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BioMonitor SmartLead
Ultium
Biomechanics
Research System
Ultium BioMonitor
SmartLead
User Manual
P-852 Rev B (Apr 2019)
i

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Summary of Contents for Noraxon Ultium EMG BioMonitor SmartLead

  • Page 1 BioMonitor SmartLead Ultium Biomechanics ™ Research System  Ultium BioMonitor SmartLead User Manual P-852 Rev B (Apr 2019)
  • Page 2 Noraxon and myoRESEARCH are registered trademarks and the Noraxon logo, myoANALOG, myoFORCE, myoMETRICS, myoMOTION, myoMUSCLE, myoPRESSURE, myoVIDEO, myoSYNC, NiNOX, TRUsync and Ultium are common-law trademarks of Noraxon U.S.A., Inc. All other trademarks are the property of their respective owners. ©2018, all rights reserved.
  • Page 3: Table Of Contents

    BioMonitor SmartLead Table of Contents 1 Introduction ........................... 1 1.1 Brief Description ........................1 1.2 Contraindications ........................1 2 Definitions ............................. 1 2.1 Graphic Symbols and Meaning ....................1 2.2 Glossary of Terms ........................1 3 Identification ..........................3 3.1 Model Designation ......................... 3 3.2 Product Versions and Configurations ..................
  • Page 4 BioMonitor SmartLead 10.1 Safety Precautions When Cleaning ................... 14 10.2 Cleaning by Users ......................14 11 Maintenance ..........................14 11.1 Device Software (firmware) updates .................. 14 11.2 Maintenance by Qualified Individuals ................15 11.3 Companion Software Updates ................... 15 12 Troubleshooting ........................15 12.1 Website Link to FAQ ......................
  • Page 5: Introduction

    BioMonitor SmartLead 1 Introduction 1.1 Brief Description The BioMonitor SmartLead is an accessory to the Ultium EMG sensor (#810) which is designed to detect the heart rate and respiration rate of the subject utilizing electrodes. The BioMonitor produces five simultaneous real-time data streams including ECG waveform, heart rate, R-R intervals, thoracic impedance (respiration) waveform, and respiration rate.
  • Page 6 BioMonitor SmartLead Ultium Serial Number – A unique five-character tag used to identify each Ultium Sensor or Ultium SmartLead. The members of any Ultium network are determined by their serial numbers. Also, Ultium Sensor Types are grouped into a predefined range of serial numbers. Thus, by serial number the Ultium system can automatically determine the type of signal parameter being transmitted from any Ultium Sensor or Ultium SmartLead in the network.
  • Page 7: Identification

    EMG Sensor (Part# 810) and the Ultium Receiver (Part #880). For additional equipment details refer to Section 9 of this manual. As the Noraxon Systems require software to perform its function, the equipment is offered in combination with the following computer program packages:...
  • Page 8: General Warnings And Cautions

    BioMonitor SmartLead 4 General Warnings and Cautions 4.1 Risks and Benefits There is no identified risk of physical harm or injury with use of the Ultium BioMonitor SmartLead. The benefit provided by use of the device is the provision of objective measures to assess the severity of pathological human movement conditions and gauge any subsequent improvement offered by therapy, training, prosthetic alterations or ergonomic design changes.
  • Page 9: Preparing The Product For Use

    BioMonitor SmartLead 6 Preparing the Product for Use 6.1 Unpacking and Component Identification Ultium BioMonitor SmartLead (Part #852) Additional contents not illustrated BioMonitor SmartLead User Manual (part #852A) This document 6.2 Component Inputs, Outputs and Indicators 1) EMG Sensor (front and top edge) Smart Lead Connector –...
  • Page 10: Component Interconnections

    BioMonitor SmartLead Serial Number: Unique 5-character SmartLead BioMonitor serial number which identifies each SmartLead. 6.3 Component Interconnections Connect the Ultium BioMonitor SmartLead to the Ultium Designated Ultium Sensor (See ‘MR3 Configuration’ Section below for instructions on how to designate a sensor to a specific Ultium Sensor) 6.4 Device Communication (Driver) Software Installation No driver installation is needed.
  • Page 11: Companion Software Installation

    MR3 software. 6.6 Companion Software Configuration Before the Ultium BioMonitor can be used with the Noraxon Ultium system, the companion software must be configured to recognize the different components that make up the system.
  • Page 12: Mr3 Configuration

    BioMonitor SmartLead 6.6.1 MR3 Configuration Step 1 Enter the Hardware Setup screen and setup the Noraxon EMG system in accordance with its provided hardware manual. Step 2 Click ‘Detect Sensors in Charger’ (All sensors which you would like to use must be in the charger) –...
  • Page 13 BioMonitor SmartLead Step 3 Once back in the Home screen, choose to create a new or edit an existing configuration. Step 4 In the measurement setup screen, insert the Ultium system into the Devices in your configuration box. It is recommended that you redetect sensors in the hardware configuration every time the SmartLeads are removed from the Ultium sensor (redetection is necessary to revert to the use of the sensor’s EMG functionality).
  • Page 14: Find My Sensor Feature

    Rate, and R-R Interval). Step 5b Continue with the measurement setup as described in the Noraxon system’s hardware manual. 6.6.2 Find My Sensor Feature Allows the user to quickly locate a specified Ultium sensor while creating/editing a MR3 configuration (refer to section 7 for guidance on how to create or edit a configuration). If one of the stars (refer to the figure below) is clicked, the corresponding sensor will repeatedly blink light purple in bursts of 3.
  • Page 15: Pre-Use Check-Out

    BioMonitor SmartLead If a SmartLead is connected to a sensor when the sensors are detected in the MR3 hardware setup (Section 6 -> MR3 Configuration) it will override the EMG functionality of that sensor. Therefore, if the SmartLead is moved to a new sensor, Step 1-5 of Section 6 (MR3 Configuration) must be recompleted.
  • Page 16: Operating Instructions

    Never use the Noraxon Ultium System on a person with an implanted pacemaker • Never operate the Noraxon Ultium System within 1 meter of any critical medical device 8.2 Normal Functions with Interface to a PC When used with the companion software, the BioMonitor SmartLead displays and records signals similar to the signals presented in Section 7.
  • Page 17: Exceptional Functions/Situations (Error Messages)

    BioMonitor SmartLead 8.3 Exceptional Functions/Situations (error messages) Please see the appropriate Noraxon system’s hardware manual for possible error messages. 8.4 Shutdown after Use At the end of the day: • Place all EMG sensors inside the sensor docking station(s). •...
  • Page 18: Accessories

    BioMonitor SmartLead 9.1 Accessories The BioMonitor SmartLeads do not have any corresponding accessories. 10 Cleaning 10.1 Safety Precautions When Cleaning WARNING Only use a damp cloth with mild soap and water or isopropyl alcohol to clean the bottom of the Ultium Sensors. Do not immerse Ultium Sensors in any water or liquid.
  • Page 19: Maintenance By Qualified Individuals

    11.3 Companion Software Updates • Perform a backup of the data folders to a separate drive as a precaution. • Click on the Patch/Update link provided in the email or as given on the Noraxon website. • Download the Patch/Update file. •...
  • Page 20: Website Link To Faq

    Receiver System. 13.2 Warranty Information Noraxon equipment including optional items is guaranteed to be free from defects in material and workmanship for 1 year from the date of purchase. The warrant period begins on the date of product shipment from Scottsdale, Arizona.
  • Page 21: Spare Parts And Consumables

    If you are shipping from outside the USA please use UPS, FedEx, DHL, or EMS (US Postal Service) and not a freight-forwarder. Using a freight-forwarder incurs additional brokerage fees. If a package is shipped to Noraxon via a carrier other than the ones listed above, it may be refused.
  • Page 22: Technical Specifications

    BioMonitor SmartLead The Ultium BioMonitor SmartLead has a usable life of seven years. 15.2 Technical Specifications Input channels: ECG, Respiration via single electrode pair Sample Rate: 500/1000Hz Input Range: +/- 24,000 uV Analog Output scale factor: 0.208mV/uV Physical Specifications • SmartLead Dimensions: 1.9 cm Width x 1.1 cm Thickness, Length varies slightly 15.3 Environmental Conditions for Storage and Transport...
  • Page 23: Respiration And Ecg

    BioMonitor SmartLead Respiration and ECG This is the recommended attachment for typical use and provides the optimal respiratory signal. However, the accompanying ECG waveform is not representative of any standard ECG lead configuration (although it most closely resembles ECG leads V3 or V4) ECG Standard Lead I This attachment provides a close approximation to ECG Lead I.

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