User manual
Version: v4.5.2
5.6.2 fusionTrack in a ME system
This section is provided as information only, the integrator
has to discuss and verify the fusionTrack integration with a
certification body.
If the fusionTrack is used as a component in a Medical Electrical system (ME system), the whole system
has to respect the 60601-1 standard in order to guarantee the safety of the operator and the patient:
- Requirements of the 60601-1 to provide
protection against electric shock
;
- Requirements of the 60601-1 regarding
touch current / enclosure leakage current
.
The standard for medical electrical equipment medical covers ME systems that are built as a combination
of – not necessarily medically certified – components. The safety of the whole ME system can therefore be
ensured when respecting the following points:
- A 60601 component can be combined with components that respects relevant safety standards but
not necessarily the medical 60601 standard
- The
total
touch current of the ME system has still to respect the 60601 standard (100 µA in NORMAL
CONDITION and 500 µA in SINGLE FAULT CONDITION).
ME system protection against electric shock using 60650-1 components
The fusionTrack can safely be connected to a non-medical(
PoE
+) power supply, a non-medical PC or a
nonmedical network. These non-medical elements have to respect the standard 60950-1 for information
systems.
The combination of a fusionTrack system on a system following IEC 60950-1 is respecting 2 MOPP.
This means that, as long as the computer or its peripherals (screen, mouse, keyboard) have not to be
considered as applied parts Type B (i.e. they are outside of the patient environment of 1
.
5 m / there is no
possible direct or indirect contact between the patient and this equipment), it is not mandatory to use a
medical grade (following IEC 60601-1) computer system, power supply or network; a commercial grade
computer system, power supply or network (following IEC 60950-1) is sufficient to guarantee the operator
and patient’s security regarding electric shock. It is however still necessary to also consider the touch
current.
ME system touch current / enclosure leakage current
It is mandatory that the
total ME system
respects the limits for the touch current.
60601-1 states (non-exhaustive list):
- In NORMAL CONDITION, the TOUCH CURRENT from or between parts of the ME SYSTEM within
the PATIENT ENVIRONMENT shall not exceed 100 µA.
- In the event of the interruption of any non-PERMANENTLY INSTALLED PROTECTIVE EARTH CON-
DUCTOR, the TOUCH CURRENT from or between parts of an ME SYSTEM within the PATIENT
ENVIRONMENT shall not exceed 500 µA.
There is no means to calculate or estimate the total touch current; it has to be measured. Even if all
individual components (medically certified and non-medically certified) respect the limits of 100 µA in NC
and 500 µA in SFC, the combination of several components is most likely to exceed the limits. In this case,
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