2.2.3.1 Environmental Limitations in Use (room climate)...............................................59
2.2.3.2 Heat Output........................................................................................................59
2.3 Equipment Classifications....................................................................................................59
2.4 IEC60601–1–2 Electromagnetic Standard Compliance & Documentation...........................60
2.4.1 General Scope.............................................................................................................60
2.4.2 Electromagnetic Emission...........................................................................................60
2.4.3 Electromagnetic Immunity...........................................................................................61
2.4.3.1 Electromagnetic Immunity..................................................................................61
2.4.3.2 Electromagnetic Immunity IEC 60601–1–2.........................................................62
2.4.3.3 Recommended Separation Distances for Portable and Mobile RF
Communications Equipment IEC 60601–1–2..............................................63
2.4.4 Limitations Management..............................................................................................63
2.4.5 Use Limitation..............................................................................................................63
2.4.6 Installations Requirements & Environment Control.....................................................64
2.5 Radiation Protection.............................................................................................................65
2.6 Audible noise........................................................................................................................65
2.7 Windows and curtains..........................................................................................................65
3 Structural Requirements................................................................................................................66
3.1 Room Size............................................................................................................................66
3.2 Door Size Requirements......................................................................................................66
3.2.1 Door Height..................................................................................................................66
3.2.2 Door Width...................................................................................................................66
3.3 Floor.....................................................................................................................................66
3.3.1 General Vascular GEMS Policy...................................................................................66
3.3.2 Floor requirements when using provided floor anchors...............................................67
3.3.3 Pan Type Floor Construction Requirement.................................................................68
3.3.4 Hole dimension and preferred location in concrete floor.............................................69
3.3.5 Water Pipe Requirements............................................................................................71
3.3.6 Seismic areas..............................................................................................................74
3.4 Ceiling...................................................................................................................................74
3.4.1 Rail Mounting...............................................................................................................75
Innova 2100-IQ, 3100/3100-IQ, 4100/4100-IQ Cardiovascular Imaging System Pre-Installation Manual
GE Healthcare Direction 5160944-13-1EN, Revision 2
Table of Contents 17
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