RAUMEDIC NeuroSmart User manual

RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 1 of 61
Instruction manual
RAUMED®NeuroSmart®
REF 095284-001 and
RAUMED®NeuroSmart®logO
095294-001
Edition with GUI Revision g3.22.
This document is for information only

RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 2 of 61
Table of contents
1General information.......................................................................................................................... 5
1.1 Intended use............................................................................................................................ 5
1.2 Operational environment ......................................................................................................... 5
1.3 Indications................................................................................................................................ 5
1.4 Contra-indications.................................................................................................................... 5
2Safety instructions............................................................................................................................ 6
2.1 General safety instructions...................................................................................................... 6
2.2 Instructions for cyber and data security................................................................................... 7
2.3 Safety symbols on the device.................................................................................................. 8
2.4 Safety symbols on the packaging............................................................................................ 9
3Operation.......................................................................................................................................... 9
3.1 Operating functions ................................................................................................................. 9
3.1.1 Main operating functions ..................................................................................................... 9
3.1.2 Important operating functions.............................................................................................. 9
3.2 Start-up.................................................................................................................................. 10
3.2.1 Connection diagram........................................................................................................... 10
3.2.2Accessories ....................................................................................................................... 11
3.3 Operating concept ................................................................................................................. 12
3.3.1 Views in the main display area.......................................................................................... 13
3.3.2 Status area ........................................................................................................................ 16
3.3.3 Menu area.......................................................................................................................... 16
3.3.4 Commonly occurring soft keys .......................................................................................... 17
3.4 Starting a measurement ........................................................................................................ 18
3.4.1 Prepare invasive pressure measurement.......................................................................... 19
3.4.2 Measuring position selection ............................................................................................. 19
3.4.3 Conventional zeroing......................................................................................................... 19
3.4.4 Start telemetric measurement (ICPT)................................................................................ 20
3.5 Adjusting the settings / installing the NeuroSmart................................................................. 22
3.5.1 General adjustment of settings.......................................................................................... 22
3.5.2 Setting the date/time.......................................................................................................... 27
3.5.3 Graphic setting................................................................................................................... 28
3.6 Alarm system......................................................................................................................... 29
3.6.1 Operator settings (Admin) ................................................................................................. 32
3.6.2 Setting physiological alarm limits....................................................................................... 33
3.6.3 Technical alarms................................................................................................................ 37
3.7 Analogue forwarding of measured parameters ..................................................................... 38
This document is for information only

RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 3 of 61
3.7.1 Making signal connections with follow-on devices ............................................................ 38
3.7.2 Forwarding pressures and temperature ............................................................................ 39
3.8 Expanded parameters ORx, PRx, CPPopt............................................................................ 40
3.8.1 Calculation methodology for PRx, ORx and CPPopt ........................................................ 41
3.8.2 Set the calculation of PRx, ORx, CPPopt.......................................................................... 42
3.8.3 View expanded parameters............................................................................................... 43
4Error messages and troubleshooting ............................................................................................. 44
4.1 Information if an error occurs................................................................................................. 48
5Cleaning and care .......................................................................................................................... 49
5.1 Cleaning the NeuroSmart...................................................................................................... 49
5.2 Cleaning, disinfection and sterilisation of the cables............................................................. 49
5.2.1 Cleaning............................................................................................................................. 49
5.2.2 Disinfection ........................................................................................................................ 50
5.2.3 Sterilisation ........................................................................................................................ 50
5.3 Cleaning the adapter ............................................................................................................. 50
6Electromagnetic compatibility......................................................................................................... 51
6.1 Measuring accuracy under the influence of electromagnetic disturbance phenomena ........ 51
6.2 General information about electromagnetic compatibility ..................................................... 51
6.3 Electromagnetic emissions.................................................................................................... 52
6.4 Electromagnetic immunity ..................................................................................................... 53
7Inspections, safety and measurement checks............................................................................... 54
7.1 Safety check (SC).................................................................................................................. 54
7.2 Measurement check (MC) ..................................................................................................... 54
8Technical Parameters (Specification) ............................................................................................ 55
8.1 Technical data ....................................................................................................................... 55
8.2 Ambient conditions ................................................................................................................ 58
8.2.1 Operating conditions.......................................................................................................... 58
8.2.2 Storage conditions............................................................................................................. 58
8.2.3Transport conditions.......................................................................................................... 58
9Environment and disposal.............................................................................................................. 59
10 Liability and warranty................................................................................................................. 59
11 Appendices................................................................................................................................ 60
This document is for information only

RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 4 of 61
Abbreviations used
Table 1: Abbreviations
Abbrevia-
tion
Explanation
ICP
Intracranial Pressure
ART
Arterial Blood Pressure
CVP
Central Venous Pressure
CPP
Cerebral Perfusion Pressure
CPPopt
Optimal Cerebral Perfusion Pres-
sure
PRx
Pressure Reactivity Index
ORx
Oxygen Reactivity Index
This document is for information only

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

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

RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 7 of 61
•With all securing and installation variants, ensure that the device cannot fall down or cause any
hazard in any other way. Route the cable safely to prevent tilting.
•Do not use the device in an explosive environment. The device must have at least 25 cm clearance
from any anaesthesia devices and gas-filled tubes.
•The accessories must be cleaned, disinfected or sterilised in accordance with the instruction man-
ual. If the accessories have a separate instruction manual, its instructions apply.
•Should the device be moved from a cold environment into a warm environment, it must only be used
once the temperature of the device and the accessories have reached room temperature and there
is no risk of condensation forming or any condensation formed has completely dried out.
•Do not allow any liquid to get into the device. However, if liquid does get in, firstly remove the adapter
from the wall outlet and give the device to Service for checking. Then carry out checks as per the
safety requirements.
•For installation of the system (with laptop or external system –patient monitor), the following instruc-
tions must always be strictly observed:
•Non-stationary universal portable socket outlets must not lie on the ground
•An additional non-stationary universal portable socket outlet or extension cable must not be
connected to the system
•Equipment that is not part of the system must not be connected to this
2.2 Instructions for cyber and data security
•The NeuroSmart is not intended to be operated with the Internet.
•The NeuroSmart is not intended for operation in public networks.
•Only connect the NeuroSmart to a USB stick or virus-free PC.
•Please delete all data before sending the NeuroSmart for routine service checks.
•Please delete all data at the end of the device’s service life if the NeuroSmart is to be perma-
nently shut down.
•Only persons/organisations authorised by RAUMEDIC may perform a software/firmware up-
date.
This document is for information only

RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 8 of 61
2.3 Safety symbols on the device
Table 2: Symbols on the device
The patient connections P1/T1, P2/T2 and pO2are Type CF ones and are classified as
having defibrillation protection.
Note: Please observe the instruction manual or important safety-related information.
For the patient connections, the sign means that only accessory parts approved by the
manufacturer may be connected to the NeuroSmart, because protection of the medical
device against the consequences of a defibrillator’s discharge depends on the use of suit-
able cables.
Inputs and outputs, digital and analogue
Follow the instruction manual
Observe disposal regulations. Do not throw used devices away in landfill waste.
Observe ESD protection measures
It is recommended that the operator instructs all employees involved in using the device
about ESD measures. Training should include:
Contact pins of plugs/sockets, which are provided with an ESD warning label, must not be
touched. Connections between these plugs must not be made without using ESD protec-
tion measures. In particular, the causing of high electrostatic discharges at the labelled
points must be avoided. This is supported through the use of appropriate ESD work cloth-
ing, an appropriate ESD working environment (ESD floors) and ESD packaging.
Manufacturer
Date of manufacture
Article number
Serial number
Device meets the basic requirements of Directives 93/42/EEC and 90/385/EEC
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RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 9 of 61
2.4 Safety symbols on the packaging
Table 3: Symbols on the packaging
Keep away from sunlight
Keep dry
Consult instruction manual!
Manufacturer
Date of manufacture
Observe disposal regulations. Do not throw used devices away in landfill waste.
Temperature limit
Humidity, limitation
Article number
Serial number
Device meets the basic requirements of Directives 93/42/EEC and 90/385/EEC
3 Operation
3.1 Operating functions
3.1.1 Main operating functions
The NeuroSmart’s main operating functions are:
•Installation of the device
•Charging the chargeable battery
•Measurement in stand-alone mode
•Saving measured data
•Monitoring the physiological parameters
3.1.2 Important operating functions
•Forwarding readings to a patient monitor
•Exporting data to the USB stick
•Download data to the PC
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RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 10 of 61
3.2 Start-up
The device (housing, foil keyboard, cable insulation, plug, label) must be visually inspected for in-
tactness every time before being started up. The device must not be used if defects are detected. It
must be returned to the manufacturer immediately.
Visual inspection
•Front foil undamaged (watertight, buttons OK)?
•Name plate fitted and legible?
•Housing and display undamaged (no cracks or sharp edges)?
•Cable connection and Redel coupling visually free from damage?
•Are there any loose parts within the device (shake the device gently)?
•Are the device or accessories dirty?
3.2.1 Connection diagram
The connection diagram with peripheral devices is shown in Figure 1. RAUMEDIC neurosurgical cath-
eters or blood pressure transducers can be connected to the inputs P1/T1 and P2/T2. The pO2input
and thus the oxygen measurement function is not available with REF 095284-001. See Figure 1 and
Table 4.
The measured pressures can be forwarded to a follow-up patient monitor via the Out1 and Out2 outputs.
Monitor-specific Cable DATALOGGER are used for this.
Other peripheral devices and associated connection cables are shown in Figure 1 and listed in Section
3.2.2 Accessories.
Table 4: NeuroSmart connectors
Inputs (application part)
Inputs/outputs (SIP/SOP)
Designation
Number
Designation
Number
P1/T1 and P2/T2
Invasive pressure
2
Power (for adapter)
1
P1/T1 and P2/T2
Invasive temperature
2
Out1/2
(Analogue output)
2
P-tel
Telemetry channel pressure
1
Rec output
(Analogue output)
1
pO2
Oxygen partial pressure
Invasive (REF 095294-001)
1
USB stick interface
(USB-A)
1
PC interface
(USB-B)
1
Ethernet interface
1 (for servicing only)
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