Electrical Safety
•
MINDRAY/ZONARE systems meet IEC 60601-1, Class I powered equipment requirements.
•
Mindray systems are rated for continuous mode of operation
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The ZS3 ultrasound system complies with the applicable medical equipment requirements
published in the European Norm (EN) and International Electronics Consortium (IEC)
Harmonized Standards.
•
The transducers, when used with the ZS3 system, are certified to be in compliance with IEC
60601-1 as Type BF or Type CF applied patient parts. Each transducer or port is labeled
accordingly.
Contrast Imaging
Cardiac rhythm disturbances during perfusion studies using gas ultrasound contrast agents
have been observed in the diagnostic range of MI values. See the Instructions for Use that
came with contrast agent being used for details.
Medical Ultrasound Safety - General
Anyone using the ultrasound system for human exams of any kind should thoroughly
understand the implications of such use. The American Institute of Ultrasound in Medicine
(AIUM) has published a document titled Medical Ultrasound Safety (AIUM 1994). ALARA is
an abbreviation for the principle of prudent use of diagnostic ultrasound by obtaining the
diagnostic information at a power output that is as low as reasonably achievable.
Diagnostic ultrasound is a technique-dependent imaging modality. To obtain the best
possible patient care from any ultrasound equipment, the system must be operated by
personnel trained in ultrasound image acquisition and interpretation. Users must become
familiar with each of their imaging systems.
•
Always make sure appropriate transducer is used for study being performed
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Always make sure active preset is appropriate for study being performed
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Know how to recognize acoustic artifacts in image
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Consult AIUM recommended protocols & equipment specifications.
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