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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.
4.2 Safety Information Summary
Cautions
•
Never use the Ultium BioMonitor on a person with an implanted pacemaker
•
Never operate the Ultium BioMonitor within 1 meter of any critical medical device
Warnings
•
Do not immerse the Ultium sensors in any water or liquid
•
Do not use the Ultium equipment on individuals undergoing MRI, Electro Surgery or
Defibrillation
•
The Ultium BioMonitor 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 BioMonitor and be able to detect anomalies that could interfere with proper
interpretation.
5 Getting Started
5.1 Quick Start Guides
Please see the hardware manual for the appropriate EMG system.
P-880: Ultium user manual
P852 Rev B (April 2019)
4
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