. All components are connected by kink-resistant tubing (KRT) . For warnings, precautions and contraindications please refer to the Instructions for Use provided on the AMS website at www . Figure 1-3. System Deflation amselabeling .com .
Coded Button Tube The MS pump is used with all types of AMS 700 Series cylinders . The single, black-striped tubing connects the pump to the reservoir . The pair of clear tubing connects the pump to the two penile cylinders .
700 lgx ms p wIth rosthesIs The AMS 700 LGX Preconnect with MS Pump components are configured as follows: • Pump and cylinders are available pre-connected and unconnected • Unconnected cylinder configuration has 30 cm of tubing • Infrapublic pre-connected package has 18 cm tubing connecting pump and cylinders • Preconnected-Penoscrotal configuration has tubing connecting...
The AMS 700 CXR prosthesis is designed for a patient with an anatomy that requires shorter and narrower cylinders . It is also useful for penile prosthesis re-implantation procedures . The AMS 700 CXR Prosthesis with MS Pump components are configured as follows: Figure 1-8.
It is intended for single use only. American Medical Systems sterilizes all of the components in the AMS 700 with MS Pump Product Line . The following tools are provided sterile in separate packages Under normal storage conditions, the components will • AMS Cavernotome...
9 SKW Retractor System (optional) systems or when all previously implanted components The AMS 700 with MS Pump Accessory Kit for the AMS are removed and replaced with new components . 700 with MS Pump Product Line contains the materials necessary for one implant procedure .
Operating Room Instructions (continued) quIpment reparatIon Unpacking the AMS Accessory Kit 1 . Remove the tray from the dust cover box in the operating room 2 . Have the scrub nurse remove the inner tray from outer tray, using appropriate sterile technique, and place inner tray on a sterile, lint free Mayo stand .
. Penoscrotal Approach It is also possible to implant all of the prostheses in the AMS 700 with MS Pump product line through a penoscrotal incision . If the prosthesis is preconnected, be certain the cylinder/pump package is labeled penoscrotal .
Surgical Procedures (continued) ncIsIon and Issect 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 .
Figure 4-5a. Penoscrotal: Dilate Figure 4-5b. Infrapubic: Dilate 2 . Measure each corpus proximally and distally using the Furlow Insertion Tool or AMS Measuring Tool slightly stretching the penis during this process . These measurements help the physician select cylinders and rear tip extenders that fit the patient’s anatomy .
• The proximal portion of the CXR cylinder is approximately 1 .5 cm longer than the CX and LGX cylinder . Sizing using Method A is recommended and will result in tubing exiting from the corporotomy . Except for the 1 .5 cm rear tip extender, the RTEs for the AMS 700 CXR cannot be stacked .
CAUTION: Do not place cloth towels on Mayo stand. They may transfer lint to the AMS components. 3 . When ready to prepare AMS components, open inner pouch and place them onto sterile, lint free Mayo stand . Note: The circulating nurse should record the part and serial/lot numbers as well as the size of the components of the PIF.
The AMS 700 CX Preconnect, CXR Preconnect and LGX Preconnect Penile Prosthesis cylinders and respective pumps are provided already connected . The only connection required of the surgeon is between the pump and reservoir . Once the surgeon has determined the proximal and distal lengths of the corpora cavernosa, choose the appropriate preconnect cylinder and pump from inventory .
Surgical Procedures (continued) repare onnected ylInders Once the surgeon has determined the proximal and distal lengths of the corpora cavernosa, choose a pair of appropriate length cylinders from inventory . Prepare the cylinders with sterile normal saline using a 15-gauge blunt tip needle and a 60 cc syringe by completing the following steps: 1 .
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Surgical Procedures (continued) CAUTION: Do not over aspirate to prevent air from being drawn into reservoir through its semi-permeable silicone elastomer. 7 . Holding syringe plunger up with thumb, clamp tubing (one notch only) 1 inch from the blunt needle tip using blue shod mosquito hemostat, and remove the 15-gauge needle and syringe .
(continued) nsert ylInders AMS has preplaced a traction suture through the distal tip of each cylinder . Depending on surgeon preference, either after or before inserting the cylinder into the crus, complete the following steps: 1 . Use the Furlow Insertion Tool (Figure 4-11) and Keith Needle to help introduce cylinders into the corpora cavernosa .
. Note: The reservoir tubing may be routed through the rectus fascia using the AMS Tubing Passer. When using AMS Tubing Passers, tubing should be placed on knobbed end of passer and passed through fascia.
(65 cc or 100 cc) . However, the Figure 4-16a. Infrapubic: Bluntly Dissect 100 ml AMS Conceal Low Profile Reservoir can be filled up to 100 ml to accomodate all cylinder sizes . 4 . Using the blue shod mosquito hemostat, re-clamp the reservoir tubing 1”...
. Note: If using mattress stitch, you may place the winged end of the AMS Reusable Closing Tool or the foot of the disposable Proximal Tool over the cylinder to protect it while suturing. Move the tool along incisions with each stitch to protect cylinder.
1 . Connect the component tubing using AMS Suture-Tie Connectors or AMS Quick Connect 1 . Place hemostat with blue shod on reservoir tubing . Sutureless Window Connectors, after the cylinders, reservoir, and pump are implanted and the 2 .
4 . Slide collet ring onto tubing (Figure 4-19a), making sure that teeth of collet ring face toward tubing end . Note: The AMS Quick Connect System cannot be resterilized. Conventional hospital sterilization will damage the connector Figure 4-19a. Slide Collet Ring Onto Tubing components.
1 . Cut the tubing (Figure 4-21) to fit the patient’s anatomy . 2 . All connections using AMS Suture-Tie Connectors are tied with 3-0 nonabsorbable polypropylene . Clamp the component tubing with blue shod mosquito tubing covered hemostats .
Surgical Procedures (continued) omplete Inal nflate eflate 1 . After all components are connected, completely inflate and deflate the cylinders at least once to ensure the device is functioning properly; to check the quality of the erection; and to evaluate flaccidity . Note: The erect penis should present a satisfactory cosmetic result.
• If the patient is unable to inflate the device and After 24 hours, remove the dressing . Support the penis you believe the tubing may be kinked, AMS on the abdomen for four to six weeks to obtain a straight recommends trying the pull-stretch technique: the erection .
. However, the 100 ml spherical and AMS Conceal Low Profile Reservoirs should always be used with the 18 cm and 21 cm AMS 700 LGX MS Pump cylinder sizes . Follow the applicable instructions for preparing the reservoir from the Component Preparation section of this manual .
Troubleshooting ylInders Problem What to Do Sized incorrectly • Redilate and remeasure. Remove cylinder and add or subtract rear tip extenders to adjust length . If unable to adjust length with rear tip extenders, remove cylinder and replace with cylinder of the appropriate size . Difficult to • Squeeze the deflation button to “reset” the lockout valve. Make the first pump bulb squeeze inflate quick and firm to activate the pump (you should feel a pop) . The remaining pump bulb squeezes can be slower .
21 cm 12 cm 14 cm AMS 700 CXR Inflates in girth 16 cm 18 cm *The 100 ml AMS Conceal Low Profile Reservoir can be filled up to 100 ml to accommodate all cylinder sizes . - 31 -...
Instructions for Use the tissue-contacting surfaces of the penile prosthesis . This for the AMS 700 with MS Pump Penile Prostheses with InhibiZone Antibiotic Surface Treatment innovation is InhibiZone and for the drugs rifampin (rifampicin) and intended to elute the antibiotics from the device surface minocycline HCl.
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Appendix (continued) indications, contraindications, warnings, precautions and potential adverse events . Rx Only . - 33 -...
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