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18.12 Pulse oximetry monitoring
Specification
SpO
display range
2
Accuracy (for all the pulse oximetry sensors quoted in
these instructions for use)
Signal quality display
Pulse rate
Reference methods for determining accuracy of pulse
rate
Wavelengths at maximum intensity
Curve form
Feed rate for plethysmogram (display and printout)
Update rate of SpO
mean
2
Averaging
Delay in data updating
Delay in alarm condition
Delay in alarm generation
Functional oxygen saturation
Biocompatibility
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
(see table). To determine bpm accuracy, comparative
measurements were carried out with an original sensor and
original monitor.
value of CO-oximeters as a reference method
Pulse oximetry
45 % to 100 %
70 % to 100 %: ≤ 2 %
45 % to 70 %: Not specified
Alarm output if SpO
signal quality is < 40 %
2
30 bpm to 300 bpm ± 3 bpm at SpO
Oxitest simulator testing
660 nm/890 nm (2.5 mW to 4.5 mW)
Normalized
12.5 mm/s
25 mm/s
50 mm/s
8 s (It may take up to 16 s for the correct SpO
to be displayed.)
12 s
500 ms
20 s
< 1 s
The pulse oximetry sensor is calibrated to display
functional oxygen saturation, and must not be
calibrated with a function tester.
•
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
MEDUCORE Standard
18 Technical data
> 45 %
2
value
2
2
EN
379
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