94 Electromagnetic compatibility statement
fabian Therapy evolution | SW 5.1.x
Ref: 121003.EN / Date 2020-01-22
Essential Performance Function
• Air/Oxygen Gas Supply Failure;
or
a technical alarm condition shall occur.
Measurement accuracy of the oxygen respiratory gas monitor (RGM) is
maintained within the IFU specification, ± (3% absolute);
or
Low and High Oxygen Level alarm conditions shall occur, as
appropriate;
or
a technical alarm condition shall occur.
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.
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.
201.11.8.101.1
201.12.4
201.13.101
18 Electromagnetic compatibility statement
NOTE:
fabian Therapy evolution is a MEDICAL APPLIANCE subject to specific precautionary
measures regarding EMC and must be installed and started up according to the notices
and the instructions in this manual.
WARNING:
Portable medical HF communication devices could impact fabian Therapy evolution.
WARNING:
NEVER use fabian Therapy evolution directly adjacent to, or stack with other equipments. If
unavoidable, be sure to monitor the equipment for proper operation with this set-up.
WARNING:
Using other accessories, cables or converters with fabian Therapy evolution could result in
increased electromagnetic interference and reduce the immunity of fabian Therapy
evolution.
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