403321001_001 2016-08-31
5.
PRECAUTIONS:
Caution:
Removing screws and opening of this device may invalidate the warranty.
Caution:
”.
Caution:
It is important to read these instructions for use and these precautions prior to device operation.
Caution:
Replace fuses only with the same type and rating: 5 x 20 mm 3.15A/250V(2 each).
Caution:
Do not sterilize the MetaSTAR RF Generator. Sterilization may damage the unit.
Caution:
Reconditioning, refurbishing, repair, modification, of the device to enable further use is expressly
prohibited as it may result in loss of function and/or patient injury.
Caution:
Do not block or restrict the openings on the bottom and back of the MetaSTAR RF Generator, as they
provide the required airflow for cooling.
Caution:
If electromagnetic interference with other equipment is suspected, reorient the device or remove
possible sources of interference (e.g., cellular phones, radios, etc.) from the room.
Caution:
Any monitoring electrodes recommended to be placed as far as possible from the SpineSTAR Ablation
Instrument when high frequency surgical equipment and physiological monitoring equipment are used
simultaneously on the same patient. Monitoring systems incorporating high frequency current-limiting
devices are recommended for use.
Caution:
Needle monitoring electrodes are not recommended.
Caution:
Patient should not come into contact with earthed metal parts, the use of antistatic sheeting is
recommended.
Caution:
Cables to the surgical electrodes are recommended to be positioned such that contact with patient or
other leads is avoided.
Caution:
Do not continue to deliver RF for more than 30 seconds if the impedance bar is more than 75% filled
and temperature is not increasing.
The lightning flash with arrowhead symbol, within an equilateral triangle, is intended to alert the
user to the presence of un-insulated "dangerous voltage" within the products enclosure that may
be of sufficient magnitude to constitute a risk of electric shock to persons.
The symbol with an open book with the letter “i” is intended to alert the user to the presence of
important operating and maintenance (servicing) instructions in the literature accompanying the
unit.
The symbol with a person reading an open book is intended to alert the user to read and
understand the operator’s manual prior to use. Failure to follow instructions could result in death
or serious injury.
6.
ENVIRONMENTAL PROTECTION:
Follow local governing ordinances and hospital practice regarding the disposal of the SpineSTAR Ablation Instrument
(see SpineSTAR Ablation Instrument IFU)
7.
HOW SUPPLIED:
The MetaSTAR RF Generator is supplied in a semi-ready-to-use state. The units’ box contains the MetaSTAR RF
Generator, and a detached power cord. All other devices are available separately.
7.1.
Accessories:
7.1.1.
Hand Switch Cable
7.1.2.
AE Cable
7.2.
Single Use Devices
– See below for other devices required for Tumor Ablation.
SpineSTAR Ablation Instrument*
* Applied Part, V
PPMax
: Same as
Output
. See Appendix A, I. Specifications.
