14
Electromagnetic interference
The EM environment for this product is the home healthcare environment and
professional healthcare facility environment.
The essential performance of this product is the accuracy of SpO
2
and pulse rate
(SpO
2
Accuracy:
±
2% in the range of 70%-100% of SpO
2
, No definition for SpO
2
under 70%;Pulse rate: 25bpm~250bpm, accuracy:
±
1% or
±
1bpm(larger)).When
used directly near strong electromagnetic interference (for example: near mobile
phones, microwave ovens, etc.), it may be temporarily inaccurate. If so, please keep
the product away from interfering devices.
The finger pulse oximeter may exhibit temporary degradation of performance
(e.g.deviation from the performance indicated in the instructions for use during
IMMUNITY testing) and the finger pulse oximeter can recover from any interference
within 30 seconds without affecting basic safety or performance without operator
intervention.The following degradations, if associated with BASIC SAFETY or
ESSENTIAL PERFORMANCE shall not be allowed:
- component failures;
- changes in programmable parameters or settings;
- reset to default settings; and
- change of operating.
During measurement, The use of this equipment adjacent to or stacked with
other equipment should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
During measurement, portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the finger pulse oximeter, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
Test Summary
Test Reference
Standard
Test Item
Result(Pass or
Fail or N/A)
Emission Measurements
CISPR 11
Conducted Emission
N/A
CISPR 11
Radiated Emission
Pass
IEC/EN 61000-3-2
Harmonic Current Emissions
N/A
IEC/EN 61000-3-3
Voltage Fluctuations and Flicker
N/A