Oromed ORO-N6 BASIC - Device Classification and EMC Declaration; Device Classification Details; Electromagnetic Immunity Guidance

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1. Internally powered equipment; (supplied by AAA battery)
2. Type BF applied part;
3. IP21;
4. No Sterilize requirement;
5. Not category AP / APG equipment
6. Mode of operation: continuous
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Guidance and manufacturer’s declaration – electromagnetic immunity
The “Digital Blood Pressure Monitor ORO-N6 BASIC” is intended for use in the
electromagnetic environment specified below. The customer or the user of the “Digital
Blood Pressure Monitor ORO-N6 BASIC” should ensure that it is used in such an
environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
• ±6 kV contact
• ±8 kV air
• ±6 kV contact
• ±8 kV air
Floors should be
wood, concrete or
ceramic tile. If
floors are covered
with synthetic ma-
terial, the relative
humidity
should be at least
30 %.
Electrical fast
transient/burst
IEC 61000-4-4
• ±2 kV for power
supply lines
• ± 1 kV for input/
output lines
• ±2 kV for power
supply lines
• ± 1 kV for input/
output lines
Mains power
quality should be
that of a typical
commercial or
hospital
environment.
Surge
IEC 61000-4-5
• ± 1 kV differen-
tial mode
• ± 2 kV common
mode
• ± 1 kV differen-
tial mode
• ± 2 kV common
mode
Mains power
quality should be
that of a typical
commercial or
hospital
environment.