Stim wave LBRD-915-2K User manual

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WEARABLE!ANTENNA!ASSEMBLY!
USER!MANUAL!
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Caution:!Federal!law!restricts!this!device!to!sale!by!or!on!the!order!of!a!physician.!
WEARABLE!ANTENNA!ASSEMBLY!PROGRAMMER!KIT!
(LBRD-915-2K)!
!WEARABLE!ANTENNA!ASSEMBLY!PROGRAMMER!!
(LBRD-915-2A)!

English!
Page!|!2!
EXPLANATION*OF*SYMBOLS*ON*PRODUCT*OR*PACKAGE*
Refer!to!the!appropriate!product!for!symbols!that!apply.!
Symbol*
English*–*EN*
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Device!reference!identification!
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Lot!number!
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Quantity!of!product!included!in!package!
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Consult!instructions!for!use!
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Do!not!reuse!
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Do!not!resterilize!
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Do!not!use!if!package!is!damaged!
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Store!in!a!cool,!dark,!dry!place!
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Caution!
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Warning!
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MR!Conditional!
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MR!Unsafe!
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Use!by!
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Manufacturing!date!
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Manufacturer!
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Device!length!
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Sterilization:!ethylene-oxide!gas!
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European!Authorized!Representative!
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Australian!Sponsor!
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Temperature!limits!
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English!
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TABLE*OF*CONTENTS*
EXPLANATION*OF*SYMBOLS*ON*PRODUCT*OR*PACKAGE*.....................*2!
HOW*TO*USE*THIS*MANUAL*................................................................*4!
INDICATIONS!FOR!USE!................................................................................!4!
SAFETY*INFORMATION*........................................................................*5!
CONTRAINDICATIONS!.................................................................................!5!
WARNINGS!..............................................................................................!6!
PRECAUTIONS!.........................................................................................!11!
ADVERSE!EVENT!SUMMARY!......................................................................!14!
PARTS*OF*YOUR*STIMULATION*SYSTEM*............................................*15!
OVERVIEW!OF!THE!WAA!PROGRAMMER!.....................................................!16!
OVERVIEW!OF!THE!USER!CONTROLS!...........................................................!17!
POSITIONING!THE!WAA!PROGRAMMER!......................................................!18!
TURNING!THE!WAA!PROGRAMMER!“ON”!OR!“OFF”!...................................!19!
STARTING!STIMULATION!FOR!THE!STIMULATOR!............................................!19!
SELECTING!A!STIMULATION!PROGRAM!........................................................!20!
INCREASING!OR!DECREASING!AMPLITUDE!....................................................!21!
MAINTENANCE*..................................................................................*22!
BATTERY!CHARGING!................................................................................!22!
CLEANING!AND!CARE!PRECAUTIONS!............................................................!24!
SAFETY!AND!TECHNICAL!CHECKS!.................................................................!24!
WAA!PROGRAMMER!DISPOSAL!.................................................................!24!
PATIENT!IDENTIFICATION!CARD!..................................................................!24!
WHEN!TO!CALL!YOUR!CLINICIAN!................................................................!25!
SPECIFICATIONS*................................................................................*26!
WIRELESS*INFORMATION*..................................................................*27!
TROUBLESHOOTING*..........................................................................*29!
CONTACT*INFORMATION*...................................................................*31!
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English!
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HOW*TO*USE*THIS*MANUAL*
This! manual! will! help! you! understand! how! to! use! and! care! for! your!
neurostimulator! system.! It! also! provides! you! with! warnings! and! precautions!
you!should!know!about.!You!should!discuss!with!your!clinician!any!questions!or!
concerns! you! have! after! reading! this!manual.! Please! refer! to! the! Freedom!
Spinal! Cord! Stimulator! (SCS)! System!Product! Safety! Guide! for!EMC! related!
safety!information.!
This! device! complies! with! Part! 18! of! the! FCC! Rules.!Per! FCC! 18.213,!See!
Warnings!section!in!this!document!for!the!interference!potential!of!the!device!
and! methods! for! correcting! interference.! See! Maintenance! section! in! this!
document!for!the!instructions!on!system!maintenance.!
Per! FCC! 15.21,! changes! or! modifications! not! expressly! approved! by! the! party!
responsible! for! compliance! could! void! the! user's! authority! to! operate! the!
equipment.!
Per! FCC! 15.19(a)(3)! and! (a)(4)! This! device! complies! with! part! 15! of! the! FCC!
Rules.!Operation!is!subject!to!the!following!two!conditions:!(1)!This!device!may!
not! cause! harmful! interference,! and! (2)! this! device! must! accept! any!
interference! received,! including! interference! that! may! cause! undesired!
operation.!FCC!ID!2AHXALBRD2R4.!
INDICATIONS*FOR*USE*
The! Freedom! Spinal! Cord! Stimulator! (SCS)! System! is! intended! as! the! sole!
mitigating! agent,! or! as! an! adjunct! to! other! modes! of! therapy! used! in! a!
multidisciplinary! approach! for! chronic,! intractable! pain! of! the! trunk! and/or!
lower!limbs,!including!unilateral!or!bilateral!pain.!The!Freedom-8A!Trial!Lead!Kit!
is! only! used! in! conjunction! with! the! Freedom-8A! Stimulator!Receiver!Kit,!and!
the! Freedom-4A! Trial!Lead!Kit!is!used!for!either!the!Receiver! Kit!Freedom-4A!
Stimulator! or! the! Receiver! Kit! Freedom-8A! Stimulator.! The! trial! devices!are!
solely!used!for!trial!stimulation!(no!longer!than!30!days)!to!determine!efficacy!
before!recommendation!for!a!permanent!(long!term)!device.!
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SAFETY*INFORMATION*
CONTRAINDICATIONS*
• Poor*surgical*risks*–!Spinal!cord!stimulators!should!not!be!used!on!patients!
who! are! poor! surgical! risks! or! patients! with! multiple! illnesses! or! active!
general! infections.! This! includes! patients! who! need! anticoagulation!
therapy! that! cannot! be! temporarily! halted! to! accommodate! the!
implantation!procedure.!
• Pregnancy*–!Safety!and!effectiveness!of! the!Freedom!SCS!System!for!use!
during!pregnancy!and!nursing!have!not!been!established.!
• Inability* to* operate* System* –!Spinal!cord!stimulators!should!not!be! used!
on!patients!who!are!unable!to!understand!or!operate!the!System.!
• Exposure*to*shortwave,*microwave,*or*ultrasound*diathermy*–!Diathermy!
should! not! be! operated! within! the! vicinity! of! a! patient! implanted! with! a!
Freedom! Stimulator! or! when! wearing! the! Wearable! Antenna! Assembly!
Programmer!(WAA).! The! energy! from! diathermy! can! be! transferred!
through! the! stimulator! or! WAA! Programmer! and! cause! tissue! damage,!
resulting!in!severe!injury.!
• Implanted*cardiac*systems*–!Patients!who!have!implanted!cardiac!systems!
should! not! use! the! Freedom! SCS! System.! Electrical! pulses! from! the!
Freedom! SCS! System! may! interact! with! the! sensing! operation! of! an!
implanted! cardiac! system,! causing! the! cardiac! system! to! respond!
inappropriately.!
• Occupational*exposure*to*high*levels*of*non-ionizing*radiation*that*may*
interfere* with* therapy* –!Users!who! regularly!work!in! environments! with!
elevated!levels!of!non-ionizing!radiation!should!not!be!implanted!with!the!
Freedom! SCS! System.! The! energy! in! high-level! areas! can! be! transferred!
through!the!stimulator!and!cause!tissue!damage,!resulting!in!severe!injury.!!
Examples!of!environments!having!high!level!non-ionizing!radiation!includes!
radio! or! cell! phone! transmission! stations,! facilities! using! radiofrequency!
heat!sealers!or!induction!heaters,!electric!power!infrastructure!controlled!
environments!(i.e.!step!down!transformers!or!high!voltage!power!lines).!

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WARNINGS*
Electromagnetic* interference* (EMI)!–!EMI! is! a! field! of! energy! generated! by!
equipment!found!in!the!home,!work,!medical!or!public!environments.!EMI!that!
is! very! strong!can!interfere! with! System.! The! device!includes! features! that!
provide!protection!from!EMI.!!Most!electrical!device!and!magnets!encountered!
in!a!normal!day!will!not!affect!the!operation!of!the!System.!!However,!strong!
sources!of!EMI!could!result!in!the!following:!
• Serious!patient!injury!resulting!from! heating! of!the! implanted! device!
and!damage!to!surrounding!tissue.!
• System!damage,!resulting!in!a!loss!of,!or!change!in,!symptom!control!
and!requiring!additional!surgery.!
• Operational!changes!to!the!WAA!Programmer.!This!may!cause!either!
external!device!to!turn!on,!turn!off,! or!to!reset! to!factory!settings.! If!
this!occurs,!the!WAA!Programmer!need!to!be!reprogrammed.!
• Unexpected!changes!in!stimulation,!causing!a!momentary!increase!in!
stimulation!or!intermittent!stimulation.!Some!patients!have!described!
as!a!jolting!or!shocking!sensation.!!Although!the!unexpected!change!in!
stimulation! could!feel!uncomfortable,!it! does! not! damage! the! device!
or! cause!a! patient! direct! injury.! In! rare! cases,! as! a! result! of! the!
unexpected! changes! in! stimulation,! patients! have! fallen! down! and!
been!injured.!!
If!you!suspect!that!your!Freedom!SCS!System!is!being!affected!by!EMI!then!you!
should:!
• Immediately!move!away!from!the!equipment!or!object.!
• Remove!the!external!transmitting!device!(WAA!Programmer)!from!the!
vicinity.!
Machinery*or*heavy*equipment!–!Machinery!and!heavy!equipment!(including!
vehicles)! should! not! be! operated! while! using! the! Freedom! SCS! System.!
Malfunction!of!the!System!could!result!in!loss!of!body!control,!body!function,!
or!a!feeling!that!could!render!the!patient!incapable!of!controlling!the!system.!
Stimulator*fracture!–!If!the!Stimulator!insulation!is!ruptured!or!pierced!due!to!
extensive!forces,!unexpected!changes!in!stimulation!could!result.!
Electromagnetic* equipment/environments!–!Avoidance! of! high!
electromagnetic! equipment! radiators! or! environments! is! highly! encouraged.!!
Examples!of!equipment!and/or!environments!include!the!following:!

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• High-power!amateur!transmitters/antennas!or!citizen!band!(CB)!radio!
or!Ham!radio!used!for!private!recreation,!communication,!and!wireless!
experimentation.!
• Electric!arc!welding!or!resistance!welding!equipment!used!for!melting!
and!joining!metals!or!plastics.!
• Industrial! electric! induction! furnace/heater! or! electric! arc!
furnace/heater!used!for!melting!metals!and!plastics.!
• High-voltage!areas!identified!by!fenced!areas,!restricted!access!signs,!
and!caution!signs!(safe!if!outside!the!fenced!area).!
• Microwave! transmitters!identified! by! fenced! areas,! restricted! access!
signs,!and!caution!signs!(safe!if!outside!the!fenced!area).!
• Television! and! radio! towers! identified! by! fenced! areas,! restricted!
access!signs,!and!caution!signs!(safe!if!outside!the!fenced!area).!
• Linear!power!amplifiers!used!for!increasing!the!power!output!of!radio!
transmitters,! wireless! communication! applications,! audio! equipment!
or!other!electronic!equipment.!
• Radio! telemetry! equipment! used! for! tracking! location! of! vehicles,!
equipment!or!animals.!
Active* Implantable* or* Body* Worn* Medical* Devices! –! Safety! has! not! been!
established! for! patients! who! use! the! Freedom! SCS! System! with! other! active!
implantable! or! body! worn! medical! devices.! ! These! devices! include! other!
neurostimulation! systems,! insulin! pumps,! automated! external! defibrillators!
(AED),! cochlear! implants,! and! wearable! medical! sensors.! ! Malfunction! and/or!
damage!could!occur!to!either!system!that!could!result!in!harm!to!the!patient!or!
other!people!nearby.!!!
Magnetic*Resonance*Imaging*(MRI)!–!The!Stimulator!Receiver!and!Stimulator!
Spare! Lead!are!MR! Conditional.!An! MRI! examination! with! the! Stimulator!
Receiver! or! Stimulator! Spare! Lead! may! be! safety! performed! under! certain!
conditions.!The!Trial!Lead!is!MR!Unsafe!due!to!the!lack!of!fixation!of!the!device!
during! the! trial! period.! Refer! to! the! Product! Safety! Sheet! for! specific! MRI!
guidelines.*
The* WAA* Programmer* component* is* MR* Unsafe;* ensure* that* the* WAA*
Programmer*does*not*enter*the*MR*system*room.*Since!the!WAA!Programmer!
is! MR! Unsafe,! the! strong! magnetic! field! of! the! MR! system! could! attract! or!
otherwise! damage! the! WAA!Programmer,! and! in! the! process! cause! serious!
harm!to!the!patient!or!other!people!or!damage!to!the!MR!system.!

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Radiofrequency* (RF)* ablation!–!Safety! has! not! been! established! for!
radiofrequency! (RF)! ablation! in! patients! with! a! Stimulator.! RF! ablation! may!
cause!induced!electrical!currents!that!result!in!heating!and!tissue!damage.!!Do!
not!use!RF!ablation!anywhere!near!the!Stimulator.!If!RF!ablation!is!used,!ensure!
that!ablation!is!not!performed!over!or!near!the!Stimulator.*
Electrocautery!–!If!electrocautery!tools!are!used!near!the!Stimulator!then!the!
insulation! can! be! damaged.! The! Stimulator! may! fail! or! conduct! induced!
currents.! ! Induced! electrical! currents! can! cause! heating! that! results! in! tissue!
damage.!
When!electrocautery!is!necessary,!these!precautions!must!be!followed:!
• The!WAA!Programmer!should!be!taken!off.!
• Bipolar!cautery!should!be!used.!
• If!unipolar!cautery!is!necessary:!
o Only!low-voltage!modes!should!be!used.!
o The!lowest!possible!power!setting!should!be!used.!
o The! current! path! (ground!plate)! should! be! kept! as! far! away! as!
possible!from!the!Stimulator.!
o Full-length!operating!room!table!ground!pads!should!not!be!used.!
• After! electrocautery,! confirm! that! the! Stimulator! is! working! as!
intended.!
Electrostatic*Discharge*(ESD)*–*Testing!indicates!the!WAA!can!be!susceptible!to!
damage! resulting! from! ESD! greater! than! +/-6kV! that! can! occur! in! certain!
environments,! such! as! home! use,! when! the! relative! humidity! is! below! 30%.!
Freedom!users!and!caregivers!should!avoid!approaching!or!touching!the!WAA!
in! these! situations! and! avoid! contact! with! highly! charged! conductors,!
particularly! synthetic! materials! (e.g.,! nylon,! polyester)! during! periods! of! low!
relative!humidity!(less!than!30%).!ESD!might!result!in!temporary!or!permanent!
loss!of!function.!If!ESD!with!the!WAA!is!observed,!remove!the!device!from!your!
body! and! power! off! then! power! on! the! device.! Confirm! the! device!
indicators/lights!are!operating!correctly!before!resuming!therapy.!If!the!device!
will! not! power! on,! your! stimulation! therapy! will! not! be! delivered! and! you!
should!contact!Stimwave!for!assistance!or!replacement.!
High-output* ultrasonics* /* lithotripsy!–!Safety! has! not! been! established! for!
high-output! ultrasonics! or! lithotripsy! when! implanted! with! the! Freedom! SCS!
System.!!Use!of!lithotripsy!may!result!in!damage!to!the!device!or!harm!to!the!
patient.!*

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Psychotherapeutic* procedures! –! Safety! has! not! been! established! for!
psychotherapeutic! procedures! using! equipment! that! generates!
electromagnetic! interference! (e.g.,! electroconvulsive! therapy,! transcranial!
magnetic! stimulation)! in! patients! who! have! spinal! cord! stimulators.! ! Induced!
electrical!currents!can!cause!heating!that!may!result!in!tissue!damage.!
Radiofrequency* Identification* (RFID)* Emitters* -* Theft* detectors,* electronic*
article*surveillance*(EAS)*systems,*and*radiofrequency*identification*systems*
–*Tests!have!been!performed!with!an!array!of!simulated!RFID!emitter!systems,!
and! have! demonstrated! that! the! Freedom! SCS! System! (implanted! device! and!
WAA)! can! be! affected! by! separation! distances! between! the! Freedom! SCS!
System! and!the! RFID! emitter! of! less! than! 3m! (~10! ft.).! More! powerful! RFID!
Emitters!might!cause!effect!at!farther!distances.!RFID!emitters!can!be!hidden!or!
portable! and! not! obvious! to! the! Stimwave! user.! Any! RFID! emitter!may!
temporarily!interrupt!stimulation,!or!cause!elevated!levels!of!stimulation.!It!is!
recommended! that! if! a! patient! feels! a! change!in! stimulation! near! a! potential!
RFID!emitter,! they! promptly! move! away! from! the! area! and! remove! the! WAA!
from!the!body.!
When! possible,! it! is! best! to! avoid! RFID! emitters!or! remove! the! WAA!while!
passing! near! RFID! emitters.! Patients! with! an! implanted! device! should! inform!
the!attendant!who!may!be!able!to!assist!them!in!bypassing!any!RFID!emitter.!If!
unavoidable,! the! patient! should! walk! through! the! RFID! emitter!and! promptly!
move!away!from!the!area.!Patients!should!not!lean!on!scanners!or!linger!in!the!
area!of!RFID!emitters.!!
Computed*Tomography*(CT)*Scanning*–*Safety!has!not!been!established!for!CT!
scanning! of! patients! with! a! Stimulator.! X-rays! from! the! scan! could! cause!
unintended!shocks!or!malfunctions!of!the!Stimulator.!!
The!CT!operator!should!use!CT!scout!views!to!determine!if!implanted!medical!
devices!are!present!and!their!location!relative!to!the!programmed!scan!range.!!
For! CT! procedures! in! which! the! device! is! in! or!immediately! adjacent! to! the!
programmed!scan!range,!the!operator!should:!
• Remove!the!WAA!Programmer!from!the!CT!scan!range.!
• Minimize!X-ray!exposure!to!the!implanted!device!by:!
o Using! the! lowest! possible! X-ray! tube! current! consistent! with!
obtaining!the!required!image!quality.!
o Making! sure! that! the! X-ray! beam! does! not! dwell! over! the!
Stimulator!for!more!than!a!few!seconds.!

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After!CT!scanning!directly!over!the!implanted!device:!
• Place!the!WAA!Programmer!on!body!and!turn!on!stimulation.!
• Check!for!proper!stimulation,!and!that!indicator!lights!are!operating!as!
expected.!
• Shut!off!the!WAA!Programmer!if!it!is!suspected!that!the!device!is!not!
functioning!properly.!
Bone* growth* stimulators! –! Safety! has! not! been! established! for! bone! growth!
stimulators! within! the! vicinity! of! the! Freedom! SCS! System.! Use! of! a! bone!
growth!stimulator!may!result!in!damage!to!the!device!or!harm!to!the!patient.!!!
Dental*drills*and*ultrasonic*probes!–!Safety!has!not!been!established!for!dental!
drills!or!ultrasonic!probes!within!the!vicinity!of!the!Freedom!SCS!System.!Use!of!
dental!drills!or!ultrasonic!probes!may!result!in!damage!to!the!device!or!harm!to!
the!patient.!
Electrolysis!–!Safety!has!not!been!established!for!electrolysis!within!the!vicinity!
of! the! Freedom! SCS! System.! Use! of! electrolysis! may! result! in! damage! to! the!
device!or!harm!to!the!patient.!
Laser*procedures!–!Safety!has!not!been!established!for!lasers!within!the!vicinity!
of!the!Freedom!SCS!System.!Use!of!lasers!may!result!in!damage!to!the!device!or!
harm!to!the!patient.!!!
Radiation*therapy!–!Safety!has!not!been!established!for!high!radiation!sources!
such!as!cobalt!60!or!gamma!radiation!when!implanted!with!the!Freedom!SCS!
System.!Use!of!radiation!therapy!could!cause!damage!to!the!device!or!harm!to!
the!patient.!!
Transcutaneous*electrical*nerve*stimulation!–!Safety!has!not!been!established!
for!use!of! transcutaneous! electrical! nerve! stimulation!(TENS)!when! implanted!
with!the!Freedom!SCS!System.!Use!of!TENS!could!cause!the!device!to!turn!off!
or!intermittent/increased!stimulation.!!!
Other* medical* procedures! –! EMI! from! the! following! medical! procedures! is!
unlikely!to!affect!the!device:!
• Diagnostic!ultrasound!(e.g.,!carotid!scan,!Doppler!studies)!
• Diagnostic!x-rays!or!fluoroscopy!
• Magnetoencephalography!(MEG)!
• Positron!emission!tomography!(PET)!scans!

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• Therapeutic! magnets! (e.g.,! magnetic! mattresses,! blankets,! wrist!
wraps,! elbow! wraps)! –! Keep! the! magnet! away! from! the! stimulator!
site.!Magnetic!fields!will!generally!not!affect!the!Stimulator.!
WAA*Programmer*Skin*Contact*–!Do!not!place!the!WAA!Programmer!directly!
on! the! skin.! Direct! skin! contact! may! cause! irritation! and/or! sensitivity! to! the!
materials.! The! WAA! Programmer! must! be! placed! overtop! a! thin! layer! of!
clothing!at!all!times.!!!
Painful* Stimulation! –! If! the! patient! experiences! painful! stimulation,! the!
amplitude!on!the!WAA!Programmer!should!be!decreased!immediately!and/or!
removed! from! the! patient’s! body.! Contact! your! clinician! if! this! continues! to!
occur.!
PRECAUTIONS*
Physician* training*–*Prescribing! clinicians!should! be! experienced! in! the!
diagnosis!and!treatment!of!chronic!intractable!pain!and!should!be!familiar!with!
using!the!Freedom!SCS!System.!Implanting!clinicians!should!be!experienced!in!
spinal! procedures! and! should! review! the! procedures! described! in! the!
Instructions!for!Use.!*
Keep* the* WAA*Programmer* dry* –!The! WAA!Programmer! is! not! waterproof.!!
Keep!it!dry!to!avoid!damage.!!Do!not!use!the!WAA!Programmer!when!engaging!
in!water!activities.!
Storage* temperatures* –!The! Freedom! SCS! System! should! be! kept! within! the!
storage! temperatures! listed! on! product! packaging.! Exceeding! the! storage!
temperature! could! cause! harm! to! you! or! the! component.! Please! contact! the!
manufacturer!if!a!storage!temperature!is!surpassed.!
!Stimulator!Receiver!
Storage!Temperature!
Wearable!Antenna!Assembly!
Programmer!
Storage!Temperature!
!
!

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Clean*the*WAA*Programmer*–!Clean!the!outside!of!the!WAA!Programmer!with!
a!damp!cloth!when!needed!to!prevent!dust!and!grime.!Mild!household!cleaners!
will!not!damage!the!device!or!labels.!
Handle*the*WAA*Programmer*with*care*–!The!WAA!Programmer!is!a!sensitive!
electronic! device.! ! Avoid! dropping! the! device! onto! hard! surfaces.! Keep! the!
WAA!Programmer!out!of!the!reach!of!children!and!pets.!!!
Medical* tests* and* procedures* –!Before! undergoing! medical! tests! or!
procedures,! contact! the! clinician!to! determine! if! the! procedure! will! cause!
damage!to!the!patient!or!to!the!System.!
Physician* instructions* –* Always!follow!the!programs!and!therapy!instructions!
established!by!the!clinician.!Failure!to!do!so!may!cause!the!therapy!to!be!less!
effective!in!providing!pain!relief.!
Airline* policies!-!Follow! airline! policies! for! use! of! medical! spinal! cord!
stimulation!systems!and!electronic!equipment!during!flights.!Refer!all!questions!
to!airline!personnel.!!!
Use*the*WAA*Programmer*as*directed*–*Use!the!WAA!only!as!explained!by!the!
clinician!or!as!discussed!in!the!User!Manual.!Using!the!WAA!Programmer!in!any!
other!manner!could!result!in!harm.!
Do* not* dismantle* the* WAA*Programmer*–*Do! not! dismantle! or! tamper! with!
the!device.!Tampering!with!the!device!could!result!in!harm.!!If!the!device!is!not!
working!properly,!contact!the!clinician!for!help.!
Flammable*or*Explosive*Environments*–*Do!not!use!the!WAA!Programmer!in!
flammable! or! explosive! environments.! Using! the! WAA! Programmer! in! one! of!
these!environments!could!result!in!harm.!
Use*of*another*patient’s*WAA*Programmer*-!Never!use!another!patient’s!WAA!
Programmer.! The! therapy! programmed! is! a! unique! prescription! for! each!
patient.! Use! of! another! patient’s! WAA! Programmer! could! result! in!
overstimulation.!
Activities* requiring* excessive* twisting* or* stretching!–!Avoid! activities! that!
potentially!can!put!undue!stress!on!the!device.!!Activities!that!include!sudden,!
excessive,! or! repetitive! bending,! twisting,! bouncing,! or! stretching! can! cause!

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Page!|!13!
your!stimulator!to!fracture!or!migrate.!This!can!result!in!a!loss!of!stimulation,!
intermittent!stimulation,!and!additional!medical!procedures.!!!
Scuba*diving*or*hyperbaric*chambers!–!Do!not!dive!below!13!meters!(45!feet)!
of!water!or!enter!hyperbaric!chambers!above!1.5!atmospheres!absolute!(ATA).!
These! conditions! can! damage! the! device.! Before! diving! or! using! a! hyperbaric!
chamber,!discuss!the!effects!of!high!pressure!with!the!clinician.!
Skydiving,*skiing,*or*hiking*in*the*mountains!–!High!altitude!should!not!affect!
the! System.! However,! take! care! to! not! put! undue! stress! on! the! Stimulator.!!
During!skydiving,!the!sudden!jerking!that!occurs!when!the!parachute!opens!can!
dislodge! or! fracture! the! Stimulator.! This! can! result! in! a! loss! of! stimulation,!
intermittent!stimulation,!and!additional!medical!procedures.!
Unexpected*changes*in*stimulation!–!Electromagnetic!interference,!changes!in!
posture,! and! other! activities! can! cause! a! perceived! increase! in! stimulation.!
Some! patients! have! described! this! as! a! jolting! or! shocking! sensation.! You!
should!reduce!your!amplitude!to!the!lowest!setting!and!turn!OFF!your!System!
before!engaging!in!activities!that!could!become!unsafe.!Discuss!these!activities!
with!your!clinician.!
Interference* during* programming! -! If! interference! is! suspected! during!
programming! of! the! WAA!Programmer,! the! clinician! should! confirm! that! the!
Bluetooth®! data! transmission! is! operating! properly.! Bluetooth®! data!
communication! is! confirmed! by! the! blue! light! indicator! on! the! WAA!
Programmer!blinking.!!If!during!the!programming!session!the!light!indicator!is!
not!blinking!then!the!clinician!should!do!the!following:!
• Terminate! the! current! programming! session! and! shut! down! the!
WaveCrest!Application.!
• Check!for!sources!of!Bluetooth®!interference!in!the!surrounding!area.!
• Remove!or!turn!off!the!source!of!interference.!
• Re-establish! the! Bluetooth®! link! with! the! WAA! Programmer! through!
pairing.!
• Resume!programming!by!opening!the!WaveCrest!Application.!
• Confirm!the!light!indicator!is!now!blinking.!

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ADVERSE*EVENT*SUMMARY*
Implantation! of! a! spinal! cord! stimulation! system! is! similar! to! any! surgical!
procedure.!!Risks!include!the!following:!
• Allergic!or!immune!system!response!to!implanted!material!
• Infection!
• Leakage!of!cerebrospinal!fluid!
• Epidural!hemorrhage,!hematoma,!or!paralysis!
Therapeutic!use!of!the!Freedom!SCS!System!incurs!the!following!risks:!
• Undesired!change!in!stimulation,!including!uncomfortable!chest!wall!
stimulation!
• Stimulator! migration,! erosion! through! the! skin,!or!fracture! causing! a!
loss!of!therapeutic!effect!
• Electromagnetic!interference!causing!a!change!in!System!performance!
• Loss!of!therapeutic!effect!despite!a!functioning!system!
Adverse!events!that!could!occur!with!the!Freedom!SCS!System:!
• Stimulator!migration,!resulting!in!altered!stimulation!therapy!that!may!
be!uncomfortable!
• Stimulator!fracture,!resulting!in!loss!of!stimulation!
• Infection,!resulting!in!tissue!sensitivity,!redness!and!swelling!
Adverse!effects!of!stimulation!are!usually!mild!and!go!away!when!stimulation!is!
turned!off.!Contact!your!clinician!immediately!if!you!experience!any!problems.!
Over! time! there! could! be! changes! in! the! level! of! pain! control.! Contact! your!
clinician!if!you!experience!a!change!in!stimulation!that!you!believe!is!a!result!of!
the!Stimulator!slipping!from!the!implant!site.!
* *

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PARTS*OF*YOUR*STIMULATION*SYSTEM*
!
Freedom* Stimulator* –!Also! known! as! an!“implant”! or! “receiver”.! The!
Stimulator!is! a! set! of! thin! wires! and! a! miniature! receiver,! covered! with! a!
protective!casing.!The!Stimulator!has!small!metal!electrodes!near!the!tip!that!
are! set! to! different! electrical! polarities! similar! to! the! poles! on! a! battery.! An!
electrical! field! of! energy! is! created! when! power! is! applied! to! the! electrodes.!
The!electrical!field!aids!in!blocking!the!pain!signals!coming!from!certain!nerves!
of!the!spinal!cord.!The!Stimulator!receives!energy!wirelessly!from!the!external!
unit!(WAA).!
Wearable*Antenna*Assembly*(WAA)*Programmer* –!The!WAA!Programmer!is!
an!electronic!device!used!to!power!the!Stimulator.!Wireless!power!is!sent!from!
the! WAA!and! through! your! skin! to! the! Stimulator.! The! WAA!Programmer! is!
worn!around!your!midsection!over!top!of!the!area! where!the! Stimulator(s)!is!
implanted.!
The! WAA! Programmer! communicates! with! your! Stimulator!by! sending!
radiofrequency!signals.!Your!Stimulator!only!accepts!communication!from!your!
WAA!Programmer.! The! clinician! programs! your! WAA! Programmer! with! your!
specific!Stimulation!parameters.!!A!Bluetooth®!connection!is!made!in!order!to!
program!your!WAA!Programmer.!

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OVERVIEW*OF*THE*WAA*PROGRAMMER*
!
1. Transmitter!–!Used!to!transmit!power!to!your!Stimulator.!
2. User! Controls!–!Controls! used! to! turn! the! power! on/off! and! adjust!
stimulation!amplitude.!
3. Belt!–!An!adjustable!belt!that!holds!the!transmitter.!
!
The!transmitter!should!be!placed!in!the!belt!as!illustrated!above.!Make!sure!the!
Back!Side!is!facing!your!body!when!worn.!

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OVERVIEW*OF*THE*USER*CONTROLS*
Button*Cover,*Buttons*and*LEDs*
!
BUTTONS*
Key*
Action*Description*
*
Power!ON/OFF!Button!–!Used!to!turn!the!WAA!ON!or!OFF.!Green!LED!is!a!
default!indicator!and!will!blink!to!indicate!power!status.*
*
Increase!Amplitude!Button!–!Used!to!increase!the!stimulation!strength.!
*
Decrease!Amplitude!Button!–!Used!to!decrease!the!stimulation!strength.*
*
Change! Program! Selection!–!Depressing! the! Increase! Amplitude! Button!
and! the! Decrease! Amplitude! Button! at! the! same! time! will! alternate! the!
programmed!setting!to!either!A,!B,!or!C.!!
LEDS*
Action*Description*
Pattern*and*Color*
Description*of*Pattern*
!
Charging*
(Correct*Alignment)*
!
Solid!Blue!
OFF,*Not*Charging*
(Misalignment)*
!
None!
Charged*
!
Blinking!Blue!
Low*Battery*
!
Blinking!Yellow!
*
Bluetooth*
Connected!
!
Solid!Blue!
Bluetooth*
No*Connection*
!
Blinking!Blue!
Receiving*
Information/Data*
!
Random!Blinking!Yellow!
*
ON*
Setting*A!
!
Blinking!Green!(single)!
ON*
Setting*B!
!
Blinking!Green!(double)!
ON*
Setting*C!
!
Blinking!Green!(triple)!
*
Minimum*
Index!
!
Blinks!Once!Yellow!
Maximum*
Index*
!
Blinks!Once!Yellow!

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POSITIONING*THE*WAA*PROGRAMMER*
WARNING:(
Do! not! place! the! WAA! Programmer! directly! on! your! skin.! Direct! skin! contact!
may!cause!irritation!and/or!sensitivity!to!the!materials.!The!WAA!Programmer!
must!be!placed!overtop!a!thin!layer!of!clothing!at!all!times.!
!
The!WAA!Programmer!must!be!placed!over!the!general!region!of!the!stimulator!
in! order! to! transfer! the! optimal! amount! of! power!to! the! device.! Refer! to! the!
following! illustrations! for! the! best! location! to! wear! the! WAA!Programmer.!
Work! with! your! clinician! to! find! the! optimal! location! for! the! most! effective!
therapeutic!relief.!
1. Attach!the!WAA!Programmer!around!your!midsection.!!!
2. Position!so!that!the!antenna!portion!is!directly!in!the!middle!of!your!
lower!back.!!!
3. Ensure!that!the!WAA!Programmer!is!placed!overtop!of!a!thin!layer!of!
clothing.!!Do!not!place!directly!on!your!skin.!!!
4. Adjust!the!position!up!or!down!depending!on!where!your!Stimulator!is!
located.!
!
The!WAA!Programmer!is!placed!over!the!center!of!the!spine.!
!

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!
!
This!figure!illustrates!the!optimal!
position!of!the!WAA!Programmer!
over!one!Stimulator.!
!
This!figure!illustrates!the!optimal!
position!of!the!WAA!Programmer!over!
two!vertically!spaced!Stimulators.!
!
TURNING*THE*WAA*PROGRAMMER*“ON”*OR*“OFF”*
CAUTION:(
Do! not! place! the! WAA! Programmer! directly! on! your! skin.! Direct! skin! contact!
may!cause!irritation!and/or!sensitivity!to!the!materials.!The!WAA!Programmer!
must!be!placed!overtop!a!thin!layer!of!clothing!at!all!times.!
!
Notes:!!
§ WAA# Programmer# automatically# starts# at# lowest# amplitude# setting#
when#turned#on.#
Steps:!
1. Press!and!hold!the!Power!ON/OFF!Key!until!the!green!Power!Indicator!
Light!activates.!
STARTING*STIMULATION*FOR*THE*STIMULATOR*
Steps:!
1. Turn!on!the!WAA!Programmer.!
2. Place! the! WAA! Programmer! directly! over! top! of! the! stimulator! as!
described.!
3. Adjust! the! amplitude! as! directed! by! your! clinician! by! using! the!
Increase!or!Decrease!Amplitude!Key.!

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Page!|!20!
SELECTING*A*STIMULATION*PROGRAM*
The!WAA!Programmer!device!has!three!program!options!that!your!doctor!may!
set.! Your! doctor! may! set! each! program! to! stimulate! a! different! part! of! your!
body.!Talk!with!your!doctor!to!determine!when!and!how!to!use!the!programs.!!
Use! the! green!indicator!light! in! order! to! identify! which! program! is! currently!
active!on!the!device.!!
• Program!A!=!One!Blink!
• Program!B!=!Two!Blinks!
• Program!C!=!Three!Blinks!
Steps:!
1. Turn!on!the!WAA!Programmer.!
2. The!WAA!Programmer!defaults!to!the!last!program!used.!
3. Press! “+”! and! “-”! buttons! at! the! same! time! to! switch! to! the! next!
program.!!
4. The!light!pattern!will!blink!to!signify!which!program!is!active.!