4. Operational safety
User Manual – PhysioGo.Lite Electro page 14 / 96
Essential performance
For the PhysioGo.Lite Electro device, the essential performance means the generation of current and voltage
signals with frequencies, shapes and amplitudes corresponding to the waveforms recognized and used in this
therapy. Unidirectional (unipolar) and / or bidirectional (bipolar) currents are available.
The device meets the requirements of IEC 60601-2-10 standard, which specifies:
• maximum amplitudes of the output currents depending on the frequency of the waveform,
• permissible pulse energy,
• duty factor, pulse frequencies and amplitude tolerances.
4.8.1 Test of essential performance and basic safety
The user of unit must perform technical inspection of the unit at year’s intervals. The inspection must be
performed by a unit authorized by the manufacturer. The inspection is performed at the user’s expense.
Table 4.2. Essential performance and basic safety testing recommendations
Test item Method of checking Acceptance criteria
Required measuring
equipment
• patient leakage current
measurement,
• touch current measurement,
• insulation resistance if
the methods compliant
with the requirements of
the standards:
• IEC 60601-1
•
The measurement results are
within the limits specified by
the applied standard
Safety tester meeting
the:
• IEC 60601-1
• IEC 62353
requirements
Control of correctness of the
performed self-test
Visual inspection No errors No requirements
Evaluation of keyboard function
and operation
Manual and visual
inspection
The keys respond properly to
pressure
No requirements
Evaluation of touchscreen
function and operation
Manual and visual
inspection
The touch panel responds
correctly to pressing
No requirements
Inspection of the controller
condition for casing defects and
damage of sockets
Visual inspection
No deformation or cracks of
the casing
No requirements
Inspection of the patient cables
and connectors
Visual inspection
No tear and bending of cable
insulation
No requirements
Inspection of the SMPS condition
for casing defects and damage of
interconnecting cables and
connectors
Visual inspection
No deformation or cracks of
the casing
No requirements
No tear and bending of cable
insulation
Verification the accuracy of
current and voltage amplitudes
recommends to apply
methods compliant with
the requirements of the
Accuracy of time / frequency
parameters and the amplitude
is within ±20% tolerance
Oscilloscope, digital
multimeter, 500 Ω
reference resistor
Open circuit detection Visual inspection
Triggering of a bad contact
message in both channels
No requirements
The inspection must also include control over the quality of applied accessories and treatment materials.
Positive result of the technical inspection confirms that basic safety and essential performance is maintained.
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