The MALIS CMC-III Bipolar Electrosurgical System Instruction Manual Revised Oct 2010

Classification

ENGLISH The MALIS® CMC®-III Bipolar Electrosurgical System (Catalog No. 80-1170 and 80-1172) Instruction Manual IMPORTANT: Please read entire Instruction Manual before attempting to operate this unit.

Table of Contents

Equipment Function:

Electrosurgical Generator

Type of protection against electrical shock:

Class I

Degree of protection against electrical shock:

Type BF

Supply Connection:

1.6 Amp 220/240 VAC 3.15 Amp 100/120 VAC 50–60 Hz

Mode of Operation:

Continuous with intermittent loading, 20 sec. on/40 sec. off

Classification ... 2 Protection against hazards of explosion:

Definitions ... 2 Table of Symbols ... 2 Background ... 3 Product Description ... 3 Indications ... 3 Warnings and Precautions ... 3 Controls, Indicators, and Connections ... 4

Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Protection against ingress of liquids:

Not protected

Degree of Mobility:

Portable

Definitions Power (Mains) Switch-The switch through which primary effective voltage and current are applied.

Generator Controls ... 4 Footswitch Controls ... 5

Bipolar Cut-The electrical division of tissue caused by the passage of high frequency current across such tissue.

Indicators ... 5 Connections ... 5

Coagulate-The sealing of blood vessels or tissue caused by the passage of high frequency voltage and current across such vessels or tissue.

Instructions for Use ... 6

Power Output Switch-Used for varying the output power to bipolar forceps.

Set Up ... 6 Preliminary Instructions ... 6

Table of Symbols

Operating Procedures-Coagulation Mode ... 6 Increase display setting

Coagulation in Mute Mode ... 6 Operating Procedures-Cutting Mode ... 7

Decrease display setting

Cutting in Mute Mode ... 7 Troubleshooting Guide ... 8

Primary (Mains) power on

Technical Specifications ... 9 Primary (Mains) power off

Operational Performance ... 9 Power Output Charts ... 9

Alternating Current

Replacing Internal Fuses ... 10 User Maintenance ... 10 Isolated bipolar output connector

Preventive Maintenance ... 10 Additional Specifications ... 10 Routine Cleaning ... 10

L.E.D. Test

Sterilization ... 10 Service and Repair ... 10 Attention, see instructions for use

Accessories ... 11 Warranty ... 11

Type BF equipment-having an applied part with or without an intentional electrical path to the patient

Table I Manufacturer’s Declaration Regarding Electromagnetic Emissions ... 12 Table II Manufacturer’s Declaration Regarding Electromagnetic Immunity ... 12

Dangerous voltage

Table III Manufacturer’s Declaration Regarding Electromagnetic Immunity – Non-life Supporting ... 13 Output power

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In bipolar coagulation the electrical difference is in the isolated output and in the lower power requirements. The output of the bipolar generator should be isolated from ground as much as possible, so all current flow takes place between the two tips of the separated forceps. There should be virtually no current flow from either side of the forceps to ground. The current geometry is dependent 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 virtually parallel, 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 separated, the current flow will be mainly between the tips with little shunting. The lowest possible generator output impedance provides the best maintenance of power at the forceps tips with the least decrease in coagulation due to shunting.

Bipolar cut Bipolar micro cut Bipolar coagulate Footswitch Voice mute

The MALIS CMC-II Bipolar Coagulator and Bipolar Cutting System provided a stiffly regulated isolated output with the impedance in the 5 to 10 ohms range. By contrast, output impedance of previously available solid state systems is approximately 150 to 500 ohms. Even the spark-gap MALIS CMC-I Bipolar Coagulator has an output impedance of 40 to 50 ohms. The lower impedance output of the MALIS CMC-II System facilitated its use under the constant irrigation desirable for cooling and protecting adjacent delicate structures. Cutting with the CMC-II System, using sharp forceps or bipolar loop forceps, was particularly effective for the precise coring of nervous system tumors with minimal bleeding, as compared to other techniques. It was less effective for cutting fibrous tissues or opening skin or fascia.

Irrigation mode on/off; Irrigator connection receptacle Tone volume control Voice volume control

Equipotentiality

Output Power Over-Current Protection

The MALIS CMC-III Electrosurgical System now provides the higher energy output needed for rapid cutting of all tissues, including dense fibrous layers, shifting the low impedance of the micro cutting automatically to match the power requirements of the high power cut settings. At the same time, the CMC-III System continues all of the other advantages already noted for the CMC-II System and provides a still lower output impedance for even more effective control of coagulation. A number of other modifications that will make its use easier have also been provided and are described in this manual.

Fuse

Product Description

Protective Earth (Ground) Alert

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 generator is equipped with a voice synthesizer that provides an audible indication of changes to the power settings. At the surgeon’s option, it also announces the operating mode and power setting each time cutting or coagulation is performed. With the exception of the generator, all the above system components can also be ordered separately (see Accessories section).

Background by Leonard Malis, M.D. The original monopolar and the MALIS Bipolar Coagulators used spark-gap generators to produce their coagulating waveform. The aperiodic waveform and random spike components of the spark-generated waveform produced good coagulation. However, the initial spike of each damped train is always much higher in voltage than the rest of the train, as a requirement for striking the arc in the internal spark gap of the generator. This high voltage initial spike is responsible for the undesirable sparking at the forceps tips and interference with television and monitoring equipment.

MALIS Bipolar Cutting Forceps and standard insulated and noninsulated forceps are available separately, as are disposable 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 Accessories section for ordering information.)

Previous electronic tube or solid state coagulators generally provided either damped trains of sine or square waves, or simply repetitive pulses. The synchronizing of these pulses or waves increased undesirable cutting or perforation of vessels being coagulated, as a result of molecular resonance. For this reason, the original MALIS CMC-I Bipolar Coagulator (catalog no. 80-1114) continues to be the choice of most microsurgeons.

Indications

The MALIS CMC-II Bipolar Coagulator and Bipolar Cutter System simulated the aperiodic wave-form of the spark gap systems, but the leading spike has now been reduced and is proportional to the remainder of the damped asynchronous train. The aperiodic wave-form results in the elimination of molecular resonance while control of the first spike of each train results in marked reduction of sparking of the forceps and interference with other equipment. In addition, the wave-form parameters are specifically programmed for smoother coagulation, and reduced neuromuscular stimulation, charring, sticking, and vascular perforation.

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.

WARNINGS AND PRECAUTIONS WARNINGS Read entire instruction manual before attempting to operate this unit. The MALIS CMC-III System is manufactured to cut or coagulate living tissue and must only be used in a medical facility under the supervision of a physician.

Bipolar coagulation has been part of microsurgical technique from the very beginning. The old standard unipolar machines worked from a single active electrode to a return plate through a large ground plate or dispersive electrode. A considerable total current, distributed roughly in a geometric cone from the active electrode to the ground plate, had its highest power per tissue volume at the active electrode, but a fair amount of current was distributed in adjacent tissues. The most conductive path to the ground had the highest current density. This could be through the blood in the small vessel being coagulated, thereby inadvertently coagulating the parent vessel. Use of the unipolar coagulator under saline irrigation was not feasible, as the saline, rather than the desired tissue, was the conductive path to ground.

Do not attempt to bypass the grounding prong on the generator by using a three-prong to two-prong adaptor. The generator must be properly grounded to ensure operator and patient safety. Grounding reliability can be achieved only when connected to a receptacle marked “Hospital Only” or “Hospital Grade.” Always replace the system’s fuse with the appropriate type and value fuse (see Technical Specifications). Before turning on the generator, verify that the supply voltage selector is set to the appropriate voltage for the electrical outlet. 3

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PRECAUTIONS

If you must make a significant change to the supply voltage setting, such as from 100/120 V to 220/240 V operation, two external fuses must be replaced. This must be done by a qualified person.

Do not operate the MALIS CMC-III System at temperatures below 50°F (10°C). Allow the CMC-III Generator to warm up to at least 50°F (10°C) before attempting to operate the coagulator.

Catalog No. 80-1170 only: The generator is shipped with the appropriate power plug for use with a 120 VAC power outlet. If using a 240 VAC power outlet, use the correct power plug, pictured below.

Keep the generator away from other electrosurgical devices and their cables. Devices producing excessive RF current radiation can cause this unit to produce voice annunciation and to output power. Patient monitoring electrodes can be used in any biologically suitable location. Needle electrodes offer no hazard with this unit and can also be placed in any location other than in direct contact with the bipolar forceps’ tips. The cables to the forceps must be positioned in such a way that contact with the patient or other leads is avoided. Always check that the power cord, bipolar cord, and footswitch are functioning properly before using in a surgical procedure. Replace if necessary. It is recommended that the output power be set as low as possible for the intended purpose. It is recommended that insulated bipolar forceps be used when higher power settings are employed.

Explosion hazard; do not use in the presence of flammable materials. Be aware of the hazard of igniting endogenous gases. Be aware that some materials, such as cotton, wool, and gauze, are also a hazard when saturated with oxygen. The sparks produced in normal use of high frequency (HF) surgical equipment can ignite these materials.

Cutting with the bipolar forceps can only take place between the tips of the forceps and is limited to tissue and vessels that can be placed between the tips. If the tips of the bipolar forceps come in contact with each other, or if the tips become coated with coagulum, no cutting or coagulating will take place.

This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, or with oxygen or nitrous oxide.

Continuous power output by the footswitch must be limited to 20 seconds, with a 40-second rest period.

Electrical shock hazard: Do not remove cover or back. No user-serviceable components. Send to qualified service personnel for servicing.

Controls, Indicators, and Connections

Do not apply the output of the generator directly to the heart.

Generator Controls (Figures 1 and 2)

Do not operate the generator near patient devices, such as pacemakers, etc., that are sensitive to radio frequency interference.

A. Power (Mains) Switch Controls the power supplied to the generator.

The unit must not be modified in any way by any user. Unauthorized modifications to the unit can cause it to malfunction or fail in use.

B. Cutting Power Control Switch Used to increase and decrease the power settings for cutting.

Be certain the voice mute switch on the rear panel is in the desired position before actual use begins.

C. Coagulation Power Control Switch Increases and decreases the power settings for coagulation.

Never adjust the power setting while using the cut or coag controls on either the remote control or the footswitch.

D. Tone Volume Control Used to control the volume of the tones that indicate cutting or coagulation power is being delivered to forceps. The tone volume can be changed at any time during the operation of the CMC-III Generator, except while cutting or coagulating. While using these controls, the tone volume settings appear in the micro cut power display window (Item O in Figure 4). Afterward, the display window again shows the actual micro cut power setting.

Never immerse the MALIS CMC-III Generator in any liquid. Do not activate generator output with only one tip of forceps in contact with tissue. Do not allow patient contact with metal parts that are earthed or that have an appreciable capacitance to earth (e.g., operating table supports, etc.). Use antistatic sheeting for this purpose.

E. Voice Volume Control Used to increase or decrease the volume of the voice synthesizer that announces the operating mode being employed and changes in the power settings. The voice volume can be increased or decreased at any time while using the CMC-III Generator, except during cutting or coagulating. While using these controls, the voice volume settings appear in the micro cut power display window (Item O in Figure 4). Afterward, the display window again shows the actual micro cut power setting.

Avoid patient skin-to-skin contact (e.g., between the arm and the body). Use dry gauze between body parts that might touch. Place monitoring electrodes as far as possible from the electrodes of high frequency (HF) surgical equipment. Needle monitoring electrodes are not recommended. However, if needle electrodes are used, do not place them in direct contact with forceps tips.

F. Cutting Reset Button By pushing this button, the cutting power immediately resets to 35 Malis units (or 9 watts).

Avoid the use of flammable anesthetics or oxidizing gases, such as nitrous oxide (N2O) and oxygen, if performing surgery on the thorax or the head, unless you evacuate these agents.

G. Coagulation Reset Button Pushing this button quickly resets the coagulation power to 35 Malis units (or 9 watts).

Ensure that flammable agents, such as cleaning agents, disinfectants, or adhesive solvents, have evaporated before using HF surgical equipment.

H. Irrigation Mode Button When the MALIS MODULE 1000 Irrigation System is properly set up and connected to the CMC-III Generator, push this button to disable and enable irrigation. The irrigation mode indicator (Item T in Figure 4) located on the generator illuminates when the irrigator is enabled, regardless of which of the two switches is used.

Be aware that interference produced by HF surgical equipment use can adversely affect the operation of other electronic equipment. Be aware that failure of the MALIS CMC-III System could result in an unintentional increase of output power. Regularly inspect the accessories. Check electrode cables and endoscopic accessories for damage to the insulation.

I. Voice Mute Button (Rear Panel) Used to prevent the voice synthesizer from announcing the operating mode being employed and the power settings each time cutting or coagulating is performed. When the voice is muted, the mute indicator (Item U in Figure 4) illuminates.

Ensure that accessories are rated for at least the maximum peak output voltage of the generator for the intended output setting in the desired operating mode. Refer to the Open Circuit Voltages vs. Power Setting graphs in Figures 10, 13, and 16.

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T. Irrigation Mode LED Irrigation is enabled when this green light is on and the MALIS MODULE 1000 Irrigation System is properly connected.

J. LED Test Button (Rear Panel) When you press this button, all numeric LED’s illuminate as a selfdiagnostic test. Any numeric LED that does not illuminate signals a problem requiring attention.

NOTE: To avoid unintentional irrigation, be sure the power on the irrigator is switched off whenever the CMC-III Generator is switched off.

Footswitch Controls (Figure 3) K. Cutting Output Pedal When you depress this pedal, cutting power is delivered to the forceps.

U. Mute LED This green LED illuminates when you disable the voice synthesizer by using the voice mute button (Item I in Figure 2).

NOTE: Never change power setting while using the cut or coag control.

V. Alert LED This red LED illuminates whenever the output power varies more than ±20% from its nominal value. Once illuminated, this LED remains lit until the power (mains) switch is cycled off, then on. If this LED turns on again, after cycling the power switch, return the unit for service.

L. Coagulation Output Pedal Coagulation power is delivered to the forceps when you depress this pedal.

Indicators (Figure 4) M. Power Output LED This green LED illuminates whenever power of any kind, for either cutting or coagulation, is delivered to the forceps.

W. Output Power Over-Current Protection LED This red LED illuminates whenever the over-current circuit is active. The over-current circuit decreases or shuts off the output power if the output current becomes dangerously high. The circuit protects the forceps tips from arcing and protects the patient from possible burns due to excessive current.

N–P. Power Display Windows These three sets of windows show the power selections for high power cutting (Item N), micro cutting (Item O), and coagulation (Item P). The power selections are shown in Malis Units. When the generator is initially turned on, the setting “0” appears in both the microcutting and coagulation windows. The high power cutting window will be blank. The following power settings are available for each operating mode.

X. Power Setting Display Area The three power display windows are in this area, along with power output mode LEDs. Tone Indicators (not shown) The CMC-III Generator produces a tone whenever power is delivered to the forceps. Two different tones differentiate between coagulation and cutting. A low frequency major chord indicates coagulation. A higher frequency minor chord indicates cutting. The volume of the tone indicator can be controlled with the tone volume control (Item D in Figure 1).

POWER SETTINGS COAGULATE Malis Units Watts 0

0.0

MICRO CUTTING

HIGH POWER CUTTING

Malis Units

Watts

Malis Units

Watts

0

0.0

60

20.0

Voice Indicator (not shown) (English only) The voice indicator enables checking or adjustment of the power setting and mode of operation without looking at the settings. As the power setting changes, the voice indicator announces each new setting. When using the cut switch on the footswitch the voice announces either “micro cut” or “cutting”. It also announces the power setting before the generator delivers either cutting or coagulating power to the forceps. The voice volume control (Item E in Figure 1) changes the volume of the voice.

8

0.7

8

0.7

70

40.0

10

1.0

10

1.0

80

60.0

15

1.6

15

1.6

90

80.0

20

3.0

20

3.0

100

100.0

25

5.0

25

5.0

110

120.0

30

7.0

30

7.0

35

9.0

35

9.0

40

11.0

40

11.0

45

14.0

45

14.0

50

17.0

50

17.0

60

19.0

70

22.0

“Memory recycle error” Operating malfunction

80

24.0

Please refer to the Troubleshooting Guide for further information.

90

25.0

Connections (Figures 5 and 6)

100

29.0

110

32.0

Y. Isolated Bipolar Output Jacks These jacks accept the banana-type plugs of the disposable bipolar cord.

120

35.0

130

40.0

140

45.0

150

50.0

In addition, the voice indicator functions as part of the self-diagnostic feature for the following five conditions. “Internal fuse”

Indicates an internal fuse must be replaced

“Memory error”

Operating malfunction

“Error”

Indicates the two front panel power setting controls were pressed simultaneously

“Footpedal error”

Indicates that both footpedals were pressed simultaneously

Z. Footswitch Receptacle Accepts the connector of the footswitch. AA. Irrigator Receptacle The MALIS MODULE 1000 Interconnecting Cable (catalog no. 80-9115) can be plugged into the generator at this receptacle to allow the use of the MALIS MODULE 1000 Irrigation System (catalog no. 80-9100) along with the CMC-III Generator. Refer to the set up instructions in the manual supplied with the connecting cable for more information.

Q. High Power Cutting LED This yellow LED illuminates whenever cutting power in the high range (60 to 110 Malis units, or 20 to 120 watts) is delivered to the forceps.

NOTE: To avoid unintentional irrigation, be sure the power on the irrigation module is switched to the off position whenever the power switch on the CMC-III Generator is in the off position.

R. Micro cutting Power LED This yellow LED illuminates when cutting power in the micro range (8 to 50 Malis units, or 0.7 to 17 watts) is delivered to the forceps.

BB. Power Receptacle This receptacle accepts the three-prong power cord plug and also contains the external fuse. (See Technical Specifications.)

S. Coagulation Power Light This blue light illuminates whenever coagulation power is delivered to the forceps.

CC. Fuse Holder Two fuse holders are located behind the removable panel above the power entry connector. See Technical Specifications for replacement fuses.

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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.

NOTE: Be sure to test the integrity of the bipolar cord before each use. Replace if necessary. 4. Using the Irrigation Tubing Set Refer to the product insert packaged with the tubing set for specific setup instructions.

EE. Equipotential Connector Use this terminal to connect a potential equalization conductor to a busbar in rooms where potential equalization is required.

NOTE: To avoid unintentional irrigation, be sure to switch off the power on the irrigator whenever the CMC-III Generator is switched off.

Instructions for Use Set Up

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 generator.

1. Place the CMC-III Generator on a stand convenient to the surgeon. We recommend the use of the CODMAN Floorstand (catalog no. 80-1177) for the MALIS CMC-II/III System. NOTE: Make sure the power switch is in the off position.

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.

Dr. Leonard Malis states the following: “In terms of power settings, there are too many variables to recommend specific output power selections. Forceps tips size, vessel diameters, and tissue size all must be considered when choosing a power setting. As with all electrosurgical devices, proper care should be taken to prevent use of a setting which is in excess of that needed to cut or coagulate. Shrinking the neck of an intracranial aneurysm could require a setting of 20 or 25 (3 to 5 watts). Coring of an intracranial tumor may be accomplished at power between 35 and 45 (9 to 14 watts). Depending on the size of the forceps, skin flap hemostasis may be achieved at settings between 30 and 50 (7 to 17 watts). Larger vessels in the muscles of the abdomen or back may require higher settings. Experience suggests that each surgeon determine the output setting which provides optimum results by beginning with the lower settings of the MALIS CMC-III System and adjusting upward as required.”

4. Insert the plug of the footswitch into the footswitch receptacle on the rear of the generator. Place the footswitch in an area accessible to the user.

NOTE: Depress the power control switches firmly to avoid partial or transient operation and to achieve correct switch function.

NOTE: Be sure to test the integrity of the footswitch before each use. Replace if necessary.

NOTE: Never adjust the power settings while using the cut or coag controls on the footswitch.

NOTE: Do not immerse the footswitch in any liquids. Inspect the footswitch cord before each use and replace the footswitch upon any evidence of deterioration.

Operating Procedures-Coagulation Mode

5. If you are using the MALIS MODULE 1000 Irrigation Module (catalog no. 80-9100) with the CMC-III System:

1. The voice indicator confirms the mode by NOT ANNOUNCING THE WORD “CUTTING.”

A. Follow the set-up instructions provided with the irrigator.

2. The voice indicator and the coagulation power displays respectively announce and display the power setting simultaneously.

2. Plug the power cord into the rear panel of the generator and then into an appropriate voltage grounded electrical outlet. WARNING: Grounding reliability can be achieved only when connected to a receptacle marked “Hospital Only” or “Hospital Grade.”

When the right (coag) pedal of the footswitch is depressed, the following occurs.

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.

3. Immediately following announcement of the power setting, the generator emits a low frequency major chord tone. The blue coagulation light illuminates to verify the use of the coagulation mode. Simultaneously, the green power output LED illuminates, indicating that power is being delivered via the isolated bipolar output jacks to the forceps’ tips.

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.

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: To avoid unintentional irrigation, be sure the power on the irrigator is switched off whenever the CMC-III Generator is switched off.

NOTE: Depress the pedal firmly to avoid partial or transient operation, and to achieve correct switch function.

Preliminary Instructions NOTE: Before turning on the generator, verify that the supply voltage to the power receptacle is correct.

NOTE: Never adjust the power settings while using the cut or coag controls on the footswitch.

1. Press the power switch to the on position. The micro cut and coagulation power setting windows illuminate when the power comes on. When the generator is first turned on, they default to power settings of 0 Malis Units.

NOTE: Continous power must be limited to 20 seconds, with a 40 second rest period.

Coagulation in Mute Mode

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 controls, the tone or voice settings appear in the micro cut power display window. Afterward, the display window again shows the actual micro cut power setting.

Silence the voice indicator by depressing the mute button on the back panel of the generator. The green mute LED lights up. Thereafter, the voice indicator WILL NOT ANNOUNCE the power setting. When you depress the coag pedal on the footswitch, coagulation power will be delivered immediately, accompanied only by a low frequency major chord tone and the illumination of the blue coagulation light. The green power output LED simultaneously lights up.

3. Using Bipolar Cords Using sterile technique as appropriate, place the forceps end of the sterile bipolar cord in an accessible area of the sterile field. Pass the cord and banana plug connectors out of the sterile field to the generator. Insert the banana plugs into the isolated 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.

The voice indicator continues to announce the power setting whenever that setting changes and announces any of the five problems detected by the self-diagnostic function, even in the mute mode.

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Operating Procedures-Cutting Mode When the left (cut) pedal of the footswitch is depressed, the following occurs. 1. The voice indicator confirms the mode by announcing either “micro cut” or “cutting”. 2. The voice indicator and the micro or high cutting power display respectively announces and displays the power setting simultaneously. 3. Immediately following announcement of the power setting, the generator emits a high frequency minor chord tone. Either the yellow microcutting or the yellow high power cutting LED, as appropriate, lights up to verify the cutting mode. Simultaneously, the green power output LED illuminates, indicating that power is being delivered via the isolated bipolar output jacks to the forceps tips. 4. Release the pedal on the footswitch to cancel the sequence and stop delivery of power to the forceps. To begin cutting again, depress the footpedal once more. NOTE: Depress the pedal firmly to avoid partial or transient operation, and to achieve correct switch function. NOTE: Never adjust the power settings while using the cut or coag controls on the footswitch. NOTE: Continous power must be limited to 20 seconds, with a 40 second rest period.

Cutting in Mute Mode Silence the voice indicator by depressing the mute button on the back panel of the generator. The green mute LED illuminates. Thereafter, the voice indicator WILL NOT ANNOUNCE either the operating mode (“micro cut” or “cutting”) or the power setting. Depressing the cut pedal on the footswitch delivers cutting power immediately, accompanied by a high frequency minor chord tone and illumination of the yellow micro cutting or high power cutting LED. The green power output LED simultaneously lights up. The voice indicator continues to announce the power setting whenever that setting changes and announces any of the five problems detected by the selfdiagnostic function, even in the mute mode.

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Troubleshooting Guide Symptoms

Probable Cause

Correction

1. Unit does not operate

a. Blown fuse b. Loose wire at power cord plug c. No power at wall outlet

a. Replace fuse b. Check plug for wiring c. Check electrical service

2. Low power output

a. Low line voltage b. Incorrect test load

a. Adjust to nominal line voltage b. Use 50 ohm non-inductive load for coag and micro cut; 400 ohm for regular cut c. Return for service and recalibration

c. Internal calibration change a. Loose or dirty connections between forceps cord and jacks b. Intermittent break in forceps cord

a. Gently clean plug surfaces with abrasive cloth

4. No power output

a. Broken wire in forceps cord

a. Replace forceps cord

5. Excessive leakage current

a. Shorted output transformer

a. Return for service and recalibration

6. Excessive power output

a. Internal calibration change

a. Return for service and recalibration

7. Voice indicator announces “Internal fuse.” Power Setting Display flashes “00”

a. Blown internal fuse

a. Replace internal fuse

8. Voice indicator announces “Memory error.” Power Setting Display flashes “01”

a. Operating malfunction

a. Return for service

9. Voice indicator announces “internal power error.” Power Setting Display flashes “02”

a. Operating malfunction

a. Return for service

10. Voice indicator announces “Memory Recycle error.” Power Setting Display flashes “03”

a. Operating malfunction

a. Return for service

11. Voice indicator announces “Footpedal error”

a. Two footpedals pressed simultaneously

a. Use care when depressing footpedal

12. Voice indicator announces “internal cut error.” Power Setting Display flashes “04”

a. Operating malfunction

a. Return for service

13. Voice indicator announces “output error.” Power Setting Display flashes “05”

a. Operating malfunction

a. Return for service

14. Voice indicator announces “high output error.” Power Setting display flashes “06”

a. Operating malfunction

a. Return for service

15. Voice indicator announces “internal micro error.” Power Setting Display flashes “07”

a. Operating malfunction

a. Return for service

16. Voice indicator announces “Error”

a. Two front panel setting controls pressed simultaneously

a. Use care when pressing controls

17. Alert LED remains illuminated

a. Operating malfunction

a. Return for service

3. Erratic power output

b. Replace forceps cord

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Technical Specifications

Power Output Charts

Power Requirements

Typical Output vs. Power Setting

100/120 ±10% VAC

Coag Output into 50 ohms using 45 cm leads (For reference only)

220/240 ±10% VAC

Power Setting (Malis Units)

50/60 Hz, 330 VA

Fuses

Output Current (RF amp)

Output Power (Watts)

0

0.00

0.0

8

0.12

0.7

10

0.15

1.1

15

0.18

1.6

20

0.24

2.9

25

0.32

5.1

30

0.38

7.2

35

0.43

9.3

40

0.48

11.5

Output Waveform

45

0.53

14.1

Coagulate: Damped Aperiodic, centered at 1 MHz

50

0.58

16.8

Cut: Sinusoidal, 1 MHz

60

0.62

19.2

70

0.66

21.3

80

0.69

23.3

90

0.71

25.2

100

0.76

28.9

110

0.80

32.0

Output Setting Indicators

120

0.84

35.3

Visual: Three-digit indicators, except micro cut, which is two-digit

130

0.89

39.6

Aural: Voice annunciator (synthesizer)

140

0.95

45.1

Power Controls

150

1.00

50.0

External

100/120 V Input: Two 3.15 Amp Type T 250 VAC 220/240 V Input: Two 1.6 Amp Type T 250 VAC

Internal Mother Board: High Voltage Power Supply Board: RF Amplifier Board:

Two (F600, F601) 1.6 Amp Type T 250 VAC F400: 4.0 Amp Type T 250 VAC F401: 4.0 Amp Type F 250 VAC F500: 0.25 Amp Type T 250 VAC

Output Power Range Coagulate (20 settings):

.72–50 watts into 50 ohm noninductive resistor load

Micro Cut (10 settings):

.72–16.8 watts into 50 ohm noninductive resistor load

Cutting (6 settings):

20–120 watts into 400 ohm noninductive resistor load

AC: ON/OFF Switch RF Output: Panel mounted three-position rocker types

Typical Output vs. Power Setting

Panel Connectors

Micro Cut Output into 50 ohms using 45 cm leads (For reference only)

Bipolar: Two high voltage jacks

Cooling

Power Setting (Malis Units)

Convection; no fan

Weight

Output Current (RF amp)

Output Power (Watts)

0

0.00

0.0

8

0.12

0.7

33.5W x 22H x 40D centimeters

10

0.15

1.1

Minimum Operating Temperature

15

0.18

1.6

50°F (10°C)

20

0.24

2.9

Operational Performance

25

0.32

5.1

30

0.38

7.2

35

0.43

9.3

40

0.48

11.5

45

0.53

14.1

50

0.58

16.8

8.60 kilograms

Dimensions

The MALIS CMC-III Bipolar Electrosurgical System can be tested for operational performance using 50 ohm and 400 ohm noninductive test loads and RF ammeter or equivalent electrosurgical analyzer. A test setup is shown in Figure 7 with typical values for each power setting. Use test leads approximately 45 cm (18 in) long. These are typical values and output power can vary depending on the line voltage, load resistor tolerances, and meter accuracy.

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Typical Output vs. Power Setting

Remove coagulum deposits as often as necessary to keep working surfaces clean. This helps ensure the flow of current between the forceps’ tips. We recommend Johnson & Johnson Medical’s Electro-Surgical Tip Cleaner (J&J Medical catalog no. 4315). If the tips become pitted or misaligned, contact your local Codman representative.

Cut Output into 400 ohms using 45 cm leads (For reference only) Power Setting (Malis Units)

Output Current (RF amp)

Output Power (Watts)

60

0.22

20.0

70

0.32

40.0

80

0.39

60.0

90

0.45

80.0

100

0.50

100.0

110

0.55

120.0

Bipolar Cord Low or erratic performance can be due to poor contact between the bipolar forceps cord plugs and the isolated bipolar output jacks on the generator. Badly oxidized surfaces impede current flow. Use an abrasive cloth to gently clean plug surfaces to keep them clean and bright. Inspect the bipolar cord before each use and replace it upon evidence of deterioration. NOTE: Pulling plugs from the jacks of the MALIS CMC-III Generator by grasping the cord could damage the cords and cause intermittent operation. Disconnect the plugs by holding the plug with one hand and the generator with the other.

Footswitch

Replacing Internal Fuses

Storing the footswitch with the cord tightly wrapped around it can damage the cord. Leave sufficient slack to prevent stress on the cord. Inspect the cord before each use and replace the footswitch upon evidence of any deterioration.

Fuses F400 and F401 are located on the power supply board (Figure 17). Fuses F600 and F601 are located on the mother board (Figure 18). Fuse F500 is located on the RF amplifier board (Figure 19). 1. Disconnect the generator from the power supply.

Power Cord

2. Remove the six Phillips head screws and the six washers that hold the cover in place. Remove the cover.

Never use extension cords, three-prong to two-prong power plug adaptors or extra length power cords with the MALIS CMC-III System. Before each use, visually inspect the power cord and plug for frayed or broken insulation. If necessary, replace the power cord with the same type, length, gauge, and insulation.

3. Remove the Phillips head screw that holds the power supply board to the metal bracket. 4. Firmly pull the power supply board upward until it disengages from the card holders on either side. Do not attempt to pull the board completely out of the chassis; it is still connected via the supply voltage wiring.

Preventive Maintenance No preventative maintenance is required. In the event that the equipment falls outside its specifications, return it for service; refer to the Service and Repair section.

5. Replace fuses F400 and F401 (see Figure 17) with the appropriate type and value fuses (see Technical Specifications). 6. Slide the board back into the card holders, making sure the pins on the bottom of the board align with their connectors. Push the board down firmly until the pins seat properly in the connectors.

Additional Specifications

7. Replace the screw holding the board to the bracket. 8. Replace fuses F600 and F601 (see Figure 18) with the appropriate type and value fuses (see Technical Specifications). 9. Replace fuse F500 (see Figure 19) with the appropriate type and value fuse (see Technical Specifications).

Environmental: Temperature

Operational: 10°C to 45°C

Transport & Storage: 5°C to 55°C

Relative Humidity (noncondensing)

30% to 70%

0% to 90%

Atmospheric Pressure

700 hPa to 1060 hPa

500 hPa to 1060 hPa

Safety Information:

10. Replace the cover and the six screws and washers.

The MALIS CMC-III System meets or exceeds the requirements of the following Standards:

User Maintenance Generator With gentle care and handling, the MALIS CMC-III Generator is virtually maintenance free. The user must observe the following precautions: • Before each use, check the integrity of equipment covers and interconnecting leads. If either covers or leads are damaged, do not use and refer equipment for service.

IEC 60601-1

Medical Electrical Equipment-General Requirements

IEC 60601-2-2

Medical Electrical Equipment Part 2-Particular Standards for the Safety of High Frequency Surgical Equipment

Routine Cleaning Clean the MALIS CMC-III Generator cabinet with a damp cloth or sponge. Use alcohol or mild cleaning solutions to remove stains or adhesives that stick to the cabinet. DO NOT immerse the MALIS CMC-III Generator in any liquid. Subjecting the generator to excessive moisture can damage the electronic components and violate the warranty.

• After exposure to transport and storage ambient extremes allow the equipment to come within operating range before use. In addition, the following accessory items user maintenance must be observed:

Wash the CMC-III Footswitch with standard hospital cleaning liquids. Ensure that no liquid enters the footswitch connector.

Bipolar Forceps Proper care and maintenance of the bipolar forceps is essential to efficient cutting and coagulation. Dr. Malis states the following:

Sterilization

“While some sticking and charring of the bipolar cutting and coagulation forceps is unavoidable, the elimination of the initial overvoltage spike in the MALIS CMC-III Generator waveform greatly reduces the incidence of sticking and charring. Coupled with additional wave-form modifications, the MALIS CMC-III System can be used with less irrigation (or no irrigation at all, if required) while reducing sticking and charring to levels lower than heavilyirrigated spark gap and solid state generators. Because the generator is effective at lower settings, pitting of the forceps tips which normally occurs is greatly reduced.”

Never sterilize the MALIS CMC-III Generator, Footswitch or Connecting Cable.

Service and Repair For service or repair outside the United States, contact your local Codman representative. Inside the United States, contact Codman Repair directly at 1-800-343-5969.

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The repair representative will coordinate the return to: Codman Repair Service 325 Paramount Drive Raynham, MA 02767-0350 USA IMPORTANT: A repair purchase order number, the serial number of the unit, and a written description of the problem must accompany the product.

Accessories Description MALIS CMC-III Footswitch (includes footswitch, cord, and plug)

Catalog No. 80-1184

MALIS MODULE 1000 Irrigation System

80-9100

MALIS MODULE 1000 Integrated Tubing and Bipolar Cord Set

80-9102

MALIS MODULE 1000 Interconnecting Cable IEC

80-9115

CODMAN Floorstand for MALIS CMC-II/III System

80-1177

The following MALIS Bipolar Forceps are recommended for use with the generator: Catalog Nos. 30-1528, 80-1122, 80-1123, 80-1124, 80-1129, 80-1216, 80-1217, 80-1218, 80-1230, 80-1231, 80-1232, 80-1555, 80-1556, 80-1557.

Warranty The MALIS CMC-III Bipolar Electrosurgical System is warranted for two full years from date of purchase. The MALIS CMC-III System is warranted to be free from defects in both materials and workmanship. This warranty shall not apply where service is required due to (i) Buyer’s failure to operate or maintain the equipment according to the Instruction Manual, (ii) Buyer’s use of unauthorized parts or consumables, (iii) accident, abuse, misuse, modification or misapplication, or (iv) improper service. THE ABOVE WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Suitability for use of the device for any surgical procedure shall be determined by the user. Neither Codman & Shurtleff nor its affiliated companies shall be liable for incidental or consequential damages of any kind. ® MALIS is a registered trademark of Synergetics IP, Inc. (Missouri) ® CMC and CODMAN are registered trademarks of Codman & Shurtleff, Inc. ™ MODULE 1000 is a trademark of Codman & Shurtleff, Inc.

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Table I Manufacturer’s Declaration Regarding Electromagnetic Emissions The CMC-III Bipolar Electrosurgical System (Model 80-1170 or 80-1172) is intended for use in the electromagnetic environment specified below. The customer or user must assure that it is used in such an environment. Emission Test

Compliance

Electromagnetic Environment

RF Emissions CISPR 11

Group II

The system must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment can be affected.

RF Emissions CISPR 11

Class A

The system is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Harmonic Emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

WARNING: The system must not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the system must be observed to verify normal operation in the configuration in which it is used.

Table II Manufacturer’s Declaration Regarding Electromagnetic Immunity The CMC-III Bipolar Electrosurgical System (Model 80-1170 or 80-1172) is intended for use in the electromagnetic environment specified below. The customer or user must assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

±6 kV Contact ±8 kV air

±6 kV Contact ±8 kV air

Floors must be wood, concrete or ceramic tile. If floors are covered with synthetic materials, the relative humidity must be at least 50%.

Electrical fast transient / burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality must be that of a typical commercial or hospital environment

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

±1 kV differential mode ±2 kV common mode

Mains power quality must be that of a typical commercial or hospital environment

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% Vac (>95% dip in Vac) for .5 cycle 40% Vac (60% dip in Vac) for 5 cycles 70% Vac (30% dip in Vac) for 25 cycles <5% Vac (>95% dip in Vac) for 5 seconds

<5% Vac (>95% dip in Vac) for .5 cycle 40% Vac (60% dip in Vac) for 5 cycles 70% Vac (30% dip in Vac) for 25 cycles <5% Vac (>95% dip in Vac) for 5 seconds

Mains power quality must be that of a typical commercial or hospital environment. If the uses of Models 80-1170 and 80-1172 require continued operation during power mains interruptions, it is recommended that Models 80-1170 and 80-1172 be powered from an uninterruptible power supply or a battery.

Power Frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 Amps/meter

3 Amps/meter

Power frequency magnetic fields must be at levels characteristic of a typical location in a typical commercial or hospital environment.

Vac is the AC mains voltage prior to the application of the test level

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Table III Manufacturer’s Declaration Regarding Electromagnetic Immunity – Non-life Supporting The CMC-III Bipolar Electrosurgical System (Model 80-1170 or 80-1172) is intended for use in the electromagnetic environment specified below. The customer or user must assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Conducted RF IEC 61000-4-6

3 volts/meter RMS 150 kHz to 80 MHz

3 Volts RMS

Radiated RF IEC 61000-4-3

3 volts/meter 80 MHz to 2.5 GHz

3 volts/meter

Portable and mobile communications equipment must be used no closer to any part of Models 80-1170 and 80-1172 (including cables) than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: D = [3.5/v1] D = [3.5/E1] 80 MHz – 800 MHz D = [7/E1] 800 MHz – 2.5 GHz where P is the maximum output power rating to the transmitter in watts (W) according to the transmitter manufacturer and D is the recommended separation distance in meters. Field strength from fixed RF transmitters as determined by an electromagnetic site surveya must be less than the compliance level in each frequency rangeb Interference can occur in the vicinity of equipment marked with the following symbol

(non-ionizing electromagnetic radiation) a Field strengths from fixed transmitters such as base stations for radios, (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast can not be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey must be considered. If the measured field strength in the location in which the Model 80-1170/80-1172 is used exceeds the applicable RF compliance level above, the Model 80-1170/80-1172 must be observed to verify normal operation. If abnormal performance is observed, additional measures can be necessary, such as reorienting or relocating the Model 80-1170/80-1172. b Over the frequency range of 150 kHz to 80 MHz field strengths must be less than [v1] volts/meter.

Note 1: At 80 MHz and 800 MHz the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures objects and people.

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The MALIS CMC-III Bipolar Electrosurgical System

LCN 194128-001/L

4

ENGLISH Front Panel Indicators (Items M through X) FRANÇAIS Voyants du panneau frontal (éléments M à X) DEUTSCH Anzeigen an der Vorderseite (M bis X) NEDERLANDS Controlelichtjes op het voorpaneel (Items M tot en met X) ITALIANO Indicatore del pannello anteriore (elementi da M a X) ESPAÑOL Indicadores del panel frontal (M a X) PORTUGUÊS Indicadores do painel frontal (Itens M a X)

5

ENGLISH Front Panel Connections (Item Y) FRANÇAIS Connexions du panneau frontal (élément Y) DEUTSCH Anschlüsse an der Vorderseite (Y) NEDERLANDS Aansluitingen op het voorpaneel (Item Y) ITALIANO Collegamenti del pannello anteriore (elemento Y) ESPAÑOL Conexiones del panel frontal (Y) PORTUGUÊS Ligações do painel frontal (Item Y)

ENGLISH Back Panel Conections (Items Z through EE)

6

FRANÇAIS Connexions du panneau arrière (éléments Z à EE) DEUTSCH Anschlüsse an der Rückseite (Z bis EE) NEDERLANDS Aansluitingen op het achterpaneel (Items Z tot en met EE) ITALIANO Collegamenti del pannello posteriore (elementi da Z a EE) ESPAÑOL Conexiones del panel posterior (Z a EE) PORTUGUÊS Ligações do painel traseiro (Itens Z a EE)

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The MALIS CMC-III Bipolar Electrosurgical System

LCN 194128-001/L

19

ENGLISH RF Amplifier Board Fuse Location A. F500: 0.25 A TYPE T FRANÇAIS Emplacement du fusible de la carte amplificateur RF A. F500 : 0,25 A TYPE T DEUTSCH Position der HF-Verstärkerplatinensicherung A. F500: 0,25 A TYP T NEDERLANDS Plaats zekeringen RF-versterkerkaart A. F500: 0,25 A TYPE T ITALIANO Posizione del fusibile sulla scheda dell’amplificatore RF A. F500: 0,25 A TIPO T ESPAÑOL Ubicación del fusible de la placa amplificadora de RF A. F500: 0,25 A TIPO T PORTUGUÊS Localização do fusível no painel do amplificador RF A. F500: 0,25 A TIPO T

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