Declaration Of Conformity; Instructions For Use; Verifying Neurostimulator Operation - Medtronic PrimeAdvanced 37702 Manual De Implantación

37702_ch.fm 12/10/07 1:57 pm
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Table 3. Material of components in the Model 37702 PrimeADVANCED 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.

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, verify that the neurostimulator is operable
by using the clinician programmer to interrogate the neurostimulator and read the
neurostimulator battery service life. (Refer to the software manual for instructions on how to
read the battery service life.)
8 English 37702 2007-12
MA16388A004 Rev A
Material Material contacts
human tissue
Titanium Yes
Polyurethane, silicone Yes
rubber, silicone medical
adhesive
Silicone rubber Yes
Titanium alloy Yes
Silicone medical adhesive Yes
Ultem Yes
Stainless steel Yes
Medtronic Confidential
NeuroImplant_R01