SWISS TECH PROCEDURE MANUAL MALLEABLE PENILE IMPLANT ZSI 100 FTM The best solution to use for erection after phalloplasty Zephyr Surgical Implants is ISO 13485 Implants are CE

SURGICAL PROCEDURE

PART 1: DESCRIPTION OF THE DEVICE DESCRIPTION OF ZSI 100 FTM STANDARD VERSION One cylinder adjustable from 200 mm to 130 mm. CENTRAL PART Cylinder of 20 mm in width. Designed for comfort and pleasant appearance. DISTAL PART Adjustable by cutting 5 mm by 5 mm. PROXIMAL PART 30 mm by 25 mm. Sutured onto the pubic bone. NARROW VERSION One cylinder adjustable from 220 mm to 130 mm. CENTRAL PART Cylinder of 20 mm in width. Designed for comfort and pleasant appearance. PROXIMAL PART 30 mm by 25 mm. Sutured onto the pubic bone. DISTAL PART Adjustable by cutting 5 mm by 5 mm.

SPECIFIC MATERIALS • Cold bistoury. • Electric cautery. • Scissors. • Pincers without teeth. • 2 Faraboeuf/Roux retractors. • 1 Foley catheter of 12 or 14 Fr. • One bowl filled with antibiotic: 500 ml saline solution + 600 mg Rifampicin + 640 mg Gentamicin. • One 60 ml syringe with conical tip for antibiotics. • Hegar dilators from 10 to 18. • Strong non-absorbable suture of 0 or 1 with strong and short needle to suture the prosthesis to the pubic bone. Patient lays on the operating table with legs stretched. Approach from right side when vascularisation of phalloplasty comes from the left. Approach...

PREPARATION OF THE NEOPENIS FOR IMPLANTATION OF PENILE IMPLANT ZSI 100 FTM 1 Inject Betadine into the urethra. Place a 12 or 14 Fr Foley catheter. (+ Refer to the note 1 next page). Incisions lateral to the penis and scrotum. Pull the skin with Farabeuf or Roux retractors to expose the central pubic bone. Perform an incision of the tissue over the pubic bone and... (+ Refer to the note 3 next page). 4 ...remove it to be in contact with the bone periost. The bone periost is white in colour. Start dilatation with scissors. (+ Refer to the note 5 next page). Then perform a dilatation with Hegar...

If it is difficult to insert the Foley catheter (due to stricture) with no possibility of reaching the bladder, suture the Foley catheter to the glans. Be careful with the neourethra. The Foley catheter will help locate the urethra. The most difficult passage is the anastomosis of neopenis with pubis skin. After the anastomosis passage, it is easier to dilate as it is fat only. Dilate with care as neopenis tissue is fragile. Never dilate up to the top of the neopenis. Always maintain a 0.5 cm to 1 cm space between the top of neopenis and the dilators. This “cushion of fat” will reduce the risk...

PART 3: PREPARATION OF THE DEVICE Cut the implant ZSI 100 FTM to the correct length: the length of neopenis measured + the length of the pubic surface cleared measured. Place the glans on the implant. And place the implant ZSI 100 FTM into antibiotics. PART 4: INSERTION OF THE DEVICE 1 Introduce ZSI 100 FTM into the neopenis. 2 Pass the needle through the metallic frame and suture the proximal part of the prosthesis to the pubic bone. 3 Close the lateral incision. Keep the catheter 24h. 6

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