Declaration Of Conformity - Medtronic RESTOREADVANCED 37713 Manual De Implantación

37713_ch.fm 12/5/07 10:05 am
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Table 3. Material of components in the Model 37713 RestoreADVANCED package
Components
Neurostimulator
Case
Connector block
Recharge coil
Grommets, seals
Setscrews
Adhesive
Torque wrench
Handle
Shaft

Declaration of Conformity

Medtronic declares that this product is in conformity with the essential requirements of Directive
1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 90/385/EEC
on Active Implantable Medical Devices.
For additional information, contact the appropriate Medtronic representative listed on the inside
back cover of this manual.
8 English 37713 2007-12
MA16387A004 Rev A
Material Material contacts
human tissue
Titanium Yes
Polyurethane, silicone Yes
rubber, silicone medical
adhesive
Polysulfone Yes
Silicone rubber Yes
Titanium alloy Yes
Silicone medical adhesive Yes
Ultem Yes
Stainless steel Yes
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NeuroImplant_R01