Mindray ZS3 - Product Labeling Information

ZS3 Instructions for Use
143 | P a g
21. Product Labeling
Contact Mindray if any of the labels are missing or damaged beyond legibility. The
ultrasound labels herein are for reference only and are not shown to scale.
With the ultrasound system, the L10-5 and L14-5sp transducers are classified as Type-CF
(Cardiac Floating). All other transducer types are Type-BF (Body Floating). Earlier
transducers labeled without these symbols are Type-BF. Type-CF is defined and regulated
by International Medical Equipment Safety Standard IEC 60601 as having the most stringent
of patient leakage current requirements. This classification is required for intra-o
perative
applications that may contact the heart.