Boston Scientific AMS 700 Mode D'emploi page 12

Sizing Method A
Method A reduces the length of the solid proximal portion of the cylinders in the shaft of
the penis and allows the tubing sleeve to contact a portion of the expandable shafts of
the cylinders (Figure 19). As the tubing is partially buried in the corpora, using Method
A has the potential to increase the likelihood of tubing compression or kinking, which
may reduce fluid flow. If you believe the tubing is kinked, attempt to gently straighten it.
Figure 19. Method A
1. Calculate the Total Corporal Length (distal + proximal)
Example
Distal Corporal Length 12 cm
Proximal Corporal Length +7 cm
Total Corporal Length 19 cm
2. Select the closest cylinder size that is shorter than or equal to the Total Corporal
Length. Add RTEs, if necessary, to fit the patient's anatomy.
Example
Total Corporal Length 19 cm
Selected Cylinder Length -18 cm
RTE Length 1 cm
Sizing Method B
Method B allows the tubing to exit directly from the corporotomy (Figure 20). Follow the
formula described below to select the appropriate cylinder length and number of RTEs.
If necessary, extend the length of the corporotomy.
Figure 20. Method B
1. Calculate the Total Corporal Length (distal + proximal)
Example
Distal Corporal Length 12 cm
Proximal Corporal Length +7 cm
Total Corporal Length 19 cm
2. Subtract 2 cm from the Total Corporal Length to obtain an Adjusted Measurement.
Total Corporal Length 19 cm
-2 cm
Adjusted Measurement 17 cm
3. Select the closest cylinder size that is shorter than or equal to the Adjusted
Measurement.
Example
Adjusted Measurement 17 cm
Selected Cylinder Length 15 cm
4. Subtract the selected Cylinder Length from the Total Corporal Length to
determine the length of the RTEs.
Example
Total Corporal Length 19 cm
Selected Cylinder Length -15 cm
RTE Length 4 cm
Note: Do not open any component packages until the cylinder length is confirmed.
Unpack the Components
The AMS 700™ Penile Prosthesis components are packaged in sterile pouches, except
the RTEs, which are packaged in sterile trays. Keep the sterile products in their boxes
or plastic travel cases until they are in the operating room.
Black (K) ∆E ≤5.0
1. Remove the product from the outer travel case or box in the operating room.
2. For products in pouches, remove the sterile inner pouch from the outer pouch and
place it on a sterile, lint free Mayo stand.
CAUTION: Do not place cloth towels on the Mayo stand. They may transfer lint to the
components.
3. When ready to prepare the components, open the inner pouches and place the
components on the sterile, lint free Mayo stand. If RTEs are used, open the sterile
tray(s) and place the RTEs on the sterile, lint free Mayo stand.
Note: Record the part and serial/lot numbers and the size of the components on the
RTE
Patient Information Form (PIF). The small, removable adhesive labels list the part and
serial/lot numbers and the size of the components.
Prepare the Components
If using preconnected components, follow the preparation steps for the preconnected
MS Pump™ and cylinders and the reservoir. If using nonconnected components,
follow the preparation steps for the reservoir, the nonconnected cylinders, and the
nonconnected MS Pump.
Boston Scientific recommends that all components of the AMS 700 Penile Prosthesis
Product Line be prepared with sterile normal saline. The sterile normal saline must
remain free of debris that can block fluid flow through the components.
Components that are treated with InhibiZone™ should not be submerged in sterile
normal saline.
CAUTION: Soaking InhibiZone impregnated devices in saline will cause the antibiotics
to diffuse off of the device into the solution. This will cause the solution to turn orange
and will reduce the concentration of antibiotics on the device.
Prepare the Preconnected MS Pump and Cylinders
The AMS 700 CX, CXR, and LGX Preconnect Penile Prosthesis cylinders and pumps are
provided preconnected. The only connection required is between the pump and the reservoir.
The following instructions outline the preparation of the device to ensure that the air is
removed from the cylinders and pump before the reservoir is connected.
Attach the RTEs to the cylinders, if needed, twisting the RTEs onto the proximal end of
the cylinders to provide a tactile indication of a proper connection.
1. Partially fill a graduate with sterile normal saline.
RTE
2. Submerge the single, black color coded tubing from the pump into the sterile normal
saline.
3. Hold the pump so that the deflate mechanism is on top.
4. Squeeze the deflation button 1 time and release.
5. Make an initial hard, quick squeeze of the pump bulb and release. Allow the pump
bulb to completely fill with saline.
Note: This step is important to lubricate the valves of the pump for further prepping.
Note: If saline does not appear in the pump bulb or if the bulb does not fully fill with saline,
squeeze the deflation button 1 time and release. This will reset the pump. Repeat Step 5.
This sequence may need to be repeated more than once to get the pump activated.
6. Continue to squeeze and release the pump bulb until the cylinders are rounded and the
pump bulb is hard to squeeze. Let the pump bulb completely refill before each squeeze.
7. Squeeze the deflation button for 2-4 seconds to allow the air to be expelled from the
components.
8. Repeat steps 6 and 7 until no bubbles are noted in the graduate during deflation.
9. Squeeze the cylinders to remove the remaining saline from the cylinders.
CAUTION: Do not squeeze the deflation button and the pump bulb at the same time.
10. With the black color coded tubing still in the saline, use a blue shod mosquito hemostat
to clamp (1 notch only) the black color coded tubing 2.5 cm from the open end.
CAUTION: Do not advance the hemostat's ratchet more than one notch. Excessive
pressure will permanently damage the tubing.
11. For components treated with InhibiZone, place the empty cylinders and filled
pump onto an empty sterile tray, empty kidney basin, or sterile Mayo stand. Do not
submerge the components in saline.
CAUTION: Soaking InhibiZone impregnated devices in saline will cause the antibiotics
to diffuse off of the device into the solution. This will cause the solution to turn orange
and will reduce the concentration of antibiotics on the device.
12. For non-InhibiZone treated components, submerge the empty cylinders and filled
pump into a kidney basin of sterile normal saline or sterile normal saline mixed with
an antibiotic solution.
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