MindMedia NeXus-10 MKII User Manual
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MindMedia NeXus-10 MKII User Manual

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NeXus-10 MKII
User manual
30-0002-0003
REV 9.0
EN
Last update: 28-03-2022
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner

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Summary of Contents for MindMedia NeXus-10 MKII

  • Page 1 NeXus-10 MKII User manual 30-0002-0003 REV 9.0 Last update: 28-03-2022 Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner...

  • Page 2: Table Of Contents

    Safety measures and warnings Precautionary measures Disclosure of residual risk Information for lays General advice Connection to an IT-network NeXus-10 MKII parts NeXus-10 MKII main unit Power pack (NX-BATTERY) Mains power adapter Bluetooth USB dongle USB cable Device Driver Device labels...
  • Page 3 Troubleshooting Maintenance Electromagnetic guidance Performance Electromagnetic emission Electromagnetic immunity Technical specifications Page 3 of 43...

  • Page 4: Service And Support

    Service and support About this manual This manual is intended for the user of the NeXus-10 MKII system – also referred to as ‘product’ or ‘NeXus-10 MKII’ 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.

  • Page 5: Additional Accessories Or Spare Parts

    Additional accessories or spare parts In case you want to order additional accessories such as cables or sensors or spare parts such as batteries, please contact for consultation and a detailed quotation. info@mindmedia.com Page 5 of 43...

  • Page 6: Safety Information

    Safety information 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. Explanation of markings This section explains the various markings and symbols used with the product. Attention: read important safety information Important information / guidance for use Consult instructions for use...
  • Page 7 USB connected USB disconnected Power symbol Recording to SDHC memory card Data logging on SDHC memory card Power pack (NX-BATTERY) remaining change level Back-up power charging Channel indicator (A-H) Sensor indicator Unauthorized access Direct current Special EU instructions for disposal are applicable to a product on which this symbol is placed.

  • Page 8: Limitations And Contra-Indications

    Limitations and contra-indications The following limitations of use are applicable due to relevant regulations and to ensure the device is able to perform as specified throughout this user manual. Limitations of use • Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner •...

  • Page 9: Safety Measures And Warnings

    EMC. • The accessories supplied with the product must only be used with the NeXus-10 MKII. • Do not connect active sensors or electrodes to any of the inputs unless they have been approved by the manufacturer.

  • Page 10: Precautionary Measures

    • Make sure to prevent electrical contact between conducting parts of accessories and other equipment. • Make sure to connect the Patient Ground lead to the patient only. • Make sure to not connect the NeXus-10 MKII with its accessories simultaneously with other equipment to the patient. Disclosure of residual risk Any residual risks are disclosed as part of the limitations, warnings and precautionary measures indicated in the previous sections.

  • Page 11: General Advice

    And, specifically regarding the measurement: • If there is any indicator or message to look out for on the display, and how to react to it. • To contact the operator in case of unexpected operation or events. General advice The following general advice should be taken into account by the user to avoid defects or disturbances.

  • Page 12: Connection To An It-Network

    Connection to an IT-network The following instructions must be observed if NeXus-10 MKII is connected to an IT network. Instructions • When connecting the product in an IT-network: Simultaneous connection of other equipment to the same USB or Bluetooth network may result in previously unidentified risks to patients, operators or third parties.

  • Page 13: Nexus-10 Mkii Parts

    NeXus-10 MKII parts Compare the contents of your purchase with the list below to verify whether all NeXus-10 MKII parts are present*. Item Description Device The data acquisition device (NeXus-10 MKII device). See Section 3.1. The internal power supply for the device. See Section 3.2. Indicated as Power pack NX-BATTERY on the product label.
  • Page 14 NeXus-10 MKII main unit - Buttons Description Display button. Power/ Memory card recording button. Marker button. NeXus-10 MKII main unit – Front view Description Patient Ground input. A&B - C&D (bipolar) inputs. E – H (auxiliary) inputs. Page 14 of 43...

  • Page 15: Power Pack (Nx-Battery)

    Description Trigger input. USB port. Serial sensor input. Power pack (NX-BATTERY) The power pack is a rechargeable battery, for use with the NeXus-10 MKII main unit. Power pack Description Connector to NeXus-10 MKII main unit. Power pack fault indicator light.

  • Page 16: Mains Power Adapter

    Device labels For identification of the NeXus-10 MKII parts, there are three labels: two on the NeXus-10 MKII main unit (exterior and interior) and one on the power pack. Exterior label The exterior label is located on the bottom of the NeXus-10 MKII device and contains generic information.
  • Page 17 Interior label The interior label can be found in the power pack compartment of the NeXus-10 MKII, near the memory card slot. An example of the interior label is displayed below. Please note that the actual label may be different from the picture shown here. It contains specific information such as the product code and serial number.

  • Page 18: Patient Accessories

    The specifications of these patient leads and sensors are in line with the input specifications of the NeXus-10 MKII (see Section 10) and are designed to operate safely with this device. More information about approved patient accessories is available on www.mindmedia.com.

  • Page 19: Description And Operational Principles

    Description and operational principles Intended use The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for the purpose of acquisition of electrophysiological signals and physiological signals from sensors and other measuring devices and further transmission of these signals to software running on a general-purpose computer.

  • Page 20: Bipolar Input Channels

    The power pack is charged (while not connected to the NeXus-10 MKII) through a mains power adapter. The NeXus-10 MKII is able to interface through USB or a wireless Bluetooth connection to a computer. The latter requires installation of the Bluetooth dongle on a USB 2.0 port of the computer.
  • Page 21 Please note: No hazardous situations have been identified for the product due to loss of the IT- network functionality. Page 21 of 43...

  • Page 22: Installation

    As soon as charging of the power pack is complete (see Section 6.1), disconnect the mains power adapter and place the power pack in the NeXus-10 MKII main unit (see Section 6.2). Install NeXus-10 MKII driver software onto the computer as described in Section 5.2.

  • Page 23: Operation

    3. The power pack is fully charged as soon as the charge indicator light is switched off. (Re)placing power pack 1. In case a power pack is present on the NeXus-10 MKII: release the power pack by pressing the release button as indicated in the Figure below.

  • Page 24: Inserting Memory Card

    Inserting memory card 1. Make sure the NeXus-10 MKII is switched off. 2. Remove the power pack (if one is inserted). 3. Remove the SDHC memory card (if necessary) by pushing the card slightly into the card slot until a clicking sound is produced. The card is now released and can be removed.

  • Page 25: Switching Off

    3 seconds (pressing the button for more than 3 seconds activates memory card recording, see Section 6.7). A shutdown message is displayed. Shutdown 2. Auto power off: if the NeXus-10 MKII is not recording, it automatically switches off after 10 minutes if no buttons are pressed. Auto power off Display of device information 1.

  • Page 26: Activating Memory Card Recording

    Activating memory card recording 1. Prepare the memory card for recording using application software on a PC. 2. Insert the prepared memory card in the NeXus-10 MKII. 3. Switch on the NeXus-10 MKII. 4. Make sure the memory card indicator light is on.

  • Page 27: Establishing A Bluetooth Connection

    Press the power/memory card recording button again (briefly). To cancel, wait 5 seconds until the display switches off automatically. 2. The NeXus-10 MKII starts recording and saves the data to the memory card as specified in the measurement configuration file. During active recording to the memory card, the NeXus-10 MKII displays a memory card symbol and recording time (press the display button in case the display is off).

  • Page 28: Activating Bluetooth Recording

    The Bluetooth indicator light stops blinking. Bluetooth recording stopped If the Bluetooth connection is lost during recording, the NeXus-10 MKII will stop and display an error message. The Bluetooth indicator light is off. Page 28 of 43...

  • Page 29: Establishing A Usb Connection

    Bluetooth connection lost during recording 6.10 Establishing a USB connection Connect the USB cable to the NeXus-10 MKII and computer. Switch on the NeXus-10 MKII and computer. The NeXus-10 MKII starts searching for available USB devices. The USB indicator light blinks fast.

  • Page 30: 6.12 Activating Bluetooth/Usb Recording With Memory Card Logging

    6.12 Activating Bluetooth/USB recording with memory card logging The NeXus-10 MKII is able to send recorded data through a Bluetooth or USB connection while simultaneously logging it to a memory card. This is called memory card logging mode and can only be activated through specific application software.

  • Page 31: Adding Markers

    5. If memory card logging is active, the recording does NOT stop automatically in case the Bluetooth or USB connection is lost. The NeXus-10 MKII displays a message to indicate that the connection is lost, but memory card logging is still active.

  • Page 32: Exchange Of Power Pack During Recording

    1. Establish the need to exchange the Power pack through Power pack status display (see Section 6.6). If the power pack runs low, the NeXus-10 MKII displays a message and the power indicator light starts to blink slowly.
  • Page 33 Power pack changed message 5. In the default display, the NeXus-10 MKII indicates that the back-up power is recharging. The ‘charging’ symbol disappears as soon as the back-up power is fully recharged. Back-up power recharging The back-up power needs to reload for approximately 10 minutes after exchanging the power pack.
  • Page 34 Unauthorized access message No Bluetooth connection possible Make sure the distance between the NeXus-10 MKII and the Bluetooth dongle is less than 10 meters and there are no conducting materials shielding either of them. Make sure drivers are installed correctly on your computer. The NeXus-10 MKII functions best in combination with Microsoft Bluetooth drivers.
  • Page 35 Main unit – Indicator lights Indicator light Condition Status Power Device Off Device On Slow blink (1 s/1 s) Boot error Power pack removed Fast blink (0,5 s/0,5 s) during device on Memory card No memory card inserted Memory card with valid measurement configuration file inserted (ready) Slow blink (1 s/1 s)
  • Page 36 Repairs can only be performed by the manufacturer, contact support@mindmedia.com in case the product needs to be repaired. Mind Media Support staff will determine whether a repair is required and possible.
  • Page 37 Electromagnetic emission Guidance and manufacturer’s declaration - electromagnetic emissions The NeXus-10 MKII is intended for use in the electromagnetic environment specified below. The customer or the user of the NeXus-10 MKII should assure that it is used in such an environment.
  • Page 38 Electromagnetic immunity Guidance and manufacturer’s declaration - electromagnetic immunity The NeXus-10 MKII is intended for use in the electromagnetic environment specified below. The customer or the user of the NeXus-10 MKII should assure that it is used in such an environment.
  • Page 39 Guidance and manufacturer’s declaration - electromagnetic immunity The NeXus-10 MKII is intended for use in the electromagnetic environment specified below. The customer or the user of the NeXus-10 MKII should assure that it is used in such an environment. Immunity test...
  • Page 40 The front-side receptacles (pins and shield) on the device enclosure • The patient accessories • Accessible parts Enclosure of the NeXus-10 MKII device including the cavity where the power pack is inserted, and the metal outside of the back-side receptacles • Enclosure of the power pack...
  • Page 41 Bipolar inputs Differential range -100 mV to +100 mV (@ 0 V common mode) Common mode range -2.0 V to +2.0 V (@ 0 V differential signal) Gain factor Noise <1 µV RMS (1 to 64 Hz) Input impedance >1 GΩ CMRR >90 dB Accuracy...
  • Page 42 Filtering Type No filtering within channel bandwidth. Channel list Name Function Resolution/bit Signal range Bipolar signal A 0.012215 µV -100 mV to +100 mV Bipolar signal B 0.012215 µV -100 mV to +100 mV Bipolar signal C 0.012215 µV -100 mV to +100 mV Bipolar signal D 0.012215 µV -100 mV to +100 mV...
  • Page 43 Bluetooth Communication RF transmitter Bluetooth v2.0+EDR Class 2 Band 2.4 GHz Maximum output +2.5 dBm power Profile Range Typical >10 m (indoors) Bandwidth Maximum 500 kb/s Data storage Memory card 4 GB up to 32 GB, SDHC only. SanDisk SDHC cards recommended. Format FAT 32 Transportation Conditions...
  • Page 44 Copyright © 2021 Mind Media B.V. All rights reserved. www.mindmedia.com Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner...

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