The sensor is an applied part of Type BF. The interface ports of the SDM meet the
same requirements as the sensor port and are tested in an analogous manner.
The safety test is performed according to IEC 60601-1. The following connections must
be tested (while the SDM is switched on):
Protective Earth Resistance Test: Earth wire of the AC power cord, equipotential
terminal (ground,
see Figure 2 Rear Panel of the SDM
), gas bottle (Caution:
the container might be insulated from the thread by the color). The resistance
between two of these must be less than 0.2 Ω. Minimum current: USA = 1 A,
Europe = 5 A
Insulation Resistance Test: AC Power Connector – housing (equipotential
terminal). The resistance must be more than 2 MΩ
Patient Insulation Resistance: Sensor Connection Port (Ground) – housing
(equipotential terminal). The resistance must be more than 2 MΩ
Earth Leakage Current: The current must be below 500 A
Enclosure Leakage Current: The current must be below 100 A
Patient Leakage Current Test: Sensor Connection Port (Ground) and interface
(Ground of the Serial Data Port) – all other connectors. The current must be
below 100 A
If the above described functions do not operate properly, the SDM needs to be
repaired. Refer to
section 4.2.4 "SDM specific troubleshooting"
to further evaluate the
problem.
Check the AC power cord for damages of the isolation. Check the connectors for
damages.
The AC power cord must be tested when connected to the AC power outlet. Thereby
the cable must be swayed to detect potential cable breaks or loose contacts. The AC
power cord must be tested together with the Ground Integrity.
If the above specifications are not met, then the AC power cord needs to be replaced
by a new AC power cord from SenTec AG, see
section 8.2 “Testing Accessories and
Spare Parts”.
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