Contents
1 General Information.......................................................................................................1
1.1 Indications and Intended Purpose ..................................................................................1
1.2 Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3 Clinical Benefit....................................................................................................1
1.4 Continuous Operating Conditions ..................................................................................2
1.5 Environmental Conditions of Transport and Storage Between Uses .....................................................2
1.6 System Requirements..............................................................................................2
1.7 Help and Assistance...............................................................................................2
1.8 EMC Compliance .................................................................................................3
2 Safety and Security....................................................................................................5
2.1 Symbols..........................................................................................................5
2.2 Precautions.......................................................................................................6
2.3 Warnings.........................................................................................................8
2.4 Network Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5 Patient Privacy ....................................................................................................9
2.6 Guidance and Manufacturer’s Declaration – Electromagnetic Emission ................................................9
2.7 Technical Specifications ..........................................................................................13