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Biomet
®
OrthoPak
®
Non-invasive Bone Growth 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 only.
DESCRIPTION
The Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System promotes (Figure 1) healing by
inducing a low electrical current at the fracture nonunion site. The therapeutic signal generates a low
energy electrical field by passing a specific current between the electrodes.
ELECTRICAL REQUIREMENTS BATTERY AND CHARGER
Input: 100-240 VAC 50/60 Hz 6 W
Output: 12 VDC 500mA
For use with the Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System rechargeable battery
pack only (PN 1067720).
Battery rating: 3.7 VDC > 800 mAh
Do not use the rechargeable battery pack supplied with this system in any other device. Use of Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System battery pack in any other device may cause
damage or malfunction to the battery pack and/or devices.
System Components
STIMULATOR
The Biomet
®
OrthoPak
®
Non-invasive Bone Growth 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
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System is designed to store the patient’s
daily therapeutic treatment which may be downloaded and read with the patient compliance software
(See Patients Compliance Monitoring Page 14). 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
