User's Manual

SpinalModulation,Inc. PhysicianImplantManual

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38

6. Slowlyawakenthepatientandtestforstimulationperceptionandtherebyverifyingthe

systemisoperational.

NOTE:TheINSoutputmaynotbeidenticaltothetrialneurostimulatoroutput.Alwaysstart

stimulatingfromasettinglowerthanthatusedtostimulatewith

thetrialneurostimulator.

7. EnsurethatthattheINSisawayfromthepocketincisionsutureline,closethepocket

incision,andapplyappropriatedressings.

8. FilloutthepatientregistrationinformationformandreturnittoSpinalModulation.

CheckingSystemIntegrity

1. Place the magnet in a sterile  pouch and wave it over the device to

startprogrammercommunication.

2. Using the clinical programmer in the non‐sterile field, program

the basic stimulation parameters, check the battery status, and

check the electrode impedances to ensure there is no short or

opencircuit.

3. Oncethesystem’sfunctionisverified,turntheneurostimulatoroff.

CompletingtheProcedure

1. Followstandardprocedureforwoundclosureandbandaging.

ReplacinganINS

ThefollowingstepsoutlinethesuggestedproceduretoreplaceanINS:

1. TurnofftheINSandverifythatithasbeenturnedoff.

PRECAUTION:Exercisecarewhenusi n g sharpinstrumentsorelectrocauteryaroundleads

ortheymightbeda m aged.

2. OpentheINSimplantsitepernormalsurgicalprocedures.

3. Remove the suture from the INS header, without damaging the lead, and carefully

removetheINSfromthepocket.

4. Clean the INS header and the lead with sterile water and then wipe with a surgical

sponge.

5. InsertthetorquewrenchthroughtheseptumoftheINSheaderandloosenthesetscrew

byturningitcounterclockwise.

PRECAUTION:Whenperforming the followingsteps, do not bend thelead sharply as this

maycauseleadbreakage. 

MagnetActivationTarget

Magnetmustbewithin3.5

cmofINSsurfacefor

activationof

communication.