2D Goniometer SmartLead User Manual
8
(Rev D January 2020)
4 General Warnings and Cautions
4.1 Risks and Benefits
There is
no identified risk of physical harm or injury
with use of the 2D Goniometer SmartLead.
The benefit provided by use of the SmartLead is that it provides users with the freedom to select the
appropriate sensor for their application.
4.2 Safety Information Summary
Cautions
•
Never use the 2D Goniometer SmartLead to collect data from a person with an implanted
pacemaker
•
Never operate the 2D Goniometer SmartLead 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 2D Goniometer SmartLead product may produce 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 2D
Goniometer SmartLead and be able to detect anomalies that could interfere with proper
interpretation.