Physio-Stim; Prescription Information - Orthofix PHYSIO-Stim Manual De Instrucciones

Prescription Information

Indication
The Physio-Stim
acquired secondary to trauma, excluding vertebrae and all flat bones, where
the width of the nonunion defect is less than one-half the width of the bone to
be treated. A nonunion is considered to be established when the fracture site
shows no visibly progressive signs of healing.
Contraindication
Use of this device is contraindicated where the individual has synovial
pseudarthrosis.
Warnings
• The safety and effectiveness of the use of this device on individuals lacking
skeletal maturity has not been established.
• In the presence of a malaligned nonunion, careful consideration of the use
of this device must be undertaken on an individual basis, as treatment with
this device is not intended to alter or affect the degree of malalignment.
• Demand type pacemaker operation may be adversely affected by exposure
to pulsed electromagnetic fields. Physicians should not prescribe a
Physio-Stim for application which may place the treatment transducer in
close proximity to the pacemaker. Further screening by the attending
cardiologist is recommended (such as with an electrocardiogram).
• Animal studies conducted to date do not suggest any long-term adverse
effects from the use of this device. However, long-term effects in humans
are unknown.
• The safety and effectiveness of this device on individuals with a nonunion
secondary to, or in connection with, a pathological condition has not been
established.
Precautions
• Nonunion fractures with gaps in excess of 1 centimeter (cm) have not
been evaluated.
• Although animal reproductive studies performed with this device
demonstrated no adverse findings, the safety of use of this device during
pregnancy and nursing in humans has not been established.
• This device should not be used if there are mental or physical conditions
which preclude patient compliance with physician and device instructions.
Adverse Events
Rare instances of reversible minor discomfort have been reported.
They were: cumbersome or uncomfortable, tingling or pain and
minor skin rash.
is indicated for the treatment of an established nonunion
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