Electromagnetic Compatibility; Iec 60601-1-2; Essential Performance In Emc - GE CARESCAPE ONE User Manual

CARESCAPE ONE User Manual DRAFT 26 October 2017

Electromagnetic compatibility

IEC 60601-1-2

The system complies with IEC 60601-1-2:2007-03.
According to parameter-specific IEC 60601-2-x series standard requirements for ESU
(electrosurgical unit) tests, the equipment is protected against malfunction caused
by electrosurgery.

Essential performance in EMC

Parameter
Essential performance
General No loss of display or user settings.
●
No loss of patient data, mode of operation, or stored data during loss of AC mains
●
or battery power > 10 s.
No invalid or erroneous alarms.
●
Ability to generate a technical alarm during abnormal operation.
●
ECG
No false beat detection that produces an incorrect heart rate measurement greater
●
than ± 10% or ± 5 bpm, whichever is greater.
No waveform amplitude error > 20%.
●
Impedance No error in respiration rate greater than ± 1 breath per minute.
●
respiration
Invasive blood No invasive pressure error greater than ± 4% of reading or ± 0.5 kPa (± 4 mmHg),
●
pressure whichever is greater.
Temperature
No errors in temperature readings > 0.3° C.
●
CO (RGM) No error in CO
●
2
level set between 71-100 mmHg..
No change in respiration greater than ± 1 breath per minute.
●
CO
●
SpO : GE TruSignal, No errors in pulse rate greater than ± 2 bpm for GE TruSignal SpO
●
2
Nellcor, Masimo ± 3 bpm for Nellcor and Masimo SpO
No error in saturation greater than ± 4%.
●
Non-invasive blood No error for the measurement of the cuff pressure greater than ± 2 mmHg (± 0.3 kPa).
●
pressure
Defibrillator sync Time delay from peak of ECG R-wave to synchronization pulse ≤ 35 ms.
●
marker output
2094480-001
greater than ±(volume fraction of +8% of Gas Level) with the gas
2
flow rate < 60 ml/min.
2
CARESCAPE ONE
.
2
J
or greater than
2
387