Subscribe to Our Youtube Channel
Summary of Contents for Neurosoft Neurosens
- Page 1 User Manual Neurosens IMU Sensor Revision 1.0.0 US-edition W089201.002.D100.03.000 (06.05.2023)
- Page 2 Neurosoft © 2023 5, Voronin str., Ivanovo, 153032, Russia Phone: +7 (4932) 95-99-99, +7 (4932) 24-04-34 Fax: +7 (4932) 24-04-35 E-mail: info@neurosoft.com Internet: www.neurosoft.com...
-
Page 3: Table Of Contents
Contents Introduction ..................5 Abbreviations ..................6 Intended Use ..................7 General Information ................7 Contraindications ................8 Safety Precautions ................. 8 Possible Side Effects ................9 1. Description ..................10 1.1. Principle of Operation ............10 1.2. Control Buttons, Sockets and Indicators ....... 14 1.3. - Page 4 Neurosens (User Manual) 6. Disposal ..................34 7. Acceptance and Package Data ..........35 8. Warranty ..................36 9. Reclamations ................37 Annex 1. Main Specifications ............39 Annex 2. List of Components ............44 Annex 3. Emissions and Immunity ..........46 Annex 4. FCC Statement ..............52...
-
Page 5: Introduction
Read the manual carefully prior to use! You can send your responses and recommendations by e-mail: help@neurosoft.com You can find additional information on Neurosoft products in the Internet: www.neurosoft.com or contact us by phone: +7 (4932) 59-21-12 (Service Centre) -
Page 6: Abbreviations
Neurosens (User Manual) Abbreviations EMC — electromagnetic compatibility EMG — electromyography/electromyogram LAN — local area network PC — personal computer IMU – inertial measurement unit... -
Page 7: Intended Use
The Neurosens set is intended for use together with medical devices that require recording of accelerometer, gyroscope, magnetometer and EMG data. General Information The main component of the set is the Neurosens IMU sensor (hereinafter referred to as “sensor”). The Neurosens set features: data recording from each sensor: 3-axis acceleration;... -
Page 8: Contraindications
Neurosens (User Manual) Please note that this manual describes all functions and technical specifications Neurosens sensors. However, the described functions can be limited by the registration certificate issued in the particular region for the medical device the sensors are used with. Refer to the user manual for the respective medical device. -
Page 9: Possible Side Effects
Possible Side Effects dropping or damaging the set components. If the set components were damaged, return them to the manufacturer for repair and/or calibration according to section 8 “Warranty” and section 9 “Reclamations” of this manual. Do not use the set if you suspect any damage. To ensure safety of medical personnel or a patient and prevent the user from electrical injury medical staff is REQUIRED to:... -
Page 10: Description
Neurosens (User Manual) 2. During the long-term fixation of the IMU sensors with tapes the transient skin redness under the tapes can occur. The medical treatment is not needed. Description 1.1. Principle of Operation The block diagram of the sensor is shown in Fig. 1. - Page 11 Designation of sensor components: 1. Button: on/off power switch. 2. Wi-Fi module: data transfer using wireless interface. 3. Indicator: informs about battery status and sensor operation mode. 4. Non-volatile memory: storage recorded data (accelerometer, gyroscope, magnetometer, 2 EMG channels). 5. 2-channel amplifier with ADC: biopotential (EMG signal) amplification and its conversion to digital signal.
- Page 12 Neurosens (User Manual) Fig. 2. The principle of sensor operation in data transfer mode Each sensor simultaneously records two types of data: biopotentials (EMG signals) and navigation data (accelerometer, gyroscope and magnetic field data). Biopotentials (first through electrodes and then through EMG cable) are delivered to amplifier input and after that to ADC for their conversion to digital signal.
- Page 13 Fig. 3. The principle of sensor operation in data saving mode The main difference of that mode from the previous one is that the digital data is saved to a memory card instead of being transferred Wi-Fi module after received microcontroller.
-
Page 14: Control Buttons, Sockets And Indicators
Neurosens (User Manual) Wi-Fi protocol and is saved to the memory card at the same time. 1.2. Control Buttons, Sockets and Indicators The front and bottom edge panels of the sensor are shown in Fig. 5. Fig. 5. The front and bottom edge panels of the sensor 1. - Page 15 Table 1. Battery status indication Indication Battery charge level Green (lights) Battery charge level is higher than 70% of the maximum value. Green (flashes, Battery charge level — 20–70% of the maximum 1Hz) value. Green (flashes, Battery charge level — 10–20% of the maximum 2Hz) value.
- Page 16 Neurosens (User Manual) Red and blue alternating flashlight of the sensor that is placed into the charging station means that the sensor cannot be removed out of it because reading of data from memory card or updating of the installed sensor software is performed.
-
Page 17: Labeling
Power ON/OFF indicator shows if the sensor charging station is switched on or off at the moment (Table 3). Table 3. Sensor charging station indication Indication Status Blue (lights) Charging station is switched on. No indication Charging station is switched off. 1.3. - Page 18 Neurosens (User Manual) Interpretation of label symbols: – type BF applied parts according to ANSI AAMI ES60601-1. The sign is on the bottom panel of Neurosens IMU sensor. – mark of conformance to 2012/19/EC directive “On waste electrical and electronic equipment (WEEE)”.
- Page 19 1 – device identifier GTIN. 2 – indicator digit. 3 – company prefix. 4 – item reference number. 5 – check digit. 6 – serial number identifier. 7 – serial number. GTIN – global trade item number (product or service) used for its identification.
-
Page 20: Preparing The Product For Use
Neurosens (User Manual) Preparing the Product for Use 2.1. Personnel Requirements The set is prepared for use by a person enabled by the manufacture or a technical specialist of a medical facility for which it is intended. Please mind that correct assembly determines safe use and efficient operation of the set. -
Page 21: Unpacking The Set
Requirements to the mains: The use of electric mains where neutral and ground conductors are combined is strongly prohibited. To avoid electrical injury, the sensor charging station and PC must be only plugged in an appropriate mains outlet that has protective earthing conductor. Use of multi-socket extension cables without additional ... -
Page 22: Assembly And Connection To Pc
Neurosens (User Manual) 2.4. Assembly and Connection to PC Follow the steps below: 1. Connect the charging station to the mains using power supply unit included in the list of components for the set. 2. Connect the sensor charging station to PC using USB cable included in the list of components for the set. -
Page 23: Elastic Strap
Apply the sticker with a desired number to the sensor as shown in Fig. 11. Fig. 11. Application of number sticker to the sensor Make sure that numbers do not repeat to avoid further confusion. 2.6. Elastic Strap Pass elastic strap of a particular size through the bars on the back side of the sensor mount as shown in Fig. -
Page 24: Proper Use
Neurosens (User Manual) Proper Use 3.1. Getting Started Operational limitations are specified in Table 5 (see climatic conditions at operation). Before power supply is switched on make sure that the sensors, the sensor charging station and the cables have no apparent mechanical failures that might cause danger. - Page 25 2. Power the charging station on by pressing power button located on the station (Fig. 6). 3. Place the sensor into the charging station (Fig. 13). Fig. 13. Sensor battery charging 4. Make sure that the battery charge indicator of the sensor lights (shows current charge level).
-
Page 26: Attaching The Sensor To A Subject
Neurosens (User Manual) Fig. 14. Charging the sensor using USB cable 1. Make sure that the battery charge indicator of the sensor lights (shows current charge level). This means that the sensor battery charging started. 2. Disconnect USB cable from the sensor and PC when the desired charge level is reached (Table 1). - Page 27 Make sure that the strap is securely fixed (tightened) to prevent mount shift during data recording because it may lead to measurement error of navigation data values. 3. Place the sensor into the mount right on a subject (Fig. 16). Fig.
-
Page 28: Connection Of Emg Cables And Electrode Placement
Neurosens (User Manual) 3.1.3. Connection of EMG Cables and Electrode Placement Electrode placement is determined by the medical device the set is used with. Apply the electrodes to a patient as follows: 1. Apply the electrodes to patient’s skin. 2. Connect EMG cables to the sensors (Fig. 17). -
Page 29: Power On/Off
3.1.4. Power ON/OFF To switch the sensor on, press and hold power button (pos. 1 in Fig. 5) for 2 seconds. If the battery status indicator lights, it means that the sensor is switched on. The sensor is switched off in the same way (by pressing and holding power button for 2 seconds). -
Page 30: Troubleshooting
Neurosens (User Manual) 6. Take the sensors out of the mount and insert them into the charging station. 7. Perform disinfection of the used EMG cables and sensor mounts according to section 4.3 “Disinfection”. 8. If a long interruption in use of the set is supposed, unplug the charging station and place it for storage under the appropriate conditions (see Table 5, climatic conditions). - Page 31 Table 4 (continued) Trouble symptom Cause Solution The sensor is USB port of the Connect the sensor to connected to the computer is faulty. another USB port of the computer using USB computer. cable, but it fails to USB cable is Replace the USB cable.
-
Page 32: Maintenance
When detecting a trouble, please refer to the information given in section 3.4 “Troubleshooting”. If the trouble cannot be eliminated, please contact the service center of Neurosoft (5, Voronin str., Ivanovo, 153032, Russia). The set is subject to user maintenance. The volume of the user maintenance is specified in section 4.2 “User Maintenance”. -
Page 33: Disinfection
4.3. Disinfection Clean the enclosure of the set components using cloth slightly dampened with mild soap solution. Dry the surfaces with a clean dry cloth or air dry naturally. Do not use silicon-based solvents, abrasive cleaners, scrubbing pads, or other abrasive applicators. For disinfection use one of the following disinfectants: phenols (Bacillotex®), ... -
Page 34: Current Repair
Neurosens (User Manual) Current Repair 5.1. General Requirements The repair of the set components requires special training of the technical staff, special equipment and service software that are available from the manufacturer or the company representative. On-site repair that requires opening sensor enclosure and charging station enclosure is prohibited. -
Page 35: Acceptance And Package Data
Acceptance and Package Data The set of Neurosens IMU sensors is collected, packed and ready for operation in compliance with the requirements of design documentation. Packed by ___________________ signature... -
Page 36: Warranty
Neurosens (User Manual) The detailed information about the list of components is provided in the packing report which is an integral part of the present document and should be kept with it. Warranty 8.1. The manufacturer guarantees the set quality conformance... -
Page 37: Reclamations
8.4. The manufacturer is obliged to repair the set components in case of their failure within the warranty period free of charge. The repair is carried out in the service center of Neurosoft (5, Voronin str., Ivanovo, 153032, Russia) according to the procedure described in section 9 “Reclamations”. - Page 38 Neurosens (User Manual) they should be disinfected before sending to the service center. Please refer to cleaning and disinfection rules specified in section 4.3 “Disinfection”; they should be packed in such a way to prevent the possibility of their damage during transportation;...
-
Page 39: Annex 1. Main Specifications
Annex 1. Main Specifications Main specifications of the set are given in Table 5. Table 5. Main specifications Parameter Value Neurosens IMU Sensor Battery type Li-pol Battery capacity not less than 850 mAh Battery voltage 3.7 V Maximum battery charge time using USB cable... - Page 40 Neurosens (User Manual) cut-off frequency with possibility to choose low limit value from the range 5, 10, 20 Hz Noise level in EMG measurement mode within not more than 2 µV RMS the range 5 to 500 Hz Input impedance (differential mode) not less than 100 MΩ...
- Page 41 1.50 ± 0.10 m Сharging cable 1.80 ± 0.10 m USB cable A-B Dimensions: (60×40×17) ± 2 mm Neurosens IMU sensor (70×70×20) ± 2 mm IMU Sensor mount (205×120×40) ± 5 mm Charging station ...
- Page 42 Neurosens (User Manual) Elastic strap: 50 ± 2 mm width length: 200 ± 10 mm for NS089221.002-020 300 ± 10 mm for NS089221.002-030 400 ± 10 mm for NS089221.002-040 500 ± 10 mm for NS089221.002-050 ...
- Page 43 Safety and electromagnetic compatibility Electromagnetic compatibility (EMC) of the set is ensured by compliance with the requirements of IEC 60601-1-2-2020. intended operation electromagnetic environment described in Annex 3. Portable and mobile RF communication equipment may affect operation of the set. Use of accessories not specified in Annex 2 of this manual may increase electromagnetic emission or reduce interference immunity of the set.
-
Page 44: Annex 2. List Of Components
The list of components (the number of sensors, fixation and elastic straps, EMG cables, etc.) depends on the medical device IMU sensors are delivered with. The complete list of components for the Neurosens IMU sensors is given in Table 6. Table 6. List of components Name... - Page 45 Table 6 (continued) Name Order code or main Qty, specification pcs. Elastic strap NS089221.002-020 Up to 12 NS089221.002-030 Up to 12 NS089221.002-040 Up to 12 NS089221.002-050 Up to 12 NS089221.002-060 Up to 12 NS089221.002-070 Up to 12 NS089221.002-100 Up to 12 NS089221.002-140 Up to 12 EMG cable...
-
Page 46: Annex 3. Emissions And Immunity
Neurosens (User Manual) Annex 3. Emissions and Immunity Guidance and manufacturer’s declaration – electromagnetic emissions The set is intended for use in the electromagnetic environment specified below. The customer or the user of the set should ensure that it is used in such an environment. - Page 47 Guidance and manufacturer’s declaration – electromagnetic immunity The set is intended for use in electromagnetic environment described below. The customer or the user of the set should ensure that it is used in such an environment. Electromagnetic IEC 60601 Compliance Immunity test environment –...
- Page 48 Neurosens (User Manual) Guidance and manufacturer’s declaration – electromagnetic immunity Electromagnetic Compliance Immunity test IEC 60601 test level environment – level guidance Voltage dips, <5% U Not applicable Mains power quality short (>95% dip in U should be that of a interruptions for 0.5 cycle...
- Page 49 Guidance and manufacturer’s declaration – electromagnetic immunity The set is intended for use in electromagnetic environment described below. The customer or the user of the set should ensure that it is used in such an environment. Compliance Electromagnetic Immunity test IEC 60601 test level level environment guidance...
- Page 50 Neurosens (User Manual) Compliance Electromagnetic Immunity test IEC 60601 test level level environment guidance Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the...
- Page 51 Recommended separation distances between portable and mobile RF communications equipment and the set The set is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the set can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the set as recommended below, according to the maximum output power of the communications equipment.
-
Page 52: Annex 4. Fcc Statement
Neurosens (User Manual) Annex 4. FCC Statement NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. - Page 53 This product is compliance to FCC RF Exposure requirements and refers to FCC website https://apps.fcc.gov/oetcf/eas/reports/GenericSearch.cfm search for FCC ID: 2AZHPW0890 All transmission frequencies of U-NII-2A and U-NII-2C comply with 47 CFR FCC Part15.407(g) and the manufacturer declares that their transmission is maintained within the U-NII-2A and U-NII-2C bands.
Need help?
Do you have a question about the Neurosens and is the answer not in the manual?
Questions and answers