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INFLATABLE PENILE IMPLANT ZSI 475 MAGNETIC RESONANCE IMAGING

INFLATABLE PENILE IMPLANT ZSI 475 MAGNETIC RESONANCE IMAGING

INFLATABLE PENILE IMPLANT ZSI 475 MAGNETIC RESONANCE IMAGING

Product catalog summary
Objective: The study aimed to assess the compatibility of the ZSI 475 inflatable penile implant with MRI imaging, focusing on potential temperature increases due to its Inox 316 components. The study confirmed no risk of device destruction or patient scrotal burning, and no magnetic field attraction concerns.
Place: The study was conducted at the Department of Radiology, Polyclinique les Bleuets, Reims, France, on June 8th, 2012.
Material & Method: The MRI used was a PHILIPS ACHIEVA 1.5 Tesla. The penile implant was filled with normal saline solution and placed in a pot with 250 ml of ultrasound transmission gel. A phantom consisting of a 5 kg bottle of hydrophilic gel was used. Temperature measurements were taken using a WELCH ALLYN Suretemp Plus thermometer and a digital STIL thermometer, with a range of -50 to +200°C. The MRI protocol included prostate imaging lasting 15 minutes with sequences: Sagittal T2, Axial T1, Axial T2, and Coronal T2.
Magnetic Resonance Imaging Conclusion: The test concluded that patients with the ZSI 475 penile implant can safely undergo MRI. Zephyr Surgical Implants is ISO 13485 certified, and the implants are CE marked.
Result: No movement of the penile implant or the pot was observed during the MRI. The temperature of the ultrasound transmission gel remained at normal room temperature (19.9°C) as measured by the STIL thermometer, which was too low for the WELCH ALLYN Suretemp Plus thermometer. No changes or failures in the device's inflating and deflating functions were observed.
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Catalog excerpts

INFLATABLE PENILE IMPLANT ZSI 475 MAGNETIC RESONANCE IMAGING-1

INFLATABLE PENILE IMPLANT ZSI 475 Solution for erectile dysfunction MAGNETIC RESONANCE IMAGING June 2012 Dr Bruno HORNOY, radiologist. Department of Radiology, Polyclinique les Bleuets, 22-44 rue du colonel Fabien, Reims, France. Dr Christophe LLORENS, Urologist. Department of Urology, Polyclinique les Bleuets, 22-44 rue du colonel Fabien, Reims, France. OBJECTIVE Control the compatibility of the Penile Implant ZSI 475 (the device) with MR imaging. The concern is that the temperature of the device can increase because of the Inox 316 components (spring, ring and axle). There is no risk with the destruction of the device and the patient scrotal burning. There is no concern with the device to be attracted by magnetic fields. PLACE Department of Radiology, Polyclinique les Bleuets, 22-44 rue du colonel Fabien, Reims France. June 8th 2012. MATERIAL & METHOD • MRI: PHILIPS ACHIEVA 1,5 Tesla ; - Penile Implant ZSI 475 filled with normal saline solution. • A pot filled with 250 ml of ultrasound transmission gel: EKO-GELÉ. • A phantom consisting of a Bottle of 5 Kg of hydrophilic gel (the machine would interpret the glass as an error). • A thermometer WELCH ALLYN Suretemp Plus. - A digital thermometer STIL (CE ): - 50 to + 200°C. The device is placed in the pot filled with ultrasound transmission gel. The pot is placed in the MR imaging beside the phantom. MRI Protocol : Prostate, lasting 15 minutes with sequences: • Sagittal T2 ; - Axial T1 ; - Axial T2 ; - Co

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INFLATABLE PENILE IMPLANT ZSI 475 MAGNETIC RESONANCE IMAGING-2

RESULT Throughout the duration of the protocol, no movement of the penile implant in the pot, or the pot itself was observed. At the end of the MRI exam the temperature of ultrasound transmission gel in contact with the penile implant was at the normal room temperature: 19.9°C with the STIL thermometer. The temperature was too low for the WELCH ALLYN Suretemp Plus thermometer. No change of the device was observed. They were no failure in the device functioning: inflating and deflating function. CONCLUSION The test is conclusive. Patient with Penile Implant ZSI 475 can take MRI. Zephyr Surgical...

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