Contraindications - Noraxon Ultium EMG System User Manual

Ultium EMG Hardware User Manual
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 System (EMG sensor and Receiver) synchronously acquires and displays muscle activity
signals from multiple muscle sites 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 no identified risk of physical harm or injury with use of the Ultium product. The benefit provided no identified risk of physical harm or injury no identified risk of physical harm or injury
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 EMG 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 EMG is contra-indicated in individuals who have implanted pacemakers.
(Rev J)
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