2042480-001 C Dash 2500 Patient Monitor 1-7
Introduction: Product Compliance
The SpO
2
parameter conforms to ISO9919 with the exception Sub-clauses
44.6 Ingress of liquids
WARNING
This clause identifies a use case of an oximeter used in an
operating room on top of an anaesthesia machine and the
possibility of the oximeter being wetted by IV or body fluids.
The the intended use for the Dash 2500 does not include the
operating room and it would not likely be expose to this
environment.
A basic level of fluid ingress including the 200ml spill test
prescribed in the standard has been established through
compliance with IEC60601-1-1988 standard, this establishes a
basic level of protection for the device. This risk has been
addressed in detail in the risk and hazard analysis document.
Do not allow fluids to come in contact with the Monitor. If fluids
are accidentally spilled on the Monitor, remove affected unit
from service as soon as possible. Contact GE Medical Systems
Information Technologies Technical Support to ensure there is
no compromise in electrical safety.
This product conforms with the essential requirements of the
Medical Device Directive 93/42. Accessories without the CE
mark are not guaranteed to meet the Essential Requirements
of the Medical Device Directive.
0459
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