Zeiss CLARUS 500 Instructions For Use Manual

Also see for CLARUS 500: Instructions for use

Contents

Instructions for Use 1 Safety and CertificationsCLARUS 500 1.4 Report Serious Accidents2660021165005 Rev. A 2017-08 15 / 144NOTE Connecting the device to a network that includes otherequipmentmay result in previously unidentified risks.u You are responsible for analyzing and controlling these risks.u You must reassess these risks when you make any changes tothe network, including connecting, disconnecting, or upgradingequipment.NOTE Unprotected devicesmay be at risk from unauthorized individuals.u Select and set the Password strength setting in the User man-agement screen.1.4 Report Serious AccidentsReport any serious incident related to this instrument, the operator,patient, or anyone else:• To the instrument manufacturer or distributor.• (European Union only) To the compentent authority in the statewhere the instrument operator is established.1.5 Essential PerformanceThe main clinical performance of the CLARUS 500 is to capture, dis-play and store images to aid in the diagnosis and monitoring of dis-eases and disorders occurring in the retina, ocular surface and visi-ble adnexa. Since there is are no surgical or treatment decisionsmade solely on data obtained by the instrument, it was determinedthat the CLARUS 500 has no “essential performance” as defined inIEC 60601-1 standard.1.6 Electromagnetic Compatibility (EMC)WARNING! Installing or putting the device into service without regard toEMC information providedmay void your Device warranty, result in damage to the instrumentand/or compromise safety for patients and operators.u CLARUS 500 has special EMC precaution requirements andneeds to be installed and put into service according to the EMCinformation provided herein.