Orthofix AccelStim Manual De Instrucciones página 10

contact of the transducer face with the skin. Failure to do so may result in
the transducer being only partially coupled to the skin. This may reduce the
effectiveness of the AccelStim device in treating the fracture.
•
Only the region of the fracture within the effective radiating area (3.5 cm2) of the
transducer is likely to benefit from the AccelStim device's treatment. Therefore,
the physician and patient should take care in appropriately placing of the device
over the fracture site.
•
Placement of the transducer directly over internal fixation may result in the
treatment signal being partially or fully blocked and may reduce the effectiveness
of the AccelStim device in treating the fracture.
•
When choosing a treatment site, the transducer shall be positioned such that
the ultrasound beam is not impeded by any internal fixation which is directly in
line with the fracture site (i.e., not directly over metal plating). This may require
placement of the transducer on the opposite side of the limb or perpendicular to
the fracture line. Correct placement should be confirmed using radiographic and/
or anatomical markers by a health care provider during the fitting of the device.
The AccelStim device's site of application should be marked onto the patient's skin
with an indelible marker to guide future transducer placements.
Adverse Events
Unlike conventional (physical therapy) ultrasound devices, the AccelStim device is
incapable of producing harmful temperature increases in body tissue.
intensity of the device is 30mW/cm2 and is typically only 1% to 5% of the output
intensity of conventional therapeutic ultrasound devices. The ultrasound intensity is
comparable to diagnostic ultrasound (1 to 50 mW/cm2), such as the intensities used
in obstetrical sonogram procedures (fetal monitoring). In addition, there is no evidence
of non-thermal adverse effects (cavitation). While no device-related adverse reactions
or medical complications were reported in the referenced clinical studies (see "Clinical
Studies" section in this manual), there are several potential adverse events associated
with the use of this device. In case you experience any pain, discomfort or other
unwanted effects related to the use of the device, stop using the device and contact
Patient Services and/or your physician.
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The output
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