Introduction; Brief Description; Device Safety Categories; Intended Use - Noraxon Ultium EMG System User Manual

Ultium EMG Hardware User Manual

2 Introduction

2.1 Brief Description:

The Ultium System for EMG and other biomechanical sensors wirelessly transmits data from the
electrode or sensor site to a desktop receiver.
This wireless transmission concept greatly simplifies the collection of EMG measurements by
eliminating cable connections between the EMG electrodes and EMG amplifier. The small, lightweight
EMG sensors are also beneficial for small subjects like children and small animals.
This unique concept gives the user the flexibility to operate the Ultium System without the traditional
laboratory-based measurement limitations. The Ultium System is designed to operate any
configuration between 1 and 16 sensors. Multiple Ultium Systems can be used simultaneously to
increase the configuration to 32 sensors.
The default system is equipped with EMG sensors but can be upgraded with other biomechanical
sensors, e.g. goniometers, inclinometers, and foot switches. The EMG sensors can also be activated to
measure IMU data or a combination of EMG with acceleration data. A synchronization capability can be
used to accurately synchronize the Ultium System to other biomechanical devices.

2.2 Device Safety Categories

The Ultium System incorporates the following ratings:
Class II (double insulation) for electrical safety with internal battery power during operation
CISPR 11 Class A radio frequency compatibility (ref. Section 17 for details)
Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class
A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer
adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as
relocating or re-orienting the equipment

2.3 Intended Use

Noraxon's Ultium EMG sensor is intended to measure and quantify muscle biopotential signals
separately or in combination with other kinematic or kinetic signals. These inter-related measurements
can provide data to assist in understanding movement abnormalities. The system is designed as a
diagnostic tool for clinical, investigational and research applications. Additionally, this device is
compliant to the international standard for diagnostic EMG (IEC 60601-2-40).
Intended Users
Researchers or individuals trained in physical medicine, physical therapy, human performance or
ergonomics and who have gained familiarity with the Ultium System and its software.
Subject Populations – Medical
Individuals with neurological disorders, physical injuries, pre/post-surgical or post stroke conditions.
Subject Populations – Non-medical
Athletes, workers at their work site, subjects in new product trials.
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