20
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.
Immunity Test | IEC 60601 Test | Compliance Level | Electromagnetic Environment - |
| Level |
| Guidance |
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Electrostatic Discharge | ±6 kV contact | ±6 kV contact | Floors should be wood, concrete |
(ESD) | ±8 kV air | ±8 kV air | or ceramic tile. If floors are covered |
IEC |
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| with synthetic material, the relative |
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| humidity should be at least 30%. |
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Electrical Fast Transient/ | ±2 kV for power supply | ±2 kV for supply mains | Mains power quality should be |
Burst | lines | ±1 kV for input/output | that of a typical home or hospital |
IEC | ±1 kV for | lines | environment. |
| lines |
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Surge | ±1 kV differential mode | ±1 kV differential mode | Mains power quality should be |
IEC | ±2 kV common mode | ±2 kV for common mode | that of a typical home or hospital |
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| environment. |
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Voltage dips, short | <5% UT | <5% UT | Mains power quality should be |
interruptions and voltage | (>95% dip in UT) for 0.5 | (>95% dip in UT) for 0.5 | that of a typical home or hospital |
variations on power | cycle | cycle | environment. |
supply input lines | 40% UT | 40% UT |
|
IEC | (60% dip in UT) for 5 | (50% dip in UT) for 5 |
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| cycles | cycles |
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| 70% UT | 70% UT |
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| (30% dip in UT) for 25 | (30% dip in UT) for 25 |
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| cycles | cycles |
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| <5% UT | <5% UT |
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| (>95% dip in UT) for 5 sec | (>95% dip in UT) for 5 sec |
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Power frequency (50/60 | 3 A/m | 3 A/m | Power frequency magnetic fields |
Hz) magnetic field |
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| should be at levels characteristic of a |
IEC |
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| typical location in a typical hospital |
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| or home environment. |
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NOTE: UT is the a.c. mains voltage prior to application of the test level.