High Frequency (Rf) Leakage Current; Standards And Iec Classifications; Operating Conditions; Class I Equipment (Iec 60601-1 - Bovie Aaron 1250 User Manual

High Frequency (RF) Leakage Current

Bipolar RF leakage current
Monopolar RF leakage current (additional tolerance)

Operating Conditions

RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut, coagulate
and ablate tissue.

STANDARDS AND IEC CLASSIFICATIONS

Class I Equipment (IEC 60601-1)

Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which
they are connected to the protective earth conductor.

Type BF Equipment (IEC 60601-1) / Defibrillator Proof

The Aaron 1250™ Electrosurgical Generator provides a high degree of protection against electric shock,
particularly regarding allowable leakage currents. It is type BF equipment. Patient connections are isolated
from earth and resist the effects of defibrillator discharge.

Drip Proof (IEC 60601-2-2)

The generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other
components which, when wet, are likely to affect adversely the safety of the generator.

Electromagnetic Interference

When other equipment is placed on or beneath an activated Aaron 1250™ Electrosurgical Generator, the unit can be
activated without interference. The generator minimizes electromagnetic interference to video equipment used in the
operating room.

Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)

The Aaron 1250™ Electrosurgical Generatorcomplies with the appropriate IEC 60601-1-2 and IEC 60601-2-2
specifications regarding electromagnetic compatibility.

Voltage Transients (Emergency Generator Mains Transfer)

The Aaron 1250™ Electrosurgical Generator operates in a safe manner when the transfer is made between line AC
and an emergency generator voltage source.

EMC COMPLIANCE

Special precautions should be taken regarding the 1250™. Medical Electrical Equipment needs special precautions
regarding EMC and needs to be installed and put into service according to the EMC information provided in this
manual.
Understand that only the Accessories supplied with or ordered from Bovie Medical Corporation should be used with
your device. The use of Accessories, transducers, and cables other than those specified, may result in increased
Emissions or decreased Immunity of the A1250™. The A1250™ and its accessories are not suitable for interconnec-
tion with other equipment.
Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The 1250™ should
not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the A1250™
should be observed to verify normal operation in the configuration in which it will be used.
A-4
< 39 mA
rms
< 150 mA
rms
Bovie Medical Corporation