2.4.7.3
Current flowing from the enclosure or other parts, excluding patient connections, back to
ground through an impedance which simulates the impedance of the human body. This is
the leakage current that would flow through an individual's body should they "touch"
that part of the medical device. Enclosure leakage measurements are required to be
performed on parts of the enclosure that are not protectively earthed.
Enclosure leakage current can be measured by connecting P2 on the back of the Guardian
6100 Plus to any parts not protectively earthed. The leakage current is then measured
from P2 to earth ground through a human body model. The tests can be performed with
any of 4 different mains conditions. These conditions are:
All conditions can be performed with the ground switch S7 open or closed.
Operation
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Enclosure (Touch/Chassis) Leakage
Normal Mains (S5 DOWN position)
Reverse Mains (Hot and Neutral reversed) (S5 UP position, as shown)
Single Fault – Normal (Neural S1 open & S5 DOWN position)
Single Fault – Reverse (Hot and Neutral reversed with Neutral S1 open)
L(N)
T
2
Mains
V
V
2
N(L)
L(N)
T
1
Mains
V
V
1
N(L)
R
Figure 2-13a: Enclosure (Touch/Chassis) Leakage
(Figure 13 of 60601-1 © IEC 2000)
S
9
SIP/SOP
S
reverse
P
5
normal
P
S
1
S
P
10
S
P
7
i
MD1
S
P
12
150799 Rev A3
Resistor to limit current in
excess of 5mA
R
P
1
3
on DUT
1
5
MD2
1
1
FE
1
PE
Patient Probe #2
1
Attached to
enclosure
Page 87 of 177
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