Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

CODMAN® MALIS® CMC® V

BIPOLAR ELECTROSURGICAL GENERATOR

BIOMED MANUAL

Contact: Codman
Phone: 800-343-5969
Fax: 508-828-3701

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 1 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

Table of Contents
TABLE OF CONTENTS .............................................................................................................................................. 2
1.0 PURPOSE OF DOCUMENT ................................................................................................................................. 3
2.0 TEST EQUIPMENT REQUIRED ........................................................................................................................... 3
3.0 REQUIRED TOOLS .............................................................................................................................................. 3
4.0 RELATED DOCUMENTS ..................................................................................................................................... 3
5.1 CLASSIFICATION ..................................................................................................................................................... 4
5.2SPECIFICATIONS...................................................................................................................................................... 4
6.0 GENERAL SAFETY SUMMARY .......................................................................................................................... 5
6.1 TABLE OF SYMBOLS ................................................................................................................................................ 5
6.2 DEFINITIONS........................................................................................................................................................... 6
6.3 PRECAUTIONS ........................................................................................................................................................ 6
6.4 SERVICE SAFETY SUMMARY.................................................................................................................................... 6
6.5 ELECTROSTATIC DAMAGE PREVENTION ................................................................................................................... 7
7.0 GENERAL DESCRIPTION ................................................................................................................................... 8
7.1 SYSTEM BLOCK DIAGRAM ....................................................................................................................................... 8
7.2.1 Main Control Board/ Reference Only ..................................................................................................... 9
7.2.2 Main MCU Section/ Reference Only ...................................................................................................... 9
7.3 RFWAVEFORM GENERATION SECTION/ REFERENCE ONLY..................................................................................... 10
7.4 HIGH VOLTAGE POWER SUPPLY/ REFERENCE ONLY .............................................................................................. 11
7.5 LOW VOLTAGE POWER SUPPLY/ REFERENCE ONLY ............................................................................................... 11
7.6 RF AMPLIFIER BOARD/ REFERENCE ONLY ............................................................................................................. 12
7.7 VIDEO CONTROLLER BOARD/ REFERENCE ONLY.................................................................................................... 13
7.8 BACKLIGHT INVERTER BOARD/ REFERENCE ONLY .................................................................................................. 13
7.9 TOUCHSCREEN CONTROLLER/ REFERENCE ONLY .................................................................................................. 13
8.0 INSTRUMENT DISASSEMBLY .......................................................................................................................... 14
8.1 TOP COVER REMOVAL .......................................................................................................................................... 14
8.2 RF AMPLIFIER BOARD REMOVAL ........................................................................................................................... 15
8.3 MAIN CONTROLLER REMOVAL ............................................................................................................................... 16
8.4 HIGH VOLTAGE POWER SUPPLY REMOVAL ............................................................................................................ 17
8.5 VIDEO CONTROLLER REMOVAL ............................................................................................................................. 18
9.0 ELECTRICAL, SAFETY AND FINALTESTING ................................................................................................. 19
10.0 TROUBLESHOOTING ...................................................................................................................................... 25
11.0 SPARE PARTS ................................................................................................................................................. 26
12.0 DEVICE HISTORY SHEET FOR TESTING…………………………………………………………………………..27

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 2 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

1.0 Purpose of document

• This document describes the process, test equipment, tools and spare parts needed to repair and test
the Codman MALIS CMC V 80-1788.

• This biomed manual is intended to be used by only qualified personnel.

2.0 Test Equipment Required

Description Supplier and Part Number

Digital multimeter Fluke 87V or equivalent
DVM Fluke 8920A Wideband DVM or
equivalent
Ground Continuity Tester Rod-L Model # M25, or equivalent
Leakage current test fixture Converts mVac to Vac Drawing DWG-G2711001 or
equivalent
Test Fixture Electrosurgical Generator Ohm Load Box or 50ohm & Drawing DWG-195213 or
400ohm load equivalent
Electric Bipedal Footswitch 80-1547 or 80-1184
MALIS Module 1000 Irrigator 80-9100 or 80-1569
Connecting Cable 80-1791
CMC-V Bipolar Forceps Cord 30-1536 or equivalent

3.0 Required Tools

Description Supplier and Part Number

Soldering Iron Weller WESD51D (240V), WESD51 (120V) or equivalent
#2 Philips Screwdriver Any standard tool supply house
Loctite 425 or equivalent Any standard tool supply house
Soft jaw pliers McMaster Carr P/N 5555A48 or equivalent
Antistatic wrist strap Any standard tool supply house
Noncorrosive RTV GE 162

4.0 Related Documents

Description Document Agile #

Malis CMC V Reference Data Sheet Section 12
IFU: The Codman Malis CMC-V Bipolar Electrosurgical Generator IFU-LCN-206912001
IFU: Malis Irrigation Module 1000 IFU-LCN-200128001
IFU: Codman Malis CMC-V Footpedal IFU-LCN-207151001

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 3 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

5.0 Product Description

The CMC V Bipolar Electrosurgical Generator is a medical instrument that provides a controlled source of radio-
frequency (RF) energy suitable for electrosurgery procedures on living human tissue. The CMC V uses a
proprietary waveform generator coupled to an isolated tuned RF power amplifier stage. A set of leads connect
the generator to the actual surgical hand piece in order to deliver the RF energy to the surgical area in a human
patient. Tight control of the output power, wave shape and output impedance gives the CMC V wide range of
operation from precise tissue coagulation in microsurgery to rapid cutting of dense tissues.

Two distinct output modes are designed for specific surgical purposes, when used with the appropriate
instrument:
Cut Mode: This mode is used to perform incision-like cuts into the tissue.
Coag Mode: This mode is used to coagulate small blood vessels in the tissue.

Control of the instrument is done by a network of microcontrollers. These constantly monitor the touchscreen
display, knobs and external peripherals for inputs as well as the operational state of all its internal subsystems.
A graphic interface guides the user through its many functions and settings.

5.1 Classification

Equipment Function: Electrosurgical Generator

Type of Protection against electrical shock: Class 1
Degree of protection against electrical
shock: Type BF
Supply Connection: 4 Amp 100/120 VAC
4 Amp 220/240 VAC
50-60 Hz
Mode of Operation: Continuous w/ intermittent loading, 20 sec. On/40 sec. Off
Degree of Mobility: Portable

5.2 Specifications

Output RF Power
Maximum Rated Output Power Cut Mode: 120 Watts
Coag Mode: 75 Watts
Rated Output Impedance Cut Mode: 400Q
Coag Mode: 50Q
Output Power Accuracy Display value + 20%, at rated output impedance

Power Source
Mains Voltage Range
Manual Switch 100 - 120V setting
220 - 240V setting
Mains Frequency Range 50 to 60Hz
Power Consumption 530 VA maximum
Power Fuse Rating 2 X 250V, 4A, T-type

Physical
Dimensions 35.5cm W, 21cm H, 42.5cm D (13" W, 8.25" H, 16.75" D)
Weight Approximately 9.1Kg (20Lb)

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 4 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

6.0 General Safety Summary

Review the following safety precautions in order to prevent injury to the patient and operator, and to avoid
damage to this product or any products connected to it. Only qualified personnel should perform service
procedures.

6.1 Table of Symbols

Primary (Mains) power on Foot Pedal

Primary (Mains) power off Protective earth (ground)

Fuse Type BF equipment with

applied part with or without
an intentional electric path
to the patient.

Attention, see instructions Remote connection terminal

Equipotentiality Isolated outputs

Output power Pen instrument connection

terminal

Isolated bipolar output connector Irrigator connection terminal

Bipolar coagulate Danger high voltage

Bipolar cut

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 5 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

6.2 Definitions

WARNING Warning statements identify conditions or practices that could result in injury or
loss of life.

CAUTION Caution statements identify conditions or practices that could result in damage to
this product or other property.

Power (Mains) Switch Primary effective voltage and current are applied through this switch.

Coagulate The sealing of blood vessels or tissue with the use of high frequency voltage.

Cut The cutting of tissue with the use of high frequency voltage.

Setting Control Knob Device used to adjust the output power to the bipolar forceps.

6.3 Precautions

• The generator should be separated from other electrosurgical instruments and their cables. Close proximity
of the generator and its cables to some electrosurgical units producing excessive RF current radiation may
cause the generator to change its output power.

• Do not operate the generator at temperatures below 10°C (50°F).

• Prior to a surgical procedure, the power cord, bipolar cord, foot pedal and any other connected accessory
must be checked for proper operation. Replace the power cord, bipolar cord, or any accessory if
necessary.

• The output power setting should be adjusted to the lowest setting for the purpose intended.

• When higher power settings are engaged, it is recommended insulated bipolar forceps be utilized.

• Cutting or coagulation will not occur if the tips of the bipolar forceps or pencil become coated in coagulum,
or if the tips become in contact with each other.

• Continuous power output should be limited to 20 seconds, with a rest period of at least 40 seconds.

• The generator is specified for use without a NEUTRAL ELECTRODE.

• Needle electrodes and patient monitoring electrodes may be placed in any location on the patient other
than the area that comes in contact with the bipolar forceps tips.

• The generator does not generate waste. Disposable products used with the generator must be disposed of
per individual hospital procedures and regulations.

6.4 Service Safety Summary

• Only qualified trained personnel should perform service procedures. Read this Service Safety Summary and
the General Safety Summary in Section 6.0 before performing any service procedures.

• Do Not Attempt to Repair a Defective Board. Component level repairs on any of the boards are not
permitted. If a board needs repair, it must be returned to the factory for repair or exchange.

• Do Not Service Alone. Do not perform internal service or adjustments on this instrument unless another
person capable of rendering first aid and resuscitation is present.

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 6 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

• Use Caution When Servicing the High Voltage Power Supply (HVPS). To avoid electric shock, use
extreme caution when removing and handling the HVPS. NEVER attempt to remove any board while the
instrument is connected to the AC mains source. The HVPS is designed to dissipate the energy stored in its
large capacitors when the instrument is turned off. However, this safety feature may be disabled if the HVPS
is defective.

• Use Care When Servicing With Power On. Dangerous voltages or currents may be present in this product.
To avoid electric shock, do not touch exposed connections. Do not remove the top cover or any protective
cover while the instrument is connected to AC mains.

• Full Safety Verification Tests Must Be Performed After a Service Procedure. Any service procedure that
involves removing the board assemblies must be followed by complete safety verification procedures.

6.5 Electrostatic Damage Prevention

The CMC V generator contains electronic components that are susceptible to damage from electrostatic
discharge. Static voltages of I kV to 30kV are common in unprotected environments. Observe the following
precautions to avoid static damage:

• Minimize handling of static-sensitive components.

• Transport and store static-sensitive components or assemblies in their original containers, or a metal rail,
or on conductive foam. Label any package that contains static-sensitive assemblies or components.

• Discharge the static voltage from your body by wearing a wrist strap while handling these components.
Servicing static-sensitive assemblies or components should only be performed at a static-free workstation
by qualified personnel.

• Nothing capable of generating or storing a static charge should be allowed on the workstation surface.

• When handling components, keep their leads shorted together whenever possible.

• Pick up components by the body, never by the leads.

• Do not slide the components over any surface.

• Avoid handling components or assemblies in areas that have a floor or work surface covering capable of
generating a static charge.

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 7 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

7.0 General Description

This section contains a block-level description of the CMC V control flow and sub-systems. This description is
written with sufficient technical detail in order to facilitate troubleshooting to the board replacement level.

7.1 System Block Diagram

The overall system block diagram is shown on Figure 1.

Figure 1

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 8 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

7.2.1 Main Control Board/ Reference Only

The main Control board performs all the control functions in the CMC V. A central MCU (Ul) manages a network
of MCUs and peripheral ICs over an 12C bus. An analog section in the board is dedicated for the impedance
measurement circuit. The block diagram is shown on Figure 2:

Figure 2

7.2.2 Main MCU Section/ Reference Only

As the central processor, the Main MCU (U1) performs the following functions:

• Performs a diagnostics test during instrument power-up. In this procedure the MCU verifies proper status of
all the slave MCUs, and other peripheral control ICs. It also verifies proper power-up status of the HVPS, RF
Amp and Video boards.

• Accesses the external EEPROM (U4) for retrieval and storage of instrument calibration and user settings
Data.

• Receives user interface information from the Touchscreen Controller board, front panel knobs, foot pedal
and remote connectors.

• Sends pointer data to Video board in order to generate proper graphics image in the LCD panel based
on current user interface and instrument status.

• When required, polls the Impedance MCU for load impedance measurement data.

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 9 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

• Sends pointer data to the Speech Generator IC (U47), Tone MCU (U16) and digital potentiometer IC
(U17) in order to generate proper speech or tone message based on current user interface and instrument
status.

• Controls operation and monitors status of the HVPS, RF Amp, backlight inverter, fan control IC (U49) and
external irrigator (when connected).

7.3 RF Waveform Generation Section/ Reference Only

The waveform MCU generates the appropriate pulse patterns depending on the state of the signals CUT,
COAG, BLEND and FTPDON. One pulse pattern is loaded on the first parallel-in, serial-out shift register and
then a second pulse pattern is loaded on the second shift register. Once both shift registers are loaded, both are
clocked out simultaneously at 20MHz. The pulse patterns are designed so the serial output of the first shift
register (Q1MHZ) is a pulse train with a 1 MHz frequency and the serial output of the second shift register
(~QIMHZ) is an "inverted" version of Q1 MHZ. Dead-time transition delays between Q1MHZ and ~QIMHZ are
designed in the pulse patterns.

Figure 3

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 10 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

7.4 High Voltage Power Supply/ Reference Only

The High Voltage Power Supply (HVPS) is an off-line power supply that incorporates a flyback topology. The
DC regulated output voltage ranges from zero to 120 volts and is controlled by a zero to 5 volts signal originated
at the main MCU in the Main Controller board. The HVPS is equipped with a multitude of supervisory protection
circuitry that insures safe operation. The HVPS block diagram is shown on Figure 4:

Figure 4

7.5 Low Voltage Power Supply/ Reference Only

The Low Voltage Power supply (LVPS), is an off-the-shelf medical-grade switch-mode power supply dedicated
to generate +5, +15 and -15 volts. These DC voltages are distributed to all the boards through the Mother
Board.

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 11 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

7.6 RF Amplifier Board/ Reference Only

The RF Amplifier board (RF Amp) generates the high power RF pulses required for the performance of cutting
and coagulation operations. It also contains the front end electronics for the impedance measuring circuitry as
well as the front end circuitry for the RF short circuit current monitor. The block diagram is shown on Figure 5:

Figure 5

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 12 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

7.7 Video Controller Board/ Reference Only

The Video Controller board receives information from the main Controller board and generates the appropriate
driving signals in order to display the requested image on the LCD panel. The block diagram is shown on
Figure 6:

Figure 6

7.8 Backlight Inverter Board/ Reference Only

The DC to AC Inverter board drives the backlight cold-cathode fluorescent tubes in the LCD panel. It has a
dimming input that is driven by the main MCU in the Main Controller board. Dimming control is user controllable.

7.9 Touchscreen Controller/ Reference Only

The Touchscreen Controller board is responsible for capturing user inputs as he/she touches the touchscreen
located in front of the LCD panel. As the user is presented with available options in the form of buttons on the
LCD panel, the user’s touch of these buttons is detected by the controller and its location in the screen is sent to
the main MCU.

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 13 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

8.0 Instrument Disassembly

CAUTION: Static discharge can damage any semiconductor component in this instrument. Observe
the electrostatic Instrument Disassembly damage precautions located in the
Electrostatic Damage Prevention section of this manual.

Disassembly should only be performed by qualified personnel.

All electrical and safety tests should be completed whenever the cover is removed.

8.1 Top Cover Removal

1. Remove the AC power cable from the CMC V, Remove all other cables and accessories connected to the
CMC.

2. Place the instrument upside down on a flat surface and remove the two screws as shown on Figure 7:
3. Use caution to ensure washers do not fall into the unit.
Figure 7

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 14 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

4. Place the instrument right side up and remove the 7 screws as shown on Figure 8:

Figure 8

5. The top cover is removed by sliding it towards the back of the instrument. Note that the top cover has a
friction-locking mechanism that may make it difficult for it to slide freely. If necessary, use a flat screwdriver
to carefully pry the top cover from the back.

8.2 RF Amplifier Board Removal (Refer to Figure 9)

1. Remove AC power from the CMC V. Remove all other cables and accessories connected to the CMC.

2. Remove the top cover following the procedure in the section "Top Cover Removal" 8.1.

3. Untwist the cable holder ① and remove all the wires. Refer to the figure 9.

4. Unlock and disconnect the RF output connector ② . Disconnect the pen switch connector ③ .

5. Remove the screw ④ that secures the RF Amp board to the stiffener rod ⑤ . Remove the stiffener rod by
removing the screw that holds it to the chassis. Be sure to catch the nylon washer ⑥.

6. Remove the 4 screws ⑦ that hold the RF Amp to the chassis. Carefully, pull the RF Amp ⑧ out of the
chassis.

7. To reinstall the RF Amp board, follow these steps in reverse order.

Figure 9

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 15 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

8.3 Main Controller Removal (Refer to Figure 10)

CAUTION: Static discharge can damage any semiconductor component in this instrument. Observe
the electrostatic damage precautions located in the Electrostatic Damage Prevention section of this
manual.

1. Remove The AC power from the CMC V. Remove all other cables and accessories connected to the
CMC V.

2. Remove the top cover following the procedure in the section "Top Cover Removal" 8.1.

3. Disconnect the top ribbon connector ① from the Main Controller board.

4. Remove the 4 screws ② that hold the board.

5. Carefully, pull the board out of the chassis ③.

6. To reinstall the board, insert the board into the chassis making sure that the long pin header at the
bottom of the board mates completely with the receptacle in the Motherboard. Press firmly.

7. Install the 4 screws ② . Do not tighten the screws until all 4 screws are installed.

8. Reconnect the ribbon connector ① to the Main Controller board.

Figure 10

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 16 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

8.4 High Voltage Power Supply Removal (Refer to Figure 11)

1. Remove The AC power from the CMC V. Remove all other cables and accessories connected to the
CMC V.

2. Remove the top cover following the procedure in the section "Top Cover Removal" 8.1.

3. Remove the RF Amplifier board following the procedure in the section "RF Amplifier Removal"8.2.

4. Disconnect the AC Power ① connector from the board.

5. Disconnect the Low Voltage Power Supply connector ② from the board.

6. Remove the screw ③ that secures the board to the stiffener rod ④ .

7. Remove the screw that secures the stiffener rod ④ to the chassis.

8. Remove the 4 screws ⑤ that secure the board to the chassis.

9. Carefully, pull the board from the chassis.

10. To reinstall the HV Power Supply board, follow these steps in reverse order.

Figure 11

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 17 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

8.5 Video Controller Removal (Refer to Figure 12)

It is recommended to remove the Main Controller board (Refer to section 8.3) before attempting to remove the
Video Controller board.

CAUTION: Static discharge can damage any semiconductor component in this instrument. Observe
the electrostatic damage precautions located in the Electrostatic Damage Prevention section of this
manual.

1. With the Main Controller board removed, disconnect the top ribbon cable ①, from the top of the Video
board.

2. Carefully, disconnect the flat ribbon cable ② that connects the Video board to the LCD panel. This
connector may be secured with RTV, so use a sharp knife to cut the RTV around the connector. Be very
careful not to damage either the flat ribbon cable, or the connector.

3. Remove the 4 screws ③that hold the Video board to the chassis.

4. To reinstall the Video board, follow these steps in reverse order. Use a small amount of electronics-grade
RTV to secure the flat ribbon connector ②. Use GE noncorrosive RTV, part number162, or equivalent.

Figure 12

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 18 of 31

 Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

9.0 Electrical, Safety and Final Testing (Record all data on Section 12.0)

If the unit fails at any point throughout the electrical, safety and final testing. Please contact Codman Repair &
Service (Outside the US please contact your local J&J Affiliate) to obtain repair charges and repair procedure.

9.1 Visual Inspection

9.1.1 The unit shall be free of major scratches, dents, and paint blemishes. All nomenclature shall be
adhering firmly and shall be clearly legible. Screws, nuts, handles, and feet shall be fastened
securely. Use of pressure sensitive, adhesive backed, plastic nameplates of subsurface print
type are recognized components and comply with all the relevant product safety standards to
conform to (IEC-60601, IEC 60601-2-2 and MDD).

9.2 Electrical Safety Inspection

All equipment and components to be room temperature prior to electrical testing

Remove and retain label covering Input Voltage Selector Switch. Configure AC inlet on the back of the unit
under test to the Vin AC value shown in Table 1 below by changing the input voltage selector switch on the
rear of the unit. Once all testing is completed, reset the input voltage selector switch to 240 VAC and reposition
label over selector switch assembly

9.2.1 Leakage Current

9.2.1.1 Leakage current tests are performed with AC power set to Vin_AC.

9.2.1.2 All leakage current tests are performed with the generator power switch in the “on”
position.

9.2.1.3 Verify that no accessory equipment (i.e., Interconnecting Cable) is attached to the
generator during all leakage tests.

9.2.2 Earth Leakage

9.2.2.1 Measure the generator's chassis leakage current for each condition listed in Table 1
(Figure13). The leakage current is not to exceed the limits in Table 4 (IEC 60601-1
(2005) Section 8.7.4.7) for Equipment type BF.

Table 1
Earth Leakage
Test S3 S4 S5 DMM Reading Limit uA Equivalent DMM Reading
Limit mVac
1. Close Normal Open 500μA 500,000 mVac
2. Close Reverse Open 500μA 500,000 mVac
3. Open Normal Open 1000μA 1,000,000 mVac
4. Open Reverse Open 1000μA 1,000,000 mVac

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 19 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

Figure 13

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 20 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

9.2.3 Patient Leakage

9.2.3.1 Measure the generator's patient leakage current for each condition listed in Table 2
(Figure 14). The leakage current is not to exceed the limits in Table 2. (IEC 60601-
1(2005)- Section 8.7.3)

Table 2
Patient Leakage

Test S3 S4 S5 DMM Reading Limit DMM Reading Limit mVac

uA
1. Close Normal Close 100μA 100,000 mVac
2. Close Reverse Close 100μA 100,000 mVac
3. Close Normal Open 500μA 500,000 mVac

Figure 14

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 21 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

9.2.4 Ground Continuity Check

Be sure the ground tester is properly set up and performing in accordance with manufacturer’s
instructions.

Connect the unit to the ground tester - see Figure 15

9.2.4.1 Turn the tester “on”. Verify that switch “b” is in the “ground only” position (down).
Verify the “Trip Point” is set at 10 prior to testing (located on back of ground tester)

9.2.4.2 Plug the generator into the voltage connect outlet on the front panel.

9.2.4.3 Connect the ground test cable firmly to rear chassis louver.

9.2.4.4 Press the start button (it is recessed).

9.2.4.5 The testing light will go on for approximately 5 seconds. Record the value displayed
on the ohm meter on the test data sheet. This value must not exceed 0.15 ohms.

9.2.4.6 If the test fails (resistance greater than 0.15 ohms), an alarm will sound and the red
Fail lamp will illuminate. Press the reset button to turn off alarm and lamp. Check
that the resistance test pot on the rear panel is set fully clockwise, then re-test.

9.2.4.7 If the unit fails at any point throughout the electrical, safety and final testing. Please
contact Codman Repair & Service (Outside the US please contact your local J&J
Affiliate) to obtain repair charges and repair procedure.

Figure 15

9.3 Output Power Test

Verify that the voltage selector switch on the rear of the generator is set to the proper input voltage. Plug the
generator's power cord into a Vin_AC outlet and turn the power switch on.

9.3.1 Connect the foot pedal to the rear of the generator. Use the Biomedical Non-Sterile Test Cord
P/N 000833 to connect the bipolar output of the CMC-V to the matching receptacles on Test
Fixture #195213 (or 50 ohm & 400 ohm resistance). Measure and verify that the RF current
readings at each power setting for both output Cut and Coag modes are within the acceptable
range per Section 12. Record any current measurement, which has “failed” on Section 12.
(Reference IEC 601-2-2,(2006) Section 50.1 & 50.2).

9.4 Functional Inspection

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 22 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

While performing power setting verification, record reading once the Fluke multimeter stops fluctuating.

9.4.1 Plug in the electric footswitch (80-1547) to the foot pedal connector located on the rear
panel of the generator.

9.4.2 Connect the generator to the test fixture using the Biomedical Non-Sterile Test Cord P/N
000833 and set the load switch to the “50” Ohm setting. Set the Voice button on the
CMC-V to “Always Announce” and the Malis/ Watts button to Malis. Verify that generator
announces the Coag mode, the Power Setting, Malis, the background around the word
“Coag” lights and a lower pitched tone is produced for each setting when the Coag foot
pedal is depressed. Verify that an announcement is made for all the power settings, i.e.
0, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180,
190 and 200. Indicate pass/fail on Section 12.

Switch the generator announce mode to “1X Announce”. Verify audio output is present
for all settings, i.e. 0, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 110, 120,
130, 140, 150, 160, 170, 180, 190 and 200. Indicate pass/fail on Section 12.

9.4.3 Set the Voice button on the CMC-V to “Always Announce”. Connect the generator to the
test fixture using the Biomedical Non-Sterile Test Cord P/N 000833 and Set the load
switch to the “400” Ohm setting. Verify that generator announces the Cut mode, the
Power Setting, “Malis”, the background around the word “Cut” lights and a higher pitched
tone is produced for each setting when the Cut foot pedal is depressed. Verify that an
announcement is made for all the power settings, i.e. 0, 10, 15, 20, 25, 30, 35, 40, 45,
50, 60, 62, 65, 67, 70, 72, 75, 77, 80, 85, 90, 95, 100, 105 and 110. Indicate pass/fail on
Section 12.

Switch the generator announce mode to “1X Announce”. Verify audio output is present
for all settings, i.e. 0, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 62, 65, 67, 70, 72, 75, 77, 80,
85, 90, 95, 100, 105 and 110. Indicate pass/fail on Section 12.

9.4.4 Set the Coag and Cut power settings to 10 Malis. Press the Cut foot pedal and then the
Coag foot pedal at the same time for 3 seconds. Verify that the generator announces
“FOOT PEDAL ERROR”. Release both foot pedals. Verify no output power is present
on Multimeter.

9.4.5 Press the Coag foot pedal and then the Cut foot pedal at the same time for 3 seconds.
Verify that the generator announces “FOOT PEDAL ERROR”. Release both foot pedals.
Verify no output power is present on Multimeter.

9.4.6 Use the Interconnecting Cable (80-1791) to attach a MALIS Module 1000 Irrigator
(80-1569 or 80-9100) to the generator. Connect one end of the 80-1791 cable to the
receptacle on the rear of the irrigator. Connect the other end of the 80-1791 cable to the
receptacle on the rear panel of the CMC-V labeled with the irrigator symbol. Plug the
irrigator into the same power source used for the generator and switch its power on.

9.4.7 Press the flow rate knob on the irrigator to select the Coag mode. Adjust the Coag flow
rate fully clockwise for the maximum flow rate. Press the flow rate knob again to select
the Cut mode. Adjust the Cut flow rate fully clockwise for the maximum flow rate. Press
the Irrigate button on the generator to engage the irrigator. Depress the generator's
Coag foot pedal, and verify that the irrigator engages. Release the Coag foot pedal and
verify that the irrigator disengages. Depress the Cut foot pedal and verify that the
irrigator engages. Release the Cut foot pedal and verify that the irrigator also
disengages.

9.4.8 Press the Irrigate button on the generator to disengage the irrigator. Depress the Coag
foot pedal and verify that the irrigator does not engage. Release the Coag foot pedal,
then depress the Cut foot pedal. Verify that the irrigator does not engage. Release the
Cut foot pedal.

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 23 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

9.4.9 Change the Voice Button to “Voice Muted All the Time”. Press the Coag foot pedal and
verify that only a Coag tone is heard. Press the Cut foot pedal and verify that only a Cut
tone is heard.

9.4.10 Verify that the Voice volume level is controllable by changing the Voice Button to “Voice
Announce All the Time”. Reduce the Voice Volume to minimum. Press the Coag foot
pedal and note the voice volume level. Increase the Voice Volume to maximum. Press
the Coag foot pedal and note the voice volume level. Verify that the Voice volume level
is controllable.

9.4.11 Verify that the Tone volume level is controllable by reducing the Tone Volume to
minimum. Press the Coag foot pedal and note the Tone volume level. Increase the
Tone Volume to maximum. Press the Coag foot pedal and note the Tone volume level.
Verify that the Tone volume level is controllable.

9.4.12 Verify the Brightness level is controllable by reducing the Brightness to a minimum and
maximum. Readjust Brightness level to a comfortable level or midpoint setting.

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 24 of 31

 Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

10.0 TROUBLESHOOTING

The generator displays an error screen when it detects an unsafe or failure condition in its internal subsystems
either during operation or at instrument start up. Press the lower right corner of the screen to display an error
message that describes the error that triggered the condition. In certain cases, the condition will disappear if the
CMC V is turned off and back on. If the CMC V passes its internal tests after cycling power, the user must
operate the unit with caution and then turn off the unit when possible. If the error message is repeatedly
displayed, the CMC V should be removed from active use and sent for service.

Symptom / Possible Cause Action

Error Messages
Unit does not power up. > No AC power at wall outlet. > Check electrical service.
> Loose connection or faulty AC power cord. > Reseat or replace power cord.
> Blown AC entry fuse(s). > Replace fuse(s).
> Defective HVPS board. > Return for service.

"NO HIGH VOLT" * Blown fuse F1 in HVPS > Return for service.
* Shorted Q1 or D1 in HVPS. > Return for service.
* Defective RF Amp > Return for service.
* HVPS board not properly seated. > Reseat HVPS.

"CUT RELAY" > Cut/Coag relay in RF Amp board not > Unplug and reseat RF Amp and Main Controller
switching properly. boards. If it still has error, return for service.
"PWR CKSUM" or > Program memory in main MCU corrupted. > Return for service.
"GO TEST MODE"
"PIC MEM CHKSUM"
"VIDEO DISPLAY" > Loss of communication between Video board and > Unplug video cable, inspect and reseat.
and/or Main Controller board.
announces "Screen > Defective Video board > Return for service.
Error"
"OVER VOLTAGE" > Over-voltage detected in RF Amp. > Unplug and reseat RF AMP, Main Controller, and HVPS.
> Defective over-voltage detection circuit in RF Amp. > Short R14 in RF Amp and perform RF output verification.
If unit still goes into OVMONI error,
replace RF Amp. If power levels exceed expected values,
replace HVPS.
> Defective HVPS. > Return for service.
> Defective RF Amp > Return for service.

"HIGH VOLT OC" > Over-current detected in HVPS. > Return for service.
> Defective RF Amp > Return for service.
"12C SOUND" > Defective waveform MCU. > Return for service.
"12C VOICEPIC" > Defective waveform MCU. > Return for service.
"12C WAVEPIC" > Defective waveform MCU. > Return for service.
"12C EEPROM" > 12C bus failure or defective peripheral IC. > Return for service.
"12C DAC"
"12C DAC2"
"12C FAN"
"12C VOLUME"
"12C UNKWN DVC"

"DOSCHKSUM" > Corrupted DOSMONI data table. > Return for service.
"NO DOS" > Blank DOSMONI table. > Return for service.

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 25 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

11.0 Spare Parts

Part Number Description

000654 COAG SWITCH ASSEMBLY
000661 IRRIGATOR JACK ASSEMBLY (4PIN CONNECTOR)
000662 FOOTPEDAL JACK ASSEMBLY (3 PIN CONNECTOR)
000663 POWER ENTRY CONNECTOR ASSEMBLY
000669 SELECTOR SWITCH ASSEMBLY
000671 CUT SWITCH ASSEMBLY
570036 4A TYPE T FUSE (FOR POWER ENTRY CONNECTOR)
400147 CMCV COVER
430013 RUBBER FEET
500095 GROMMET 13/16I D 1/4 OD

250088 POWER SWITCH

500040 SCREW, STUD

530007 WASHER, EXTERNAL TEETH SS

510009 NUT EQUALIZATION CONNECTOR

510005 NUT, HEX 6-32 THREADED BRASS

500029 SCREW, MACH, SS 4-40X1/4

530008 WASHER, INT TEETH #4

480001 NYLON CABLE TIE, UL#NT-70

500001 SCREW, MACH STL, SS 4-40X1/4

490009 NYLON CABLE CLAMP

510001 NUT, 4-40 THREAD SS

480007 STANDOFF - TWIST LOCK CLAMP

520002 NYLON WASHER

330023 3/8" DIA 3" LONG STANDOFF

500064 SCREW 6-32X3/8 SS

530013 LOCK WASHER #6 INTERNAL TEETH

330013 13/16 FEMALE STANDOFF

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 26 of 31

 Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

12.0 Device History Sheet For Test Process

Technician
DATE :
Name :

Type : Malis Generator Model : CMC-V (80-1788)

Manufacturer: Codman S/N :

Measure Device used :

Multimeter – Tool # :
Foot Pedal – Tool # :
Irrigator – Tool # :
Electrical Safety Analyser – Tool # :

9.1 – VISUAL TEST

CHECKING RESULT COMMENTS
1. General aspect (External damage) OK Not OK Initials:

2. Connectors and Switches OK Not OK Initials:

3. Fuses and AC input housing OK Not OK Initials:

4. Ground Cable Connections OK Not OK Initials:

5. Serial Number Label OK Not OK Initials:

6. Fastener and security lacquer OK Not OK Initials:

9.2 – ELECTRICAL TESTING

9.2.2 Earth Leakage (Table 1, Figure 13)

CHECKING RESULT COMMENTS

S5 should be OPEN throughout this test

1. S3 Close & S4 Normal (Max. leak is 500μA) OK Not OK Initials:

2. S3 Close & S4 Reverse (Max. leak is 500μA) OK Not OK Initials:

3. S3 Open & S4 Normal (Max. leak is 1000 μA) OK Not OK Initials:

4. S3 Open & S4 Reverse (Max. leak is 1000 μA) OK Not OK Initials:

9.2.3 Patient Leakage (Table 2, Figure 14)

CHECKING RESULT COMMENTS

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 27 of 31

 Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

S3 should be CLOSE throughout this test

1. S4 Normal & S5 Close (Max. leak is 100μA) OK Not OK Initials:

2. S4 Reverse & S5 Close (Max. leak is 100μA) OK Not OK Initials:

3. S4 Normal & S5 Open (Max. leak is 500 μA) OK Not OK Initials:

9.2.4 Ground Continuity (Figure 15)

CHECKING
RESULT COMMENTS

9.2.4.5 Measure Resistance (Max. is 0.15 ohms) OK Not OK Initials:

9.3 Output Power

CHECKING
RESULT COMMENTS
Coagulate (Into 50 ohms)

1. Malis setting 10 (Amps range 0.127--0.155)

OK Not OK Reading: Initials:
(Watts range 0.8-1.2)
2. Malis setting 15 (Amps range 0.161--0.197)
OK Not OK Reading: Initials:
(Watts range 1.28--1.92)
3. Malis setting 20 (Amps range 0.221--0.270)
OK Not OK Reading: Initials:
(Watts range 2.4--3.6)
4. Malis setting 25 (Amps range 0.284--0.348)
OK Not OK Reading: Initials:
(Watts range 4.0--6.0)
5. Malis setting 30 (Amps range 0.337--0.411)
OK Not OK Reading: Initials:
(Watts range 5.6--8.4)
6. Malis setting 35 (Amps range 0.382--0.466)
OK Not OK Reading: Initials:
(Watts range 7.2--10.8)
7. Malis setting 40 (Amps range 0.422--0.516)
OK Not OK Reading: Initials:
(Watts range 8.8--13.2)
8. Malis setting 45 (Amps range 0.476--0.582)
OK Not OK Reading: Initials:
(Watts range 11.2--16.8)
9. Malis setting 50 (Amps range 0.525--0.641)
OK Not OK Reading: Initials:
(Watts range 13.6--20.4)
10. Malis setting 60 (Amps range 0.554--0.678)
OK Not OK Reading: Initials:
(Watts range 15.2--22.8)
11. Malis setting 70 (Amps range 0.597--0.729)
OK Not OK Reading: Initials:
(Watts range 17.6--26.4)
12. Malis setting 80 (Amps range 0.624--0.762)
OK Not OK Reading: Initials:
(Watts range 19.2--28.8)
13. Malis setting 90 (Amps range 0.636--0.778)
OK Not OK Reading: Initials:
(Watts range 20--30)
14. Malis setting 100 (Amps range 0.686--0.838)
OK Not OK Reading: Initials:
(Watts range 23.2--34.8)
15. Malis setting 110 (Amps range 0.720--0.880)
OK Not OK Reading: Initials:
(Watts range 25.6--38.4)
16. Malis setting 120 (Amps range 0.753--0.921)
OK Not OK Reading: Initials:
(Watts range 28--42)
17. Malis setting 130 (Amps range 0.805--0.983)
OK Not OK Reading: Initials:
(Watts range 32--48)
18. Malis setting 140 (Amps range 0.854—1.05)
OK Not OK Reading: Initials:
(Watts range 36--54)
19. Malis setting 150 (Amps range 0.900--1.10)
OK Not OK Reading: Initials:
(Watts range 40--60)

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 28 of 31

 Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

20. Malis setting 160 (Amps range 0.945--1.16)

OK Not OK Reading: Initials:
(Watts range 44--66)
21. Malis setting 170 (Amps range 0.981--1.20)
OK Not OK Reading: Initials:
(Watts range 48--72)
22. Malis setting 180 (Amps range 1.02--1.25)
OK Not OK Reading: Initials:
(Watts range 52--78)
23. Malis setting 190 (Amps range 1.06--1.30)
OK Not OK Reading: Initials:
(Watts range 56--84)
24. Malis setting 200 (Amps range 1.10--1.35)
OK Not OK Reading: Initials:
(Watts range 60--90)

Cut (Into 400 ohms)

1. Malis setting 10 (Amps range 0.045--0.055)

OK Not OK Reading: Initials:
(Watts range 0.8--1.2)
2. Malis setting 15 (Amps range 0.057--0.069)
OK Not OK Reading: Initials:
(Watts range 1.28--1.92)
3. Malis setting 20 (Amps range 0.078--0.096)
OK Not OK Reading: Initials:
(Watts range 2.4--3.6)
4. Malis setting 25 (Amps range 0.101--0.123)
OK Not OK Reading: Initials:
(Watts range 4.0--6.0)
5. Malis setting 30 (Amps range 0.119--0.145)
OK Not OK Reading: Initials:
(Watts range 5.6--8.4)
6. Malis setting 35 (Amps range 0.135--0.165)
OK Not OK Reading: Initials:
(Watts range 7.2--10.8)
7. Malis setting 40 (Amps range 0.149--0.183)
OK Not OK Reading: Initials:
(Watts range 8.8--13.2)
8. Malis setting 45 (Amps range 0.168--0.206)
OK Not OK Reading: Initials:
(Watts range 11.2--16.8)
9. Malis setting 50 (Amps range 0.185--0.227)
OK Not OK Reading: Initials:
(Watts range 13.6--20.4)
10. Malis setting 60 (Amps range 0.202--0.246)
OK Not OK Reading: Initials:
(Watts range 16--24)
11. Malis setting 62 (Amps range 0.225--0.275)
OK Not OK Reading: Initials:
(Watts range 20--30)
12. Malis setting 65 (Amps 0.247--0.301)
OK Not OK Reading: Initials:
(Watts range 24--36)
13. Malis setting 67 (Amps range 0.266--0.326)
OK Not OK Reading: Initials:
(Watts range 28--42)
14. Malis setting 70 (Amps range 0.284--0.348)
OK Not OK Reading: Initials:
(Watts range 32--48)
15. Malis setting 72 (Amps range 0.302--0.369)
OK Not OK Reading: Initials:
(Watts range 36--54)
16. Malis setting 75 (Amps range 0.319--0.389)
OK Not OK Reading: Initials:
(Watts range 40--60)
17. Malis setting 77 (Amps range 0.334--0.408)
OK Not OK Reading: Initials:
(Watts range 44--66)
18. Malis setting 80 (Amps range 0.348--0.426)
OK Not OK Reading: Initials:
(Watts range 48--72)
19. Malis setting 85 (Amps range 0.376--0.460)
OK Not OK Reading: Initials:
(Watts range 56--84)
20. Malis setting 90 (Amps range 0.402--0.492)
OK Not OK Reading: Initials:
(Watts range 64--96)
21. Malis setting 95 (Amps range 0.427--0.521)
OK Not OK Reading: Initials:
(Watts range 72--108)
22. Malis setting 100 (Amps range 0.450--0.550)
OK Not OK Reading: Initials:
(Watts range 80--120)
23. Malis setting 105 (Amps range 0.472--0.576)
OK Not OK Reading: Initials:
(Watts range 88--132)

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 29 of 31

 Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

24. Malis setting 110 (Amps range 0.493--0.602)

OK Not OK Reading: Initials:
(Watts range 96--144)

9.4 Functional Inspection

9.4. 2. Coag Audio announcements (both “Always Announce” and “1X Announce” settings)

CHECKING
RESULT COMMENTS

a. Coag mode is announced OK Not OK Initials:

b. Power setting is announced OK Not OK Initials:

c. Power units (Malis) is announced OK Not OK Initials:

d. Background around the word “Coag” is

OK Not OK Initials:
illuminated
e. Low pitch tone is heard OK Not OK Initials:

9.4.3. Cut Audio announcements (both “Always Announce” and “1X Announce” settings)

CHECKING
RESULT COMMENTS

a. Cut mode is announced OK Not OK Initials:

b. Power setting is announced OK Not OK Initials:

c. Power units (Malis) is announced OK Not OK Initials:

d. Background around the word “Cut” is

OK Not OK Initials:
illuminated
e. Higher pitch tone is heard (compared to coag
OK Not OK Initials:
tone)

9.4 Functional Inspection - continued

CHECKING
RESULT COMMENTS
9.4.4 “Foot pedal Error occurs” when the Cut and
then the Coag foot pedals are depressed at OK Not OK Initials:
the same time.
9.4.5 “Foot pedal Error occurs” when the Coag and
then the Cut foot pedals are depressed at the OK Not OK Initials:
same time.
9.4.7 Irrigator engages when the Irrigator Button is
engaged and the Coag and Cut foot pedals
OK Not OK Initials:
are depressed and disengages when the foot
pedals are released.
9.4.8 Irrigator doesn’t engage when the Irrigator
Button is dis-engaged and the coag and Cut OK Not OK Initials:
foot pedals are depressed.
9.4.9 No announcements when the voice is muted
OK Not OK Initials:
and either foot pedal is depressed.
9.4.10 Voice volume is controllable. OK Not OK Initials:

9.4.11 Tone volume is controllable. OK Not OK Initials:

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 30 of 31

Codman-Neuro CMC V Biomed Manual WI-9720 Rev B

9.4.12 Brightness level is controllable OK Not OK Initials:

CODMAN® MALIS® CMC V® BIOMED MANUAL Page 31 of 31