HCEN12630 Revision 07.2015
Program version 1.xx
AK 98™ Dialysis Machine - Electrical safety inspection 217
9.5.2 PET for AK 98™ dialysis machine
Check no Description Measured
value
Approved
check
Check that the resistance between the protective
earth connection of the mains plug and...
1 ...the exterior cover of the power supply... ……. mΩ □
2 ...the heater rod... ……. mΩ □
3 ...the mounting plate for the suction pump, measure
on one of the screws,...
……. mΩ □
4 ...the mounting plate for the flow pump, measure on
one of the screws,...
……. mΩ □
5 ...the mounting plate to the safety couplings for the
dialysis fluid tubes...
……. mΩ □
6 ...the pressure regulator, PR1,... ……. mΩ □
7 ...the mounting plate to the water inlet/drain-nipples,
measure on one of the screws,...
……. mΩ □
8 ...the mounting plate to the external communication
port, measure on one of the screws,...
……. mΩ □
9 ...the mounting plate to the potential equalization
connector, measure on one of the screws,...
……. mΩ □
10 ...the potential equalization connector... ……. mΩ □
11 ...the heparin pump (rear plate)... ……. mΩ □
...does not exceed 300 mΩ.
9.5.3 ELT - Earth Leakage Current Test
Description Measured value Approve
d check
File the highest measured earth leakage current, normal
condition (N.C.) reading according to Section 9.4.3 “ELT” on
……. μA □
File the highest measured earth leakage current, single fault
condition (S.F.C.) reading according to Section 9.4.3 “ELT” on
……. μA □
9.5.4 PLT - Patient Leakage Current Test
File both the highest AC-reading and the highest DC-reading, when the machine is
running, according to Section 9.4.4 “PLT” on page215.
Description Measured
value
Approved
check
File the highest measured patient leakage current, normal
condition (N.C.) reading according to Section 9.4.4 “PLT” on
……. μA DC
……. μA DC
□
□
File the highest measured patient leakage current, single fault
condition (S.F.C.) reading according to Section 9.4.4 “PLT” on
……. μA DC
……. μA DC
□
□
Compare with the measured leakage currents at the last
1
ESI and evaluate if the
changes are approved or not for the next operational period of the machine. Write
notes here:
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