CONTENTS
REVISION HISTORY………………………………………………………………………i-1
1. GENERAL...................................................................................................... 1-2
2. SAFETY ......................................................................................................... 2-2
2.1 Important Instructions for Safety ...................................................................................... 2-2
2.2 Electric installation.............................................................................................................. 2-3
2.3 Symbols Used ....................................................................................................................... 2-3
2.4 Remarks for Safe Use .......................................................................................................... 2-5
2.5 Environmental Conditions for Operation ......................................................................... 2-6
2.6 Instruction for Use............................................................................................................... 2-6
2.7 Biopsy Lines ......................................................................................................................... 2-7
2.8 ECG preamplifier (MAN) ................................................................................................... 2-7
2.9 Cleaning and Maintenance ................................................................................................. 2-8
2.10 Safety Test ............................................................................................................................ 2-8
2.11 Manufacturer Responsibility.............................................................................................. 2-9
2.12 Service Documents...............................................................................................................2-9
2.13 Basic Interaction between Ultrasound and Matter........................................................... 2-9
2.13.1 Bioeffects......................................................................................................................... 2-9
2.13.2 Intensities Measured in Water and Recalculated In Situ ............................................... 2-11
2.13.3 Derivation and Meaning of the Thermal and Mechanical Indices................................. 2-12
2.13.4 FDA-Limits for Acoustic Output and Bioeffects .......................................................... 2-15
2.13.5 Summary........................................................................................................................ 2-15
2.13.6 Display Accuracy of the Indices.................................................................................... 2-16
2.13.7 Recommendation to Use and for the Need for Following the ALARA Principle ......... 2-16
2.13.8 Notes for Acoustic Output Tables for Track 3 .............................................................. 2-17
2.13.9 Acoustic Measurement Uncertainties ............................................................................ 2-18
2.13.10 Acoustic Output Tables ................................................................................................. 2-18
2.14 3D Resolution and Sensitivity ........................................................................................... 2-19
2.15 Disposal............................................................................................................................... 2-19
3. DESCRIPTION OF THE SYSTEM ................................................................. 3-2
3.1 System Survey ...................................................................................................................... 3-2
3.1.1 Product Description ......................................................................................................... 3-2
3.1.2 Biological Safety ............................................................................................................. 3-3
3.1.3 Limitation Vectors ........................................................................................................... 3-3
3.1.4 Bioeffects......................................................................................................................... 3-4
3.2 Mechanical Design ...............................................................................................................3-4
3.2.1 System Configuration ...................................................................................................... 3-4
3.2.2 Mechanical Adjustment ................................................................................................... 3-5
Voluson
®
730Pro - Basic User Manual
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