Safety - Mindray ZONARE z.one pro Instructions For Use Manual

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

According to the type of protection against electric shock: Externally powered
CLASS I + Internally powered EQUIPMENT

According to the degree of protection against electric shock: TYPE-BF APPLIED
PART and TYPE-CF APPLIED PART

According to the degree of protection against harmful ingress of water or
particulate matter:
– The main unit is classified as IPX0
– The probe is classified as IPX7
– The footswitch (can be used in the operating room) is classified as IPX8

According to the disinfection and sterilization method(s) recommended by
manufacturer: The devices recommended by the manufacturer.

According to the degree of safety of application in the presence of a
FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR
NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of a
FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR
NITROUS OXIDE.

According to the mode of operation: CONTINUOUS OPERATION

The device equipped with the applied part of defibrillation protection: The device
is not equipped with the applied part of defibrillation protection.

Permanently installed or non-permanently installed: Non-permanently installed
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
z.one pro Instructions
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