device consists of three components: an occlusive cuff (cuff), a control
pump, and a pressure regulating balloon (PRB). Kink-resistant tubing (KRT) connects
these components to form a closed system. The AMS 800 AUS simulates sphincter
function by applying circumferential pressure to aid in opening and closing the urethra.
When the cuff is inflated, the urethra is closed and urine stays in the bladder (Figure 3).
When the patient wishes to void, he or she cycles the device by squeezing and releasing
the pump several times, moving the fluid from the cuff to the PRB (Figure 4). The cuff
deflates and urine passes through the open urethra. Pressure from the PRB pushes fluid
back into the cuff, occluding the urethra and restoring continence (Figure 5).
The AMS 800 AUS cuffs and pumps are available with InhibiZone
treatment of rifampin (rifampicin) and minocycline hydrochloride (minocycline HCl)
InhibiZone Antibiotic Treatment is not available in all markets.
†
™
, an antibiotic
™
Figure 3. Urethra closed by cuff
Figure 5. Automatic cuff inflation and
Occlusive Cuff
The cuff (Figures 6, 7) occludes the urethra by applying pressure circumferentially. It is
made of silicone elastomer and is available in thirteen sizes in length: 3.5 cm, 4.0 cm,
4.5 cm, 5.0 cm, 5.5 cm, 6.0 cm, 6.5 cm, 7.0 cm, 7.5 cm, 8.0 cm, 9.0 cm, 10.0 cm, and
11.0 cm. All cuffs are approximately 1.8 cm wide when deflated. The proper size to be
used in the patient is determined by the circumference of the tissue around the urethra
intraoperatively. The cuff tubing is joined to the control pump tubing with a connector.
Figure 7. Occlusive cuff, side view
†
.
3
Figure 4. Opening of cuff and
urination by manipulation of pump
urethral coaptation
Figure 6. Occlusive cuff
Black (K) ∆E ≤5.0