403321001_001 2016-08-31
MetaSTAR RF Generator User Manual
Catalog No. 3195 (English) (EN)
CAUTION: Federal law (US) restricts this device to sale by or on the order of a physician.
1.
BRIEF DEVICE DESCRIPTION:
The MetaSTAR RF Generator is a microprocessor controlled low power radiofrequency (RF) generator used for
percutaneous delivery of bi-polar radiofrequency energy intended to heat the target tissue of the SpineSTAR™
Ablation Instrument.
2.
INDICATIONS FOR USE:
The MetaSTAR RF Generator is indicated for palliative treatment in spinal procedures by ablation of metastatic
malignant lesions in a vertebral body.
3.
CONTRAINDICATIONS:
In some cases the system may interfere with normal functions of some types of implanted pacemakers. The
MetaSTAR RF Generator is contraindicated for patients who have pacemakers or other electrical implants. Please
refer to the SpineSTAR Ablation Instrument instructions for use for a more comprehensive list of contraindications
regarding specific procedures.
4.
WARNINGS:
Warning:
Do not ablate in painful osteoporotic vertebra without tumor.
Warning:
Do not use this device in patients without metastatic malignant lesions in a vertebral body.
Warning:
Do not use this device in patients with multiple myeloma, solitary plasma cytoma, or primary malignant
lesions in the index vertebra.
Warning:
The device is designed for tumor ablation; follow the IFU for the applicable device(s) used during the
procedure.
Warning:
Hazardous electrical output. This equipment is for use only by qualified medical personnel trained in the
use of the MetaSTAR RF Generator.
Warning:
Do not operate the unit in close proximity to volatile solvents such as methanol or alcohol, or in the
presence of flammable anesthetics, as explosion may occur.
Warning:
Do not operate unit in moist environment, as a shock hazard may exist. If liquids have entered the unit,
the MetaSTAR RF Generator must be returned to the manufacturer for testing prior to use.
Warning:
Interference produced by the operation of high-frequency equipment may adversely affect the operation
of other electronic medical equipment such as monitors, imaging systems.
Warning:
Failure of the equipment could result in an unintended increase of output power.
Warning:
Use of accessories and cables, other than those specified may affect system performance, resulting in
increased emissions or decreased immunity of the system.
Warning:
Servicing other than replacing the fuse should be performed by the manufacturer.
Warning:
Use only hospital grade power cord.
Warning:
In case of Generator failure switch off/unplug the power cord.
Warning:
Ablation procedures must be performed under fluoroscopic image guidance. Do not perform ablation
without imaging as it may result in severe injury to patient.
Warning:
Do not remove data port cover or connect any equipment to the data port.
Warning:
To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective
earth.
