User's Manual
SpinalModulation,Inc. PhysicianImplantManual
12
Note: For detailed information and instructions related to the Clinical and Patient
ProgrammerandtheTrialNeurostimulator,refertotherespectiveusermanuals.
SterilizationInformation
Single‐use,steriledevice‐ThesterilecomponentsoftheAxium™NeurostimulatorSystemare
provided sterile in a double pouch or tray assembly and are intended for single use only. An
expiration date (or “use‐before” date) is marked on the label of each package.Use proper
steriletechniquestoopenthepackaging.
WARNING: Do not resterilize or reuse any devices for any reason because of risk of
infectiontothesubjectandmalfunctionofthedevices.
Sterilization – The Spinal Modulation INS, Trial Lead Kit, Implant Lead Kit, Lead Extension Kit,
LeadAccessoriesKitandTunnelingToolKitshavebeensterilizedusingethyleneoxide(EO)gas.
StorageConditions
StoreallsterileproductincludingtheINS,Leads,andLeadAccessoriesKitsasfollows:
Storage Temperature – Store components between 14°F (‐10°C) and 122°F (50°C).
Temperaturesoutside thisrangemaydamagethecomponents.Ifatemperaturedeviationhas
occurred,donotusetheproduct.
StorageHumidity–Storecomponentsbetween10%and90%humidity.
Storage Environment – Store components and their packaging where they will not come in
contactwithliquidsofanykind.
ProductMaterials
PortionsoftheAxium™NeurostimulatorSystemwillcomeincontactwithbodilytissues.
WARNING:Neurostimulationsystemshavematerialsthatcomeincontactwithtissue.A
physician should determine whether or not a patient may have an allergic reaction to
thesematerialsbeforethesystemisimplanted.
Thefollowingmaterialsareimplantedandcomeincontactwithtissue:
• Platinumiridium • StainlessSteel
• Polyurethane • MP35N(nickel‐cobalt‐chromium‐molybdenumalloy)
• Titanium • PEEK(polyetheretherketone)
• Epotek • PFA(perfluoroalkoxycopolymerresin)
• Siliconerubber • PMMA[poly(methylmethacrylate)]