RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 5 of 61
1 General information
The RAUMED NeuroSmart (called the NeuroSmart for short) is available in two different hardware ver-
sions (REF 095284-001 and REF 095294-001). An additional feature of hardware version REF 095294-
001 (NeuroSmart logO) is oxygen partial pressure measurement. The hardware version without an ox-
ygen partial pressure measurement function has the item number REF 095284-001 and is referred to
as the NeuroSmart. Both hardware versions are described in the instruction manual when the Neu-
roSmart is referred to.
1.1 Intended use
The NeuroSmart is a diagnostic device and is used for monitoring up to four invasively measured phys-
iological pressures and up to two patient temperatures (with alarm function). In addition to measuring
and monitoring the aforementioned vital parameters, the NeuroSmart offers long-term storage of the
readings. The NeuroSmart may only be used on a single patient at the same time.
The intended use of the NeuroSmart is based on the application part:
• As part of the transdermal telemetric system readP, the NeuroSmart is a monitoring device with an
alarm function for data logging and data storage of physiological invasive pressure. In the process,
pressure is measured by the NEUROVENT-P-tel.
• In conjunction with RAUMEDIC catheters for single-channel ICP measurement or RAUMEDIC multi-
parameter catheters for combined ICP, temperature and oxygen partial pressure measurement, the
NeuroSmart is a diagnostic tool with alarm function for displaying and recording the data of physio-
logical invasive parameters. Display of oxygen partial pressure is only possible with hardware version
REF 095294-001 (NeuroSmart logO). Furthermore, external transducers can also be used for inva-
sive pressure measurement.
Invasive pressure measurement and temperature measurement are essential features of the device.
Optionally, up to two pressure signals can be forwarded via the two analog outputs to a bedside monitor
with limit value monitoring. The Rec, USB, and PC interfaces are available for transferring additional
readings. See Figure 1 and Table 4.
1.2 Operational environment
The NeuroSmart is intended for use by trained medical professionals in a clinical environment. The
device can be either stationary or mobile while being operated during transport in a hospital. For tele-
metric use of the NeuroSmart, its use is limited to stationary area.
It is used by doctors, intensive care nurses and medical engineers. The device is not intended for use
outside a hospital, such as operation in a domestic environment, medical practices, helicopters or am-
bulances.
1.3 Indications
If the doctor considers it necessary, the NeuroSmart can be used to measure and monitor several phys-
iological parameters such as invasive pressure and temperature.
1.4 Contra-indications
Please be aware of the following contra-indications when using the NeuroSmart:
• The NeuroSmart is contra-indicated for use in CT or MRI and must not be operated in a
corresponding environment.
This document is for information only
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