Table of Contents
Advertisement
General Information for the Safe
Use of Bipolar Instruments
(Continued)
Description of Device
KARL STORZ bipolar instruments and Take-
apart
bipolar instruments include, but are
TM
not limited to, forceps, coagulating electrodes
and suction coagulators. All KARL STORZ
bipolar instruments conform to the following
voluntary standards applicable to medical
devices of this type and conditions of use:
IEC 60601-1-2; IEC 60601-2-18 and ANSI/
AAMI HF18.
Indications: Bipolar instruments are
indicated for use whenever bipolar electro-
surgical laparoscopic, endoscopic or non-
endoscopic procedures are indicated.
Contraindications:
instruments is contraindicated whenever
endos copy or laparoscopy is contraindicated.
•
Gas emboli and cardiac arrest have
been reported during electrosurgical
procedures performed in conjunction
with gas insufflation. Careful monitoring
of gas volume and patient pressure
should be performed throughout the
electrosurgical procedure in order to
minimize any such risk.
•
Bipolar forceps HAVE NOT been shown
to be effective for female sterilization by
destruction of the fallopian tubes.
Special Instructions for Use of
Bipolar Instruments
The following WARNINGS and PRECAU-
TIONS must be closely observed when
using bipolar instruments for electrosurgical
procedures.
WARNING: Be certain that bipolar instru-
ments are connected ONLY to bipolar outlets.
DO NOT connect a bipolar instrument to a
monopolar outlet, it will result in unintended
activation of the instrument in the monopolar
mode.
Use of bipolar
8
Advertisement
Table of Contents
