Warnings:

The safety and effectiveness of this device has not been established for:

• Fractures with post-reduction displacement of more than 50% (i.e., fractures in which the opposing broken bone ends are out of alignment by more than one half of the width of the bone).
• Pathological fractures due to bone pathology or malignancy (fractures due to disease).
• Pregnant or nursing women.
• Individuals with thrombophlebitis (blood clot in a vein), vascular insufficient (poor blood supply), abnormal skin sensitivity (very sensitive skin), sensory paralysis (lack of sensation), alcoholism and/or nutritional deficiency.
• Individuals receiving steroid, anticoagulant, prescription non-steroidal antiinflammatory, 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.
• Treatment of non-unions or fractures of the vertebra or the skull.
• Individuals lacking skeletal maturity.
• 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 your lower leg).
• 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 (manipulation of the fracture without surgery) and cast immobilization (cast treatment).

Precautions:

• The ManaFuse 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 should not be placed on an open wound.
• The operation of active, implantable devices, such as cardiac pacemakers, may be adversely affected by close exposure to the ManaFuse 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 ManaFuse 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 12 units, and diathermy equipment may cause interference. Don’t use the ManaFuse device closer than 15 cm (6 inches) from these electromagnetic (EM) emitters.
• The safety and effectiveness of the ManaFuse device for use of more than one daily 20-minute treatment period has not been studied.
• Check the transducer and the transducer cord before starting treatment. If there are any signs of damage, do not use the device and call Customer Service at 800-263-6004.
• 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 ManaFuse device in treating the fracture.
• Only the region of the fracture within the effective radiating area (3.88 +/- 20% square cm (cm2) ) of the transducer is likely to benefit from the ManaFuse 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 ManaFuse 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 ManaFuse device’s site of application should be marked onto the patient’s skin with an indelible marker to guide future transducer placements.
• The ManaFuse device is NOT safe for use in a Magnetic Resonance (MR) environment and may be damaged or present a projectile hazard in that environment.