Appendix C Statement Of Manufacturer - Apex MD300M Bedienungsanleitung

MD300M
B.3 Clinical study details of MD300M Pulse Oximeter and its supporting M-50J033CS045
Oximeter probe
Table 6-3 ARMS Value Analysis Statement
Item 90--100
#pts 78
Bias -0.51
A 1.34
RMS
Bland-Altman Plot Graphic
PULSE OXIMETER
80--<90 70--<80
74 66
-0.41 1.56
1.49 2.36
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INSTRUCTION MANUAL

APPENDIX C Statement of Manufacturer

Guidance and manufacturer's declaration - Electromagnetic emission----
for all EQUIPMENT AND SYSTEM
1 Guidance and manufacturer's declaration- electromagnetic emission
The model MD300M Pulse Oximeter is intended for use in the electromagnetic
2 specified below. The customer or the user of the model MD300M Pulse Oximeter
should assure that it is such an environment.
3 Emissions test Compliance
RF emissions
4 Group 1
CISPR11
RF emissions
5 Group B
CISPR11
Harmonic
6 emissions IEC Class A
61000-3-2
Voltage
7 fluctuations/ Complies
IEC 61000-3-3
Guidance and manufacturer's declaration - Electromagnetic Immunity-
For all Equipment and Systems
Guidance and manufacturer's declaration- electromagnetic immunity
The model MD300M Pulse Oximeter is intended for use in the electromagnetic environment
specified below. The customer or the user of the model MD300M Pulse Oximeter should
assure that it is used in such an environment.
IEC 60601 test
Immunity test
level
Electrostatic
±6kV contact
discharge(ESD)
±8kV air
IEC 61000-4-2
Electromagnetic environment-guidance
The model MD300M Pulse Oximeter uses RF
energy only for its internal function. Therefore,
its RF emissions are very low and are not likely
to cause any interference in nearby electronic
equipment.
Electromagnetic
Compliance level
environment-guidance
Floors should be wood,
concrete or ceramic tile.
±6kV contact If floors are covered with
±8kV air synthetic material, the
relative humidity should be
at least 30%.
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MD300M