bioMetric SpinalPak - Patient Counseling Information; Compliance; Battery Pack; Electrodes

16 17
Patient Counseling Information
ThepatientshouldbethoroughlyinstructedonhowtoproperlyuseandcarefortheBiomet
®
SpinalPak
®
Non-invasiveSpineFusion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assuretheproperfunctionofthedeviceandeffectivetreatment.
Battery Pack- The patient should be instructed to insert a fully charged battery pack into 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 9). The patient should be
instructedtokeeptheaudiblealarmsystemengagedasoftenaspractical,andto
engagethealarmsystemifithasbeendisengaged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 eitherremove
the electrodes, or to cover the electrodes with the protective retainer patches,
duringshowering.
Storage and Handling
TheBiomet
®
SpinalPak
®
Non-invasiveSpineFusion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 (see page 10), Biomet
requests that the patient disposes of the
Biomet
®
 SpinalPak
®
 Non-invasive Spine Fusion Stimulator
Systemaccordingtolocalstatutesandregulations.