Background; Product Description; Indications; Warnings And Precautions - Codman MALIS CMC-III Bedienungsanleitung

Bipolar cut
Bipolar micro cut
Bipolar coag u late
Foot switch
Voice mute
Irri ga tion mode on/off; Irri gator con nec tion recep tacle
Tone volume control
Voice volume control
Equi po ten tiality
Pro tec tive Earth (Ground)
Alert
Output Power Over-Current Pro tec tion
Fuse
Back ground
by Leonard Malis, M.D.
The orig inal mono polar and the MALIS Bipolar Coagulators used spark-gap
gen er a tors to produce their coagulating wave form. The ape ri odic wave form
and random spike com po nents of the spark-generated wave form pro duced
good coag u la tion. However, the initial spike of each damped train is always
much higher in voltage than the rest of the train, as a require ment for striking
the arc in the internal spark gap of the gen er ator. This high voltage initial
spike is responsible for the unde sir able sparking at the forceps tips and inter-
fer ence with tele vi sion and mon i toring equip ment.
Pre vious elec tronic tube or solid state coagulators gen er ally pro vided either
damped trains of sine or square waves, or simply repet i tive pulses. The syn-
chron izing of these pulses or waves increased unde sir able cutting or per fo ra-
tion of vessels being coag u lated, as a result of molec ular res o nance. For this
reason, the orig inal MALIS CMC-I Bipolar Coag u lator (catalog no. 80-1114)
con tinues to be the choice of most micro sur geons.
The MALIS CMC-II Bipolar Coag u lator and Bipolar Cutter System sim u lated
the ape ri odic wave-form of the spark gap systems, but the leading spike has
now been reduced and is proportional to the remainder of the damped asyn-
chronous train. The ape ri odic wave-form results in the elim i na tion of molec-
ular resonance while control of the first spike of each train results in marked
reduc tion of sparking of the forceps and inter fer ence with other equip ment.
In addi tion, the wave-form param e ters are spe cif i cally programmed for
smoother coag u la tion, and reduced neu ro mus cular stim u la tion, char ring,
sticking, and vas cular per fo ra tion.
Bipolar coag u la tion has been part of microsurgical tech nique from the very
begin ning. The old stan dard uni polar machines worked from a single active
electrode to a return plate through a large ground plate or dis per sive elec-
trode. A con sid er able total current, dis trib uted roughly in a geo metric cone
from the active elec trode to the ground plate, had its highest power per
tissue volume at the active elec trode, but a fair amount of current was dis trib-
uted in adja cent tissues. The most con duc tive path to the ground had the
highest current density. This could be through the blood in the small vessel
being coag u lated, thereby inad ver tently coag u lating the parent vessel. Use
of the uni polar coag u lator under saline irri ga tion was not fea sible, as the
saline, rather than the desired tissue, was the con duc tive path to ground.
CODFR08059xx01v05.indd 3 CODFR08059xx01v05.indd 3
In bipolar coagulation the electrical dif fer ence is in the iso lated output and
in the lower power requirements. The output of the bipolar gen er ator should
be iso lated from ground as much as pos sible, so all current flow takes place
between the two tips of the sep ar ated forceps. There should be vir tu ally no
current flow from either side of the forceps to ground. The current geom etry
is depen dent upon the tip size and angle at which the tips meet, as well as
the medium in which they are immersed. If the forceps blades are vir tu ally
par allel, and the forceps are deep in saline, there will be major shunting in
the saline. If the forceps are bowed or angled so the tips almost meet while
the blades are still well sep ar ated, the current flow will be mainly between
the tips with little shunting. The lowest pos sible gen er ator output impe dance
pro vides the best main te nance of power at the forceps tips with the least
decrease in coagulation due to shunting.
The MALIS CMC-II Bipolar Coag u lator and Bipolar Cutting System pro vided
a stiffly reg u lated iso lated output with the impe dance in the 5 to 10 ohms
range. By con trast, output impe dance of pre vi ously avail able solid state
systems is approx i mately 150 to 500 ohms. Even the spark-gap MALIS
CMC-I Bipolar Coagulator has an output impe dance of 40 to 50 ohms. The
lower impe dance output of the MALIS CMC-II System facil i tated its use
under the con stant irrigation desir able for cooling and pro tecting adja cent
del i cate struc tures. Cutting with the CMC-II System, using sharp forceps
or bipolar loop forceps, was par tic u larly effec tive for the precise coring
of nervous system tumors with minimal bleeding, as com pared to other
tech niques. It was less effec tive for cutting fibrous tissues or opening skin
or fascia.
The MALIS CMC-III Elec tro sur gical System now pro vides the higher energy
output needed for rapid cutting of all tissues, including dense fibrous layers,
shifting the low impe dance of the micro cutting automatically to match the
power require ments of the high power cut set tings. At the same time, the
CMC-III System con tinues all of the other advan tages already noted for
the CMC-II System and pro vides a still lower output impe dance for even
more effec tive control of coagulation. A number of other mod ifi ca tions
that will make its use easier have also been pro vided and are described in
this manual.
Product Descrip tion
The MALIS CMC-III Bipolar Electrosurgical System (catalog no. 80-1170
or 80-1172) includes the generator; a bipedal footswitch for operating
the cutting and coagulation functions; a connecting cable to allow the
use of the MALIS MODULE 1000™ Irrigation system with the CMC-III
Generator. The gen er ator is equipped with a voice synthesizer that pro vides
an audible indi ca tion of changes to the power set tings. At the surgeon's
option, it also announces the oper ating mode and power setting each time
cutting or coagulation is performed. With the excep tion of the gen er ator,
all the above system com po nents can also be ordered sep ar ately (see
Accessories section).
MALIS Bipolar Cutting Forceps and stan dard insu lated and non in su lated
forceps are avail able sep ar ately, as are dis pos able bipolar cords. The system
can be used with the MALIS MODULE 1000 Irrigation System (catalog
no. 80-9100). The CODMAN ® Floorstand for the MALIS CMC-II/III System is
designed to accommodate the CMC-III Generator and the Irrigation System
together. (See Acces so ries section for ordering infor ma tion.)

Indications

The CODMAN MALIS CMC-lll Bipolar Electrosurgical Generator is indicated
for use in Neurosurgery. All procedures must be performed by a qualified
Neurosurgeon with electrosurgical experience.
WARN INGS AND PRECAU TIONS
WARN INGS
Read entire instruc tion manual before attempting to operate this unit.
The MALIS CMC-III System is man u fac tured to cut or coag u late living
tissue and must only be used in a medical facility under the super vi sion of
a phy si cian.
Do not attempt to bypass the grounding prong on the gen er ator by using
a three-prong to two-prong adaptor. The gen er ator must be prop erly
grounded to ensure oper ator and patient safety. Grounding reli ability can
be achieved only when con nected to a recep tacle marked "Hos pital Only"
or "Hos pital Grade."
Always replace the system's fuse with the appro priate type and value fuse
(see Tech nical Spec ifi ca tions).
Before turning on the generator, verify that the supply voltage selector is set
to the appropriate voltage for the electrical outlet.
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