Guidance And Manufacturer's Declaration - Electromagnetic Emissions And Immunity - Progetti RESCIE SAM Manual De Instrucciones

20
7.1.5.1 Patient Analysis System Performance
Rhythm Class
Shockable Rhythm –
Ventricular Fibrillation
Shockable Rhythm –
Ventricular Tachycardia
Non-Shockable Rhythm
– Normal Sinus Rhythm
Non-Shockable Rhythm
– Asystole
Non-Shockable Rhythm
– All other non-
shockable rhythms
7.1.6 Guidance and Manufacturer's Declaration - Electromagnetic Emissions and
Immunity
Electromagnetic emissions
The RESCUE SAM is intended for use in the electromagnetic environment specified
below. The customer or the user of the RESCUE SAM should assure that it is used in
such an environment
Emissions Test
RF Emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations
IEC 61000-3-3
Sample
Performance
Size
220 >97%
165 >95%
130 99%
148 100%
219 >98%
Compliance
Group 1
Class B
not applicable
not applicable
RESCUE SAM User Manual vers.1.0 March 2011
Specifications
Meets the IEC60601-2-4:2004
Sensitivity > 90%
Meets the IEC60601-2-4:2004
Sensitivity > 75%
Meets the IEC60601-2-4:2004
Specificity >95%
Meets the IEC60601-2-4:2004
Specificity > 95%
Meets the IEC60601-2-4:2004
Specificity > 95%
Electromagnetic
environement
guidance
The RESCUE SAM uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The RESCUE SAM is suitable for use in all
establishments including domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes.