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Patient Counseling Information
The patient should be thoroughly instructed on how to properly use and care for the Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System, and receive the Patient Manual, which provides detailed
instructions. A summary of the key points in the patient labeling is provided below.
Compliance
The patient should be instructed that compliance with device use and care is critical
to ensure the proper function of the device and effective treatment.
Battery
The patient should be instructed to insert a charged battery pack in the stimulator
every 24 hours.
Electrodes
The patient should be instructed to replace the electrodes when needed and
to clean the electrode sites thoroughly with soap and water prior to applying
the electrodes.
Skin Irritation
The patient should be instructed to examine the skin for irritation when replacing
the electrodes. If irritation is present, the patient should be instructed to relocate the
electrodes adjacent to the original sites. The patient should be evaluated periodically
to assess the skin for sensitivity.
Alarms
See LCD Symbol Descriptions and Instructions (page 14). The patient should
be instructed to keep the audible alarm system engaged as often as practical and
to reset the alarm system if it has been toggled to the disengaged position as soon
as practical.
Bathing
The patient should be instructed to disconnect the stimulator during bathing,
showering or swimming. It should be reconnected as soon as practical following
these activities. The patient should also be instructed to remove or cover the
electrodes with the electrode cover patches during showering.
Storage and Handling
The Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System should be stored in a cool and
dry place. The device components should be handled with care. Damage may occur if the device is
inappropriately handled or abused.
Disposal Instructions
When treatment has concluded as determined by the prescribing physician, Zimmer Biomet requests
that the patient dispose of the Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System
according to local statutes and regulations.
