BIOMET SpinalPak Руководство для пациентов - Страница 11
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Печатать страницуIndications for Use
The Biomet
SpinalPak
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non-invasive bone growth stimulator indicated as an adjunct electrical treatment
to primary lumbar spinal fusion surgery for one or two levels.
Warnings
• C ardiac pacemakers or cardioverters may be adversely affected by the Biomet
SpinalPak
Non-invasive Spine Fusion Stimulator System. The concomitant use of
®
the device and a pacemaker or cardioverter must be assessed on an individual basis,
such as with an electrocardiogram, prior to use. The patient should be referred
to a cardiologist for monitoring of pacemaker function while wearing the active
Biomet
SpinalPak
®
any observable adverse changes in the pacemaker rhythm or output, the Biomet
SpinalPak
Non-invasive Spine Fusion Stimulator System should not be used.
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• T he safety and effectiveness of the Biomet
Stimulator System in pregnant women has not been studied, and the effects
of the device on the mother or the developing fetus are unknown. A patient who
is either pregnant or is intending to become pregnant should be referred to her
doctor prior to treatment with the Biomet
Stimulator System.
Precautions
• T he safety and effectiveness of the Biomet
Stimulator System in individuals with the following conditions have not been
studied, and therefore the safety and effectiveness of the device in these individuals
are unknown:
– spondylitis, infection, Paget's disease
– cancer, diabetes mellitus, renal disease
– trauma of the lumbar spine
– osteoporosis
• A pply the electrodes after the skin has been cleaned and dried. If erythema develops
at the electrode sites, the electrodes should be relocated either immediately above or
b elow the original sites. If the reaction does not resolve after 48 hours after relocating
the electrodes, the patient should be instructed to consult the prescribing physician.
• D o not submerge or expose the Biomet
Stimulator System to water or any liquid. The patient should be instructed to
remove the stimulator during bathing, showering or swimming.
• C ompliance with the treatment schedule, daily battery changes, and replacing the
electrodes (from 1 to 7 days) as needed is essential for proper stimulator function.
• P atients should be able to use the stimulator in accordance with the instructions for
use. If a patient cannot comply with these instructions for any reason, use of the
stimulator is not recommended.
• T his system should only be used with components and parts recommended
by Biomet. Other components and parts may not be compatible, and may damage
the stimulator.
• I f any component does not function properly, contact Biomet. No attempt should be
made to modify or repair the stimulator.
Adverse Events
During a multi-center clinical study of 349 patients treated with the device for the
indication listed above, skin irritation was the most common adverse effect associated
with the use of the Biomet
It occurred in 9 patients (2.6% of the trial population) — 4 patients treated with the
active device and 5 patients treated with the placebo device.
Non-invasive Spine Fusion Stimulator System is a
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Non-invasive Spine Fusion Stimulator System. If there are
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SpinalPak
Non-invasive Spine Fusion Stimulator System.
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10
SpinalPak
Non-invasive Spine Fusion
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SpinalPak
Non-invasive Spine Fusion
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SpinalPak
Non-invasive Spine Fusion
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SpinalPak
Non-invasive Spine Fusion
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