
MyLab
- G E T T I N G S T A R T E D
4 - 14
- Auxiliary device must be powered through a safety insula-
tion transformer complying to IEC 60601.
MyLab
+ auxiliary device not complying to IEC 60601 (com-
plying to IEC XXX
) in area B or area C connected by WiFi
or Ethernet cable
- No additional safety requirements.
MyLab
+ auxiliary device not complying to IEC 60601 in area
B or area C connected by cable (USB, HDMI,...)
- Auxiliary device must be powered through a safety insula-
tion transformer complying to IEC 60601.
Additional safety measures are:
Additional protective earth connection between the two
devices, or a safety insulation mains transformer for the aux-
iliary device
Do not connect a multiple-socket outlet or extension cord to
MyLab
.
Avoid touching the patient and the auxiliary device
simultaneously.
Additionally the IEC 60601 requires control measurement of leakage currents.
The system integrator (any person connecting the medical device to other devices)
is responsible that the connections are safe.
1.
IEC XXX stands for standards such as: IEC 60601 for medical devices,
IEC 60950 for information technology equipment etc.
Note
Auxiliary Devices must be approved by Esaote. Auxiliary Devices
must also comply with EN 60601-1-2 safety standard and
subsequent amendments or the electromagnetic compatibility.
Summary of Contents for 350009500
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