Medical Information Technology Medical Information technology Information for manufacturers, resellers and users Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology Medical PC … definition A short trip into the world of electrotechnology Case study based on a room - plan Baaske Medical Products for electrical safety Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology A „Medical PC“ … . . . Is desinged to meet medical standards . . . is equipped with a medical approved power supply according to (IEC 60601-1 Safety) . . . is protected against electromagnetical interferences (EMI) ……(IEC 60601-1-2 EMC) . . . does not emit any electromagnetical interferences ……(IEC 60601-1-2 EMC) . . . is individually tested for IEC 601 in line production Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology … can be combined with active medical devices (new System) … no medical device according to MDD 93/42 EEC … allowed to be used in ‚patients environment‘defined …. in IEC 60601-1 Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology The ‚Patient Environment‘ is defined in IEC 60601-1:2006 Subclause 3.79 Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected] Patientenumgebung und Ableitstrom – DIN EN 60601

Medical Information Technology The Leakage Current Normal Condition Single Fault Condition (Protective Earth broken) Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Example for missing protective Ground Medical Information Technology Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Example for missing protective ground Medical Information Technology Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology Leakage Current in normal case (NC) 2. Applied Part Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology Leakage current in single fault condition (SFC) 2. Applied Part Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology Example: Medical electrical system (MES) Ethernet Patients Monitor Applied Part Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Medical Information Technology Resistance of the human body Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

Threshold levels for current conduction Medical Information Technology Threshold level unhand Ventricular level fibrillation level Example for the current conduction between hand and both feet for an adult person. The unhand level will be reached after a conduction Period of 10 seconds at 11 mA. Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske - Bacmeister Str. 3- 32312 Liibbecke - Phone (0 57 41) 236 270 - Email: [email protected]

Example: Stress ECG with bicycle ergometer Medical Information Technology Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

MES: Reducing current with Ethernet Isolation Medical Information Technology Ethernet Isolation Applied Part Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

MES: Reducing Current with Monitor Power Set Medical Information Technology Ehternet Isolation Patients Cable Set Office PC Applied Part Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]

MES: Reducing Current using a Medical PC Medical Information Technology Ehternet Isolation Applied Part Created by: Baaske Medical GmbH & Co.KG - Andreas Baaske – Bacmeister Str. 3– 32312 Lübbecke – Phone (0 57 41) 236 270 – Email: [email protected]