Contents
Operator’s Manual 11
E.4.2 MI/TI Display  .....................................................................................................E - 3
E.5 Acoustic Power Setting  .................................................................................................E - 3
E.6 Acoustic Power Control  ................................................................................................E - 4
E.7 Acoustic Output .............................................................................................................E - 4
E.7.1 Derated Ultrasonic Output Parameters  ...............................................................E - 4
E.7.2 Limits of Acoustic Output  ..................................................................................E - 5
E.7.3 Differences between Actual and Displayed MI and TI  ......................................E - 5
E.8 Measurement Uncertainty  .............................................................................................E - 6
E.9 References for Acoustic Power and Safety  ...................................................................E - 6
F Electrical Safety Inspection ............................................................................... F - 1
F.1 Power Cord Plug ............................................................................................................F - 1
F.2 Device Enclosure and Accessories  ................................................................................ F - 2
F.2.1 Visual Inspection ................................................................................................. F - 2
F.2.2 Contextual Inspection  ......................................................................................... F - 2
F.3 Device Labeling ............................................................................................................. F - 2
F.4 Protective Earth Resistance  ........................................................................................... F - 2
F.5 Earth Leakage Test  ........................................................................................................ F - 2
F.6 Enclosure Leakage Test ................................................................................................. F - 3
F.7 Patient Leakage Current  ................................................................................................ F - 3
F.8 Mains on Applied Part Leakage  .................................................................................... F - 4
F.9 Patient Auxiliary Current ............................................................................................... F - 4
G EMC Guidance and Manufacturer’s Declaration ..........................................G - 1
H Ultrasound Gel Heater ......................................................................................H - 1
H.1 Structure ....................................................................................................................... H - 1
H.2 Specifications ............................................................................................................... H - 1
H.3 Function and Requirement ........................................................................................... H - 2
H.4 Install the Heater  .......................................................................................................... H - 2
I Software and Hardware Specification  ............................................................... I - 1
I.1 Operating Environment  ................................................................................................... I - 1
I.2 Off-the-Shelf Software .................................................................................................... I - 1
I.3 Electronic Interface .......................................................................................................... I - 2
J Indications For Use  .............................................................................................J - 1