Orthofix Cervical-Stim 2505CE, Инструкция по эксплуатации

Страница: 10 / 137

8
Safety
The adverse events observed in this study are shown in the Adverse Events
Table presented in the Prescription Information section. At six months, the
numbers of subjects who experienced one or more adverse events is similar
in the two groups. A total of 14 severe events were reported in 13 subjects;
nine of the subjects were in the Cervical-Stim treatment group and five
subjects were in the control group. These events included experiences such
as increased pain, shortness of breath, dizziness, unrelated trauma and injury,
unrelated death, surgical complication and adjacent level pathology. For the
nine subjects in the Cervical-Stim treatment group, all severe adverse events
were, in the judgment of the investigators, definitely or probably unrelated to
the device.
Safety data obtained between the six month visit and the final contact with
each subject indicate that 57 adverse events were experienced by a total of
51 subjects between both groups. The number of subjects who experienced
one or more adverse events is similar in the two groups. None of the adverse
events reported between the six month visit and the final contact were severe
and are similar to those reported at six months.
Device Life
The Cervical-Stim can provide up to 270 consecutive (daily) treatments of four
hours each. The overall length of treatment will be determined by the physician
based on the patient and progress toward fusion.
Treatment Time
The Cervical-Stim should be worn for four hours per day. At the end of the
daily treatment the device will turn itself off. The device may be turned off
at any time by simply pressing the On/Off button on the control panel.
The Cervical-Stim may be used at any time of day that is convenient for the
patient. It is lightweight and adjustable. And because the Cervical-Stim is
portable, treatment can be received while sitting, walking, reclining, sleeping,
etc. However, since each patient is unique, the overall activity level should be
based on the physician’s instructions.
E
n
gli
sh