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Directions For Use

RECOMMENDED USAGE

The Biomet

SpinalPak

Stimulator is designed to deliver 270 days of continuous therapeutic treat-

ment for 24 hours per day. The recommended daily therapeutic treatment is continuous for 24 hours.

OPERATING INSTRUCTIONS

The Biomet

SpinalPak

Stimulator has been specifically designed to be convenient to use, comfort-

able to wear, and safe to operate. Patients should begin using the Biomet

immediately after reading the instructions for use and having received instructions from their

prescribing physician.

To begin treatment - Electrode Placement

• Clean and dry the skin where the electrodes will be placed. Trimming (not shaving) body hair from

the electrode application area is often helpful.

• Note: To ensure electrode placement and adhesion, you may use one of the provided electrode

retainer patches. Place one electrode

two to three inches to the left of the

area of the surgery and a second

electrode two to three inches to the

right of the area of the surgery so that

the electrodes are four to six inches

apart. See Figure 2. Depending on the

patient's ability to move after surgery,

it may be helpful for the patient to ask

another person to assist them in placing these electrodes. See instructions for use on the electrode

packet. The patient should consult their prescribing physician or Biomet if they have any questions

or concerns regarding proper electrode placement. If their skin becomes abnormally red at the

electrode sites, the electrodes should be moved adjacent to the original sites. If the redness does

not go away after 48 hours with the electrodes removed, the patient should contact their

prescribing physician.

Tips:

Loose electrodes – Confirm that both electrodes are in complete contact with clean, dry skin. See

instructions on the electrode packet.

Incomplete circuit/disconnection – Check all connection points, confirming a snug fit.

Broken electrode lead wire –

If alarming

continues after confirming connection, attach a new

electrode lead wire.

To begin treatment - Lead Wires

• The patient is provided with two stimulator lead wire

lengths with the Biomet

SpinalPak

Spine Fusion

Stimulator system. The patient should select the

length of the stimulator lead wire in order to

provide both convenience and comfort when

wearing the stimulator during treatment.

• Insert the stimulator lead wire male connection into each female electrode lead wire connection.

• Insert the lead wire plug into the opening at the top of the stimulator. See Figure 3.

SpinalPak

Stimulator

Figure 2

Figure 3

Operating Instructions

Both battery packs provided with the Biomet

packaged and distributed. Upon receipt of the Biomet

the second battery pack be immediately placed into the charger and completely charged. In the

meantime, the first battery pack may be used to begin your treatment immediately. Note: The first

battery pack may not provide a complete 24-hour treatment initially.

STEP 1:

Insert the charged battery pack into the Biomet

Stimulator (Figure 4). The LED light on top of the device will

blink, indicating power. Each symbol will be indicated on the

display and the alarm will flash and beep if the electrodes are

not properly applied. To silence the audio alarm press the

button below the display.

If the light does not blink, which indicates that the battery is

not charged, change the battery pack (See Charging the

Battery Pack below).

STEP 2:

Attach electrodes as per instructions on the

package, and as per "To Begin Treatment -

Electrode Placement" section on page 6.

Charging the Battery Pack

Charge the battery pack at room temperature (24˚ C (75˚ F)). Charging may require two to three hours.

Charging may vary in warmer or colder temperatures.

STEP 1:

Plug the battery pack charger into a wall outlet (Figure 5). A green light on the AC adaptor will

illuminate indicating power (Figure 6).

SpinalPak

Stimulator are charged prior to being

SpinalPak

Stimulator, it is recommended that

SpinalPak

Figure 5

Figure 4

Figure 6