User Training使用者培训FS 502 Step 5软件版本 A 2.007/2011© Echosens 2011. Tous droits réservés. Toute reproduction totale ou partielle sur quelque support que ce soit ou utilisation du contenu de ce document est interdite sans l’autorisation écrite préalable d’EchosensCONFIDENTIALLegal information 法律信息Legal information3[UTS FibroScan® 502.3] - Revision date [15/07/2012] - FibroScan® 502 is a class IIa medical device according to Directive EC/93/42 and is manufactured by Echosens. Assessment of its conformity with the essential requirements of the Directive EC/93/42 is established by the LNE-G-MED (France). FibroScan® is indicated for the non invasive measurement of liver stiffness (E) [and controlled attenuation parameter (CAP)] in human beings.It is expressly recommended to closely read the instruction of the users’ guide and labeling of the device. FibroScan® examination must be performed only by operator certified by the manufacturer or its accredited local representative. FibroScan® must not be used in the following situation: other organs but liver, patients with active implantable medical devices (such as pacemaker, defibrillators, pump, etc.), wound at the measurement point, pregnant women. Presence of ascites can prevent from obtaining valid measurements. The values obtained with FibroScan® must be interpreted by a physician experienced in dealing with liver disease, taking into account the complete medical record of the patients.In France, liver stiffness measurement by FibroScan® is included on the list of acts and services covered by the national Social Security medical insurance under the code HLQM002 and the following conditions. [UTS FibroScan® 502.3] - Revision date [15/07/2012] – 根据 EC...
