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hematoma, or abscess. The impact of such soft tissue abnormalities within the
effective radiating area of the transducer has not been studied by any manufacturer.
Precautions
• The AccelStim device will not correct or alter post-reduction (when your fracture is
initially set and placed in a cast) aspects of a fracture such as displacement, angulation or
malalignment.
• The transducer, strap and gel are not sterile and placement on an open wound is not
advised.
• The operation of active, implantable devices, such as cardiac pacemakers, may be
adversely affected by close exposure to the AccelStim device. The physician should advise
the patient, or other person in close proximity during treatment, to be evaluated by their
attending cardiologist or implant physician before starting treatment with the AccelStim
device.
• The cords pose a risk for strangulation. Keep out of reach of children.
• Cell phones, televisions, and other devices using radio frequency identification (RFID)
readers, electronic security systems (e.g., metal detectors, electronic article surveillance),
near-field communications (NFC) systems, wireless power transfer and unique medical
emitters such as electrocautery, electrosurgical units, and diathermy equipment may
cause interference. Don’t use the AccelStim device closer than 15 cm (6 inches) from
these electromagnetic (EM) emitters.
• The safety and effectiveness of the AccelStim device for use of more than one daily
20-minute treatment period has not been studied.
• When choosing a treatment site, ensure that the site selected allows for full 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.26 The output
intensity of the device your patient receives is 30mW/cm2and is typically only 1% to 5%
of the output intensity of conventional therapeutic ultrasound devices. The ultrasound
