ACUTRONIC fabian +nCPAP evolution - Page 136

128 19 Technical specifications
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
#
Essential Performance Function
Standard
Clause
Measurement accuracy of the SpO
2
monitor is
maintained within the IFU specification only within the
range 70 to 100%:
± 2% pediatric patients, no motion conditions;
± 3% pediatric patients, motion conditions, and all
neonatal patients;
or
Low and High SpO
2
Level alarm conditions shall occur,
as appropriate;
or
a technical alarm condition shall occur.
208.6.1.2.101
201.11.8.101.1
201.12.4
201.13.101
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