FCC ID: 2AZHPW0890 Neurosens IMU sensor

User Manual Neurosens IMU Sensor Revision 1.0.0 US-edition W089201.002.D100.03.000

(06.05.2023) 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 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. Labeling ................................................................................. 17 2. Preparing the Product for Use .................................................. 20 2.1. Personnel Requirements ....................................................... 20 2.2. Room Selection and Placement ............................................ 20 2.3. Unpacking the Set ................................................................. 21 2.4. Assembly and Connection to PC ...........................................22 2.5. Applying Number Sticker to the Sensor .................................22 2.6. Elastic Strap .......................................................................... 23 3. Proper Use .................................................................................. 24 3.1. Getting Started ...................................................................... 24 3.1.1. Charging of Sensors ...........................................................24 3.1.2. Attaching the Sensor to a Subject ...................................... 26 3.1.3. Connection of EMG Cables and Electrode Placement .......28 3.1.4. Power ON/OFF ...................................................................29 3.2. Workflow ................................................................................29 3.3. After Use Procedure .............................................................. 29 3.4. Troubleshooting .....................................................................30 4. Maintenance ................................................................................32 4.1. General Requirements .......................................................... 32 4.2. User Maintenance ................................................................. 32 4.3. Disinfection ............................................................................ 33 4.4. Lifetime .................................................................................. 33 5. Current Repair ............................................................................ 34 5.1. General Requirements .......................................................... 34 3 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 4 Introduction Introduction This user manual (hereinafter referred to as manual) is the combined document describing operation and servicing of the Neurosens set (hereinafter referred to as set). The document certifies technical parameters of the set which are guaranteed by the manufacturer. Read the manual carefully prior to use!

You can send your responses and recommendations by e-mail:

help@neurosoft.com You can find additional the Internet:

www.neurosoft.com or contact us by phone:

information on Neurosoft products in

+7 (4932) 59-21-12 (Service Centre)

+7 (4932) 95-99-99

+7 (4932) 24-04-34 You can also contact TeleEMG LLC Authorized USA Representative of Neurosoft Ltd. by the following contacts:

Phone: 1-877-835-3364. E-mail: sales@mycloudtms.com 5 Neurosens (User Manual) Abbreviations EMC electromagnetic compatibility EMG electromyography/electromyogram LAN local area network PC personal computer IMU inertial measurement unit 6 Indications for Use Indications for 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;

3-axis angular velocity;

3-axis magnetic field;

2 EMG channels;

o o o o transfer of recorded data using wireless Wi-Fi protocol;

storage of recorded data on the sensor memory card;

transfer of data from the sensor memory card to PC using USB interface;

possibility of attaching the sensor to the subject;

charging sensor battery. 7 Neurosens (User Manual) Please note that this manual describes all functions and technical specifications of Neurosens IMU 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. Contraindications There are no contraindications for use of the set. Safety Precautions To ensure safety of medical personnel or a patient and prevent the user from electrical injury medical staff is PROHIBITED from:

connecting devices that are not included in the list of components to the electrode sockets;

eliminating faults that requires opening enclosures of the sensor or sensor charging station;

using the set if the enclosure of the sensor or sensor charging station is open;

connecting electrodes placed on the patient to protective earthing or other conductive surfaces;

components set immersing

(hereinafter referred to as set components) in water or other liquids;

the of allowing children to use the set;

8 Possible Side Effects dropping or damaging the set components. If the set components were damaged, return them to the manufacturer 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. for To ensure safety of medical personnel or a patient and prevent the user from electrical injury medical staff is REQUIRED to:

check set components for signs of damage of the enclosure, cable isolation, contacts, etc. regularly and carefully;

clean and disinfect the reusable components of the set after each use according to the established rules;

switch off and unplug all the set components prior to cleaning and disinfection. The manufacturer is not responsible for any health or material damage caused by fault of the user, servicing or medical personnel. The set shall not be placed near active HF surgical equipment or MRI imaging equipment. Possible Side Effects Inform patient about possible side effects prior to using the set. 1. In rare cases the skin irritation and local allergic reactions to patient skin preparation agents and adhesive and working surfaces of disposable electrodes may occur. 9 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. 1. Description 1.1. Principle of Operation The block diagram of the sensor is shown in Fig. 1. Fig. 1. The block diagram of the sensor 10 Designation of sensor components:

1. Button: on/off power switch. 2. Wi-Fi module: data transfer using wireless interface. Indicator: informs about battery status and sensor operation 3. mode. 4. Non-volatile memory:

(accelerometer, gyroscope, magnetometer, 2 EMG channels). recorded storage of data 5. 2-channel amplifier with ADC: biopotential (EMG signal) amplification and its conversion to digital signal. Inertial measurement unit sensor:

6. acceleration, rotation speed and magnetic field data. recoding of 3-axis 7. Socket: connection to charging station or connection of charging USB cable, connection of EMG cable. 8. Charge controller: control of sensor battery charge level. 9. Microcontroller: sensor operation control. The set has three operation modes that are enabled depending on the medical device it used with:

Transfer of data to PC using Wi-Fi. Saving of data to memory card. Transfer of data to PC using Wi-Fi and data saving to memory card. The operation principle of the first mode (transfer of data to PC through Wi-Fi) is shown in Fig. 2. 11 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. Navigation data is recorded by IMU that is also responsible for data conversion to digital signal. The obtained is transferred to digital data (biopotentials and navigation) its further microcontroller which generates data packet transfer through Wi-Fi. The information is received by PC where it is processed depending on the used software. for This mode is mostly needed in medical devices requiring in immediate response to patient motion (for example, upper/lower limb trainers with biofeedback (BFB), in functional electrical stimulation systems where it is important to deliver pulse at a particular motion phase and in other devices). The operation principle of the second mode (data saving to memory card) is shown in Fig. 3. 12 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 by transferred received microcontroller. Later when the sensor is placed into the charging station the data can be loaded from the memory card to PC for further processing. to Wi-Fi module after is it This operation mode is usually needed in diagnostic systems that do not require online motion data processing. The operation principle of the third mode (transfer of data using Wi-Fi and data saving to memory card) is shown in Fig. 4. Fig. 4. The principle of sensor operation in the mode of data transfer using Wi-Fi and data saving to memory card This operation mode combines the two described above modes which means that the recorded data is transferred to PC using 13 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. Power button. 2. Battery status indicator. 3. Operation mode indicator. 4. Socket connection of EMG cable. for charging station, charging USB cable or Battery status indicator provides information about the current battery charge level of the sensor (Table 1). The indicator is active when the sensor is switched on and/or is placed into charging station. 14 Table 1. Battery status indication Indication Green (lights) Battery charge level Battery charge level is higher than 70% of the maximum value. Green (flashes, 1Hz) Battery charge level 2070% of the maximum value. Green (flashes, 2Hz) Battery charge level 1020% of the maximum value. Green (flashes, 5Hz) Battery charge level lower than 10% of the maximum value. No indication Sensor is powered off. Charging is not started. It is not recommended to use the sensor if the battery charge level the maximum value. Otherwise data recording can be terminated before it is planned. is less than 20% of Operation mode indicator informs about the current operation mode of the sensor (Table 2). This indicator is active only if the sensor is switched on. Table 2. Operation mode indication Indication Sensor operation mode White1 Sensor battery charging is going on Blue (flashes) Data is being transferred using Wi-Fi. White (flashes) Data is being saved to memory card. White-blue (flashing alternately) Data is being both transferred using Wi-Fi and saved to memory card. Blue (lights) No indication Sensor is connected to Wi-Fi and is waiting for command. Sensor is switched off or is not connected to Wi-Fi. 15 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. The front and side panels of the sensor charging station are shown in Fig. 6. Fig. 6. The front and side panels of the sensor charging station 1. Power button. 2. Power ON/OFF indicator. 3. USB connector for connection to PC. 4. Power supply unit connector. 16 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. Labeling The example of the label for the IMU sensor is shown in Fig. 7. The example of for the sensor charging station is shown in Fig. 8. the label Fig. 7. The example of the label for the IMU sensor Fig. 8. The example of the label for the sensor charging station 17 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). consult operational documentation. attention: consult user and user manuals. The sign is on the bottom panel of Neurosens IMU sensor. catalogue number according to ISO 15223-1. serial number according to ISO 15223-1. manufacture date according to ISO 15223-1. manufacturers name and address according to ISO 15223-1. RX ONLY federal law restricts this device to sale by or on the order of a physician FCC ID:

2AZHPW0890 this exterior label referring to the enclosed module according to part 15.212 vi(A) of CFR The device is identified with GS1-128 barcode that includes GTIN code and serial number (Fig. 9). Fig. 9. GS1-128 barcode 18 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. It is assigned to any trade item (product or service) that is priced, ordered or invoiced at any point in the supply chain. To ensure automatic reading of barcode GS1-128 it represented as DataMatrix code on the label (Fig. 10). is Fig. 10. DataMatrix code DataMatrix two-dimensional matrix barcode made up of black and white or light and dark square modules of different shade arranged in a square or rectangular pattern. Information on DataMatrix code is provided in ISO/IEC 16022:2006. For decoding item information DataMatrix code can be read using scanner or smartphone camera. 19 Neurosens (User Manual) 2. 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. Particular requirements that determine safe use of the set are given below in bold italics. 2.2. Room Selection and Placement Prior to assembly choose the site for the set considering power wiring and protective grounding in the room intended for equipment placement and read the following requirements and recommendations. Requirements placement:

and recommendations for equipment Use the set at the maximum possible distance from power cables, switchboards, and different powerful electrical devices that can emit electromagnetic fields of mains frequency. Do not use the set in the immediate vicinity (less than 5 meters) of short-wave or microwave therapeutic equipment. It may lead to its unstable operation. The sensor charging station and PC shall be placed at the minimum distance of 1.5 meters from the patient environment, otherwise PC shall comply with safety requirements of ANSI AAMI ES60601-1 for medical devices and systems or PC shall be connected to the mains and LAN only using isolators that comply with the above mentioned requirements. 20 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 precautions is prohibited for the reason that the probable break of the circuit of protective ground of the multi-socket extension cable might lead to leakage current summation up to dangerous values. Check of three-pole sockets and protective ground carried out by an electrician is strictly required prior to use the set. 2.3. Unpacking the Set If the box with the set was kept under the conditions of high humidity and low temperature that differ greatly from operating values keep the box for 24 hours in the room with normal ambient conditions. Open the box and take out the set components from package. Check whether the delivery conforms to the packing report. Examine the set and make sure there is no visual damage. 21 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. require charging station Sensor charging does not to be connected to PC using USB cable. However, if this type of connection is not ensured the following options shall not be available:

transfer of data from sensor memory card to PC;

setup of Wi-Fi parameters of the sensors;

update of the sensor firmware. 3. If the charging station was connected to PC with the help of USB cable, make sure that the station is placed at more than 1.5 meter distance from the patient environment. 2.5. Applying Number Sticker to the Sensor It is recommended to number the sensors using particular stickers with numbers 1 to 12 prior to use the set. This makes the use of the set easier. 22 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. 12. Fig. 12. Arrangement of the sensor elastic strap 23 Neurosens (User Manual) 3. Proper Use 3.1. Getting Started Operational conditions at operation). limitations are specified in Table 5 (see climatic 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. The range of setting up procedures depends on the medical device the set is used with. Usually it includes the following steps:

1. Charging of sensors. 2. Application of sensors to a subject. 3. Connection of EMG cables and application of electrodes. 4. Sensor switch on. 3.1.1. Charging of Sensors The sensor can be charged in two ways:

1. Using special USB cable included into the list of components. 2. Using the sensor charging station. It is recommended to use the sensor charging station. To charge the sensors with the help of the charging station, perform the following steps:

1. Plug the sensor charging station into mains outlet. 24 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). This means that the sensor battery charging started. 5. Remove the sensor from the charging station when the desired charge level is reached (Table 1). To charge the sensors with the help of the USB cable, perform the following steps:

Connect one end of the USB cable to the sensor (pos. 4 in Fig. 5) and another end of the cable to the USB port of the computer (Fig. 14). 25 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). 3.1.2. Attaching the Sensor to a Subject The sensor is attached to a subject using elastic straps and sensor mounts included into the list of components. To fix the sensor on a subject, do the following:

1. Pass elastic strap through the sensor mount bars (see section 2.6 Elastic Strap), if it was not done earlier. 2. Attach elastic strap with the mount to a subject (Fig. 15). Fig. 15. Attaching elastic strap with a mount to a subject 26 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).

(a)

(b) Fig. 16. Variants of sensor placement into the mount: (a) with socket facing down, (b) with socket facing up 27 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 patients skin. 2. Connect EMG cables to the sensors (Fig. 17). Fig. 17. Connection of EMG cable to the sensor 3. Connect EMG cables to the electrodes. Taking into consideration that red/black pair is +/ of the 1st EMG channel, yellow/purple pair is +/ of the 2nd EMG channel and green one is grounding electrode. 28 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). If the battery status indicator doesnt light, it means that the sensor is switched off. 3.2. Workflow The workflow depends on the medical device the set is used with. Please follow the instructions of the user manual for the particular medical device. 3.3. After Use Procedure Upon test completion perform the following steps:

1. Disconnect EMG cables from the electrodes applied to a patient. 2. Disconnect EMG cables from the sensors. 3. Take elastic strap together with sensor that is still in the mount off a patient. 4. Take the electrodes off a patient. Discard disposable electrodes according to section 6 Disposal. 5. Switch the sensor off. To do this press and hold sensor power button (pos.1 in Fig. 5) for 2 seconds. If the battery status indicator doesnt light, it means that the sensor is switched off. 29 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). If long interruption in use of the set (one month and more) is supposed it is necessary to perform full charge of sensor battery regularly (not less than once a month). This prevents the battery from full discharge which may affect battery capacity. 3.4. Troubleshooting The list of possible troubles that can be eliminated by the user on its own are given in Table 4. If troubles other than those specified in the table below occur, the user shall contact the service center of Neurosoft. Table 4. Possible troubles and the way of their removal Trouble symptom Cause Solution The sensor fails to switch on. The sensor battery is discharged. Charge the sensor battery. The sensor battery discharges fast (holds the charge for less than 4 hours at the full charge). The service life of the sensor battery is expired. Contact service center of Neurosoft. 30 Table 4 (continued) Trouble symptom Cause Solution The sensor is connected to the computer using USB cable, but it fails to charge (battery status indicator doesnt light). The sensor is placed into the charging station but fails to charge (battery status indicator doesnt light). The sensor is switched on, but the operation mode indicator doesnt light. USB port of the computer is faulty. USB cable is damaged. The computer is switched off. The charging station is switched off. The charging station is not plugged to the mains. The sensor is placed into the charging station incorrectly. The router is switched off. The sensor didnt receive the IP-

address of the access point. The access point specified in the sensor settings is not found. Connect the sensor to another USB port of the computer. Replace the USB cable. Switch the computer on. Switch the charging station on. Check connection of the charging station to the mains. Check if the sensor is placed into the charging station correctly (see Fig. 13). Switch the router on. Enable DHCP in router settings. Make sure that the channel number in the router settings is within the range 113 and standard 802.11b/g/n is selected. Check if Wi-Fi network name is correct in the sensor settings using the software of the medical device the set is used with. 31 Neurosens (User Manual) Table 4 (continued) Trouble symptom Cause Solution Check if Wi-Fi network password is correct in the sensor settings using the software of the medical device the set is used with. Replace the EMG cable. The password specified in the sensor settings is incorrect. No EMG signal or strong interference of EMG signal is detected. EMG cable is damaged. 4. Maintenance 4.1. General Requirements Safety precautions when carrying out maintenance comply with those described in section Safety Precautions. The requirements to the service personnel qualification are specified in section 2.1 Personnel Requirements. When detecting a trouble, please refer to the information given in section 3.4 Troubleshooting. the trouble cannot be eliminated, please contact the service center of Neurosoft (5, Voronin str., Ivanovo, 153032, Russia). If The set is subject to user maintenance. The volume of the user maintenance is specified in section 4.2 User Maintenance. 4.2. User Maintenance User maintenance of the set includes visual inspection, check of connectors and cables, decontamination of enclosure surface and disinfection according to the recommendations specified in section 4.3 Disinfection. 32 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), 70 % ethyl or isopropyl alcohol solution, 0,5 % chlorohexidine solution. If hepatitis or any other dangerous virus contamination is suspected use:

aldehydes (Cidex, Korsolin) or chlorinates (Diversol BX). Prepare and use disinfectant as stated by the manufacturer. Be careful not to drip water or disinfectant directly into the input and output plugs and other openings of the sensors and the charging station. Keep all cleaning fluids away from electrical connectors. Remove excess disinfectant with a dry cloth. 4.4. Lifetime The set lifetime is 3 years from the shipment date to the user. The manufacturer is obliged to provide technical support of the product throughout its lifetime. 33 Neurosens (User Manual) 5. 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 requires opening sensor enclosure and charging station enclosure is prohibited. that The set components must be switched off and disconnected form mains during the repair. 6. Disposal The set shall not be disposed of in the general waste. The set disposal is performed according to your local regulations. The used rechargeable batteries should be disposed as a hazardous waste as they contain hydride of heavy metals. 34 7. 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 35 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. 8. Warranty 8.1. The manufacturer guarantees the set quality conformance to the design documentation requirements if the rules of operation, storage, transportation, installation and maintenance established in the technical documentation are observed. 8.2. Warranty period for the sensors and charging station is 24 to the customer. The months from the date of shipment shipment date is the date of invoice or any other document the items were delivered with. Warranty period for components subject to wear and tear (EMG cables, sensors mounts, fixing and elastic straps) is 30 days. The warranty does not cover consumables (surgical pastes and disposable electrodes). tapes, The warranty period can be prolonged for the period from reclamation submission up to repair completion (see section 9 Reclamations). Warranty storage period is not less than 6 months. 8.3. Warranty is voided in the following cases:

if the rules of operation, storage, transportation, installation and maintenance established in the technical documentation are not observed;

when the warranty period is expired;

36 if a user breaks the seal without permission of manufacturer. the 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 Ivanovo, 153032, Russia) according to the

(5, Voronin str., procedure described in section 9 Reclamations. 9. Reclamations 9.1. In case of the set components failure or detection of their fault within the warranty period or during primary acceptance the consumer shall send written notification to Neurosoft, to the authorized European representative or to the nearest distributor. the The actual website:

This notification shall include the following information:

list of Neurosoft distributors is available at www.neurosoft.com/en/pages/dealers. consumers name and address;

serial number of the sensor or sensor charging station

(specified in package report and on the label);

number and date of confirming the set purchase;

the invoice or other document detailed description of faults. If possible state the reasons and circumstances preceding fault detection (in addition it is recommended to attach test report, exam data, photos and other materials that allow solving the problem as soon as possible). 9.2. If the set components are returned to the service center for repair the following rules should be observed:

37 Neurosens (User Manual) they should be disinfected before sending to the service to cleaning and disinfection rules center. Please refer specified in section 4.3 Disinfection;

they should be packed in such a way to prevent possibility of their damage during transportation;

the the notification (see p. 9.1) must be included into the shipment with the set components being returned. 38 Annex 1. Main Specifications Main specifications of the set are given in Table 5. Table 5. Main specifications Parameter Neurosens IMU Sensor Battery type Battery capacity Battery voltage Value Li-pol not less than 850 mAh 3.7 V Maximum battery charge time using USB cable not more than 3 h Channel type Channel type Wireless connection with PC accelerometric gyroscopic magnetometric electromyographic accelerometric gyroscopic magnetometric electromyographic yes Continuous operation at a fully charged battery not less than 4 h Wireless IMU connection Interface Transmission range Maximum number of sensors simultaneously connected to PC Wi-Fi, standard IEEE 802.11n not less than 10 m, in the line of sight 12 pcs. Mal-synchronization of the sensors not more than 0.005 s EMG Acquisition Number of differential channels Sampling rate A/D converter 2 2 kHz 24 bits Common mode rejection ratio at 50 Hz not less than 100 dB Bandwidth in EMG measurement mode 5 to 500 Hz @ ( 3 0.5) dB 39 Neurosens (User Manual) Noise level in EMG measurement mode within the range 5 to 500 Hz cut-off frequency with possibility to choose low limit value from the range 5, 10, 20 Hz not more than 2 V RMS Input impedance (differential mode) not less than 100 M Input range of EMG signal 0.07 V to 20 mV EMG signal measurement error within the range 0.07 V to 20 mV and bandwidth 5 to 500 Hz not more than (7 V + 5%

of the measured value) DC offset rejection Patient leakage current Suppression of power line interference by on/off notch filter Electrode impedance Electrode impedance error 330 mV to + 330 mV not more than 0.1 A not less than 40 dB 5 100 k not more than (3 k + 10%

of the measured value) Accelerometer and Gyroscope Channels Sampling rate Input range of measured accelerations

(for each axis) 200 Hz 16 g to + 16 g Permissible acceleration measurement error

(for each axis) not more than (0.04 g + 5%

of the measured value) Angular velocity input range (for each axis) 2000 deg/s to +2000 deg/s Permissible angular velocity measurement error (for each axis) not more than (0.5 deg/s

+ 2% of the measured value) Magnetometer Channel Sampling rate Input range of measured magnetic field

(for each axis) 20 Hz 1000 T to + 1000 T Permissible magnetic field measurement error

(for each axis) not more than (3 T + 5%

of the measured value) Charging Station AC frequency AC voltage DC voltage 40 50/60 Hz

(220 22) V 5 V Power consumption including power supply unit not more than 100 W Maximum number of simultaneously charged sensors Battery status indicator of each sensor 6 yes Maximum battery charge time of each sensor

(fully discharged up to fully charged state) not more than 3 h Power Supply Unit of the Charging Station Input voltage Output voltage Rated output power Climatic Conditions Operation:

o ambient temperature o relative humidity o atmospheric pressure Transportation:

o ambient temperature o relative humidity o atmospheric pressure Storage:

o ambient temperature o relative humidity o atmospheric pressure 100240 V, 50/60 Hz, 0.71.4 A 5 V DC, 6.0 A not less than 30 W

+ 15 to + 35 30 to 75%, non-condensing 70 kPa to 106 kPa 25 to +60 20 to 95%, non-condensing from 70 kPa

+5 to +45 30 to 75%, non-condensing 70 kPa to 106 kPa General Specifications Ingress protection provided by sensor enclosure and charging station enclosure code IP21 according to EN60529 Cable length:

EMG cable:

for NS089103.001-015 for NS089103.001-020 for NS089103.001-030 for NS089103.001-040 for NS089103.001-050 for NS089103.001-060 for NS089103.001-070 for NS089103.001-080 harging cable USB cable A-B Dimensions:

Neurosens IMU sensor IMU Sensor mount Charging station 0.15 0.01 m 0.20 0.02 m 0.30 0.03 m 0.40 0.04 m 0.50 0.05 m 0.60 0.06 m 0.70 0.07 m 0.80 0.08 m 1.50 0.10 m 1.80 0.10 m

(604017) 2 mm

(707020) 2 mm

(20512040) 5 mm 41 Neurosens (User Manual) length:

for NS089221.002-020 for NS089221.002-030 for NS089221.002-040 for NS089221.002-050 for NS089221.002-060 for NS089221.002-070 for NS089221.002-100 for NS089221.002-140 Elastic strap:

width Fixing elastic strap:

width max. length Bottom box insert Upper box insert Transportation bag Weight:

Neurosens IMU sensor IMU Sensor mount Charging station Elastic strap:

for NS089221.002-020 for NS089221.002-030 for NS089221.002-040 for NS089221.002-050 for NS089221.002-060 for NS089221.002-070 for NS089221.002-100 for NS089221.002-140 Fixing elastic strap EMG cable:

0.15 m length 0.2 m length 0.3 m length 0.4 m length 0.5 m length 0.6 m length 0.7 m length 0.8 m length Charging cable USB cable A-B Bottom box insert Upper box insert Transportation bag 50 2 mm 200 10 mm 300 10 mm 400 10 mm 500 10 mm 600 10 mm 700 10 mm 1000 10 mm 1400 10 mm 25 2 mm 1000 10 mm

(40330760) 10 mm

(40330743) 10 mm

(430345165) 10 mm 40 4 g 18 2 g 300 30 g 10 2 g 14 2 g 19 2 g 23 2 g 28 3 g 32 3 g 46 5 g 65 7 g 18 2 g 15 2 g 16 2 g 20 2 g 25 3 g 27 3 g 30 3 g 35 4 g 40 4 g 37 4 g 95 5 g 94 5 g 53 5 g 1.2 0.1 kg Total weight with accessories in package not more than 5 kg Applied parts (sensors) BF type 42 Safety and electromagnetic compatibility Electromagnetic compatibility (EMC) of the set is ensured by compliance with the requirements of IEC 60601-1-2-2020. The set environment described in Annex 3. is intended for operation in electromagnetic 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.

AAMI Regarding safety the set complies with the requirements of A1:2012, ANSI ES60601-1:2005/(R)2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text)

[Incl. AMD2:2021] and EN 60601-2-40:2019. EMC of sensors and sensor charging station is ensured by compliance with the requirements of IEC 60601-2-40(2016). The sensors fall under the class of equipment with a built-in power supply unit according to ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text)

[Incl. AMD2:2021]. 43 Neurosens (User Manual) 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 Order code or main specification Neurosens IMU sensor NS089201.002-020 harging station Power supply unit NS089201.003-02 input voltage:

100240 V, 50/60 Hz, 0.71.4 A;

output voltage:

5 V DC, 6.0 A, maximum power consumption:

30 W Qty, pcs. 2 to 12 Up to 2 Up to 2 Main supply cable connectors: NEMA 5-15P, IEC Up to 2 320-C13 15A/125VAC length: 2 m Charging cable USB cable A-B IMU sensor mount IMU sensor stickers Fixing elastic strap NS089103.002-15 NS007103.005-01 NS089221.010 NS089210.002 Up to 12 Up to 2 Up to 24 1 NS089221.003 Up to 2 44 Table 6 (continued) Name Elastic strap EMG cable Order code or main specification NS089221.002-020 NS089221.002-030 NS089221.002-040 NS089221.002-050 NS089221.002-060 NS089221.002-070 NS089221.002-100 NS089221.002-140 NS089103.001-15 NS089103.001-20 NS089103.001-30 NS089103.001-40 NS089103.001-50 NS089103.001-60 NS089103.001-70 NS089103.001-80 Qty, pcs. Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Up to 12 Operational documentation User manual W089201.002.D100.03.000 1 Package set Bottom box insert Upper box insert Package NS002901.001 NS089212.002 NS089212.004 Up to 2 Up to 2 Up to 2 45 Neurosens (User Manual) Annex 3. Emissions and Immunity Guidance and manufacturers 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. Emission test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Not applicable Not applicable Electromagnetic environment guidance The set uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. establishments The set is suitable for use in all including establishments, domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 46 Guidance and manufacturers 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC 61000-4-2 6 kV contact 6 kV contact Floors should be 8 kV air 8 kV air wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines Not applicable Mains power quality should be that of a typical commercial or hospital environment. 1 kV for input/output lines Not applicable Surge IEC 61000-4-5 1 kV differential mode Not applicable Mains power quality 2 kV common mode Not applicable should be that of a typical commercial or hospital environment. 47 Neurosens (User Manual) Guidance and manufacturers declaration electromagnetic immunity Compliance level Electromagnetic environment guidance Not applicable Mains power quality Immunity test IEC 60601 test level Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT

(>95% dip in UT) for 0.5 cycle 40% UT

(60% dip in UT) for 5 cycles 70% UT

(30% dip in UT) for 25 cycles

<5% UT

(>95 % dip in UT) for 5 s Not applicable Not applicable Not applicable Power frequency magnetic field IEC 61000-4-8 3 A/m 3 A/m should be that of a typical commercial or hospital environment. If the user of the set requires continued operation during power mains interruptions, it is recommended that the set is powered from an uninterruptible power source. Power frequency magnetic fields should be that of a typical commercial or hospital environment. Note: UT is the a.c. mains voltage prior to application of the test level. 48 Guidance and manufacturers 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Radiated RF IEC 61000-4-6 3 V/m 80 MHz to 2.5 Hz 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the set, including cables, than the recommended separation distance calculated from the equation below applicable to the frequency of the transmitter:

17.1 d

(80 MHz to 800 MHz) d

(800 MHz to 2.5 GHz) where P is the maximum output power rating of the transmitter in watts

(W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). 33.2 P P 49 Neurosens (User Manual) Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1) should be less than the compliance level in each frequency range2) Interference may occur in the vicinity of equipment marked with the following symbol:

1) Field strengths from fixed transmitters, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. the measured field strength in the location in which the set is used exceeds the applicable RF compliance level above, the set should be observed to verify normal operation. If abnormal performance is observed, additional measures set. may 2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. necessary, reorienting relocating such the be as or If Notes:

1) At 80 MHz and 800 MHz, the higher frequency range applies. 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 50 Recommended separation distances between portable and mobile RF communications equipment and the set is intended for use in an environment The set 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. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) d 17.1 P d 17.1 P d 33.2 P 150 kHz to 80 MHz 80 MHZ to 800 MHz 800 MHz to 2.5 GHZ 0.117 0.369 1.167 3.689 0.117 0.369 1.167 3.689 0.233 0.738 2.333 7.379 11.667 11.667 23.333 0.01 0.1 1 10 100 Notes:

1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 3. For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. 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 interference in a designed to provide reasonable protection against harmful residential installation. This equipment generates, uses and can radiate radio installed and used in accordance with the frequency energy and, interference to radio communications. instructions, may cause harmful However, there is no guarantee that interference will not occur in a particular installation. interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

this equipment does cause harmful if not If Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, including this device must accept any interference received, and (2) interference that may cause undesired operation. RF Exposure Information:

FCC RF Exposure requirements: The highest SAR value reported under this standard during product certification for use next to the Body/ Limb with the minimum separation distance of 0mm. This transmitter must not be collocated or operating in conjunction with any other antenna or transmitter. 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.

Neurosoft Ltd Voronin str.5, lvanovo, 153032, Russia Federation Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 05-10-2023 Ref: Attestation Statements Part 2.911(d)(5)(i) Filing FCC ID: 2AZHPW0890 Neurosoft Ltd (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Sincerely, Yo Qe:

Vv

(Applicant signature)

(Alexey Ivanov)

Neurosoft Ltd Voronin str.5, lvanovo, 153032, Russia Federation Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 05-10-2023 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID: 2AZHPWO0890 Neurosoft Ltd (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Sincerely, fr ey A (ok

(Applicant signature)

(Alexey Ivanov)

oy :

) Neurosoft www.neurosoft.com, info@neurosoft.com Phone: +7 4932 95-99-99 5 Voronin str., lvanovo 153032, Russia Section 2.911(d)(7) USA Agent for Service of Process Company name: Neurosoft Ltd Address: Voronin str.5, ivanovo, 153032, Russia Federation Product Name: Neurosens IMU sensor FCC ID: 2AZHPWO0890 Model(s): Neurosens IMU sensor 2.911(d)(7) USA Designated Agent for Service of Process We, Neurosoft Ltd (the applicant) designate TeleEMG LLC for the purpose of accepting service of process on behalf of the applicant. Applicant consent: We Acknowledge our consent to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S, address and email address of the designated agent and acknowledge our acceptance of our obligation to maintain an agent for service of process in the United States for no jess than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Agent obligation: We Acknowledge our obligation to accept service of process in the United States for matters related to the applicable equipment at our physical U.S. address and email address for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. USA Agent Applicant Company name: TeleEMG LLC Company name: Neurosoft Ltd Address: 167 N Poinsettia Pl, Los Angeles, CA Address: Voronin str.5, lvanovo, 153032, Russia 90036, United States Federation FRN: 0033712530 Contact Name: Mr. Alexey Ivanov Contact Name: Dr, Joe F Jabre Telephone No: +74932592112 Telephone No: (617) 840-3253 Email: help@neurosoft.com Email: info@teleemg.com Signature:

Signature: 5 ; we pl Ae Title"CEO Title: product manager Date: 28/04/2023 Date: 28/04/2023 RNA A TALEND

Neurosoft Ltd Voronin str.5, Ivanovo, 153032, Russia Federation Agent Authorization Company: Neurosoft Ltd Address: Voronin str.5, Ivanovo, 153032, Russia Federation Product Name: Neurosens IMU sensor Model Number(s): Neurosens IMU sensor Product Description: Neurosens IMU sensor We authorize MiCOM Labs Inc., 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the certification of above named equipment. We declare that MiCOM Labs Inc. is allowed to forward all information related to the approval and certification of equipment to the regulatory agencies as required and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Signature:

Date: 2023-05-16 Name:

Company: Neurosoft Ltd Alexey Ivanov

Neurosoft Ltd Voronin str.5, Ivanovo, 153032, Russia Federation FCC Software Configuration Control Declaration Date: May 17, 2023 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Attn: OET Dept. Product/ Model Number: Neurosens IMU sensor/ Neurosens IMU sensor Regarding FCC Country Code Selection guidelines identified in KDB 594280 v02r01. All applications for equipment authorization for transmitters that can have radio parameters, or other technical parameters, reported to the Commission set by software must have an attestation indicating that no third party will have software, or configuration control, to program the device out of compliance of the technical rules under which it has been certified. We declare that no third party will have software, or configuration control, to program the device out of compliance of the technical rules under which it has been certified. Name: Alexey Ivanov Date: 2023-05-17 Signature of applicant FCC Software Configuration Control Declaration Rev1.1

Neurosoft Ltd Voronin str.5, lvanovo, 153032, Russia Federation Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 2023-05-10 Subject; Request for Confidentiality FCC ID: 2AZHPW0890 To Whom It May Concern, Pursuant to the provisions of the Commissions rules Title 47 Sections 0.457 and 0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. XX] Schematic Diagram XX] Block Diagram

[_] Parts List Operational Description

[_] Tune-up Procedure In additional to above mentioned documents, in order to comply with the marketing regulations in Title 47 CFR 2.803 and the importation rules in Title 47 CFR 2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices, we request Short Term Confidentiality of the following attachment(s);

[_] External Photos

[_] Test Setup Photos

[_] Internal Photos

[_] User Manual

[_] For 45 days, pursuant to Public Notice DA 04-1705. OR

[_] For 180 days pursuant to KDB 726920 D01. It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely Contact person: Alexey Ivanov