Orthofix AccelStim Manual De Instrucciones página 9

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Calcium channel blocker and/or diphosphonate therapy. Individuals using these
therapies were excluded from the studies because of the possible effects of these
therapies on bone metabolism.
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Nonunions of the vertebra and the skull.
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Individuals lacking skeletal maturity.
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Fresh fracture locations other than the distal radius (end of the large bone in the
forearm) or tibial diaphysis (middle 80% of the large bone in lower leg).
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Fresh fractures that are open Grade II or III (fractures with large wounds), or that
require surgical intervention with internal or external fixation (screws and/or
plates used to hold your broken bones in place), or that are not sufficiently stable
for closed reduction and cast immobilization (manipulation of the fracture without
surgery).
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Clinical studies leveraged to support the safety and effectiveness of the AccelStim
device may not necessarily be applicable to patients of all races and ethnicities.
Such demographic details were not provided in the referenced clinical studies.
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The AccelStim device is MR Unsafe. The device presents a projectile hazard in this
environment.
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The device should not be used over skin that is infected or is not intact, if
scarring or blood is evident at the application point, or in the presence of other
local substances or abnormal tissues that may affect the acoustic signal such
as inflammation (rash), 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
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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.
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The transducer, strap and gel are not sterile and placement on an open wound is
not advised.
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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.
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The cords pose a risk for strangulation. Keep out of reach of children.
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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 30 cm (12 inches) from these electromagnetic (EM) emitters.
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The safety and effectiveness of the AccelStim device for use of more than one
daily 20-minute treatment period has not been studied.
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When choosing a treatment site, ensure that the site selected allows for full
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