Search results for "Equipment Safety"
showing 4 items of 14 documents
Prospective, randomized, single-center trial comparing 3 different 10F plastic stents in malignant mid and distal bile duct strictures.
2003
Abstract Background: The aim of this study was to determine whether patency rates differ with respect to the material, design, and surface texture of 3 different plastic stents. Methods: A total of 120 patients (median age 70.5 years; interquartile range 62-78 years) with malignant mid or distal bile duct strictures, seen between March 1996 and May 1999, were prospectively randomized to receive a 10F polyurethane stent, a Teflon Tannenbaum stent, or a hydrophilic hydromer-coated polyurethane stent. The primary study outcome measure was the interval between stent insertion and the first episode of clogging (or the presence of jaundice at death without stent exchange). All 3 types of stent we…
A Monte Carlo study of intersource effects in dome-type applicators loaded with LDR Cs-137 sources
2005
In this study, the dose rate distributions produced by low dose rate Cs-137 sources loaded in afterloadable dome applicators are studied using the Monte Carlo method. Dose differences between Monte Carlo results and calculations done using the superposition principle are within 1-3% in front of the applicator and between 3 and 10% near and along the longitudinal source axis. Consequently, the real doses to lateral vaginal wall, rectum and bladder are very close to the doses estimated applying the superposition principle, while the dose to the vaginal cuff has been overestimated by up to 10%.
Assessment of a Modified Acoustic Lens for Electromagnetic Shock Wave Lithotripters in a Swine Model
2013
The acoustic lens of the Modularis electromagnetic shock wave lithotripter (Siemens, Malvern, Pennsylvania) was modified to produce a pressure waveform and focal zone more closely resembling that of the original HM3 device (Dornier Medtech, Wessling, Germany). We assessed the newly designed acoustic lens in vivo in an animal model.Stone fragmentation and tissue injury produced by the original and modified lenses of the Modularis lithotripter were evaluated in a swine model under equivalent acoustic pulse energy (about 45 mJ) at 1 Hz pulse repetition frequency. Stone fragmentation was determined by the weight percent of stone fragments less than 2 mm. To assess tissue injury, shock wave trea…
[Is ICD-programming for double intraoperative defibrillation threshold energy safe and effective during long-time follow-up? Results of a prospective…
1999
The aim of this prospective and randomized study was to evaluate the safety and efficacy of a reduced shock strength in transvenous implantable defibrillator therapy. So far clinical data concerning the safety margin of the shock energy in ICD therapy do not exist. The shock energy tested during long-term follow-up in this study was twice the intraoperatively measured defibrillation threshold (DFT). A total number of 176 consecutive patients representing a typical cohort of ICD patients were evaluated. All patients received a non-thoracotomy lead system (CPI, Endotak 0070, 0090) and a biphasic cardioverter-defibrillator with the ability to store episodes (Cardiac Pacemakers Inc., Ventac TM …