3 SAFETY
It is extremely important to read the following definitions of WARNING information, prior to beginning
any service on any sub-system within the system. As you see applicability of each of these noted
WARNINGs, during the course of the servicing process, be prepared to avoid harm to persons and
equipment by proper adherence.
WARNINGS & Cautions
It is not possible for ZONARE to anticipate every condition and situation in which ZONARE 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 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 UL 60601 (Standard Medical Electrical Equipment, Part 1: General Requirements for Safety),
IEC 60601 (Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance), IEC 60601-2-37 (Medical electrical equipment - Part 2-37: Particular requirements for the safety
of ultrasonic medical diagnostic and monitoring equipment) 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 ZONARE’s
z.one
pro
Ultrasound System and compatible transducers.
Warnings
Do not remove any of the System covers other than the module cover. Other than the scan module
there are no user-serviceable parts internal to the system. Only trained ZONARE service personnel
should access the system’s internal electronics.
The ultrasound systems contain no operator-serviceable components within the enclosures. To avoid
electrical shock, do not remove covers. As with any other electrical equipment, always observe care
when operating this instrument. For service issues, contact Mindray Technical Support. Failure to
follow these restrictions may void your warranty or service contract coverage.
To reduce the risk of electric shock, DO NOT connect the z.one
pro
system input or output
connections to equipment that is not properly connected to an Earth ground
To achieve proper grounding reliability, the ultrasound system power plug must be fully inserted
into a receptacle marked “hospital grade.” Do not remove the grounding wire. If there is any
question of power outlet or power cord integrity, do not proceed. Obtain qualified assistance
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