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Ultium Motion Hardware User Manual
Subject Populations – Non-medical
Athletes, workers at their work site, subjects in new product trials.
Common Applications
Gait analysis; identification of inconsistencies and abnormalities; tracking over time the outcome of
surgical, therapeutic or orthotic interventions; identification of ergonomic stress factors in the
workplace or new product designs.
Suitable Environments
The Ultium System is suitable for use in hospitals, clinics, academic laboratories except near active HF
SURGICAL EQUIPMENT or MRI IMAGING EQUIPMENT.
Expected (Essential) Performance
The Ultium Motion System (Sensor & Receiver) synchronously acquires and displays motion signals
from joint segments in real time.
Consideration should be given to common place wireless networks that may be present in the
environment. Under the conditions of excessive wireless communications performance of the Ultium
System may exhibit sluggish (non-real-time) behavior.
Risk-Benefit
There is no identified risk of physical harm or injury with use of the Ultium product. 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 or design changes.
Special Concerns
The Ultium Motion system operates by means of microwave radio frequency transmissions. Certain
(older, vintage model) pacemaker devices may be susceptible to such microwave transmissions.
Therefore, use of the device is contra-indicated in individuals who have implanted pacemakers.
2.4 Contraindications
Use of the Ultium Motion System is contra-indicated in individuals who have implanted pacemakers.
8
(Rev B)
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