Manual Temperature Input; Masimo Set Spo Measurement - Seca mVSA 535 Instructions For Use Manual

Manual temperature input

Device versions
Measuring methods
Temperature range
Masimo SET SpO measurement
®
2
Measurement
Measuring method
LED wavelength:
Red
Infrared
Maximum light output
This information may be of particular interest to clinicians
Measuring time:
• Device switched on, sensor not applied
• Device switched off, sensor applied
Measuring range:
• SpO
2
• Pulse rate
• Perfusion index
Measuring accuracy:
• Measuring range
• SpO (no patient movement)
2
• SpO (patient movement)
2
• Pulse rate (no patient movement)
• Pulse rate (patient movement)
Low perfusion performance
• Pulse amplitude
• Transmission
• Oxygen saturation (SpO
• Pulse rate
Resolution:
• Oxygen saturation (SpO
• Pulse rate
IEC 60601-1: Medical electrical device, type BF
a.The accuracy of the Masimo SET
with induced hypoxia on healthy adult male and female volunteers with light to dark skin pigmentation in the range from 70
– 100 % for SpO compared to a laboratory CO oximeter and ECG monitor. This fluctuation corresponds to ± 1 standard
2
deviation. Plus or minus one standard deviation covers 68 % of the population.
b.The accuracy of the Masimo SET
with induced hypoxia on healthy adult male and female volunteers with light to dark skin pigmentation, 2 to 4 Hz rubbing and
tapping movements being performed at an amplitude of 1 to 2 cm and a non-repetitive movement being performed at 1 to
5 Hz at an amplitude of 2 to 3 cm in the range from 70 – 100 % for SpO
monitor. This fluctuation corresponds to ± 1 standard deviation and thus covers 68 % of the population.
c.The accuracy of the Masimo SET
Biotek Index 2™ simulator and the Masimo simulator with signal strengths of over 0.02 % and a transmission of over 5 % for
saturations in the range from 70 to 100 %. This fluctuation corresponds to ± 1 standard deviation. Plus or minus one standard
deviation covers 68 % of the population.
Manual temperature input
General technical data
Masimo SET
®
)
2
)
2
®
technology with Masimo sensors was validated with no movement in human blood studies
®
technology with Masimo sensors was validated with movement in human blood studies
®
technology in the case of poor perfusion was validated on the test bench compared to a
a b c d e f g
SpO module
2
compared to a laboratory CO oximeter and ECG
2
Versions without integrated
temperature measurement
Oral, axillary, rectal,
in-ear, on the skin, contactless
32 °C – 44 °C (89.6 °F – 111.2 °F)
Functional oxygen saturation
Spectrophotometry (red/infrared)
≤ 12 sec
0 % – 100 %
25 min – 240 min
-1
0.02 % – 20 %
70 % – 100 %
70 % – 100 % ± 2 digits
0 % – 69 % not specified
70 % – 100 % ± 3 digits
0 ‰ – 69 % not specified
25 min – 240 min ± 3 digits
-1 -1
25 min – 240 min ± 5 digits
-1 -1
> 0.02 %
± 2 digits
± 3 digits
Technical data • 97
English
660 nm
905 nm
15 mW
≤ 8 sec
-1
h
> 5 %
1 %
1 min
-1