Path medical Senti, User Manual

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Page 33 / 44
Do not use the device during the application of high-frequency surgical devices, cardiac
pacemakers, defibrillators or other electrical stimulators. This may result in burns at the
site of electrodes and possible damage to the applied parts.
Do not use the device in close proximity to shortwave or microwave therapy equipment
as it may produce instability in the applied parts.
If the device is used during surgery, the connectors must not touch conductive items
including ground.
When using the power supply unit Sinpro MPU16C-104 (protection class I), in order to
avoid risk of electrical shock, the power supply unit must only be connected to a supply
mains with protective earth.
Do not connect the label printer, RS232, or modem cable to the device during testing.
If a connection is established from the device to a standard PC which is powered through
the mains network, special precautions must be taken in order to maintain medical
safety. A standard USB cable can only be used if the connected PC is outside the patient’s
close range or if the PC is running on battery, is medically approved, or is powered via a
medically approved safety transformer. In all other cases, a galvanic separator must be
inserted in the USB connection.
8.4 Electromagnetic Compatibility
The use of Senti/Sentiero devices next to other electronic equipment or with other
electronic equipment in a stacked form should be avoided, as this could result in
improper operation (Senti/Sentiero: e.g. occurrence of unwanted noise). Electronic
equipment may include e.g. mobile phones, pagers, walkie-talkies, or RFID systems. If
such an application cannot be avoided, Senti/Sentiero and the other electronic devices
should be observed to make sure they are working properly. It may be necessary to
implement suitable corrective measures (e.g. new orientation or positioning of
Senti/Sentiero or shielding). Please also refer to section
10: Electromagnetic Compatibility
Information.
Portable radio frequency communications equipment (radio equipment) including their
accessories such as antenna cables and external antennas should not be used closer than
30 cm (12’’) to Senti/Sentiero and its accessories.
During testing it is recommended to keep low-power radio equipment (≤ 2 W) at a
distance of at least 3 m (118’’) from Senti/Sentiero and its accessories.
It is recommended to keep very strong sources of radio frequency emissions (e.g. high-
power transmitting antennas from radio or TV stations) at a distance of at least 2 km
(6560 ft.) from Senti/Sentiero (minimum required distance depends on signal power and
directional characteristics of the sender).
Failure to do so may result in a reduction of device performance.
Use of other accessories than the ones specified or provided by PATH MEDICAL may
result in higher electromagnetic emission or reduced immunity to interference of the
device and may result in improper device operation.