General Warnings And Cautions; Risks And Benefits; Safety Information Summary - Noraxon Ultium EMG System User Manual

Ultium EMG Hardware User Manual

1 General Warnings and Cautions

1.1 Risks and Benefits

There is no identified risk of physical harm or no identified risk of physical harm or no identified risk of physical harm or injury no identified risk of physical harm or
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 or design changes.

1.2 Safety Information Summary

Cautions
Never use the Ultium System on a person with an implanted pacemaker

Never operate the Ultium System within 1 meter of any critical medical device

Warnings
Do not immerse the EMG Sensors in any water or liquid

Do not drop

Do not use in conditions where the temperature can exceed 55 °C (130 °F)

Do not use the Ultium equipment on individuals undergoing MRI, Electro Surgery or

Defibrillation
The Ultium product produces results that are informative, not diagnostic. Qualified individuals

must interpret the results
Attention
The operator must be familiar with typical characteristics of the signals acquired by the Ultium

equipment and be able to detect anomalies that could interfere with proper interpretation.
(Rev J)
injury injury with use of the Ultium EMG System. The benefit injury
5