Section 1: Device Description - Baylis Medical RFP-100A Gebrauchsanweisung

SECTION 1: DEVICE DESCRIPTION

The Baylis Medical Company Radiofrequency Puncture Generator is a component of the
Baylis Medical Company Radiofrequency Puncture System. The Generator is operated in
conjunction with a BMC Catheter and a commercially available external Disposable
Indifferent (Dispersive) Patch (DIP) Electrode that meets or exceeds ANSI/AAMI
Standard HF-18 and/or ISO 60601-2-2. The BMC Catheter delivers power in a
monopolar mode between its distal tip electrode and the indifferent patch electrode.
Detailed information regarding the Catheter is contained in a separate manual that
accompanies each Catheter.
The Generator produces continuous radiofrequency (RF) power output at a fixed
frequency in the range of 455 kHz to 465 kHz in a monopolar mode. Connections for the
Catheter and a patient return electrode are provided. Controls on the front panel allow
the power level and the duration of the RF output to be set. In addition, controls on the
front panel provide on/off control of the output. Measured values for output power,
impedance, and elapsed time are displayed during RF output whilst a constant audible
tone is also produced. The Generator has several built-in safety features, such as warning
messages, an automatic shutoff (if the measured impedance falls below 100 ohms or
exceeds 6000 ohms), and maximum voltage and current limits.
7 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc