WM 68401 04/2021
MEDUCORE Standard
2
EN 379
18 Technical data
18.12 Pulse oximetry monitoring
The statistical distribution of the measured values of pulse oximetry
sensors means that an average of two-thirds of all measurements
are within the ±A
rms
value of CO-oximeters as a reference method
(see table). To determine bpm accuracy, comparative
measurements were carried out with an original sensor and
original monitor.
Specification Pulse oximetry
SpO
2
display range 45 % to 100 %
Accuracy (for all the pulse oximetry sensors quoted in
these instructions for use)
70 % to 100 %: ≤ 2 %
45 % to 70 %: Not specified
Signal quality display Alarm output if SpO
2
signal quality is < 40 %
Pulse rate 30 bpm to 300 bpm ± 3 bpm at SpO
2
> 45 %
Reference methods for determining accuracy of pulse
rate
Oxitest simulator testing
Wavelengths at maximum intensity 660 nm/890 nm (2.5 mW to 4.5 mW)
Curve form Normalized
Feed rate for plethysmogram (display and printout)
12.5 mm/s
25 mm/s
50 mm/s
Update rate of SpO
2
mean
8 s (It may take up to 16 s for the correct SpO
2
value
to be displayed.)
Averaging 12 s
Delay in data updating 500 ms
Delay in alarm condition 20 s
Delay in alarm generation < 1 s
Functional oxygen saturation
The pulse oximetry sensor is calibrated to display
functional oxygen saturation, and must not be
calibrated with a function tester.
Biocompatibility
• The pulse oximetry sensor is latex-free. No
material used in its production contains latex
protein. The materials with which the patient
comes into contact have undergone extensive
biocompatibility tests. Further information is
available on request.
• Acc. to EN ISO 10993-10
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