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Biomet
®
SpinalPak
®
Non-invasive Spine Fusion Stimulator System
Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician.
Rx Only.
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This device is not intended for re-sale or re-distribution. Single patient use.
DESCRIPTION
The Biomet
®
SpinalPak
®
Non-invasive Spine Fusion Stimulator System (Figure 1) promotes healing
by inducing a low electrical current at the fusion site. The therapeutic signal generates a low energy
electrical field by passing a specific current between the electrodes.
ELECTRICAL REQUIREMENTS FOR BATTERY AND CHARGER
Charger
Input: 100-240 VAC 50/60 Hz 6 W
Output: 12V DC 500mA
For use with the Biomet
®
SpinalPak
®
Non-invasive Spine Fusion Stimulator System battery pack
only (PN 1067720).
Battery rating: 3.7 VDC > 800 mAh
Do not use the battery pack supplied with this unit in any other device. Use of the Biomet
®
SpinalPak
®
Non-invasive Spine Fusion Stimulator System battery pack in any other device may cause damage or
malfunction to the battery pack and/or device.
System Components
STIMULATOR
The
Biomet
®
SpinalPak
®
Non-invasive Spine Fusion Stimulator System operates on a rechargeable battery pack,
which allows for ambulatory use. It includes an audible and visible self-checking alarm mechanism to alert the
patient if it is not functioning properly. The
Biomet
®
SpinalPak
®
Non-invasive Spine Fusion Stimulator System
is designed to store the patient’s daily therapeutic treatment data which may be downloaded and read with the
patient compliance software (See Patient Compliance Monitoring Page 10). Patients are encouraged to bring the
stimulator to each follow-up visit with the prescribing physician to review how they are using their stimulator.
Figure 1
