f3649b49-dd42-450a-ac14-3e948fcb5e71UpdatePublished32023-11-032019-01-09In Commercial DistributionEAMITRI20700PrimaryHIBCCWi-3 ArmTRI2070TRI2070303655286AMI Agency for Medical Innovations GmbH1The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance gradual opening of the RAR window when mucopexy is performed, allowing the surgeon, the nurse or any assistant to comfortably hold the system in position. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary. truefalsefalsefalsefalsefalsetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse44311Noninvasive vascular ultrasound systemAn electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.falseActiveIYNSystem, Imaging, Pulsed Doppler, UltrasonicFHNLigator, HemorrhoidalStorage Environment Atmospheric PressureStorage Environment HumidityStorage Environment TemperatureHandling Environment Atmospheric PressureHandling Environment HumidityHandling Environment TemperaturefalsetrueMoist Heat or Steam Sterilization