SWISS TECH PROCEDURE MANUAL INFLATABLE PENILE IMPLANT ZSI 475 The best solution for erectile dysfunction For more information, visit WWW.ZSIMPLANTS.CH Zephyr Surgical Implants is ISO 13485 Implants are CE

PREPARATION OF THE PENIS, THE SCROTUM AND THE PELVIS FOR IMPLANTATION OF THE PENILE IMPLANT ZSI 475 1 The patient is placed in a supine position. Insert a 16 Fr Foley catheter. Perform a peno-scrotal incision. 5 Dilate the distal part of the corpus cavernosum with dilators from 10 mm to 13 mm using Hegar candles. 9 Prepare the scrotal pouch for the pump of the Penile Implant in the subdartos pouch. 2 Expose the tunica albuginea of both corpus cavernosum to achieve deep exposure of the proximal corpora. Make an incision in each area. 6 Dilate the proximal part of the corpus cavernosum with dilators...

PREPARATION OF THE CORPUS CAVERNOSUM PROSTHESIS AND THE PUMP 1 Supply and instruments requirements: A bowl + saline solution, A bowl + antibiotics, A 60 ml syringe, The cylindrical needle from the kit. 4 Repeat the procedure with the second inflatable distal part. 7 Place a clamp on the tubing, avoiding the return of air back into the assembled prosthesis. 2 Change gloves. Only the surgeon should touch the device. Open the kit. 5 Squeeze the pump to fill the assembled prosthesis with normal saline solution. 8 Minimize the time the device is in open air. Plunge the assembled prosthesis in antibiotics....

With the 60 ml syringe and the cylindrical needle, inject normal saline solution in the reservoir. Remove the air and the saline solution from the reservoir. Place a clamp on the tubing to avoid air returning in the reservoir. 3 Plunge the reservoir in antibiotics. The reservoir is ready to be implanted. PREPARATION OF THE NEEDLE AND THE INTRODUCER 1 Pass the thread into the hole of the distal part of the prosthesis. You do not need a needle. 4 Introduce the bottom of the needle and the thread in the introducer. Push with the spatula to introduce the needle completely. 2 Remove the needle. Repeat...

IMPLANTATION OF THE PENILE IMPLANT 1 Place the introducer into the corpus cavernosum. Push the needle through the glans penis with the piston. Pull up the needle and remove the introducer. Inject local antibiotics in the distal part of the corpus cavernosum. 5 Place the reservoir into the pelvis and the pump into the scrotum. Cut the thread and remove them. Inject local antibiotics in the proximal part of the corpus cavernosum. Fill the reservoir with a maximum of 80 ml. Introduce the prosthesis into the corpus cavernosum. First the proximal part, then the distal part. With the thread, pull up...

CHOOSE THE LENGTH OF THE CORPUS CAVERNOSUM PROSTHESIS 1 Three inflatable pairs of distal cavernous prosthesis are available: 13, 16 and 19 cm. 4 For length between 13 cm to 22 (19 cm + 3) use proximal extenders of 1, 2, 3 cm. 2 If a 12 cm is required : cut 1 cm of the proximal part of the cavernous corpus prosthesis at the mark. 5 For length over 21 cm, use distal extender of 1 or 2 cm. Turn the clap inside out. 7 Push back in place the flap, over the inflatable part. EXAMPLE Length of 17 cm: use the 16 cm inflatable distal part + 1 proximal extender of 1 cm. Length of 15 cm: use the 13 cm inflatable...

IMPLANTATION HIGHLIGHTS 1 Measure the length of the distal part and proximal part of the corpus cavernosum with the introducer/ruler. The threads are the reference line to take the measure. 4 Pass the two ends of the thread through the needle eye. 7 To ease the connection, soak the armed tubing, the connector and the rings into saline solution. 2 Pass the thread into the hole of the distal part of the prosthesis. You do not need a needle. 5 With the index finger, follow the spermatic cord to the inguinal space and pierce the transverse facia to reach the pelvis. Open a space for the reservoir....

Properly complete the patient information form and send it back to ZSI company in order to activate the guarantee for mechanical failure. Do not forget to stick the traceability label of the ZSI 475 you have implanted. Send us by email us the document at: [email protected] FAX COMPLETED FORM TO: +41 22 327 1027 ZSI 475/ ZEPHYR Surgical Implants rue du Conseil-Général 14, CH - 1205 Geneva. Switzerland [email protected] PATIENT INFORMATION FORM IMPLANT PENIEN ZEPHYR - FICHE D'INFORMATION SUR LE PATIENT / PENISIMPLANTAT ZEPHYR - PATIENTEN INFORMATIONSBLATT PROTESI DEL PENE ZEPHYR- MODULO...

SWISS TECH For more information, visit WWW.ZSIMPLANTS.CH