Instructions For Use; Set Up; Preliminary Instructions; Operating Procedures-Coagulation Mode - Codman MALIS CMC-III Bedienungsanleitung

DD. Supply Voltage Selector
Indicates the supply voltage setting of the generator. Set the selector to the
correct voltage for the electrical outlet being used.
EE. Equi po ten tial Con nector
Use this ter minal to connect a poten tial equalization con ductor to a busbar
in rooms where poten tial equal iza tion is required.
Instruc tions for Use

Set Up

1. Place the CMC-III Gen er ator on a stand con ven ient to the surgeon. We
recom mend the use of the CODMAN Floor stand (catalog no. 80-1177) for
the MALIS CMC-II/III System.
NOTE: Make sure the power switch is in the off posi tion.
2. Plug the power cord into the rear panel of the gen er ator and then into an
appro priate voltage grounded electrical outlet.
WARNING: Grounding reli ability can be achieved only when con nected to a
recep tacle marked "Hos pital Only" or "Hos pital Grade."
3. Verify that the setting shown on the supply voltage selector is appropriate
for the electrical outlet. If you must change the settings, use a tool, such
as a screwdriver, to pry down the top edge of the panel. Using a fingernail
or screwdriver, gently pull the two fuse holders out and completely remove
them. Then pry out the voltage selection drum. Turn the drum and reinsert
it so the appropriate voltage setting will appear in the window. Replace the
fuses if necessary. Reinsert the fuse holders so the arrows match the arrows
on the inside of the panel. Snap the panel back into position.
4. Insert the plug of the foot switch into the foot switch recep tacle on the rear
of the gen er ator. Place the foot switch in an area access ible to the user.
NOTE: Be sure to test the integ rity of the foot switch before each use.
Replace if nec es sary.
NOTE: Do not immerse the foot switch in any liquids. Inspect the foot-
switch cord before each use and replace the foot switch upon any evi dence
of deteriora tion.
5. If you are using the MALIS MODULE 1000 Irrigation Module (catalog
no. 80-9100) with the CMC-III System:
A. Follow the set-up instructions provided with the irrigator.
B. Use the MALIS MODULE 1000 Interconnecting Cable (catalog
no. 80-9115). Plug the cable's connectors into the receptacles at the rear
of the irrigation module, the generator, and the footswitch cable. The cable
allows you to control irrigation and cutting or coagulation simultaneously
with the CMC-III Footswitch. Refer to the instructions provided with
the cable.
C. Continue with the set-up of the irrigator. Use only MALIS tubing with the
CMC-III System. Refer to the instructions provided with the tubing set.
NOTE: To avoid unin ten tional irri ga tion, be sure the power on the irri gator is
switched off when ever the CMC-III Gen er ator is switched off.
Pre lim i nary Instruc tions
NOTE: Before turning on the gen er ator, verify that the supply voltage to the
power recep tacle is correct.
1. Press the power switch to the on posi tion. The micro cut and coag u la tion
power setting windows illu mi nate when the power comes on. When the
gener ator is first turned on, they default to power set tings of 0 Malis Units.
2. As soon as numerals display in the power setting windows, the voice
indicator announces "output power is off". The voice volume control
increases or decreases the volume. The tone volume control increases or
decreases the tone volume. While using the tone volume or voice volume
con trols, the tone or voice set tings appear in the micro cut power display
window. After ward, the display window again shows the actual micro cut
power setting.
3. Using Bipolar Cords
Using sterile tech nique as appro priate, place the forceps end of the sterile
bipolar cord in an accessible area of the sterile field. Pass the cord and
banana plug con nec tors out of the sterile field to the gen er ator. Insert the
banana plugs into the iso lated bipolar output jacks. Be sure both plugs are
securely inserted into the jacks. Attach the sterile bipolar forceps to the
sterile end of the bipolar cord. Remove the plugs by grasping and pulling the
molded strain relief only; do not pull on the cord itself.
CODFR08059xx01v05.indd 6 CODFR08059xx01v05.indd 6
NOTE: Be sure to test the integ rity of the bipolar cord before each use.
Replace if nec es sary.
4. Using the Irri ga tion Tubing Set
Refer to the product insert pack aged with the tubing set for spe cific set-
up instruc tions.
NOTE: To avoid unin ten tional irri ga tion, be sure to switch off the power on
the irri gator when ever the CMC-III Gen er ator is switched off.
5. Change the cutting and coagulation power settings to the desired amount
by pressing the cutting power control switch and the coagulation power
control switch on the front panel of the generator. To return quickly to a
power setting of 35 Malis units (9 watts), use the cut and coag reset buttons
on the front of the gen er ator.
Dr. Leonard Malis states the fol lowing:
"In terms of power set tings, there are too many var i ables to rec om mend spe-
cific output power selec tions. Forceps tips size, vessel diam e ters, and tissue
size all must be con sid ered when choosing a power setting. As with all elec-
tro sur gical devices, proper care should be taken to prevent use of a setting
which is in excess of that needed to cut or coag u late. Shrinking the neck of
an intra cra nial aneu rysm could require a setting of 20 or 25 (3 to 5 watts).
Coring of an intra cra nial tumor may be accom plished at power between
35 and 45 (9 to 14 watts). Depending on the size of the forceps, skin flap
hemo stasis may be achieved at set tings between 30 and 50 (7 to 17 watts).
Larger vessels in the muscles of the abdomen or back may require higher set-
tings. Expe ri ence sug gests that each surgeon deter mine the output setting
which pro vides optimum results by begin ning with the lower set tings of the
MALIS CMC-III System and adjusting upward as required."
NOTE: Depress the power control switches firmly to avoid partial or tran sient
oper a tion and to achieve correct switch func tion.
NOTE: Never adjust the power set tings while using the cut or coag con trols
on the footswitch.
Oper ating Pro ce dures—Coag u la tion Mode
When the right (coag) pedal of the footswitch is depressed, the
following occurs.
1. The voice indi cator con firms the mode by NOT ANNOUNCING THE
WORD "CUTTING."
2. The voice indi cator and the coag u la tion power dis plays respec tively
announce and display the power setting simul ta ne ously.
3. Imme di ately fol lowing announce ment of the power setting, the gen er ator
emits a low fre quency major chord tone. The blue coag u la tion light illu mi-
nates to verify the use of the coag u la tion mode. Simultaneously, the green
power output LED illu mi nates, indi cating that power is being deliv ered via
the iso lated bipolar output jacks to the forceps' tips.
4. Release the coag pedal on the footswitch to cancel the sequence and
stop delivery of power to the forceps. To begin coagulation again, depress
the footpedal once more.
NOTE: Depress the pedal firmly to avoid partial or tran sient oper a tion, and to
achieve correct switch func tion.
NOTE: Never adjust the power settings while using the cut or coag controls
on the footswitch.
NOTE: Con ti nous power must be limited to 20 seconds, with a 40 second
rest period.
Coag u la tion in Mute Mode
Silence the voice indi cator by depressing the mute button on the back panel
of the gen er ator. The green mute LED lights up. There after, the voice indi-
cator WILL NOT ANNOUNCE the power setting. When you depress the coag
pedal on the foot switch, coagulation power will be deliv ered imme di ately,
accom pa nied only by a low fre quency major chord tone and the illu mi na tion
of the blue coag u la tion light. The green power output LED simul ta ne ously
lights up.
The voice indi cator con tinues to announce the power setting when ever that
setting changes and announces any of the five prob lems detected by the
self-diagnostic func tion, even in the mute mode.
6
11/6/2008 1:30:52 PM 11/6/2008 1:30:52 PM