Table of Contents
1 -
Operator Safety.............................................................................................1-1
Installation Requirements .......................................................................................1-1
Electrical Safety......................................................................................................1-1
Environmental Safety..............................................................................................1-2
Moving the Equipment ...........................................................................................1-2
Explosive Hazard....................................................................................................1-3
Transducers.............................................................................................................1-3
Biocompatibility and Infection Control ..................................................................1-4
Repetitive Strain Injury...........................................................................................1-4
Working with Video Display..................................................................................1-5
Safety Symbols .......................................................................................................1-5
2 -
Patient Safety.................................................................................................2-1
Electrical Safety......................................................................................................2-1
Electromagnetic Compatibility ...............................................................................2-2
Biocompatibility and Infection Control ..................................................................2-2
Ultrasound Safety....................................................................................................2-3
Glossary and Definition of Terms.........................................................................2-12
3 -
Devices Standards.........................................................................................3-1
Medical Device Directive .......................................................................................3-1
Medical Electrical Equipment Standard .................................................................3-1
Electromagnetic Compatibility ...............................................................................3-1
Biocompatibility .....................................................................................................3-1
Standards Summary Table ......................................................................................3-2
Acoustic Output ......................................................................................................3-2
Peripherals Standard Requirements ........................................................................3-2