Guidelines And Manufacturer's Declaration - Electromagnetic Emissions - Primedic HeartSave AED Operating Instructions Manual

Guidelines and manufacturer's declaration – Electromagnetic emissions
False positive rate
= Number of "incorrect shockable" algorithm decisions
Total number of ECGs in which a shock is not clinically recommended
Positive predictive value
= Number of "correct shockable" algorithm decisions
Total number of ECGs where the device recommends VF shock therapy
13 Guidelines and manufacturer's declaration –
Electromagnetic emissions
for PRIMEDIC
HeartSave)
The PRIMEDIC TM HeartSave is designed for use in an environment as described below. The customer or user of the
PRIMEDIC TM HeartSave should ensure that the device is only used in an environment of this kind.
Emitted interference measurements
HF emissions according to CISPR 11
HF emissions according to CISPR 11
HF emissions according to CISPR 11
Emission of harmonics according to
IEC 61000-3-2
Transmission of voltage fluctuations
/ Flicker according to IEC 61000-3-3
HeartSave AED / AED-M, 21212 / GB / E02
TM
HeartSave AED/AED-M (in the following referred to as PRIMEDIC
Conformance Electromagnetic environment - code of practice
Group 1 The PRIMEDIC
internal function. This means that its HF emission is very low
and it is unlikely that electronic devices in the vicinity are
disrupted.
Group 2 The PRIMEDIC
energy to warrant its intended function. Neighbouring
electromagnetic devices could be influenced.
Class B
n/a for battery /
The PRIMEDIC
TM
PRIMEDIC
including those in residential areas and those which are in the
battery pack
immediate vicinity of a public supply network which also
n/a for battery /
supplies buildings that are used for residential purposes.
PRIMEDIC TM
battery pack
TM
TM
HeartSave only uses HF energy for its
TM HeartSave has to emit electromagnetic
TM HeartSave is suitable for use in all locations
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