
A-4
A.5 Signal Output
Item Specification
Applicable standards
Meet the requirements of EC60601-1 for short-circuit
protection and leakage current
Nurse call output
Driving mode Driven by relay
Electrical specification ≤60W, ≤2A, ≤36VDC, ≤25VAC
Isolation voltage >1500VAC
Working mode N/O or N/C (optional)
Sound output
Speaker
Issues alarm tones (sound pressure 45 to 85 dB), key tones,
pulse tones and audible temperature done prompt, supporting
Pitch Tone and multiple volume levels. Audible alarm signals
meet the requirement of IEC60601-1-8.
A.6 SpO
2
Specification
A.6.1 Mindray DS SpO
2
Specification
All SpO
2
sensors for Mindray DS SpO
2
Module specified in the section 10.1meets the
following specifications.
Item Specification
Measurement validation: The SpO2 accuracy has been validated in human studies against
arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are
statistically distributed, and only about two-thirds of the measurements can be expected to fall
within the specified accuracy compared to CO-oximeter measurements.
SpO
2
Measurement range 0 to 100%
Resolution 1%
Accuracy
70% to 100%:
70% to 100%:
0% to 69%:
(adult/pediatric, in non-motion conditions)
±3%(neonate, in non-motion conditions) *
Undefined
*Studies were performed to validate the accuracy of this monitor with neonatal SpO2 sensors by
contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age of
22 weeks to full term were involved in this study. The statistical analysis of data of this study
shows the accuracy (Arms) is within the stated accuracy specification. Please see the following
table.
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