Section 3: Warnings, Precautions, And Adverse Events; Warnings - Baylis Medical RFP-100A Gebrauchsanweisung

SECTION 3: WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS

3.1.

WARNINGS

• DO NOT attempt to operate the Generator before thoroughly reading this User's
Manual. It is vital that the operating instructions for the equipment be read,
understood, and followed properly.
Manual in a convenient, readily accessible place.
• The Generator is intended for use with approved Catheters and accessories only.
• Do not remove the cover of the Generator. Removal of the cover may result in
injury and/or damage to the Generator.
• When the Generator is activated, conducted and radiated electrical fields may
interfere with other medical equipment. Care should be taken to limit the effects
that electromagnetic interference (EMI) produced by the Generator has on other
equipment.
• Laboratory staff and patients can undergo significant x-ray exposure during RF
Puncture procedures due to the continuous usage of fluoroscopic imaging. This
exposure can result in acute radiation injury as well as increased risk for somatic
and genetic effects. Therefore, adequate measures must be taken to minimize this
exposure.
• Do not attempt to puncture with an initial power setting greater than that
recommended by the Catheter Instructions For Use. The output power selected
should be as low as possible for the intended purpose.
• Failure of the Generator could result in an unintended increase of output power.
• Place monitoring electrodes as far away from the surgical site as possible, to
avoid burns or interference with other equipment. The use of needle monitoring
electrodes (or other small area electrodes) during RF output is not recommended.
In all cases, monitoring systems incorporating high frequency current limiting
devices are recommended.
• Skin-to-skin contact (for example between the arms and body of the patient)
should be avoided, for example by insertion of dry gauze).
• The Generator is not equipped with a Contact Quality Monitor, thus loss of safe
contact between the dispersive and the patient will not result in an auditory alarm.
• During RF output, implated devices such as pacemakers may be affected.
Qualified advice should be obtained as necessary, to minimize the risk from
injury to due implanted device malfunction.
For future reference, retain this User's
9 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc