Baylis RFP-100A - DEVICE DESCRIPTION

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SECTION 1: DEVICE DESCRIPTION

The Generator is a component of the Baylis Medical Company Radiofrequency (RF) Puncture

System. The Generator is operated in conjunction with separately cleared BMC RF Devices, BMC

connector cables such as (but not limited to) the RFX-BAY-TS, RFX-BAY-TS-12-SU or RFX-

BAY-OTW-10-SU cables, an optional DuoMode

Cable, a commercially available return

(dispersive) electrode that meets or exceeds IEC 60601-2-2:2017, and an optional accessory

footswitch. The Generator delivers energy in a voltage-controlled monopolar mode between the

BMC RF Device’s distal tip electrode and the return electrode. Detailed information regarding the

BMC RF Device is contained in a separate manual that accompanies each BMC RF Device.

The Generator produces continuous radiofrequency power output at a fixed frequency in the range

of 450 kHz to 480 kHz in a monopolar mode. Connections for the Generator connector cable

(which connects to the separately approved BMC RF Device) and a patient return electrode that

meets or exceeds IEC 60601-2-2:2017 are provided. Controls on the front panel allow the cut mode

and the duration of the RF output to be set. In addition, on/off control of the output can be achieved

through the optional accessory footswitch or through the dedicated front panel button. The elapsed

time and the cut mode are displayed on the liquid crystal display (LCD) during RF energy delivery.

An audible tone synchronized with the RF output is also produced during energy delivery. The

Generator has several built-in safety features, such as device identification, alert messages, an

automatic shut-off for out-of-range parameters or metal contact, and maximum voltage, current,

and power limits.

The Generator has been tested for compliance with the following standards:

• IEC 60601-1:2005+A1:2012

• IEC 60601-2-2:2017

• IEC 60601-1-2:2014