MALIS MODULE 1000 Irrigation System Instruction Manual Revised May 2012

Classification

ENGLISH

Equipment Function:

Irrigator

Type of protection against electrical shock:

Class I

Degree of protection against electrical shock:

Type BF

Classification ... 2

Supply Connection:

60 Volt-Amp 100–230 VAC 50–60 Hz

Table of Symbols ... 2

Mode of Operation:

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

Protection against hazards of explosion:

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

Warnings ... 3

Protection against ingress of liquids:

Drip-proof

Precautions ... 3

Degree of Mobility:

Portable

Cleaning and Sterilization ... 3

Table of Symbols

MALIS® MODULE 1000™ Irrigation System (Catalog No. 80-9100 and 80-1569) Table of Contents

Page

Important Information ... 3 Description ... 3 Indications ... 3

System Description ... 3 Controls, Indicators and Connections ... 3

Primary (Mains) power on

Instructions for Use ... 4 Primary (Mains) power off

Set Up ... 4 Loading the Irrigation Tubing Set ... 4

Alternating current

Irrigation ... 4 Accessory Product Codes ... 4

Fuse

Troubleshooting Guide ... 4 Service and Repair ... 5

Saline bag

End of Useful Life ... 5 Warranty ... 5

Forceps

Appendix A: Service Manual ... 5 Field Maintenance and Repair ... 5

Attention, see instructions for use

Technical Specifications ... 5 Safety Information ... 5

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

Maintenance ... 5 Theory of Operation ... 5

Electrosurgical generator connection receptacle

Controller Board ... 5 Power Supply Board ... 5 Block Diagram ... ii

Equipotentiality

Schematic Diagram ... iii Schematic Diagram–Chassis ... v

Alert

Cut Irrigation

Coag Irrigation

Cut-Coag Irrigation Selector

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IMPORTANT INFORMATION Please Read Before Use

System Description

MALIS MODULE 1000 Irrigation System

FRONT PANEL

(Catalog No. 80-9100 and 80-1569)

A. Irrigation Rate Display This LED indicator numerically shows the flow setting.

Controls, Indicators and Connections

B. Irrigation Rate Knob The Irrigation Rate Knob adjusts the rate of irrigation. Turning the knob clockwise increases the irrigation rate and counterclockwise decreases the rate. The irrigation rate is indicated on the Irrigation Rate Display. When the irrigation rate is set to zero, irrigation is disabled for that mode (Coagulation or Cut). Pushing in the Flow Rate Knob switches between the Coagulation Irrigation and Cut Irrigation display modes. When the Coagulation Irrigate Indicator is illuminated, the Flow Rate Knob controls the Coagulation rate of irrigation. When the Cut Irrigate Indicator is illuminated, the Flow Rate Knob controls the Cut rate of irrigation.

Instruction and Service Manual IMPORTANT: Please read entire Instruction Manual before attempting to operate this module.

Description The MALIS MODULE 1000 Irrigation System (referred to as the module) is an irrigation control system designed for use with the CODMAN® MALIS CMC®-III and CMC-V or the SYNERGY® Bipolar Electrosurgical Generators (catalog nos. 80-1170, 80-1172, 80-1187, 80-1788) connected to bipolar irrigating forceps to deliver irrigation fluids during (neuro) surgical procedures. Delivery rate of irrigation fluid is adjustable and is controlled by the operator. See Table 1 for details regarding connection to the CMC and SYNERGY generators. Note: The irrigator is designed to function optimally when used with the specified cord and cord and tubing sets described in Table 1.

C. Coagulation and Cut Mode Irrigate Indicators When the Coagulation Irrigate Indicator is illuminated, the Display indicates the Coagulation rate of irrigation. When the Cut Irrigate Indicator is illuminated, the Display indicates the Cut rate of irrigation. To change the display from one mode to the other, push in on the Irrigation Rate Knob.

Indications The MALIS MODULE 1000 Irrigation System is indicated for use with irrigating bipolar forceps with the CODMAN/MALIS generators.

FLOW RATE SETTINGS

WARNINGS

Cut or Coag Irrigation Setting

Flow Rate

1–5 6–15 16–18 19–20

Slow Drip Medium Drip Fast Drip Stream

Read the entire instruction manual before attempting to operate the module. Electrical shock hazard: • Do not attempt to bypass the grounding prong on the module by using an adapter. The module must be grounded properly to ensure operator and patient safely. Grounding reliability can be achieved only when connected to a receptacle marked “Hospital Only” or “Hospital Grade.”

D. Alert Indicator If the Alert Indicator is illuminated or flashing, an error condition has been detected by the module. Return for service.

• Do not remove the module cover. Refer servicing to qualified service personnel.

REAR PANEL

• Disconnect the power cord to isolate the module from the supply mains. Serious shock hazards are present inside this case even with the power switch off.

E. Power Switch This rocker switch controls the primary AC power to the module. When the module is ON the Irrigation Rate Display above the Irrigation Rate Knob illuminates.

• Always replace the module’s fuse with the appropriate type and value fuse see Technical Specifications.

F. Generator Connection Receptacle Refer to cable instructions for use for the correct method of connecting the cable to the irrigator.

• Do not modify the module in any way. Unauthorized modifications to the module can cause it to malfunction or fail in use. When used in conjunction with an Electrosurgical Generator, do not operate the system near patient devices such as pacemakers or other active implants sensitive to radio frequency interference.

G. Equipotential Connector Connect a potential equalization conductor to a bus bar in rooms requiring potential equalization. A bus bar is a grounded metal bar in a breaker box to which all neutral and grounding wires are connected.

Precautions

H. Power Receptacle The power receptacle accepts the three-prong power cord plug and also contains the external fuses. See Technical Specifications.

Use only CODMAN MODULE 1000 Tubing Sets and Floorstands with the module. Check the power cord and connecting cable for proper function prior to use. Replace if necessary. Verify operation of the irrigator before loading the tubing set or connecting the forceps cable. See Set Up instructions.

Cleaning and Sterilization Clean the module exterior surfaces as necessary with a damp cloth or sponge. Use alcohol or a mild cleaning solution to remove stains or adhesives that stick to the surface. Do not immerse the module in any solution. Subjecting the module to excessive moisture can damage the electronic components and nullify the warranty. Never sterilize the module or power cord. The irrigation tubing sets are sold sterile and are for single use only. Do not resterilize.

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Instructions for Use

Irrigation

Set Up

1. After the tubing set has been loaded, depress the footpedal to activate irrigation. Release the footpedal to deactivate.

The MALIS MODULE 1000 Irrigation System is for use with the MALIS CMC-III, the SYNERGY, or the CODMAN MALIS CMC-V Bipolar Electrosurgical Systems.

Note: To avoid unintentional irrigation, ensure that the irrigation module is switched off during set up. Always power up the generator before turning on the irrigator.

Note: To avoid unintentional irrigation, ensure that the irrigation module is switched off during set up. Always power up the generator before turning on the irrigator.

2. Select the irrigation rate using the rate knob on the front panel of the module. With forceps attached, turn the knob clockwise to increase the irrigation rate and counterclockwise to decrease the irrigation rate.

1. Mount the module on the appropriate CODMAN Floorstand. 2. Plug the MALlS MODULE 1000 Interconnecting Cable into the footpedal connection receptacle on the rear panel of the irrigator. Refer to cable instructions for use for the correct method of connecting the cable to the irrigator. Support the irrigator with one hand while inserting or removing the cable connector.

3. When switched on, the module defaults to coagulation irrigation mode (Coagulation Irrigate Indicator is illuminated). In order to change to the cut irrigation mode, either push in the Irrigation Rate Knob or depress the cut footpedal. This will illuminate the Cut Irrigate Indicator and change the numeric display to the cut irrigation setting.

Note: The MALlS MODULE 1000 Interconnecting Cable connects the circuits of the irrigator to the bipolar generator, eliminating the need for a second footpedal.

Note: The coagulation irrigation and cut irrigation settings can be set to different levels. For example, coagulation irrigation setting can equal 10 while the cut irrigation setting can equal 3.

3. Plug the power cord into the power receptacle on the rear panel of the irrigator and into an appropriately grounded 100–230 VAC 50/60 Hz power supply. The power receptacle provides an interface to cord/mains source and fuse replacement.

4. To change back to the coagulation irrigation mode, push in the Irrigation Rate Knob or depress the coagulation footpedal. This will illuminate the Coagulation Irrigate Indicator and change the numeric display to the coagulation irrigation setting.

WARNING: Do not attempt to bypass the grounding prong on the module by using an adapter. The module must be grounded properly to ensure operator and patient safety. Grounding reliability can be achieved only when connected to a receptacle marked “Hospital Only” or “Hospital Grade.”

Table 1 Accessory Product Codes

4. Push the power switch on. The flow rate indicator above the flow rate knob will illuminate.

Irrigator

Generator

Interconnecting Cable

Floorstand

Tubing Sets

5. Turn the flow rate knob clockwise until the flow rate indicator reads “10.”

80-9100

80-1170, 80-1171, 80-1172, or 80-1187

80-1174

80-1177

80-9103, or 80-9104

80-1569

80-1788, 80-1789

80-1791

80-1559

80-9103, or 80-9104

6. Open the module door and lift the pump hood. 7. Depress the footpedal (connected to the generator) and verify that it causes the pump roller to spin. Note: Verify operation of the irrigator before loading the tubing set or connecting the forceps cable.

Loading the Irrigation Tubing Set Use only CODMAN MODULE 1000 Tubing Sets (catalog no. 80-9103, or 80-9104) with the irrigator. After verifying operation of the module (see Set Up), load the tubing set as follows:

Table 2 Symptoms

Probable Cause

Correction

1. Push the power switch of the module on.

Irrigator does not operate (irrigation rate display does not light)

Irrigator not plugged into power outlet

Plug in irrigator

Blown fuse

Replace fuse

Loose wire at power cord plug

Check plug for wiring

No power at wall outlet

Check electrical service

Troubleshooting Guide

2. Using sterile technique, remove the tubing set from the peel pouch. 3. Remove the protective cap from the irrigation tubing inlet spike. While holding the irrigation solution container vertically (with prepared stopper on top), push the spike into the center of the prepared stopper with a quick thrust. DO NOT TWIST. 4. Engage the irrigation tubing clamp.

Irrigator defective

Return for repair

5. Place the container, stopper face down, on the IV pole.

Alert LED is illuminated or blinking

Irrigator diagnostic failure, return for repair

6. Open the module door and lift the pump hood.

Irrigation fluid not controlled

Tubing not primed

Prime tubing

7. Locate the silicone portion of the tubing which is between the two plastic fittings.

Tubing not seated properly

8. Starting from the top, thread the tubing through the slot, around the rollers, and through the exit opening at the bottom of the pump head (Figure 1). The plastic fitting nearest the irrigation solution container should be at the top of the pump head and the fitting nearest the forceps should be at the base.

Check tubing alignment in pump head

No irrigation fluid flow

Tubing pinched in pump head

Check tubing alignment in pump head

Tubing clamp engaged

Release tubing clamp

Generator turned off

Power up generator before turning on irrigator

9. Connect the tubing set and forceps designed to provide irrigation by inserting the male tubing connector into the female forceps connector. 10. Prime the system by releasing the irrigation tubing clamp and allowing irrigation fluid to flow through the tubing. Remove as many air bubbles as possible from the tubing before use. Verify flow in the system by observing irrigation through the forceps tips. When the tubing set is fully primed, close the pump hood to stop the fluid flow. Avoid pinching the silicone tubing when closing the pump hood (Figure 2).

Irrigates without pressing footpedal

Note: Only qualified service personnel should attempt to repair the module.

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Service and Repair

Controller Board

For service and repair, contact Codman Repair Customer Service at 1-877-806-9151.

The controller board contains the microcontroller, U2, and software that operate the module. The microcontroller communicates via the I2C bus with the display driver, U1, to set the numeric displays and indicator LEDs. Rotating the rotary switch, S1, increases or decreases the irrigator setting. Pushing in the rotary switch switches between cut and coag irrigation modes. The microcontroller interfaces to the stepper motor controller, U3, via several signals. A LO to HI transition on the STEP_CLK signal causes the motor controller to step or rotate the motor and peristaltic pump.

End of Useful Life Dispose of the equipment in accordance with local ordinances.

Warranty Codman & Shurtleff, Inc., warrants that this medical device is free from defects in both materials and workmanship for two full years from date of purchase. Only the CODMAN MODULE 1000 Tubing Sets are approved for use with the module. Use of any other tubing set nullifies this warranty. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Suitability for use of this medical device for any particular surgical procedure should be determined by the user in conformance with the manufacturer’s instructions for use. There are no warranties that extend beyond the description on the face hereof.

Inputs to the controller board include the footpedal/generator interface (connecting cable). Depressing the footpedal causes the irrigator to begin pumping action. The rate at which the pumping action occurs is controlled by the microcontroller and software.

Power Supply Board The power supply board consists of an off-line switching power supply to produce regulated low voltage supplies. The mains voltage connects to an EMI filter and bridge rectifier to produce unregulated DC voltage. The switching controller, U1, and transformer, T1, regulate the DC voltage to a lower level, which is fed into a linear regulator, U2. The linear regulator, U2, produces a regulated 27 volt supply that is used to drive the motor controller. The 27 volts is fed into another linear regulator, U3, to produce a 5 volt supply that powers the controller board circuits.

® CMC, CODMAN, and SYNERGY are registered trademarks of Codman & Shurtleff, Inc. ™ MODULE 1000 is a trademark of Codman & Shurtleff, Inc. ® MALIS is a registered trademark of Synergetics USA, Inc.

APPENDIX A: Service Manual Field Maintenance and Repair This section contains the necessary information to allow a qualified service technician to perform maintenance and repair in the field. Equipment under warranty should be returned to Codman & Shurtleff, Inc. It will be repaired or replaced without charge to the purchaser.

Technical Specifications Supply Voltage 60 VA at 100–230 ±10% VAC

Supply Frequency 50/60 Hz

Supply Current 0.60 A

Fuses 5 x 20 mm, T1A, 250 V (slow blow) Environmental: Temperature

Operational: 10°C to 45°C

Transport & Storage: 5°C to 55°C

Relative Humidity (non-condensing)

30% to 70%

0% to 90%

700 hPa to 1060 hPa

500 hPa to 1060 hPa

Atmospheric Pressure

Safety Information The MALIS MODULE 1000 Irrigation System complies with the requirements of IEC 60601-1.

Maintenance A change in the flow characteristics of the module could indicate the need to replace the rollers located in the pump head. Consult the appropriate facility for this possible repair. No other preventive maintenance is required.

Theory of Operation The MALlS MODULE 1000 Irrigation System operates by use of a peristaltic pump in conjunction with the silicone insert portion of the MALIS MODULE 1000 Tubing Set. The tubing set is connected to an irrigation solution container. The fluid flow is propelled by the peristaltic pump. The irrigation rate is operator controlled by the knob located on the front panel.

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