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ACUTRONIC fabian
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97 17 Technical specifications
fabian Therapy evolution | SW V5.1.x
Ref: 121003.EN / Date: 26Jan2021
#
Essential Performance Function
Standard
Clause
Measurement accuracy of the pulse rate from the SpO
2
monitor is maintained within the IFU specification
within the range 25 to 240 bpm:
± 3 bpm (no motion conditions); or
± 5 bpm (motion conditions);
or
Low and High Pulse Rate alarm conditions shall occur,
as appropriate;
or
a technical alarm condition shall occur.
ISO 80601-2-61:
2017
201.12.1.104
208.6.1.2.101
201.11.8.101.1
201.12.4
201.13.101

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