Operational Instructions - Boston Scientific AMS 800 Mode D'emploi

Sterile Tools
• SKW Deep Scrotal Retraction System
• Deactivation Package
Contents:
(3) Tubing plugs
(1) Straight Suture-Tie Connector
The Deactivation Package is not required for an initial implant. The Package contains
3 stainless steel tubing plugs and 1 straight Suture-Tie Connector. The tubing plugs
may be used to prevent fluid from entering or leaving the prosthesis during revision
surgeries.
Required Materials
Supplies and Instrument Requirements
Instruments normally required for a urological procedure are recommended. In addition
to the AMS 800 AUS components and the AMS 800 Accessory Kit, the following sterile
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setup should be available.
• Sterile stainless steel tray
• 1000 ml graduate container
• 500 ml graduate container
• Sponge bowl
• Medicine cup
• Emesis basin
• Two 30 ml disposable syringes
• One 10 ml disposable syringe
• Eight shod hemostats (for clamping tubing)
• One straight pair of clean, sharp scissors for trimming tubing
• Hegar dilators
• Babcock clamps
• Asepto syringe
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• Antibiotic solution (for irrigation)
• Catheter
• Penrose drain
• Umbilical tape
• Vaginal pack
• Sterile normal saline (filling and flushing solution)
• Retractor
• Extended nasal speculum (optional)
• Rectal tube (optional)
• Centimeter ruler (optional)
Use a plastic-draped surgical stand or a stainless steel tray as a station for handling and
filling the components of the prosthesis.
Position splash basins so that the surgeons can conveniently clean their gloves during
the surgical implantation procedure, especially before they make the tubing connections.
Filling Solutions
The fluid used to fill the prosthesis must be sterile and free of blood and particulate
matter. The presence of any foreign materials in the fluid can affect the operation of the
prosthesis. The solution must also be isotonic to minimize the transfer of fluid across
the silicone membrane, which is semi-permeable. Normal saline is the recommended
isotonic solution to use when filling the prosthesis.
However, if contrast media is preferred, one of the tested solutions in Table 9 may be
used for filling. If you do not use the contrast media in the mixture proportions, you may
alter the isotonicity of the mixtures and promote the formation of particulate matter.
Note: The products listed below are some of the radiographic solutions tested by
Boston Scientific for use in the AMS 800 AUS; only sterile water should be used for
dilution. For a complete list, contact Boston Scientific.
CAUTION: Do not use sterile saline or lactated Ringer's solution to dilute the contrast
solutions.
WARNING: Contrast media are contraindicated if the patient has an iodine allergy.
Black (K) ∆E ≤5.0
Table 9. Filling Solution Dilution
Contrast Media
Conray 43 30 ml Conray 43 + 60 ml sterile H
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Cysto-Conray II 60 ml Cysto-Conray II + 15 ml sterile H
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Isovue 200 60 ml Isovue 200 + 23 ml sterile H
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Isovue 300 57 ml Isovue 300 + 60 ml sterile H
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Isovue 370 38 ml Isovue 370 + 60 ml sterile H
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Omnipaque 180 60 ml Omnipaque 180 + 14 ml sterile H
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Omnipaque 240 60 ml Omnipaque 240 + 38 ml sterile H
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Omnipaque 300 57 ml Omnipaque 300 + 60 ml sterile H
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Omnipaque 350 48 ml Omnipaque 350 + 60 ml sterile H
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Telebrix 12 53 ml Telebrix 12 + 47 ml sterile H
Use an equivalent ratio of contrast media and sterile water for a larger total volume.

OPERATIONAL INSTRUCTIONS

Surgical Approaches
There are several approaches to implant the AMS 800 AUS components. It is
important for the surgical staff to know which approach the surgeon intends to use
because the approach will influence the position of the patient, instrumentation, and
surgical procedure.
The following are brief descriptions of surgical approaches that can be used to implant
the AMS 800 AUS.
Male Perineal Approach
The patient is placed in the lithotomy position. The cuff is placed around the bulbous
urethra (Figure 14) by making a midline perineal incision followed by dissection of the
bulbocavernous muscle from around the urethra. The PRB is placed in the prevesical
space, by making a transverse suprapubic incision through the rectus fascia, followed
by dissection of the linea alba and prevesical space. The pump is placed within a
subdartos pouch in the scrotum through the suprapubic incision, using blunt dissection.
A second cuff can be placed using this surgical approach; for additional information
refer to the Troubleshooting section.
Transverse Scrotal Approach
The patient is placed in the supine position with legs gently abducted with spreaders.
The cuff is placed around the proximal bulbar urethra (Figure 14) by making a transverse
scrotal incision followed by dissection of the subcutaneous tissue and scrotal septum.
The PRB is placed in the prevesical space by displacing the transverse scrotal incision
and dissection of the transversalis fascia. Alternatively, to avoid the necessity of piercing
the fascia in patients with scarred retroperitoneum from radiation or radical surgery,
create a pouch beneath the rectus abdominus and anterior to the transversalis fascia.
The pump is placed within a subdartos pouch in the scrotum using blunt dissection. A
second cuff can be placed using this surgical approach; for additional information refer
to the Troubleshooting section.
Figure 14. Bulbous urethra placement
Male Bladder Neck Approach
The patient is placed in the supine position with legs gently abducted with spreaders.
The cuff is placed around the bladder neck (Figure 15) by making a suprapubic incision
followed by dissection around the bladder neck. The PRB is placed in the prevesical
space by blunt dissection. The pump is placed within a subdartos pouch in the scrotum
using blunt dissection.
10
Dilution Validated for
InhibiZone
O Yes
2
O Yes
2
O No
2
O No
2
O No
2
O No
2
O No
2
O Yes
2
O No
2
O Yes
2
Use
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