Appendix B Clinical Study Summary - Apex MD300M Bedienungsanleitung

MD300M
According to the mode of operation.
Equipment not suitable for use in the presence of a flammable anesthetic mixture air or
with oxygen or nitrous oxide.
Note: the applied part of the device: the SpO
Box contents:
1. Three AA alkaline batteries.
2. One instruction manual
3. One adult finger probe: M-50E012CS09
4. One pediatric finger probe: M-50B008CS09 (optional)
5. One single use probe: M-50J033CS045 (optional)
6. Software CD
7. USB Cable
8. Adapter(optional)
PULSE OXIMETER
Continuous operation
probe.
2
- 28 -
INSTRUCTION MANUAL

APPENDIX B Clinical study summary

The following details are provided to disclose actual performance observed in the clinical
validation study of healthy adult volunteers. The ARMS value analysis statement and Bland-
Altman plot of data for MD300M and its supporting probes are shown as following:
B.1 Clinical study details of MD300M Pulse Oximeter and its supporting M-50E012CS09
Oximeter probe:
Table 6-1 ARMS Value Analysis Statement
Item 90--100
#pts 78
Bias -0.73
A 1.46
RMS
Bland-Altman Plot Graphic
B.2 Clinical study details of MD300M Pulse Oximeter and its supporting M-50B008CS09
Oximeter probe
Table 6-2 ARMS Value Analysis Statement
Item 90--100
#pts 78
Bias -0.10
A 1.19
RMS
Bland-Altman Plot Graphic
MD300M
80--<90 70--<80
74 66
-0.59 0.45
1.80 1.99
80--<90 70--<80
74 66
-0.31 0.03
1.40 1.82
- 29 -