Declaration Of Conformity - Medtronic Itrel 4 Implantationsanleitung

Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Table 3. Material of components in the Itrel 4 Model 37703 package
Components
Neurostimulator
Case
Connector block
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 37703 2012-03
2012-03
Template version: 12-13-2011
Material
Titanium, parylene
Polyurethane, silicone rubber,
silicone medical adhesive
Silicone rubber
Titanium alloy
Silicone medical adhesive
Polyetherimide
Stainless steel
Medtronic Confidential
ImplantManual.xsl - IPGTemplate.fm
Material contacts
human tissue
Yes
Yes
Yes
Yes
Yes
Yes
Yes
M948681A002