Mindray Zonare ZS3, Instructions For Use Manual

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ZS3 Instructions for Use 120 | P a g e
Support group for assistance with the ZPAK battery.
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Follow guidelines provided by relevant IEC standards when connecting peripherals.
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The USB thumb drive supplied by Mindray are the recommended brand, type, and sizes
for use in ZS3 Systems. They have been verified for optimum reliability and performance
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No modification of the system is permitted. Modifying the system may subject the operator
or patient to hazardous conditions.
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To reduce the risk of electric shock, do not connect the ZS3 input or output connections to
equipment that is not properly connected to an Earth ground.
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The ZS3 ultrasound system represents a potential explosion hazard if used in the
presence of flammable gases or oxygen rich environment.
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Use only transducers that are specifically approved and licensed for the ultrasound
system. If the proper identification of a connected transducer is not displayed on screen,
do not proceed with its use.
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Transducers covers may be contaminated and must be handled accordingly.
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Inspect the transducer and ZS3 System before each use. Inspect the transducer face,
housing, cable, connectors, and cases. Do not use the unit if damage is detected.
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Bent, broken, or missing pins on the transducer connector may cause poor image quality,
including possible mirror image artifact. Be sure to check pins before connecting
transducer to the ultrasound system. If pins are bent, broken, or missing, do not use the
transducer and call Mindray Technical Support.
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To avoid electrical shock, always unplug the ultrasound system AC power cord from wall
outlet before cleaning any part. Do not immerse the transducer past the specified
cleaning/disinfection level, as specified in Transducer Cleaning and Disinfection. Do not
immerse the transducer for longer than the specified cleaning/disinfecting time. Do not use
any transducer that has been immersed beyond the maximum limit or has been soaked
longer than the maximum specified time.
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Do not allow disinfectant to contact metal surfaces. Always use protective eyewear and
clothing when cleaning or disinfecting device
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Disinfectant wipes and topical spray products are not FDA cleared high-level disinfectants
and do not provide adequate protection should the transducer become cross-
contaminated.
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The transducer must be removed from patient contact before application of a high-voltage
defibrillation.
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The system is not intended for use in conjunction with high frequency (HF) surgical
equipment (tissue ablation devices). Do not use transducers connected to the ultrasound
system on patients while HF surgical devices are in use.
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If using relevant IEC standards compliant equipment that was not provided by
MINDRAY/ZONARE, it is required that total leakage currents be tested and validated to be
below the IEC 60601-1 limits in chapter 21.
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This equipment must only be connected to a supply main with protective earth.
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Validate that measured and calculated results shown in Calc Package reports reflect the
clinical observations.
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Auto-Dop Trace is intended to serve as an adjunct to the diagnostic process in evaluating
blood flow during PW Doppler examinations. When using the Auto-Dop Trace feature,
please
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Evaluate the results to verify that you are in agreement before committing the values to the
Calc Report Package.