Boston Scientific AMS Ambicor Mode D'emploi page 7

Sizing Method
Select the appropriate size cylinders and if needed, RTEs.
This method allows the tubing to exit directly from the corporotomy. Follow the formula
described below to select the appropriate cylinder length and number of rear tip
extenders. If necessary, extend the length of the corporotomy.
1. Calculate the Total Corporal Length (Distal + Proximal)
Example
Distal Corporal Length 11 cm
Proximal Corporal Length +8 cm
Total Corporal Length 19 cm
2. Subtract 2 cm from the Total Corporal Length to obtain an Adjusted Measurement.
Example
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 16 cm
4. Subtract the Selected Cylinder Length from the Total Corporal Length to determine
the length of rear tip extenders required to fit the patient.
Example
Total Corporal Length 19 cm
Selected Cylinder Length -16 cm
Rear Tip Extender Length 3 cm
Unpack the Device
NOTE: Do not open the prosthesis package until the surgeon dilates and sizes both
corpora cavernosa intraoperatively. The adhesive label at one end of the box and the
small, peelable labels on the foil pouches show the part and serial/lot numbers and the
size of the components. Record this information on and affix this label to the Patient
Information Form.
Keep the AMS Ambicor Device in the box until it is in the operating room.
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Remove the AMS Ambicor Penile Prosthesis from the Packaging
1. Remove the pouch from the box. Remove the inner fluid-filled foil pouch from the
outer pouch.
CAUTION: To avoid the possibility of cutting the AMS Ambicor Penile Prosthesis or
RTEs, do not open the package with scissors.
2. Place the sterile, fluid-filled foil pouch onto a sterile, lint free Mayo stand.
CAUTION: Cloth towels placed on the Mayo stand may transfer lint to the
AMS Ambicor Components.
3. Hold the foil pouch over a basin containing sterile normal saline. Carefully tear
the foil pouch at the side notch (Figure 4). Empty the AMS Ambicor Device, its
RTEs, and the fluid into the basin. Add sterile normal saline as needed to cover the
components in the basin (Figure 5).
Figure 4. Tear the pouch at the notch
NOTE: Do NOT leave the prosthesis exposed to air. Submerge the prosthesis in the
fluid from the foil pouch or in sterile normal saline immediately after removing it
from the foil pouch. Keep the prosthesis submerged until implantation to prevent air
from entering the device.
Figure 5. Empty the AMS Ambicor Device
and RTEs into the basin
4. Remove the tips of the AMS Ambicor Penile Prosthesis cylinders from the
protective end cushion.
5. Discard the end cushion.
6. Leave the device and RTEs in the basin until implantation.
Apply the RTEs if Needed
The RTEs are supplied in two stacks of four each in the following lengths:
(2) 0.5 cm, (2) 1 cm, (2) 2 cm, and (2) 3 cm RTEs (Figure 6).
Figure 6. RTEs: 0.5 cm, 1 cm, 2 cm, and 3 cm
1. Gently pull the RTEs apart (Figure 7).
The 0.5 cm RTEs are not stackable and if used, must be the last RTE placed on the
cylinders. The 1 cm, 2 cm, and 3 cm are stackable and can be combined in lengths
appropriate for the patient's anatomy. Stack the RTEs from longest to shortest on
the cylinder.
Figure 7. Gently pull the RTEs apart
2. Attach the RTEs to the proximal end of the cylinders using the same size RTEs on
each cylinder (Figure 8).
Figure 8. Attach the RTEs
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Black (K) ∆E ≤5.0