How Supplied; Handling And Storage; Operational Instructions; Pre-Procedural Instructions - Boston Scientific AMS 700 Mode D'emploi

• Use of InhibiZone™ results in a significant reduction in the rate of revision due to
device-related infection among penile prosthesis implants in diabetic patients.
• Use of InhibiZone results in a significant reduction in the rate of revision due to
device-related infection in original and revision penile prosthesis implants.

HOW SUPPLIED

The AMS 700™ Penile Prosthesis and Accessory Kit components are provided sterile.
• Do not use if package is open or damaged.
• Do not use if labeling is incomplete or illegible.
• Do not use the device if past the "Use By" date.

Handling and Storage

InhibiZone treated components: Keep dry and protect from light. Recommended
storage at 25°C (77°F); excursions permitted to 15°C-40°C (59°F-104°F).
Non-InhibiZone treated components: Store in a cool, dry, dark place.
Supplemental Surgical Tools
The following BSC surgical tools used to help facilitate implantation of the AMS 700
Penile Prosthesis may be ordered separately.
Non-Sterile Tools
The following tools are provided non-sterile and must be sterilized before use (for
reprocessing information, refer to the instructions manual provided with the tools):
• Quick Connect Assembly Tool
There are two systems for connecting components and tubing for the AMS 700
Penile Prosthesis.
• Quick Connect Window Connectors (provided sterile)
• Suture-Tie Connectors (provided sterile)
In order to use the Quick Connect Window Connectors in the Accessory Kit, the
Quick Connect Assembly Tool must be ordered. This is a reusable stainless steel
instrument used to close the connectors. The Quick Connect Assembly Tool is
shipped non-sterile and may be re-sterilized. Quick Connect Window Connectors
should not be used on revision surgeries, except when all previously implanted
components are removed and replaced with new components.
• Insertion Package (2 stainless steel Tubing Passers)
• Closing Tool
• Furlow Insertion Tool
• Sizer
Contents:
(1) 9.5 mm Sizer
(1) 12 mm Sizer
Sterile Tools
The following are provided sterile and are intended for single use only:
• SKW Deep Scrotal Retraction System
• Disposable Dilators
• 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 which 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 surgical procedure are recommended.
In addition to the AMS 700 Penile Prosthesis components, the RTEs, and Accessory Kit,
the following sterile set up is needed:
• Sterile normal saline (filling and flushing solution)
• Two 60 mL and two 10 mL syringes (for filling and flushing prosthesis components)
• Eight mosquito hemostats (for clamping tubing when prepared with shods)
• One straight pair of clean, sharp scissors for trimming tubing
• Disposable Dilators or a set of corporal dilators for dilating the corpora cavernosa
• Furlow Insertion Tool (for passing traction sutures through the glans)
• Corporal length measuring tool
• Quick Connect Assembly Tool (needed for Quick Connect Window Connectors)
• Antibiotic solution for irrigation
Black (K) ∆E ≤5.0

OPERATIONAL INSTRUCTIONS

Pre-procedural Instructions

Open the AMS 700 Accessory Kit
1. Remove the tray from the box in the operating room
2. Remove the inner tray from outer tray, using appropriate sterile technique, and
place the inner tray on a sterile, lint free Mayo stand.
3. Open the inner tray.
Note: Record the part and serial lot/numbers of the 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 side of the plastic trays contain the part and serial/lot
numbers. This information is also listed on the Tyvek™ lid of the outer tray.
Prepare the Hemostats
Use the following procedure to cover the hemostats with the blue tubing provided in
the Accessory Kit:
1. Place blue tubing on both jaws of the mosquito hemostats to completely cover the
serrated surfaces.
2. Clamp the jaws together one notch only to prevent excessive pressure on the tubing.
3. Trim the tubing at each jaw tip with sharp, clean scissors.
4. Reserve one pair of straight scissors as "clean" tubing scissors throughout the
procedure. These will be used for trimming tubing prior to connecting.
Prepare the Patient
Before surgery, take adequate steps to limit the risk of postoperative infection.
CAUTION: Using a device with InhibiZone does not change the need to follow 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: infrapubic or penoscrotal.

Procedural Instructions

Surgical Approaches
The following descriptions are an overview of the infrapubic and penoscrotal surgical
approaches.
Infrapubic Approach
All of the AMS 700 Device components can be implanted through an infrapubic
incision. If the prosthesis is preconnected, be certain that the cylinder/pump package
is labeled infrapubic.
Penoscrotal Approach
It is also possible to implant all of the AMS 700 Device components through a
penoscrotal incision. If the prosthesis is preconnected, be certain the cylinder/pump
package is labeled penoscrotal.
Make the Incision and Dissect
1. Place a Foley catheter to facilitate urethra identification. The Foley catheter will help
decompress the bladder and help avoid bladder injury during reservoir placement.
2. Make the appropriate incision for the surgical approach chosen.
Infrapubic: Make a 4 cm to 5 cm longitudinal or transverse incision, at the
symphysis pubis (Figure 11). Avoid the midline neurovascular bundle.
Figure 11. Infrapubic: Identify incision site
Penoscrotal: Make a 2 cm to 3 cm incision through the median raphe of the scrotum
at the penoscrotal junction.
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