bioMetric SpinalPak - Directions for Use; RECOMMENDED USAGE; OPERATING INSTRUCTIONS

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Directions for Use
RECOMMENDED USAGE
The Biomet
®
 SpinalPak
®
 Non-invasive Spine Fusion 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.
OPERATING INSTRUCTIONS
TheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemhasbeenspecificallydesigned
tobeconvenienttouse,comfortabletowear,andsafetooperate.Patientsshouldbeginusingthe
Biomet
®
 SpinalPak
®
Non-invasive Spine Fusion Stimulator System immediately after reading the
instructionsforuseandhavingreceivedinstructionsfromtheirprescribingphysician.
To begin treatment - Electrode Placement
• Cleananddrytheskinwheretheelectrodeswillbeplaced.Trimming(notshaving)bodyhairfrom
theelectrodeapplicationareaisoftenhelpful.
• Note: To ensure electrode placement and adhesion, you may use one of the provided electrode
retainer patches. Place one electrode
twotothree inches totheleft of the
area of the surgery and a second
electrode two to three inches to the
rightoftheareaofthesurgerysothat
the electrodes are four to six inches
apart. See Figure 2.Dependingonthe
patient’sabilitytomoveaftersurgery,
it may be helpful for the patient to
ask another person to assist them
inplacing the electrodes. See instructions for use on Page 10. The patientshould consult their
prescribingphysicianorBiometiftheyhaveanyquestionsorconcernsregardingproperelectrode
placement.If theirskinbecomesabnormallyred attheelectrodesites,theelectrodesshouldbe
moved adjacent to the original sites. If the redness does not go away after 48 hours with the
electrodesremoved,thepatientshouldcontacttheirprescribingphysician.
Tips:
Loose electrodes–Confirmthatbothelectrodesareincompletecontactwithclean,dryskin.See
instructionsontheelectrodepacket.
Incomplete circuit/disconnection –Checkallconnectionpoints,confirmingasnugfit.
Broken electrode lead wire–Ifalarmingcontinues
afterconfirmingconnection,attachanewelectrode
leadwire.
To begin treatment - Lead Wires
• Thepatientisprovidedwithtwostimulatorleadwire
lengthswith theBiomet
®
SpinalPak
®
Non-invasive
SpineFusionStimulatorSystem.Thepatientshould
selectthelengthofthestimulatorleadwireinorder
to provide both convenience and comfort when
wearingthestimulatorduringtreatment.
• Insertthestimulatorleadwiremaleconnectioninto
eachfemaleelectrodeleadwireconnection.
• Inserttheleadwireplugintotheopeningatthetopofthestimulator.See Figure 3.
Figure 2
Figure 3