RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 6 of 61
2 Safety instructions
2.1 General safety instructions
Carefully read the whole instruction manual before using the NeuroSmart and ensure you are familiar
with device operation.
Avoid extended direct skin contact between the patient and the NeuroSmart’s housing.
Do not make changes or modifications to the device.
To guarantee the safety, reliability and performance of the system, the following instructions must
always be strictly observed:
• The NeuroSmart may only be operated by qualified medical personnel.
• Before using the NeuroSmart, you must be thoroughly familiar with the instruction manual.
• The NeuroSmart may only be operated with the specific adapter, see Section 3.2.2 Accessories.
• The NeuroSmart may only be used on a single patient at the same time.
• For the NeuroSmart’s mains operation, only choose a wall socket that can be reached without diffi-
culty if the adapter has to be disconnected from the wall socket
• The adapter is part of the medical device. To perform an all-pole disconnection of the NeuroSmart
from the supply network, pull the adapter out of the wall socket.
• Everyone who connects an accessory unit to the signal input or signal output configures a medical
system and is thus responsible for this system’s compliance with the requirements of IEC 60601-1.
• Under certain circumstances, when used simultaneously with other devices connected to the pa-
tient, interference can occur between the devices, which can also affect the measurement results.
• If the NeuroSmart is operated along with an electric surgical instrument, a measurement inaccuracy
as described in Section 6.4 can occur.
• Transducers or catheters not equipped with suitable safety measures to prevent the patient from
being burnt must be removed from the device before the use of electric surgical instruments.
• The NeuroSmart is authorised for use in conjunction with an electric surgical instrument. See also
Section 6.2.
• Using a defibrillator can result in temporary disruptions to the signal shape and readings. Normal
operation is continued 10 seconds after the defibrillation.
• Always contact the manufacturer first if questions about servicing arise. The manufacturer will pro-
vide you with a list of authorised service partners.
This document is for information only
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