Linear Force SmartLeadP-802 Rev B (May 2019) 44 General Warnings and Cautions4.1 Risks and BenefitsThere is no identified risk of physical harm or injury with use of the Ultium Linear ForceSmartLead. 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 Linear Force SmartLead to collect data from a person with animplanted pacemaker• Never operate the Ultium Linear Force SmartLead within 1 meter of any critical medicaldeviceWarnings• 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 Linear Force SmartLead 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 Linear Force SmartLead and be able to detect anomalies that could interfere withproper interpretation.