BIOMET SpinalPak Повний посібник та вкладиш до упаковки - Сторінка 4

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System Components (cont)

BATTERY PACK AND BATTERY CHARGER

The

Biomet SpinalPak

Stimulator includes two rechargeable battery packs. Upon receipt, it is

recommended that the second battery pack be immediately placed into the charger and fully charged. In the mean-

time the first battery pack may be used to begin your treatment.

Note: The first battery pack may not provide a 24-hour treatment initially. It is recommended that the patient keep one

battery pack in the battery charger to assure that it is fully charged and ready, and the other inserted into the Biomet

SpinalPak

Stimulator. This will ensure continuous treatment prescribed by the prescribing physician.

The battery charger is designed to recharge the

Biomet

emitting diode) lights monitor and indicate the operational status of the battery charger. The AC Power indicator

light is located on the AC Adaptor.

The charging status indicator light is located on the charger

cradle. The following table lists and describes the operational functions of the LED lights:

Electrodes

There are two types of electrodes that are packaged with the Biomet

assembly: 72R and LT-4500. The 72R electrodes have green writing on their packaging. The LT-4500

electrodes have black writing on their packaging. The 72R electrodes have a hydrogel that is stickier

than the LT-4500 electrode hydrogel. The patient can use whichever electrodes best suit their skin type.

Electrode Covers

The electrode covers are water resistant and are intended to enhance electrode security to the skin,

if needed, or for showering with the electrodes attached, if desired.

Device Holster

The device holster is designed to securely hold the Biomet

clip on the back which allows the patient to wear the device on their waistband or belt.

Lead Wires

Two different length lead wires are included with the Biomet

patient should choose the lead wire that best accommodates their needs for where they would like

to wear the control unit.

Status

No battery pack inserted

(idle) on AC powered

battery charger

Battery pack in charging state

Fully charged battery pack

AC power deficiency

Error

Following are possible error conditions and possible resolutions.

Error Conditions (flashes orange)

Battery pack not properly connected

to the charger

Battery temperature is too low or high

Battery voltage is too low

SpinalPak

Stimulator battery packs only. Two LED (light

OrthoPak

Stimulator System

SpinalPak

Stimulator in place. It has a

SpinalPak

Stimulator system. The

AC Power

Charging Status

Indicator Light

Solid green

Off

Solid green

Solid orange

Solid green

Off

Solid green

Off

Possible Resolutions

Remove and re-install the battery pack to ensure

a complete connection to the charger

Normal operating temperature is

5˚C to 38˚C [41˚F - 100˚F]

Call Biomet for a new battery pack

Full Prescribing Information

INDICATIONS FOR USE

The Biomet

SpinalPak

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

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

Stimulator device. If there are any observable adverse changes in the pacemaker rhythm or output, the

device should not be used.

The safety and effectiveness of the Biomet

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

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

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.

Stimulator is a noninvasive bone growth stimulator indicated as an adjunct

SpinalPak

Stimulator in pregnant women have not been

SpinalPak

Stimulator in individuals with the following

SpinalPak

Stimulator to water. The patient must be

SpinalPak

Stimulator.

SpinalPak