Pre-Procedural Instructions; Procedural Instructions - Boston Scientific AMS 800 Mode D'emploi

Figure 15. Bladder neck cuff placement, male
Female Single Incision 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 16) 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 pouch in the labium
using blunt dissection.
Female Double Incision Bladder Neck Approach (Transvaginal)
The patient is placed in the lithotomy position. The cuff is placed around the bladder
neck by making a transvaginal incision in the shape of an inverted "U" on the anterior
wall of the vagina, followed by dissection from around the bladder neck. The PRB is
placed in the prevesical space by making a suprapubic incision followed by blunt
dissection. The pump is placed within a subdartos pouch in the labium through the
suprapubic incision, using blunt dissection.
Figure 16. Bladder neck cuff placement, female

PRE-PROCEDURAL INSTRUCTIONS

Use appropriate surgical and sterile techniques per the hospital's standard procedures.
CAUTION: Be certain that the components do not come into contact with paper or
cloth drapes. Fragments of these can cause possible obstruction of fluid flow if they
enter the device.
Open the AMS 800 Accessory Kit
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1. Remove the tray from the box in the operating room.
2. Remove inner tray from outer tray and place the inner tray on a sterile, lint free or
plastic draped surgical stand.
3. Open inner tray.
Note: Record the part and serial/lot numbers of the AMS 800 Accessory Kit on the
Patient Information Form (PIF). The adhesive label at one end of the outer box and
the small, removable labels on the outer trays contain the name of the component,
the part and serial/lot numbers, and the size of the components. This information is
also listed on the Tyvek lid of the outer tray.
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Prepare the Hemostats
Use the following procedure to cover the hemostat jaws with the blue tubing provided
in the AMS 800 Accessory Kit:
1. Place blue tubing on both jaws of hemostats to completely cover the serrated
surfaces.
2. Close the jaws until the first notch to prevent excessive pressure on the blue tubing.
3. Trim blue tubing at jaw tip with sharp, clean scissors.
4. Reserve scissors for use as tubing scissors throughout procedure.
CAUTION: When clamping KRT, do not advance a hemostat's ratchet more than one
notch. Excessive pressure will permanently damage the tubing.
Prepare the Patient
Before surgery, take adequate steps to limit the risk of postoperative infection.
CAUTION: Using a device treated with InhibiZone
normal hospital protocols for prophylactic antibiotic administration.
Once the patient is in the operating room, shave the abdominal and genital area. Following
the shave, scrub the area using the approved hospital preoperative scrub procedure.
Establish the sterile field, drape, and prepare the patient. Throughout the procedure,
flush the surgical site with copious amounts of broad-spectrum antibiotics. Position the
patient according to the preferred surgical approach.

PROCEDURAL INSTRUCTIONS

Make the Incision and Dissect
1. Place a Foley catheter or a 20 Fr sound to facilitate urethra identification. The
catheter will help decompress the bladder and help avoid bladder injury during PRB
placement.
2. Make the appropriate incision for the surgical approach chosen.
3. Bluntly dissect to the urethra (Figures 17, 18, 19).
CAUTION: Ensure that there is an adequate amount of muscle tissue at the
implant site.
Figure 17. Dissect bulbocavernosus muscle
Figure 18. Posterior dissection of the urethra
Figure 19. Dissect around bladder neck
4. Assess the size of the urethra and select the appropriate cuff size (Figures 20, 21).
a. Remove the catheter or sound from the urethra. Place the cuff sizer (or Penrose
drain) around the urethra where the cuff is to be implanted. It should fit snugly
without constricting the urethra.
NOTE:
• A cuff length of 4.0 cm to 4.5 cm is typically required for bulbous urethra
placement.
• Do not stretch the cuff sizer before use.
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does not change the need to follow
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Black (K) ∆E ≤5.0