Orphée F02-QAD-04_02 /14.01.2019 ADVISORY NOTE Date of sue 10 September 2018 Note number ND_1909_01 Product name and catalogue numer | Mythic 22 OT Lot number Not Applicable Expiry date ‘Not Applicable Issue description ‘The Software for Mythic 22 OT instrument was updated to version V3.2.2. New version of software introduces below changes: 1. Improvement of V2.10 cycle. In order to avoid any PLT rejections observed with LOW QC, the rinsing with diluent of the sensing zone of counting heads has been improved. The User Manual for Mythic 220T was updated to version V14. Additionally the communication protocol for C2 format for Mythic 22 was revised. Updated document contains particularly the new parameters transmission. Necessary actions 1. Download and update software for Mythic 220T. The new version — V3.2.2. is downloadable from ORPHEE- MEDICAL.COM website in distributors zone, haematology section, NEW-SoftwareVersionMYTHIC, M220T. 2. Download and read the content of new version User Manual V14. Document is downloadable trom ‘ORPHEE-MEDICAL.COM website in distributors zone, haematology section, Manuals, Users Manuals, Mythic 220T. 3. If necessary dowload the document with comunication protocol from ORPHEE-MEDICALCOM website in distributors zone, haematology section, Service Support, Communication protocol for Mythic fami Please provide this information to all Users of the above product and keep the Advisory Note as a quality system documentation. Please complete and return the attached Verification Form to confirm receipt of the Advisory Note. We apologize for any inconvenience caused by the above situation. Sincerely, xX Sait pn Sona Konic Hematology Product Merager