8
www.stryker.com
EN
0406-900-702 Rev-E
Indications For Use
The Stryker RF MultiGen (generator), in combination with the Stryker RF
Electrodes and Cannulae, are intended for coagulation of soft tissues in
orthopedic, spinal, and neurosurgical applications. Examples include, but
are not limited to: Facette Denervation, Trigeminus Neuralgia, Peripheral
Neuralgia and Rhizotomy.
The Stryker MultiGen Cable is intended for coagulation of soft tissues
in orthopedic, arthroscopic, spinal, and neurosurgical applications in
combination with the separately cleared Stryker RF MultiGen, Electrodes
and Cannulae. Examples of procedures include, but are not limited to,
Facette Denervation, Trigeminus Neuralgia, and Rhizotomy.
Contraindications
None known.
Accessories
WARNINGS:
• Use only Stryker-approved system components and accessories, unless
otherwise specified. Other system components and accessories may not
properly fit into connectors or operate with the generator, and may result
in increased emissions or decreased immunity of the generator.
• DO NOT modify any system component or accessory, including the
ground connection of the power cord.
Specifically:
• Use only Stryker-approved cannulae.
• Use only Stryker-approved ground pads.
• Cannulae are SINGLE USE ONLY. DO NOT use if package is damaged.
DO NOT reuse. DO NOT resterilize single use accessories.
• Ground pads are SINGLE USE ONLY. DO NOT reuse.
• DO NOT reuse, reprocess, or repackage a single use device. A single
use device is intended for a single use only. A single use device may
not withstand chemical, chemical vapor, or high temperature sterilization
reprocessing. Design features may make cleaning difficult. Reuse
may create a serious risk of contamination and may compromise the
structural integrity of the device resulting in operational failure. Critical
product information may be lost if the device is re-packaged. Failure to
comply may lead to infection or cross-infection and result in patient and/
or healthcare staff injury.
DESCRIPTION
REF
MultiGen Cable
0406-900-100
RF Hand Controller
0406-850-100
Cable Identification Tags
0406-900-200
Ground Pad (neutral electrode)
0406-650-205
Ground Pad Cable (monopolar return electrode
cable)
0406-850-200
Sterile Plastic Bag
0406-001-000
Venom
®
Nitinol Electrodes
0406-825-01X series
Venom RF Cannulae
0406-XXX-XXX series
Additional Electrodes, Cannulae, and Catheters
See below.
NOTES:
• If you need more information, contact your Stryker sales representative
for a complete list of accessories, including Stryker-approved electrodes,
cannulae and catheters.
• See the instructions for use supplied with the Venom electrodes and
cannulae for important safety and compatibility information.
• Stryker does not sell printers for the generator. As a minimum
requirement, any printer used with the generator must be printer
command language level 3 (PCL3) compatible. Printers using versions
of PCL greater than 3 may also work. See your printer manual for
compatibility information. Incompatible printers will not work with the
generator.
Trademarks not the property of Stryker Corporation are the property of their
respective owners.
Содержание RF MultiGen 0406-900-000
Страница 3: ......