natus XLTEK Protektor32, Инструкция по эксплуатации

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Instructions for Use XLTEK Protektor32
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When both a high-frequency surgical instrument and the electric stimulator are used for
the patient at the same time, there is a possibility that burns will result where the electrode
is applied or damage to the electrode used. Remove the electrode when you use a high-
frequency surgical instrument.
The output of the electric stimulation parts might be unstable when a shortwave or
microwave therapeutic instrument is close to the electrode. Turn off the power of the
electrical stimulator when using a microwave therapeutic instrument.
Stimulation limitations of the TcMEP modality
1. Energy limitation per pulse
50mJ per pulse on a 1000 Ohm Load (Safety requirement according to IEC60601-2-40 –
collateral standard)
2. Energy limitation per time period
Maximum = 100mJ per second distributed in maximum 9 pulses on a 1000 Ohm load.
Pulse Train Safety Limits
To prevent excessive delivery of stimulation to the patient, Protektor32 is set-up with specific conditions
for the relationship between the output voltage and number of pulses of stimulation. The Total energy
delivered to the patient by the Protektor32 TcMEP stimulator depends on the number of pulses per train
and the selected stimulation voltage.
The calculated energy the device will deliver to the patient is depicted in the following figure:
Energy Limitation vs. Allowable Settings
Settings outside the ranges depicted in the figure are not allowed by the device. If the set value is
exceeded, the Protektor32 function for limiting output is triggered.