Declaration Of Conformity; Instructions For Use; Verifying Neurostimulator Operation - Medtronic ITREL 3 Implantationsanleitung

7425IPG_ch.fm 4/27/04 2:22 pm
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Table 3. Material of components in the Model 7425 package.
Component
Neurostimulator
Case
Connector block
Grommets, seals
Setscrews
Insulation coating
Adhesive
Hex 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.

Instructions for use

Implanting physicians should be experienced in epidural-access procedures and should be
thoroughly familiar with all product labeling.
#
Cautions:
When using sharp instruments near the neurostimulator, be extremely careful to
■
avoid nicking or damaging the case, the insulation, or the connector block. Damaging
the neurostimulator may require surgical replacement.
Do not use saline or other ionic fluids at connections, which could result in a short
■
circuit.

Verifying neurostimulator operation

Before opening the sterile neurostimulator package, use the clinician programmer to
interrogate the neurostimulator and verify neurostimulator battery status and current settings.
221656002 Rev A
Material Material contacts
human tissue
Titanium Yes
Polyurethane Yes
Silicone rubber Yes
Titanium Yes
Fluoropolymer Yes
Silicone adhesive Yes
Acetal resin Yes
Stainless steel Yes
Medtronic Confidential
NeuroImplant_R01
7425 2004-05 English 9