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. n the mean-
time the first battery pack may be used to begin your treatment.
Note: The first battery pack may not pro ide 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®SpinalPak®Stimulator battery packs only. Two LED (light
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®OrthoPak®Stimulator System
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®SpinalPak®Stimulator in place. t has a
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®SpinalPak®Stimulator system. The
patient should choose the lead wire that best accommodates their needs for where they would like
to wear the control unit.
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
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
Status AC Power
Indicator Light
Charging Status
Indicator Light
No battery pack inserted
(idle) on AC powered
battery charger
Solid green Off
Battery pack in charging state Solid green Solid orange
Fully charged battery pack Solid green Solid green
AC power deficiency Off Off
Error Solid green Off
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Full Prescribing Information
INDICATIONS FOR USE
The Biomet®SpinalPak®Stimulator is a noninvasive bone growth 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®SpinalPak®Stimulator.
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®
Stimulator device. f 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®SpinalPak®Stimulator 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®SpinalPak®Stimulator 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. f erythema develops at the
electrode sites, the electrodes should be relocated adjacent to the original sites. f 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®SpinalPak®Stimulator 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. f 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. t
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.
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