13
Setting up and starting up
If you have to use portable multiple sockets, attention must be paid to the following:
•
The portable multiple sockets must comply with IEC 60601-1.
•
The portable multiple sockets cannot be extended repeatedly.
•
Do not exceed the permissible nominal load of the multiple socket.
•
Only devices which are part of the medical system may be connected to the multiple
socket. Otherwise the leakage current could exceed the permissible limit.
PC to USB interface
The USB interface is electrically isolated and therefore complies with the requirements
of EN 60601-1.
If your PC does not comply with IEC 60601-1, please observe the following:
•
Your PC must comply with the IEC 60950 and the applicable EMC standards.
•
If your PC is positioned in the immediate vicinity of the patient then it must be pow-
ered via an isolation transformer which complies with the requirements IEC 60601-1.
CD player, active free field loudspeaker, printer
If other devices do not comply with IEC 60601-1,observe the following:
•
The devices must be powered via an isolation transformer or power supply unit
which complies with IEC 60601-1.
•
The devices must comply with EMC standards.
Connecting the system
1. Observe the notes in this chapter.
2. Connect the device.
3. Ensure that it does not present a tripping hazard e.g. cables, multiple socket etc.
4. Protect the connecting cables between the system components from mechanical
damage.
5.
Measure and document the leakage current on site. The leakage current must
comply with the following conditions (IEC 60601):
Housing leakage current from or between parts of the system within
the vicinity of the patient (Normal Condition).
< 0.1 mA
Housing leakage current from or between parts of the system within
the vicinity of the patient (Single Fault Condition).
< 0.5 mA
Patient leakage current (Normal Condition).
< 0.1 mA
6.
Measure and document the following values (IEC 62353):
Protective earth conductor resistance: Accessible conductive parts –
connector power cable to wall socket (including multiple distributor)
≤ 0.3 Ω
Housing leakage current: Accessible conductive parts, no protective
earth conn protective earth conductor
≤ 0.5 mA
