Electromagnetic immunity
immunity test
electrostatic discharge (ESD)
IEC
power frequency (50/60 Hz) magnetic field IEC
radiated RF IEC
IEC 60601 | compliance level | electromagnetic environment - | |
test level | guidance | ||
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± 6 kV contact | ± 6 kV contact | There are no special requirements | |
± 8 kV air | ± 8 kV air | with respect to electrostatic | |
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| discharge.a | |
3 A/m | 3 A/m | Power frequency magnetic fields | |
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| should be at levels characteristic of a | |
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| typical location in a typical | |
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| commercial/hospital environment. | |
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| There are no special requirements for | |
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| environments. | |
10 V/m | 20 V/m | Portable and mobile RF | |
80 MHz to 2.5 |
| communications equipment should be | |
GHz |
| used no closer to any part of the | |
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| HeartStart, including cables, than is | |
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| absolutely necessary.b,c The | |
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| recommended separation distances | |
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| for various transmitters and the AED | |
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| are shown in the following table. | |
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| Interference may occur in the | |
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| vicinity of equipment marked | |
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| with the following symbol: |
Philips Medical Systems
NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a.Generally, AEDs are sometimes susceptible to interference generated by patient and/or responder motion in environments in which a high static electric field is present (e.g., low humidity, synthetic carpets, etc.). As a safety measure, Philips AEDs incorporate a patented method to sense possible corruption of the ECG signal by such interference and to respond by directing the user to stop all motion. In these cases, it is important to minimize movement in the vicinity of the patient during rhythm analysis in order to ensure that the signal being analyzed accurately reflects the patient’s underlying heart rhythm.
b.The ISM (industrial, scientific and medial) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
c.Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HeartStart is used exceeds the applicable RF compliance level above, the HeartStart should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as