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NEURO20 PRO System Operating Manual

Whole-body electrical muscle stimulation
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Whole-Body
Electrical Muscle Stimulation
NEURO20 PRO System
OPERATING MANUAL
Version 1.7
© 2024 Neuro20 Technologies
®

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  • Page 1 Whole-Body Electrical Muscle Stimulation NEURO20 PRO System OPERATING MANUAL Version 1.7 © 2024 Neuro20 Technologies ®...
  • Page 2 ® Indicates a trademark is registered in the U.S. and other countries. Published by Neuro20 Technologies Corp. 140 Pine Ave N, Oldsmar, FL 34677 USA +1 (917) 503-6876 support@neuro20.com www.neuro20.com Copyrighted in the United States of America Product No. Neuro20 PRO System 1.1 Operating Manual: N20PRO-OM-V1.7 02/24...
  • Page 3 ® Neuro20 ® PRO System OPERATING MANUAL N20PRO-OM-V1.7 02/24 © NEURO20 TECHNOLOGIES 2024 See symbols glossary in the TECHNICAL SPECIFICATIONS section of the User Manual.

  • Page 4: Table Of Contents

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 TABLE OF CONTENTS SYMBOLS DESCRIPTION................IV INTRODUCTION..................INDICATIONS OF USE ................1 INTENDED USE ENVIRONMENT..............2 SAFETY.......................2 ADVERSE REACTIONS................2 CONTRAINDICATIONS................3 WARNINGS....................3 PRECAUTIONS...................6 CONTACT....................9 PRODUCT DESCRIPTION.................10 SYSTEM COMPONENTS AND OVERVIEW..........12 Neuro20 PRO Control Box..............13...
  • Page 5 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 TABLE OF CONTENTS (continued) OPERATING PROCEDURES..............22 Putting on Neuro20 Smart Suit............22 Neuro20 Control Box.................23 Attaching Neuro20 Control Box............24 Detaching Neuro20 Control Box............25 Initial Software Setup................26 Neuro20 PRO Software - Accounts & Profiles........27 Software Registration and Admin/Owner Profile Setu......28 Accessing Neuro20 PRO Manual............29...

  • Page 6: Symbols Description

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 SYMBOLS DESCRIPTION The symbols and their descriptions will appear throughout sections of the Operating Manual. These symbols are associated with the Contraindications, Warnings, Precautions, and potential Adverse Effects. When seeing a symbol read carefully and consider the information prior to operating the equipment.

  • Page 7: Introduction

    +1.917-503-6876. Proper use and maintenance of the System is the sole responsibility of the registered owner/operator. The Neuro20 PRO System is a medical device not intended for resale, loan, or lease to any third-party operator. Any resale, lease, loan, or distribution of the Neuro20 PRO System may only occur with the written consent of Neuro20 Technologies.

  • Page 8: Intended Use Environment

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 INTENDED USE ENVIRONMENT The Neuro20 Pro System is intended to be used in a professional setting such as physicians’ office, physical therapist, professional sports setting, and nursing homes, as well as in the home healthcare environment.

  • Page 9: Contraindications

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 Submitting Adverse Event Reports to FDA Use one of the methods below to submit voluntary adverse event reports to the FDA: Report Online at www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home Consumer Reporting Form FDA 3500B.
  • Page 10 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 WARNINGS (continued) Implanted Defibrillator Do not use electrical stimulation on patients with an implanted defibrillator, because this may cause electric shock, burns, electrical interference, or death. Implanted Medical Device...
  • Page 11 Explosion hazard exists if the Neuro20 PRO System is used in the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide. External Stimulator Systems Electrical stimulation should not be applied directly over external stimulator Systems with lead wires.

  • Page 12: Precautions

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 WARNINGS (continued) User Activity Portable powered muscle stimulators should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury. Do not use when bathing or swimming. Do not apply powered muscle stimulators while falling asleep.
  • Page 13 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 PRECAUTIONS (continued) Lead Wires Never connect lead wires to a power line or electro-surgery equipment. Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.
  • Page 14 Keep out of the hands/reach of children at all times. The Neuro20 PRO System contains small parts that will be harmful if swallowed and no part or component is intended for human consumption. Seek medical attention if swallowed.

  • Page 15: Contact

    Neuro20 PRO System. The Neuro20 PRO System has been tested in the presence of these types of devices and while no adverse event occurred, the device should not be operated within the vicinity or environment as another RF emitting device.

  • Page 16: Product Description

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 PRODUCT DESCRIPTION The Neuro20 PRO System is a powered muscle stimulator designed for individual or group rehabilitation and recovery. The System can create co-contraction muscle resistance as well as optimized sequenced movement patterns. The involuntary muscle activation can be voluntarily over-ridden through intentional exercise.
  • Page 17 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 Model Number: N20-PRO-SYS The Neuro20 PRO System is designed to be operated for sessions for 1-10 users at a time. One Control Box is assigned per user and attaches to each user’s Smart Suit.

  • Page 18: System Components And Overview

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 SYSTEM COMPONENTS AND OVERVIEW Neuro20 PRO System Components: • Neuro20 PRO Control Box - Model Number: N20-PRO-CB • Neuro20 PRO Software - Model Number: N20-PRO-SW • Neuro20 Smart Suit - Model Number: N20-SS •...

  • Page 19: Neuro20 Pro Control Box

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 SYSTEM COMPONENTS AND OVERVIEW (continued) Neuro20 (PRO) System Operating Manual: N20-PRO-SOM-Ver 1.7 02/24 Neuro20 System Operating Manual Neuro20 System Operating Manual is a guide for safe operation and maintenance.

  • Page 20: Battery & Charger

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 System COMPONENTS AND OVERVIEW (continued) Battery & Charger The provided battery (LP-E5 battery, model LF7.4900) & charger for the Neuro20 PRO Control Box are certified for the use with Neuro20 PRO System.

  • Page 21: Operating Tablet

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 System COMPONENTS AND OVERVIEW (continued) Operating Tablet – (Apple iPad, 9th generation or above) The Operating Tablet comes with pre-setup for Neuro20 PRO use needs. The tablet wirelessly connects to the Neuro20 PRO Control Box and operates the Neuro20 PRO Software (app).

  • Page 22: Neuro20 Smart Suit

    Lanyard with connector magnetic attachment Velcro Strap at the bottom for extra of the zipper protection of Control Box * Color of the Neuro20 Smart Suit displayed in this manual may not reflect the actual final product. 16 | www.neuro20.com...
  • Page 23 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 System COMPONENTS AND OVERVIEW (continued) Neuro20 Smart Suit - N20-SS (continued) Electrodes (pads) on the Neuro20 Smart Suit fit over the following muscle groups. Neuro20 Smart Suit - Electrodes / Muscle Group Diagram Pectorals &...

  • Page 24: Neuro20 Smart Suit Sizing

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 Neuro20 Smart Suit - Sizing The Neuro20 Smart Suit is unisex and comes in 7 sizes. The Smart Suit is made from durable, anti-microbial, flexible, fitting material. The chart below is an approximate size guide.

  • Page 25: Operating Modes

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING MODES The Neuro20 PRO System features five operating modes: Strength, Conditioning, Cool Down, Massage and Patterned Movements. Operating Stimulation (Work) Rest Period Mode Period No stimulation No stimulation...

  • Page 26: Instructions Of Use

    It is recommended that increases in stimulation time should not go beyond 30 minutes overall. Treatment and use of the Neuro20 PRO System should be terminated at the physician’s discretion. The physician should be aware of all warnings and precautions listed in this manual.

  • Page 27: Running Asession

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 INSTRUCTIONS OF USE (continued) Strength, Conditioning, Cool Down, Massage, Patterned Movements Trainings should be separated by a regeneration phase of at least 3 days between the sessions. Depending on the athlete’s/patient’s physical condition and fitness level, the regeneration phase may have to be longer.

  • Page 28: Operating Procedures

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES Neuro20 Smart Suit Prior the first use, inspect the Smart Suit to ensure there are no exposed wires, holes, or tears. Prior to putting on the...

  • Page 29: Neuro20 Control Box

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Neuro20 PRO Control Box Prior to each training session, ensure a charged battery is in the Neuro20 PRO Control Box. Inserting and removing the battery: 1. Twist the knob to the left to unlock the cover.

  • Page 30: Box

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Neuro20 PRO Control Box (continued) Attaching Neuro20 PRO Control Box 1. Ensure the Velcro strap on the suit is not in the fastener and out of the way (Fig.1) prior to connecting the Control Box, and that the silicone plug is out...

  • Page 31: Detaching Neuro20 Control Box

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Detaching the Neuro20 PRO Control Box 1. Press the Neuro20 PRO Control Box Power Button (Fig.1) and ensure that the indicator lights are off. 2. Open the velcro fastening strap attached to the suit (Fig.2), remove from the fastener, and close the hook and pile strap to each other (Fig.3) to prevent...

  • Page 32: Initial Software Setup

    Neuro20 PRO Software Installation To ensure proper functionality and updates of the Neuro20 PRO Software, make sure the iPad is signed in with the Neuro20 PRO System Owner’s Apple ID credentials. Follow these steps to install the Neuro20 PRO app on your tablet: 1.

  • Page 33: Neuro20 Pro Software Accounts/Profiles

    Each profile contains personal data and stores individual training information. Profiles have different levels of access to the software and its functionality. The profiles can be created and managed via the Neuro20 PRO App or via any browser on the Neuro20 Web Panel.

  • Page 34: Software Registration And Admin/Owner Profile Setu

    Neuro20 PRO App (Pg. 32). If there is more than one Admin, or if the Admin of the Neuro20 PRO System is not involved in daily operations, another account with same privileges - Manager Account - can be created from “Manage Profiles”...

  • Page 35: Manual

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) The Neuro20 PRO System Operating Manual can be accessed in four locations. 1. Login Screen of Neuro20 PRO Software/App 2. Home Screen of Neuro20 PRO Software/App 3.
  • Page 36 Power-on the Operating Tablet by pressing the power button, then press the home button. If iPad is already On, skip this step. Power Button Home Button Open the Neuro20 PRO Software by tapping the icon at the bottom of the screen. 30 | www.neuro20.com...

  • Page 37: Logging In

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Log-In To Log-in, fill in the user name (registered profile e-mail) and password created during the activation of the profile. If you forgot the password, click on Forgot Password.

  • Page 38: Manage Profiles

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Manage Profiles Manage Profiles allows the Admin/Manager to control and manage all Trainers and Users within the Admin’s Organization Profile. If the user is in an account with Admin/Manager permissions, the screen shall...
  • Page 39 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Importing a User This option allows the user to import a member assigned to a different Organization registered with Neuro20. The import function is accessible via the Import Profile or QR code buttons: 1.
  • Page 40 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Search function If the operator clicks the Search Icon, a pane will appear on the right-hand side, showing the profiles registered in the Owner’s Account database.

  • Page 41: Manage Devices

    On the Home Screen, click on “Manage Devices”, which appears as follows: To activate a Control Box, follow these steps: 1. Press Red “Stop” Button on Neuro20 Control Box to turn the device on. 2. The Control Box with the Wireless ID number will appear. (Fig. 1) 3.

  • Page 42: Updating Firmware - Neuro20 Control Box

    Control Box and Software communicate smoothly. The Admin/Manager or Trainer will be notified about the new available firmware via the Neuro20 PRO App after logging in and turning the Control Box on. The update process needs to be done manually.
  • Page 43 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Updating Firmware - Control Box (continued) To proceed with the Firmware Update, follow these steps: Fig. 1 Press and Hold 1. Make sure the Control Box is turned OFF for 3 seconds 2.
  • Page 44 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Checking Control Box Details Within the Neuro20 PRO Software, the Operator is able to verify the Control Box details, including: – Serial Number – Firmware Version –...
  • Page 45 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Software Screen - Control Box Indicators The connection status of the device is shown at the bottom of each block. If the Control Box is correctly connected, a green dot appears and the text reads “Connected”.

  • Page 46: Starting A Training Session

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Starting a Training Session Press “Start Training” on the Home/Main Screen. The “Assign Session Members” screen will appear. 40 | www.neuro20.com...
  • Page 47 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Assign Session Members Turn on and Assign Control Box to a Member one at a time, to assure correct assignment. Fig. 1 1. Power-on the Control Box by pressing the red “Stop”...
  • Page 48 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Fig. 1 The member assigned to a Control Box will have their Profile Name appear beneath the box. (Fig. 1) The Trainer should verify the correct assignment on each Control Box prior to assigning the next Member.
  • Page 49 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Operator Agreement Prior to every training session the operator must read the Operator Agreement Form shown on the Device Screen and press the “I agree” button to proceed.

  • Page 50: Training Session Setup - Basic Training Modes

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Training Session Setup - Basic Training Modes Whole-Body Patterns - Strength, Conditioning, Cool Down, Massage 1. Select a Training Mode, and the chosen mode will appear on a blue background with a checkmark to indicate its selection.
  • Page 51 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) 2. Select the desired Duration of the training session. The selectable durations range from 10-40 minutes with five-minute increments. 3. Select the desired “Ramp Up” setting. “Ramp Up” is how quickly your stimulation will reach peak intensity.

  • Page 52: Training Session Screen

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) 5. Press the “Begin Training” button in the top right corner to open the Training Session window. Training Session Screen - Basic Training Modes The training screen appears with all the Assigned Members and the selected Training Mode in the top center of the screen.

  • Page 53: Adding Stimulation

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Adding Stimulation 1. Press on the member’s profile picture at the top of the screen, or press “Select All” in the top right of the screen. A blue circle (highlight) will appear around the User’s picture.
  • Page 54 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) 5. Adjust the stimulation intensity with the + and – buttons on screen. The percentage value will increase or decrease by 0.5% increments. The increase of the stimulation (+) can be adjusted only during the Stimulation Period.
  • Page 55 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Continue with step 6, adjusting the level of each individual muscle group for each individual User, one by one, until you reach the desired level for the training session.
  • Page 56 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Training Timer - Basic Training Modes For Basic Training Modes the bottom of the Training Screen features a timer showing the Elapsed Time and Remaining Time of the training session and a countdown within the circle for the remaining: •...

  • Page 57: Pausing Training Session

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Pausing the Training Session Training can be Paused in two (2) different locations: 1. At the bottom of the Muscle groups - “Pause” symbol (will pause all Users) 2.
  • Page 58 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Resuming Paused Training Session (continued) 2. To Resume the session paused for an Individual User - press “Resume” under the name of the paused User. The User will automatically resume the session at whatever timeline the rest of the group has progressed to, and at stimulation levels which were set for this User at the time of pause.

  • Page 59: Training With Pems - Patterned Ems Modes

    PEMS mimics voluntary movement patterns. This stimulation is mostly targeted for Athletic Recovery and Performance training, specific to the movement. As Trainer of Neuro20 PRO System, you need to understand the major difference in setting up the PEMS Training, as there are 2 major groups within PEMS Modes:...
  • Page 60 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Training Session Setup - CONTINUOUS PEMS Modes Cycling, Sprinting, Walking, Jogging, Running 1. Select “Patterned Movements” on the Training Session Setup Screen. This will reveal the list of PEMS Modes. Select one of the Continuous PEMS Modes (Cycling, Sprinting, Walking, Jogging, Running).
  • Page 61 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Training Screen - CONTINUOUS PEMS Modes Cycling, Sprinting, Walking, Jogging, Running The PEMS Modes Training Screen features distinct layouts and muscle group categorizations tailored to the selected mode. This customization is designed to target and activate specific muscle groups essential for providing assistance during the corresponding movement associated with each mode.
  • Page 62 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Training Session Setup - REACTIVE PEMS Modes Jumping, Sitting/Standing, Throwing, Swinging, Kicking 1. Select “Patterned Movements”, on the Training Session Setup Screen to reveal the list of PEMS Modes. Select the desired Reactive PEMS Mode, which will appear on a blue background with a checkmark.
  • Page 63 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Training Session Setup - REACTIVE PEMS Modes (continued) Jumping, Sitting/Standing, Throwing, Swinging, Kicking Throwing, Swinging and Kicking modes have an additional setting feature: a toggle switch to set up the User’s dominant hand/foot in these specific activities (training modes).
  • Page 64 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) REACTIVE PEMS Modes Training Screen - Jumping, Sitting/Standing, Throwing, Swinging, Kicking (continued) Training Session - PHASE 1 - Stimulation Level Setup 1. Click on Play on the bottom right of the screen. This will activate the Phase 1 session setup - Stimulation Level Setup.
  • Page 65 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) The muscle group selection and layout are different for each Reactive PEMS training mode. Muscle groups have been chosen very carefully to activate all necessary muscles, in a very specific order, to perform the desired move.
  • Page 66 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) REACTIVE PEMS Modes Training Screen - Jumping, Sitting/Standing, Throwing, Swinging, Kicking (continued) Training Session - PHASE 1 - Stimulation Level Setup (continued) Kicking - Left Handed...
  • Page 67 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) REACTIVE PEMS Modes Training Screen - Jumping, Sitting/Standing, Throwing, Swinging, Kicking (continued) Training Session - PHASE 2 - Training Cycles During Phase 2 of Reactive PEMS Training Session, all parameters have been preset, and the Trainer can focus on assisting the User, assuring the body position and form are adequate to the specific move (i.e.

  • Page 68: Session End

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 OPERATING PROCEDURES (continued) Session end Once the elapsed time ends and the remaining time becomes zero, stimulation intensities are reduced to zero and all users are deselected. An extra dialogue box shall appear, as follows: Press Exit training to open the Main Screen.

  • Page 69: Electromagnetic Compatibility

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 ELECTROMAGNETIC COMPATIBILITY This device uses Bluetooth Low Energy (IEEE 802.15.1) on the 2.4 GHz frequency and at a maximum of 8 dBm. The Neuro20 PRO System was tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices to IEC 60601-1- 2.
  • Page 70 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 ELECTROMAGNETIC COMPATIBILITY (continued) Caution: Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions. It is possible that high levels of radiated or conducted radio-frequency electromagnetic...
  • Page 71 Table 201: Guidance and manufacturer’s declaration - electromagnetic emission The Neuro20 PRO System is intended for use in the electromagnetic environment specified below. The customer or the user of the Neuro20 PRO System should ensure that it is used in such environment...
  • Page 72 The Neuro20 PRO System is intended for use in the electromagnetic environment specified below. The customer or the user of the Neuro20 PRO System should ensure that it is used in such an environment, and that precautions regarding that environment are heeded.
  • Page 73 Table 204: Guidance and manufacturer’s declaration – electromagnetic immunity The Neuro20 PRO System is intended for use in the electromagnetic environment specified below. The customer or the user of the Neuro20 PRO System should ensure that it is used in such an environment.
  • Page 74 Table 206: Recommended separation distances between portable and mobile RF communications equipment and Neuro20 PRO System The Neuro20 PRO System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Neuro20...

  • Page 75: Technical Specifications

    During intended use, the user should wear the Neuro20 PRO Smart Suit, whilst the trainer should adjust stimulation intensity on the Neuro20 PRO Operating Tablet, in liaison with the user. The Neuro20 Smart Suit is for single patient use only! Do not share Neuro20 Smart Suits between different users.
  • Page 76 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 TECHNICAL SPECIFICATIONS (continued) Symbols on the Unit and Case Caution! (electrical output) Patient’s shock protection type: BF (Body Floated) Equipment. This equipment is not earthed but contains a battery within an insulated unit.

  • Page 77: Troubleshooting

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 TROUBLESHOOTING What if my Neuro20 Operating Tablet does not turn on? a. Check to ensure the Neuro20 Operating Tablet is properly charged. If not, plug in and ensure that the charging indication light and charging symbol are on.
  • Page 78 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 TROUBLESHOOTING (continued) What if an Orange Exclamation Point in a Triangle appears when searching for Members? If the user’s account is not confirmed, an orange exclamation mark will appear next to the member’s name and e-mail address in the search.
  • Page 79 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 TROUBLESHOOTING (continued) What if the Neuro20 PRO Control Box is not connecting to the Operating Tablet? a. Check the Indicator Light on the Neuro20 PRO Control Box to ensure that the Control Box is on.
  • Page 80 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 TROUBLESHOOTING (continued) What if one or more of the User’s icons shows a warning indication? a. Warning indications may appear for multiple reasons. b. This feature occurs when the Control Box is out of range of the Operating Tablet, is turned OFF, or the battery runs out.

  • Page 81: General Maintenance

    Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 GENERAL MAINTENANCE It is expected that all operators maintain the Neuro20 PRO System and all of the component parts by using the guidelines provided herein. Neuro20 recommends that the Neuro20 PRO System is only operated after the owner is comfortable and knowledgeable of all contents within the Operating Manual.
  • Page 82 System is not in operational use. Keep away from lint, dust and debris. To clean the Neuro20 PRO Control Box use a soft, clean, lint free, dry, nylon brush and gently wipe the surface. If there is any visible damage to a Neuro20 PRO Control Box, remove the item in question from use, store properly, and immediately contact at support@neuro20.com.
  • Page 83 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 GENERAL MAINTENANCE (continued) Neuro20 Smart Suit (continued) Do Not! 1. Do not dry clean or clean chemically. 2. Do not bleach or use any fabric softener or fragrance enhancer.
  • Page 84 Neuro20 Smart Suit, remove the suit from serviceability and contact customer support at support@neuro20.com. The Neuro20 Smart Suit should be stored indoors in a clean, dry, pest free environment away from pets and children, and never stored in direct sunlight.

  • Page 85: Limited Warranty

    To initiate a warranty claim, the following steps shall be followed: 1. Contact your Sales Representative (if applicable), or refer to the Troubleshooting section at www.neuro20.com to determine if a claim needs to be filed or if the issue can be resolved directly by customer; 2. If problem persists, submit a warranty claim in writing to warranty@neuro20.com, or in another manner specified by the...
  • Page 86 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 LIMITED WARRANTY (continued) This warranty does not cover any damage caused by misuse, abuse, accidents, wear and tear from normal use, alterations to the Product, or use of the Product with components made by any manufacturer other than Manufacturer.
  • Page 87 Neuro20 PRO System Operating Manual | © Neuro20™ | N20PRO-OM-V1.7 | 02/24 LIMITED WARRANTY (continued) NON-WARRANTY REPAIR SERVICE: Non-warranty repair service may be available for a fee. Contact Manufacturer at warranty@neuro20.com for further information. All limitations and exclusions herein are agreed to and accepted by the Purchaser upon purchase of the Product.
  • Page 88 “Attention: Permissions Coordinator,” at info@neuro20.com. Published by Neuro20 Technologies Corp. support@neuro20.com www.neuro20.com For orders and more information please contact: Tel: +1 (917) 503-6876 email: support@neuro20.com or visit www.neuro20.com Product No. Neuro20 PRO System Operating Manual: N20PRO-OM-V1.7 02/24 82 | www.neuro20.com...
  • Page 89 | 83...

  • Page 90: Www.neuro20.Com

    WWW.NEURO20.COM All Rights reserved © 2024 Neuro20 Technologies ®...

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