User's Guide

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Electromagnetic immunity – for all ME equipment and ME systems
Emissions test IEC 60601 test level Compliance Electromagnetic environment
Electrostatic
discharge(ESD)
IEC 61000-4-2
±8㎸ contact
±15㎸ air
±8㎸ contact
±15㎸ air
The Diabecare DANA-i should
not be affected by electrostatic
discharge that might occur
under normal conditions of use.
Electric fast
transient/burst
IEC 61000-4-4
±2㎸ for power
supply lines
±1㎸ for input/
output lines
Not
applicable
Not applicable
Surge
IEC 61000-4-5
±1 ㎸ line(s) to
line(s)
±2 ㎸ line(s) to
earth
Not
applicable
Not applicable
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
For 0, 5 cycles
40% UT
(60% dip in UT)
For 5 cycles
70% UT
(30% dip in UT)
For 25 cycles
<5% UT
(>95% dip in UT)
for 5 seconds
Not
applicable
Not applicable
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Emissions test IEC 60601 test level Compliance Electromagnetic environment
Conducted RF
IEC 61000-4-6
3 Vrms
150 ㎑ to 80 ㎒
Not
applicable
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Diabecare DANA-i
insulin pump, including cables,
than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance