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医療機器 bioMetric SpinalPakのPDF 完全マニュアルをオンラインで閲覧またはダウンロードできます。bioMetric SpinalPak 20 ページ。 Non-invasive spine fusion stimulator system

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Full Prescribing Information

INDICATIONS FOR USE

The Biomet

SpinalPak

stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one

or two levels.

WARNINGS

Cardiac pacemakers or cardioverters may be adversely affected by the Biomet

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

observable adverse changes in the pacemaker rhythm or output, the device should not be used.

The safety and effectiveness of the Biomet

in pregnant women have 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 device.

PRECAUTIONS

The safety and effectiveness of the Biomet

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.

Apply the electrodes after the skin has been cleaned and dried. If erythema develops at the electrode

sites, the electrodes should be relocated adjacent to the original sites. If the reaction does not

resolve after 48 hours after relocating the electrodes, the patient should be instructed to consult with

the physician.

Do not submerge or expose the Biomet

to water. The patient must be instructed to remove the stimulator during bathing, showering

or swimming.

Compliance with the treatment schedule, daily battery pack changes, and replacing the electrodes

(1 to 7 days) as needed are essential for proper device function. This system should only be used with

components and replacement parts supplied by Biomet. Other components, parts and accessories may

not be compatible, and may damage the device. If any component does not function properly, contact

Biomet. No attempt should be made to modify or repair the device.

Patients should be able to use the device in accordance with the instructions for use. If a patient cannot

comply with these instructions for any reason, use of the device is not recommended.

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 device. 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 noninvasive spine fusion

Non-invasive Spine Fusion Stimulator System device. If there are any

SpinalPak

Non-invasive Spine Fusion Stimulator System

SpinalPak