403321001_001 2016-08-31
9.
INSTRUCTIONS FOR USE:
9.1.
Initiation
Once the device
Preparation
(8.0) is complete and power is turned on using the
ON/OFF Main Switch
at the back of the MetaSTAR RF Generator, the system performs a self-check. All LEDs and pixels
on the graphics display will be on and the speaker will sound for a few seconds upon initiation (Power-
On Tone). In case an error is detected during Self-Test the Fault or Warning LED will turn on and the
Fault or Warning Tone will sound.
NOTE
: The Hand Switch Cable can be inserted in the Hand Switch Cable Socket prior to powering
up the MetaSTAR RF Generator.
After self-check is performed, the software versions are displayed.
9.2.
Setting Ablation Cycle Time
Upon completion of the self-check the generator will go to the set Ablation Cycle Time Screen. In
the Ablation Cycle Time Screen pressing the Up and Down Arrow Buttons will increase or decrease
the RF Cycle time. Once the desired time is selected, pressing the Confirm Button will enter the time
and advance to the Main Procedure Screen. During operation (below), the user can re-set the
Ablation Cycle Time by pressing and holding the Reset Cycle Button for 2seconds.
9.3.
Operation
SpineSTAR Ablation Instrument and AE Cable
“Connect Device” will flash until the SpineSTAR Ablation Instrument is connected to the MetaSTAR
RF Generator. The SpineSTAR Ablation Instrument should be connected to the AE Cable socket on
the MetaSTAR RF Generator using the AE Cable (inspect the AE Cable for damage). If the
SpineSTAR Ablation Instrument is connected properly, Distal and Proximal temperature readings will
display.
Hand Switch Cable
The Hand Switch Cable should be inspected and inserted into the Hand Switch Cable socket on the
MetaSTAR RF Generator.
The MetaSTAR RF Generator will display the following information:
1.
RF Cycle: Displayed at the top left portion of the Generator Display in minutes:seconds. (00:00)
2.
Cycles: Displayed at the top center portion of the Generator Display in number of cycles (00)
performed.
3.
RF Total: Displayed at the top right portion of the Generator display in minutes:seconds (00:00) format.
This value represents the cumulative time RF power has been delivered.
4.
Distal TC: Displayed in (ºC): Temperature of the Distal Thermocouple of the SpineSTAR Ablation
Instrument.
5.
Proximal TC: Displayed in (ºC): Temperature of the Proximal of the SpineSTAR Ablation Instrument.
6.
Ω (Impedance): Displayed as a box filling from bottom to top on bottom left of Generator’s display.
7.
Power: Displayed in (Watts): Ablation RF output power of the MetaSTAR RF Generator.
RF Power Level
This generator has four power settings, 3w, 5w, 7.5w and 10w.
The selected output power should be as low as possible for the intended purpose. Certain devices
or accessories may present SAFETY HAZARDS (See WARNINGS and PRECAUTIONS above). Set
the power level to 5W and modify during procedure as required to create thermal distribution for the
major and minor diameter as displayed in
Figure 1
.
