Mind Media NeXus-32 User manual

NeXus-32
User Manual
Version 2.0
92-0208-0002-0-5 REVISION 5 2015

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Contents
1. Service and support ........................................................................................ 3
1.1 About this manual ..................................................................................................... 3
1.2 Contact information ................................................................................................... 3
1.3 Warranty information ................................................................................................ 3
2. Sa ety in ormation .......................................................................................... 4
2.1 Explanation of markings............................................................................................ 4
2.2 Limitations of use ......................................................................................................
2.3 Safety measures and warnings ................................................................................ 6
2.4 Precautionary measures ............................................................................................ 7
2. Disclosure of residual risk ......................................................................................... 8
2.6 Information for lay operators .................................................................................... 8
3. Product overview ............................................................................................ 9
3.1 Product components ................................................................................................. 9
3.2 Intended use ............................................................................................................. 10
3.3 NeXus-32 views ........................................................................................................ 11
3.4 User interface ........................................................................................................... 12
3. Patient connections ................................................................................................. 13
3.6 Trigger input ............................................................................................................. 14
3.7 Device label ............................................................................................................... 14
4. Instructions or Use ....................................................................................... 15
4.1 Software ................................................................................................................... 1
4.2 Powering the NeXus-32 ........................................................................................... 1
4.3 Transfer data to PC .................................................................................................. 16
4.4 Perform measurement ............................................................................................. 19
4. Mobility ..................................................................................................................... 20
5. Operational principles ................................................................................... 21
.1 Unipolar input channels .......................................................................................... 21
.2 Bipolar input channels ............................................................................................. 21
.3 Auxiliary input channels .......................................................................................... 21
.4 Filtering ..................................................................................................................... 21
6. Maintenance................................................................................................. 22
7. Electromagnetic guidance ............................................................................. 23
8. Technical Speci ication .................................................................................. 25
8.1 NeXus-32-B ............................................................................................................... 27
8.2 NeXus-32-F ............................................................................................................... 30

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1. Service and support
1.1 About this manual
This manual is intended for the user of the NeXus-32 system – referred to as ‘product throughout
this manual. It contains general operating instructions, precautionary measures, maintenance
instructions and information for use of the product. Read this manual carefully and familiarize
yourself with the various controls and accessories before starting to use the product.
1.2 Contact in ormation
This product is exclusively manufactured by Twente Medical Systems International B.V. for Mind
Media B.V. Distribution and service is exclusively performed by or through Mind Media B.V.
Mind Media Support can be reached via email ( [email protected] ) or by phone during office
hours (CET). Visit our Support section on www.mindmedia.com , because this may resolve your
problem. Always provide as much information on your problem as possible, including serial
numbers of the products.
Address
Mind Media B.V.
Louis Eijssenweg 2B
6049CD Herten
The Netherlands
Phone [phone]
Website www.mindmedia.com/
Important In case of need for repair ALWAYS first contact Mind Media Support. The
support staff will supply you with an RMA number in case a return is
required. Never ship products back to Mind Media without this authorization
and/or RMA number.
1.3 Warranty in ormation
The product, except its cables and accessories, is warranted against failure of materials and
workmanship for a period of 2 years from the date of delivery. Cables and accessories have a
warranty period of 6 months.
Repairs can only be performed by the manufacturer. Warranty will terminate automatically when
the product is opened by any person other than qualified personnel (authorized by Mind Media).
The warranty does not cover the following:
•failure resulting from misuse, accident, modification, unsuitable physical or operating
environment, or improper maintenance
•failure caused by a product for which Mind Media is not responsible
•damage resulting from use of non-approved accessories
•any non-Mind Media products
The warranty is voided by removal or alteration of identification labels on the product or its parts.
Warranty is also voided in case seals on the enclosure are broken. Mind Media does not warrant
uninterrupted or error-free operation of wired or wireless data transmission.
Any technical or other support provided for a product under warranty, such as assistance with
“how-to” questions and those regarding device set-up and installation, is provided without
warranty.

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2. Sa ety in ormation
This section contains general warnings, explanation of markings, limitations of use, safety measures,
and precautionary measures that are important for the safe use of the product.
2.1 Explanation o markings
This section explains the various markings and symbols used with the product.
Manual contains important safety information
Attention: read important safety information
Important information / guidance for use
Consult instructions for use
Device has type CF applied parts
Ingress protection rating
Keep dry
CE-certified (93/42/EC Annex XII), see declaration of conformity
Identification of the manufacturer
Reference number
Serial number
Contains transmitter module
Contains Bluetooth transmitter
Special EU instructions for disposal are applicable to a product on which this symbol
is placed. The Maintenance section of this manual contains information on how to
dispose of this equipment.

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2.2 Limitations o use
Limitations o use
• Under federal law (only applicable to the USA) this product may only be
sold by or on the order of a physician or licensed practitioner.
•The product may only be used under the constant supervision of or on the
instructions of a physician or other authorized medical professional.
The product is NOT intended for:
•critical patient monitoring
•use in life support systems
The product is NOT to be:
•used near MRI equipment
•exposed to ionizing radiation
•used on patients undergoing electro surgery
•used in oxygen rich environments (concentration > 25 % at 1 atm)
The product is NOT:
•suitable for use in an inflammable mixture of anesthetics or agents and air,
oxygen or nitrous oxide
•defibrillator proof
•suitable for sterilization
Do not use, store or transport the product outside the specified environmental
conditions, this may damage the product.
Do not store or use in environments with Magnetic Resonance Imaging (MRI)
equipment, or equipment capable of emitting diagnostic levels of ionizing radiation.
Apart from the above, there are no contra-indications. There are no known side effects from the use
of this product.

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2.3 Sa ety measures and warnings
Warnings
•IEC60601-1 compliance is the responsibility of the end user. To ensure
compliance to IEC60601-1, the system must meet the following conditions:
1. The PC and peripherals (e.g. USB hubs) must comply with IEC60950 or
equivalent, and must be located outside the patient environment (the
patient environment is defined as the area within 1.5 m (6 ft around
and 7.5 ft above) of the patient;
•AND
2. The enclosure leakage current from any device within the patient
environment, including any parts of equipment which extend into that
environment, is not more than 0.1 mA in normal condition and 0.5 mA
in single fault conditions.
The required low enclosure leakage current may be achieved by powering the PC
and peripherals from an isolation transformer. It is not recommended that
the equipment be connected to other non-isolated monitoring equipment or
communication networks. In this event it is the end user's responsibility to
ensure compliance with IEC60601-1.
•Make sure the computer is installed according to local regulations and
safety precautions. If the computer is equipped with a safety earth
conductor, use it and connect it to a well-earthed wall socket.
•The only mains power supply that may be used is the one supplied with the
system, a type ‘SUP3 , a type ‘SUP5 or power supply approved by Mind
Media. DO NOT replace it with something else. If any non-Mind Media type
of supply is used, then patient safety is not guaranteed.
•Do not combine the use of the product with any other electronic
equipment, except those specified in this manual. Doing so may impair the
product s emissions and immunity regarding EMC.
•The product can only be used with the accessories designated by the
manufacturer. The use of other accessories may impair the product's
emissions and immunity regarding EMC.
•The accessories supplied with the device can only be used with Mind Media
approved devices.
•Sensors with their own power are not to be connected to any of the inputs.
•Transmission quality decreases when there are other radio devices in the
neighborhood. The wireless transmission may be interfered with by other
equipment.
•The product should not be used adjacent to or stacked with other
equipment. If this is required, then it should be observed if normal
operation of the product in that configuration is confirmed.
•Before batteries are replaced, disconnect the patient from the device,
make sure that the mains power supply is disconnected and the device is
switched off (LCD screen is clear). All batteries have to be replaced
simultaneously, and all have to be of the same type. Note the orientation
of the batteries.
•Do not use batteries that contain lithium
•Do not use rechargeable batteries
•Do not immerse the product in any liquid.
•The product is to be kept dry. If operated out of office, it must be fitted in a
carrying case that provides an ingress protection of at least IP02.
•Do not expose the product to direct sunlight, heat from a source of thermal
radiation, excessive amounts of dust, moisture, vibrations, or mechanical
shocks.

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•Do not incinerate any part of the product.
•If any liquids or moisture penetrate the product or any part thereof,
remove the batteries from the device; and remove the plug from the wall
socket and have the product checked by the manufacturer.
•Take care in arranging patient and sensor cables to avoid risk of patient
entanglement or strangulation.
•The manufacturer cannot guarantee safety and performance of the
product when used in conjunction with accessories that are not
manufactured or approved by the manufacturer.
•No modification of this product is allowed. The product should not be
tampered with.
•Do not touch the electrical connectors that are accessible inside the
battery bay if the battery cover is removed.
•Do not touch the connector pins of interface plugs or receptacles.
•Do not open the product using tools.
•The product is not to be used when it is clearly damaged or wet, or
suspected to be wet inside.
•The product connectors contain nickel, avoid prolonged skin contact with
patients with nickel allergy.
•Disposable electrodes, which are used for electrophysiological
measurements, may be a biohazard. Handle, and when applicable dispose
of these materials in accordance with accepted medical practice and any
applicable local, state and federal laws and regulations.
•Reusable electrodes present a potential risk of cross-infection especially
when used on abraded skin, unless they are restricted to a single patient.
•To prevent contamination: store electrodes in a separate bag within the
packaging.
•Do not attempt to service any part of the product while it is in use or
connected to a patient.
•Except for the batteries there are no user serviceable parts within the
product. Repairs can only be performed by the manufacturer.
•When connecting the system in an IT-network:
Simultaneous connection of other equipment to the same optical fiber or
Bluetooth network may result in previously unidentified risks to patients,
operators or third parties. Such risks must be identified, analyzed,
evaluated and controlled. Subsequent changes to the optical fiber or
Bluetooth network can introduce new risks that require additional analysis.
Changes to the IT-network include: changes to its configuration, connecting
additional items, disconnecting items, updates and upgrades of connected
equipment.
•
Clean the product only according to the cleaning instructions in this
manual. Before cleaning, make sure the device is switched off. Never use
any aggressive chemicals to clean the product.
2.4 Precautionary measures
Precautionary measures
•Make sure that the wall socket is well earthed, to reduce 50 or 60Hz
disturbances.
•Reliability of the signal transmission decreases when the distance between
the Bluetooth PC receiver and the device increases or when there are
conducting materials in the straight line between the Bluetooth PC receiver
and the device.

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•Do not use an operating cellular phone within 50 cm of the device to avoid
excessive noise on the signals.
•Sharp bends or winding the cables in a loop smaller than 5 cm diameter
may damage the cables.
•Do not bend the glass fiber too sharply, as it may break.
•Do not use sharp objects such as pencil-points or pen-tips to manipulate
the buttons on the control panel, as this can cause damage.
•When the product is not in use for a longer time (more than a few days)
the batteries have to be removed to prevent damage in case they start
leaking.
•Dispose of batteries according to local regulations.
2.5 Disclosure o residual risk
The risk analysis process for the product has determined that there are no residual risks which need
to be disclosed for the product.
2.6 In ormation or lay operators
Operators must convey the following information to patients in case they carry the product out of
the professional's office:
•Precautions to be taken with respect to environmental temperature and EM fields, ingress
of liquid
•That wireless equipment (network, phone, walkie-talkie) should be kept >4 m away from
the device
•How to deal with accessories and accessory cables
•How to deal with information provided by indicators and the display
•How to replace batteries

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3. Product overview
3.1 Product components
The product comprises the following functional components:
# Item Description
1. NeXus-32 device The data acquisition device (NeXus-32 Amplifier).
2. Carrying bag The carrying bag to be used when the system is used in portable
measurement configurations.
3. Optical iber Glass fiber used to provide isolation from the PC to the patient.
4. Bluetooth dongle Bluetooth interface to be used on the PC side to provide wireless IT
network with the device.
5. Fusbi Module used as interface between glass fiber and USB cable.
6. So tware*
(PC Driver)
Device driver with application programming interface. The device is
supplied to you either on CD or via email (download).
7. USB Cable USB cable to connect Fusbi to the PC.
8. Power supply
(SUP3, SUP5) Power supply to be used when the device is powered via mains.
9. Power cable Power cable to be used in combination with power supply.
10. Accessories
Patient ground lead is depicted. Together with this cable, various
other electrodes, sensors and accessories may be delivered with the
package. Refer to the list of supported active sensors to see which
are supported by the product.
* Optional: Software may be sent to you as download by email
Not on the picture but also part of the total product are:
•Suitcase for storage of the product when not in use.
•User manual and other labelling: Accompanying documentation
•Other accessories for electrophysiological measurements, such as headcaps, bipolar leads,
unipolar leads etc. Refer to the documents supplied with those sensors for specific
instructions for use.
•Active accessories
oThe device supports active sensors that are supplied by Mind Media. Supported
sensors can be found on the website: www.mindmedia.com.

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3.2 Intended use
The product is intended to be used for acquisition of (electro)-physiological signals by, or under
supervision of, a physician. The user must have knowledge of current good practice in physiological
measurement in science and clinical application. The product is intended to be used within a clinical
or home environment and can be used stationary or ambulatory.
Electrophysiological signals (e.g. EEG, EMG or ECG) are measured via the unipolar or bipolar inputs
on the device via electrode leads connected to a patient or subject. Other physiological parameters,
such as respiration, body position, body movement and temperature are measured using the
auxiliary input channels. These types of signals require additional sensor interface modules.
Important
The system does not perform any signal interpretation or signal analysis.
This is left to the researcher/physician.
The system is not intended for use in a life supporting system.
The device has a maximum sampling frequency of 2048 Hz (via optical fiber). For Bluetooth
connection the sampling rate is lower. Supported sampling rates are specified in chapter 8.
For stationary measurements the device transfers the data to the PC by means of a glass fiber or
wireless (Bluetooth) connection, where the signals can be viewed or stored for further processing.
The device is powered by either a power supply, a set of batteries, or both.
For ambulatory measurements the data can be stored on a Compact Flash disk within the NeXus-32.
The card recording functionality is an add-on of the NeXus-32 that is to be ordered separately. The
PCMCIA Card and Compact Flash Card may therefore not be present in your package. Instructions
for use of the card recording option, are provided with the add-on.

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3.3 NeXus-32 views
Front View
# Description
1. GND Patient Ground input
2. ON/OFF On/Off button
3. TRIG Trigger Input*
4. LCD User Interface
5. POWER Power Connector
6. PATIENT
CONNECTION(s) Input for Patient leads; Unipolar, Bipolar, Auxiliary or Saturation **
* The presence of this input depends on the configuration
** Type and number of patient lead inputs depend on the NeXus-32 configuration
Back View
# Description
1. Battery Cover
2. Thumbscrew for battery cover
3. Fiber interface

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3.4 User inter ace
On/Off Button
When the device is solely powered by batteries, the device will switch on when the On/Off button is
pressed shortly.
When the device is transmitting data (via optical fiber or Bluetooth), the On/Off button acts as a
Marker button. This will result in a signal in the digital channel of the product. In this case, the
device will not shut down.
When you press and hold the On/Off button for more than 4 seconds, a
card recording will be started or stopped. Please note that this mode
requires the PCMCIA card module that is to be ordered separately.
An error message will appear if the card is missing or not configured.

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Messages and indicators on LCD screen
The table below states all possible states of the LCD screen of the device
Topic LCD Screen appearance Description
Starting up
•LCD screen when device is starting up.
•SW X.xx indicates Firmware version
•Time is the Real Time Clock of the device
Ready
Device is in stand-by mode and waiting for connection.
Saturation
In case a saturation input is present, this will be
indicated in the top right corner. (Also for other LCD
Screen messages)
Shutting
down
Device is shutting down because:
•On/Off button was pressed when running on
batteries
•Device goes in (battery) power saving mode
because it was not used for 10 minutes
•Batteries in the device are depleted
Fiber
Device is transmitting data over the Fiber optic link
Bluetooth
Device is transmitting data via Bluetooth
Battery low
Batteries of the device are running low.
Recording
Error
On/Off button was pressed for more than 4 seconds,
but no flash disk was found.
3.5 Patient connections
Patient Ground
The patient ground should always be connected in order to keep the amplifier in range. The location
of the patient ground is ideally away from your measurement electrodes.
Patient Lead Connectors: Unipo ar, Bipo ar, Auxi iary, Saturation
The number and type of inputs on your device depend on the configuration you have. NeXus-32
devices exist in different configurations. In general there are three types of patient connection
inputs on the device: unipolar, bipolar or auxiliary. Some configurations also include a fourth type,
being the digital saturation input.

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Type o input Connector Description
Unipolar
Used for EEG, EMG, ECG, or in general, ExG leads. Signals are
measured against the mean of all connected electrodes of this type
(average reference). The type of connector is micro coax.
Bipolar
Used for differential measurements. Leads that fit in the bipolar
inputs have two bipolar channels and four cables going to the
patient. The bipolar input uses a 6 pin metal connector.
Auxiliary
Used for sensors that require (5V) power or additional sensor
modules. The auxiliary input is a 5 pin metal connector.
Saturation
Used for saturation input. The connector is a 4 pin metal connector.
NeXus-32 devices exist in different configurations. Not all types of inputs may be
available on your device.
3.6 Trigger input
The trigger input can be used to record a TTL trigger signal on the digital channel of the NeXus-32.
The trigger input is isolated from all other inputs and the patient within the NeXus-32.
3.7 Device label
The device label can be found at the bottom of the device
(example of device label is shown here). It contains the REF
code, Serial Number, power requirements and other
properties of the device. Use the REF number to look up the
channel specifications as listed in chapter 8.

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4. Instructions or Use
4.1 So tware
Software, that is needed to use the product, is supplied to you by email as download or by one or
more CDs in the package. It is recommended to download the most up-to-date software via
www.mindmedia.com/ . Once installed and activated, this step can be skipped.
PC requirements
Hardware
•Processor: > 1 GHz
•RAM: > 1 GB
•HDD: > 50 GB (> 250 GB recommended)
•Internet connection or CD/DVD Drive
Operating system
Windows
•Windows 10 (64-bit)
•Windows 8.1 (64-bit)
•Windows 7 (32-bit & 64-bit)
Important
Disconnect all Mind Media products from the PC before installing any Mind
Media software .It is recommended to uninstall older versions of the driver
before installing new drivers.
Mind Media Driver
Start the installer by clicking setup.exe . The Mind Media Driver Setup Wizard starts and guides you
through the process of installation of the driver. Follow the steps on screen.
4.2 Powering the NeXus-32
The NeXus-32 can be powered using batteries, via the mains power supply, or both.
Mains power supp y
Mains Power Cable
Check that the power supply is labeled as ‘SUP3 .
Connect the mains cable to the power supply and the
other side into a well-grounded power outlet. The LED
on the power supply will light up green.
NOTE: Position the power supply such that it is easy
to disconnect the power supply from the mains.
Connect power cable to Power Connector on the NeXus-32

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Connect the power supply cable into the power
supply socket on the front of the device (POWER).
Make sure the notch of the connector is at the top of
the connection, turn the connector part to position
the notch correctly.
After inserting of the power connector, the NeXus-32
starts up automatically.
Battery
The batteries should be placed in the battery compartment on the backside of the NeXus-32. Follow
the steps below.
STEP 1: Unscrew battery cover STEP 2: Remove battery cover
STEP 3: Insert batteries STEP 4: Tighten thumbscrew
Important
•Do not use rechargeable batteries.
•Do not use batteries that contain lithium.
•High quality AA batteries are strongly recommended (for example
Duracell Procell) in order to have optimal performance.
Please note that it is not required to use all free battery slots in order to power the device. NeXus-
32 devices also run on 6 AA batteries (in one row) instead of 12.
4.3 Trans er data to PC
Both USB (via optical fiber) and Bluetooth IT-network connections are supported by the product.
The purpose of the IT-network connection is for device control and/or data transfer. The intended
information flow is:
•Control from a PC to the device
•Raw data from the device to the PC

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The supported versions of the IT network connections are:
•USB: 2.0 and higher
•Bluetooth: 1.1 and higher
The following two sections describe the installation of the USB (via optical fiber) link and Bluetooth
IT-network connections.
Please note: No hazardous situations have been identified for the product due to loss of the IT-
network functionality.
Wired transmission: Fiber to USB interface (Fusbi)
1. Connect the optical fiber to the
input of the Fusbi and the other end to
the fiber connector on the NeXus-32. It
does not make a difference which
connector goes where.
2. Connect the USB cable to the
Fusbi and to a free USB port on the PC. In
case this is the first time you use the
system, Windows will report that a driver
is being installed.
3. The LED next to the USB input of
the Fusbi will light up green to indicate
the Fusbi is ready to use.

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Wire ess transmission: B uetooth interface
1. Insert the Bluetooth dongle in a USB port.
Wait for Windows Update to install the drivers for
the Bluetooth dongle.
2. After Windows has finished installing the
Bluetooth drivers, click the Bluetooth tray icon in
the right bottom corner of the Windows taskbar.
3. Click, ‘Add a
device . If you do not see
the Bluetooth tray icon,
click Start > Devices and
Printers > Add a device
4. Windows will start
scanning the
environment. Make sure the NeXus-32 is powered
on. The NeXus-32 should automatically show up in
the list.
5. Select the device and click ‘Next . Windows will
ask for a pairing code. The pairing code
consists of the last four digits of the serial
number. The serial number can be found on
the back of the NeXus-32 on the silver label
next to ‘SN . In the figure displayed to the
right the pairing code is 0018. Click Next to
finish the Bluetooth setup.
6. Windows may report that drivers are being
installed. Wait until Windows reports that the
‘Device is ready to use .
The Bluetooth pairing remains valid until you plug the Bluetooth dongle into a
different USB port, delete the link from Windows, or pair the device with
another PC.

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4.4 Per orm measurement
Possib e Use Scenarios
The most suitable combination of means of power and data transfer depends on your application.
Below we list the four options and considerations for deciding which setup to use.
OPTION 1: Fusbi and Mains power supply OPTION 2: Bluetooth and Battery
•ADVANTAGES
oMaximum sampling rate
oOptimal data transmission reliability
o
Virtually unlimited measurement time
•ADVANTAGES
oOptimal freedom of movement for
patient
•DISADVANTAGES
oLimited freedom of movement for
patient
•DISADVANTAGES
oSampling rate may be limited due to
limited bandwidth
oIncreasing chance of data loss when
distance between NeXus-32 and PC
increases
oMeasurement time limited
OPTION 3: Fusbi and Battery OPTION 4: Bluetooth and Mains power supply
•ADVANTAGES
oMaximum sampling rate
oOptimal data transmission reliability
oIncreased freedom of movement
when using a long optical fiber
•ADVANTAGES
oVirtually unlimited measurement time
•DISADVANTAGES
oMeasurement time limited
•DISADVANTAGES
oSampling rate may be limited due to
limited bandwidth
oIncreasing chance of data loss when
distance between NeXus-32 and PC
increases.

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Connect Patient Leads
Connect the Patient Ground lead to the GND input of the amplifier and to the patient. Ensure
adequate contact with the patient skin.
Connect all patient leads and patient ground. Please refer to instructions for use of the accessories
and sensors for more information.
4.5 Mobility
It is recommended to use the carrying bag in case the patient needs to carry the device during the
measurement.
•Slide the device in the carrying bag. This may require some force. The elastic bands hold
the device in place.
•Use the clip on the carrying bag to fix it to a belt or waistband.
•There is a rectangular cut-out on the back of the carrying bag. This is where the fiber can be
connected.
Device in Carrying bag Backside: Rectangular cut-out or
optical iber
Carry device using the clip on your
belt or waist band
Important
For ambulatory measurements it is required to use a suitable carrying bag(REF 95-8020-
0001-0) with ingress protection rating IP02 instead of the carrying bag depicted above.
This bag is to be ordered separately. Contact [email protected] for more information
and refer to the separate instructions for use for the ambulatory carrying bag.