Mindray/Zonare systems meet IEC 60601-1, Class I powered equipment
requirements.
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 Mindray/Zonare ultrasound systems 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
Always make sure active preset is appropriate for study being performed
Know how to recognize acoustic artifacts in image
Consult AIUM recommended protocols & equipment specifications
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