BioMonitor SmartLeadP852 Rev B (April 2019) 44.1 Risks and BenefitsThere is no identified risk of physical harm or injury with use of the Ultium BioMonitorSmartLead. The benefit provided by use of the device is the provision of objective measures toassess the severity of pathological human movement conditions and gauge any subsequentimprovement offered by therapy, training, prosthetic alterations or ergonomic design changes.4.2 Safety Information SummaryCautions• Never use the Ultium BioMonitor on a person with an implanted pacemaker• Never operate the Ultium BioMonitor within 1 meter of any critical medical deviceWarnings• Do not immerse the Ultium sensors in any water or liquid• Do not use the Ultium equipment on individuals undergoing MRI, Electro Surgery orDefibrillation• The Ultium BioMonitor product produces results that are informative, not diagnostic.Qualified individuals must interpret the resultsAttention• The operator must be familiar with typical characteristics of the signals acquired by theUltium BioMonitor and be able to detect anomalies that could interfere with properinterpretation.5.1 Quick Start GuidesPlease see the hardware manual for the appropriate EMG system.P-880: Ultium user manual4 General Warnings and Cautions5 Getting Started