Mindray Zonare ZS3, Instructions For Use Manual

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ZS3 Instructions for Use 118 | P a g e
16.
Safety
It is not possible to anticipate every condition and situation in which ultrasound system
will be used. The following warnings and cautions represent typical situations that
require special attention. User knowledge and experience with a specific application
and environment must also be taken into consideration in order to help ensure the
safety of personnel and equipment.
Safety Standards
All MINDRAY/ZONARE instruments, cables, and diagnostic ultrasound imaging
transducers have been designed to meet the essential requirements contained in
93/42/EEC (Medical Device Directive), and all appropriate requirements contained within
IEC 60601-1,
AAMI STD ES 60601-1, CSA STD C22.2 NO. 60601-1
(Medical electrical
equipment - Part 1: General requirements for basic safety and essential performance), IEC
60601
(Medical electrical equipment - Part 2-37: Particular requirements for the safety of
ultrasonic medical diagnostic and monitoring equipment),
IEC 60601-1-2(Medical
electrical equipment - Part 1-2: General requirements for basic safety and essential
performance Collateral Standard: Electromagnetic Compatibility),
and JIS-T-1501
(General Methods of Measuring the Performance of Ultrasonic Pulse-Echo Diagnostic
Equipment), including limits for current leakage and isolation from a primary power line.
Testing for compliance with the essential requirements of the Medical Device Directive
has been performed.
The following is a comprehensive list of the Warnings & Precautions associated with
the use of ZS3 Ultrasound System and compatible transducers.
Warnings
•
Do not use an aftermarket probe other than those specified by Mindray. The probes may
damage the system causing a profound failure, e.g. a fire in the worst case.
•
Accessory equipment (analog or digital) connected to the ultrasound system must comply
with the relevant IEC standards (e.g., IEC 60950 information technology equipment safety
standard and IEC 60601-1 medical equipment standard). Furthermore, all configurations
must comply with the standard IEC 60601-1. It is the responsibility of the person, who
connects additional equipment to the signal input or output ports and configures a medical
system, to verify that the system complies with the requirements of IEC 60601-1. If you
have any questions regarding these requirements, please consult your sales
representative.
•
When the wireless LAN function is turned on, the ultrasound system may suffer
interference from other equipment, even if that other equipment complies with CISPR
EMISSION requirements.
•
Keep at least 20 cm away from the ultrasound system when the wireless LAN function is in
use.
•
Do not connect or disconnect the system’s power cord or its accessories (e.g., a printer or
a recorder) without turning OFF the system power first. This may damage the system and