6
PRECAUTIONS:
Although laboratory teratological studies performed with this device demonstrate no adverse findings,
the safety of this device used during pregnancy and nursing in humans has not been established.
Compliance with the treatment schedule, daily battery change and proper maintenance of the device
and the change of the electrodes are essential. The device will not perform properly and treatment may
be unnecessarily prolonged if you fail to adhere to the care regimen. Components in this system are
to be used only with Zimmer Biomet approved parts. No attempt should be made to modify, repair or
substitute parts or components for this device.
ADVERSE EFFECTS
NOTE: With the exception of the following, no known adverse effects have resulted from the use of
this device:
General tissue sensitivity at the skin/electrode site with unknown specific etiology may occur. This
tissue sensitivity may be caused by the electrode gel, excess perspiration or a combination of both.
Such a reaction generally may be resolved spontaneously following diagnosis and correction of the
underlying cause.
Operating Instructions
RECOMMENDED USAGE
The Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System is designed to deliver 270
days of continuous therapeutic treatment for 24 hours per day. The recommended daily therapeutic
treatment is continuous for 24 hours.
Prior to initial treatment, the battery pack must be fully charged. After 24-hours of continuous use, the
battery pack requires charging. Each Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System
includes two rechargeable battery packs. Always have one battery pack installed in the stimulator and
have one battery pack charging in the battery charger. Additional battery packs are available through
Customer Service (See Page 2). Each day, preferably at the same time, you should change the battery
pack following these instructions.
Step 1:
BATTERY CHARGING
Charging will take between two to three hours.
1) Plug the battery charger into a wall outlet.
Attach charger and cradle.
2) A solid green light on the A/C adapter will
illuminate indicating power.
