3000302 Megadyne Operators Manual Rev C May 2021

Chapter One INTRODUCTION INDICATIONS DESCRIPTION SYMBOLS WARNINGS CAUTIONS


  

  

UNDESIRABLE SIDE EFFECTS / RESIDUAL RISKS

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Indications The MegadyneTM Smoke Evacuator with accessories is intended to be used to remove surgical smoke created at the surgical site.

Description

Introduction The MegadyneTM Smoke Evacuator is designed to provide smoke evacuation in open and laparoscopic procedures for the removal of surgical smoke.


  

  

Using a scroll pump and 4 stages of filtration, the MegadyneTM Smoke Evacuator is designed to evacuate surgical smoke both quietly and effectively. An intuitive front panel design allows users to customize both the rate of suction FLOW and the length of RUN TIME after the active electrode is deactivated. Push button selections for OPEN, LAP (laparoscopic), and MANUAL modes also are clearly marked and easily accessible.

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Megadyne - Operator's Manual

The MegadyneTM Smoke Evacuator is designed for use during open and laparoscopic procedures. The MegadyneTM Smoke Evacuator is used with accessories such as sterile smoke evacuation pencils, advanced energy sealing devices, and tubing of various sizes in conjunction with electrosurgical generators. This manual provides basic MegadyneTM Smoke Evacuator instructions for use as well as preventative maintenance and service guidelines. The intended purpose of the Megadyne™ Smoke Evacuator with accessories is to remove surgical smoke created at the surgical site, resulting in a reduction of surgical smoke exposure and for better surgical site visibility for the surgeon and healthcare workers.

Chapter One

Symbols

Megadyne Medical Products Inc. 11506 South State Street

` Draper, Utah 84020 USA

Power Switch Designation

Caution

Power Switch Designation

Temperature Limit

Catalog Number

Batch Code

Authorized Representative in the European Community

Serial Number

Packaging Unit Manufacturer

+1 (801) 576-9669

Consult Instructions For Use Caution: Federal (USA) law restricts this device to sale by or on the order of a Licensed Healthcare Practitioner Humidity Limitations

Voltage Rating (Specific Conditions)

Separate Collection

Use By Date Do Not Use If Package Is Damaged Keep away from heat Keep Dry

Type CF Applied Part Alternating Current

Equipotentiality

Fuse Flow

Run Time

Pressure Limits

  

Manufacture Date

TM

Trademark


  

Do not re-use

Indicates that the Electrical and Electronic Product (EEP) contains toxic and hazardous substances or elements over the defined maximum concentration values. The names and content of the toxic and hazardous substances or elements shall be provided in the Chinese product instruction manual. The number “50” in the symbol refers to the environment-friendly use period; after their environment-friendly use period expires, they shall be put into the recycling system (People’s Republic of China symbol for Restriction of Hazardous Substances (RoHS) in electrical and electronic products). Indicates that the Electrical and Electronic Product (EEP) does not contain toxic and hazardous substances or elements above the maximum concentration values, and that it is an environment-friendly product which can be recycled (People’s Republic of China symbol for Restriction of Hazardous Substances (RoHS) in electrical and electronic products). Indicates that the Electrical and Electronic Product (EEP) contains toxic and hazardous substances or elements over the defined maximum concentration values. The names and content of the toxic and hazardous substances or elements shall be provided in the Chinese product instruction manual. The number “10” in the symbol refers to the environment-friendly use period; after their environment-friendly use period expires, they shall be put into the recycling system (People’s Republic of China symbol for Restriction of Hazardous Substances (RoHS) in electrical and electronic products).

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Warnings • Read this manual thoroughly and be familiar with its contents prior to using this equipment. • The MegadyneTM Smoke Evacuator is only intended and suitable for the applications specified in the operating instructions.

• Non-flammable agents should be used for cleaning and disinfection wherever possible.

• This equipment is intended for use by trained healthcare professionals only.

• If liquids have entered the smoke evacuator, the unit must be returned to the manufacturer for testing prior to use.

• To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

• This device is not MR safe and is not MR compatible.

TM

• Removal of the Megadyne Smoke Evacuator cover or panels may create the risk of an electrical shock and will void the warranty. • Do not operate this device in the presence of flammable agents or explosive gases. • Electrical equipment attached to the Energy Generator Connection must be UL Classified device or equivalent to ANSI/AAMI ES 60601-1 AND IEC 60601-1. Furthermore, all configurations shall comply with the system standard IEC 60601-1. Anyone who connects additional equipment to the Energy Generator Connection mains outlet configures a Medical System and is therefore responsible that the system complies with the requirements of IEC 60601-1. If in doubt, consult the facility's Biomed service department or your local representative. • The MegadyneTM Smoke Evacuator is not to be serviced while in use with a patient.

  

• Check the FLOW setting to prevent patient injury and to prevent suction of surgical materials and surgical specimens. If in a laparoscopic procedure also check trocar placement to prevent patient injury and suction of surgical materials and surgical specimens.


  

• Follow the leakage table specifications located in the technical specification when plugging energy source into Energy Generator Connection port.

• Do not attach multiple socket-outlets or extension cords to the Energy Generator Connection. Attaching to a multiple socket-outlet could reduce safety. • Do not plug energy source into Energy Generator Connection port that exceeds 8 Amperes current draw.

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Megadyne - Operator's Manual

• Do not allow the MegadyneTM Fluid Trap to fill over the Max Fill Line. • No modification to this equipment is allowed. • To isolate the MegadyneTM Smoke Evacuator from supply mains power, disconnect the power cord either from the back panel of the generator or from the wall. Ensure that access to these points is kept clear. • Do not allow suction to seal off on tissue or it could cause damage to capillaries. • Max current draw of energy source connected to Energy Generator Connection shall not exceed 8A. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of the MegadyneTM Smoke Evacuator (MESE1) including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. • This equipment and the other equipment should be observed to verify that they are operating normally if adjacent to or stacked with other equipment. • Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

Chapter One

Cautions • Federal (USA) law restricts this device to sale by or on the order of a physician. • Do not place containers of fluids on the smoke evacuator or allow fluids to spill on the smoke evacuator. • Do not operate without adequate clearance for ventilation. At least one inch of air should separate the back of the smoke evacuator from any ventilation obstructing surface. • The installation of this equipment must be performed such that the intake and exhaust vents located on the back of the system are not obstructed. • Failure to properly install the smoke evacuator may cause reduced performance, damage and/or cause the system to be inoperable and may void the warranty. • If the smoke evacuator becomes superficially wet, immediately disconnect the smoke evacuator from the mains outlet and wipe dry or allow to air dry before proceeding. • Refer annual preventative maintenance to qualified biomedical technical personnel. • Use only with the power cord provided.

• This device is not intended for use in LAP mode if the exhaust port has been connected to a negative pressured in-house exhaust system. • Using unapproved filters or accessories with the smoke evacuator may cause damage and will void the warranty. • This device is not intended for the evacuation of fluids. If fluid is expected to be aspirated to the smoke evacuation filter, a fluid trap must be installed. Failure to install the MegadyneTM Fluid Trap could cause filter blockage, reduced filter performance and result in electrical damage. • The MegadyneTM Filter should be changed according to the FILTER life indicator. Failure to change the filter may result in decreased efficiency and contamination of the vacuum pump, sound dampening media within the unit and other internal components. The FILTER life is a measure of activation time only, not a measure of filter performance. If diminished effect is observed, replace the MegadyneTM Filter. • Replace fuses only with the appropriate type and rating. See Fuse Replacement section within Chapter 7. • If an energy source other than the types identified above is attached to the MegadyneTM Smoke Evacuator via the RF Activation Port, sporadic operation from continuous to no activation of the smoke box may be experienced.

• Placement of the MegadyneTM Laparoscopic Tubing (REF 2390J) on the camera port may decrease visualization. • Care should be taken to route the power cord to not cause a tripping hazard or crimping of cords or cables when using the MegadyneTM Laparoscopic Tubing (REF 2390J), MegadyneTM Speculum Tubing (REF 2395J), MegadyneTM Connect Cable (REF 2403J, 2406J) and/or MegadyneTM RF Sensor (REF 2255J).

• Use the lowest flow and activation settings possible to achieve desired effects. Prolonged activation via MANUAL mode within laparoscopic cases may deflate the pneumoperitoneum.

Undesirable side effects and risks associated with MegadyneTM Smoke Evacuator and its accessories include the potential for introduction of non-sterile surfaces or pathogen transfer, bleeding, electrical shock, and property or environmental damage. Extended surgery may result from issues related to device activation or damaged devices.


  

  

• Use of the OPEN mode in laparoscopic cases will deflate the pneumoperitoneum.

Undesirable Side Effects / Residual Risks

7

Chapter Two INSPECTION AND INITIAL SET-UP DESCRIPTION OF CONTROLS


  

  

BACK PANEL

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Megadyne - Operator's Manual

Chapter Two

Inspection and Initial Set-Up The MegadyneTM Smoke Evacuator is manufactured and packaged to arrive in operating condition. The following components are shipped with the MegadyneTM Smoke Evacuator and should be inspected for damage prior to initial set-up.

MEGADYNE

TM

SMOKE EVACUATOR

• MegadyneTM Smoke Evacuator (REF MESE1) • MegadyneTM Filter (REF 2550J) • MegadyneTM Connect Cable, 1m (REF 2403J) • MegadyneTM Fluid Trap (REF 2555J) • Hospital Grade Power Cord (REF 4600034) • MegadyneTM Operator's Manual • Certification Data Sheet Reference sections on Compatibility and Approved Accessories within Chapter 7 for a list of optional accessories.

Complete Inspection by following the set-up steps below. Read the Use Instructions in Chapter 4 of this manual prior to use. • Remove the MegadyneTM Smoke Evacuator and components from shipping materials • Visually inspect for damage • Attach the power cord • Insert and verify secure placement of the MegadyneTM Filter (REF 2550J) • See MegadyneTM Filter (REF 2550J) and MegadyneTM Fluid Trap (REF 2555J) installation details in Chapter 3 • With the MegadyneTM Smoke Evacuator in the “OFF” position be sure that the power cord is fully inserted into both the Power Entry Module on the back of the smoke box and into the appropriate grounded 100V to 240V outlet • Position the MegadyneTM Smoke Evacuator in a manner that provides access to the power cord for disconnection • Turn on the power switch • Press the MANUAL button to verify suction • Turn off the MegadyneTM Smoke Evacuator and unplug as necessary • Place the MegadyneTM Smoke Evacuator onto a cart, a boom or other as per hospital procedure • Position to allow adequate (1”) ventilation at the back of the unit • The device should sit securely on its rubber feet and be positioned so that the control panel is easily accessible to the user


  

  

Contact the Ethicon Customer Service Department or your local representative for any customer or technical support. Call +1-877-ETHICON in the U.S. only.

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Description of Controls 1 5 6 7

2 The MegadyneTM Smoke Evacuator interface/controls are designed for intuitive use.

1. POWER SWITCH • Powers the MegadyneTM Smoke Evacuator On/Off

3

8

5. OPEN • The OPEN mode sets the system into a high FLOW state for open procedures •

When selected, the indicator light adjacent to OPEN button will illuminate

•

When activated, the indicator light adjacent to OPEN button will blink

2. MEGADYNETM FILTER • MegadyneTM Filter with both ULPA and Carbon filtration 3. FLOW • Controls the rate of FLOW

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6. LAP • The LAP mode sets the system into a low FLOW state for laparoscopic procedures

•

One of the five indicator lights adjacent to FLOW will illuminate to indicate the selected setting

•

When selected, the indicator light adjacent to LAP button will illuminate

•

To increase/decrease FLOW, push the up/down arrow

•

When activated, the light next to LAP button will blink

•

When in LAP mode, the smoke evacuator passively seals off the flow path to maintain pneumoperitoneum pressure while the smoke evacuator is not active

4. RUN TIME • Indicates the length of RUN TIME that the smoke evacuation is active after the energy device is deactivated •

One of the five indicator lights adjacent to RUN TIME will illuminate to indicate the selected setting

•

To increase/decrease RUN TIME, push the up/down arrow

INCREASES

  

DECREASES

7. MANUAL START/STOP • Operates in either OPEN or LAP mode •

Provides continuous FLOW at selected setting

•

Press to activate, press again to deactivate

8. FILTER LIFE INDICATOR • Three lights provide a visual indication of active FILTER life o Green o Yellow o Red


  

Reference section on Filter Life Indicator within Chapter 3 for more information as needed

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Megadyne - Operator's Manual

Chapter Two

Back Panel

4 3 1

6

5

2

1. RF ACTIVATION PORT This port accommodates connection to: • The MegadyneTM RF Sensor (REF 2255J) 2. POWER ENTRY MODULE Power connection from a grounded 100V or 240V outlet to the MegadyneTM Smoke Evacuator Warning: Max current draw of energy source connected to Energy Generator Connection shall not exceed 8A.

3. ENERGY GENERATOR CONNECTION Connects the MegadyneTM Smoke Evacuator to a chosen energy generator (monopolar, bipolar, ultrasonic, or advanced bipolar). This provides automatic activation at the chosen setting. 4. EXHAUST PORT Exhausts filtered air from the system


  

  

Caution: This device is not intended for use in LAP mode if the exhaust port has been connected to a negative pressured in-house exhaust system.

5. POTENTIAL EQUALIZATION GROUND LUG If required by code, connect the lug to the hospital potential equalization system with an equipotential cable. 6. FUSE BOX Reference section on Fuse Replacement within Chapter 7 for how to replace fuses. 11

Chapter Three PRE-PROCEDURE SET-UP


  

  

FILTER AND FLUID TRAP DISPOSAL

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Megadyne - Operator's Manual

Chapter Three

Pre-Procedure Set-Up Confirm all MegadyneTM Smoke Evacuator components are available and ready for use.

MEGADYNETM SMOKE EVACUATOR • MegadyneTM Smoke Evacuator (REF MESE1) • MegadyneTM Filter (REF 2550J) • MegadyneTM Connect Cable, 1m (REF 2403J) • MegadyneTM Connect Cable, 2.1m (REF 2406J) • MegadyneTM Fluid Trap (REF 2555J) • Hospital Grade Power Cord (REF 4600034) • MegadyneTM RF Sensor (REF 2255J)

ELECTRICAL CONNECTIONS • Plug the power cord into an appropriate power outlet (100V/240V) • If connecting via the MegadyneTM Connect Cable (REF 2403J, 2406J) note the port output is 100/240V, 50-60 Hz, 8A. Contact the Biomed if there are any questions.

MEGADYNE™ FILTER REF 2550J

If the device is stored outside operating temperature range (see Technical Specification section within Chapter 7), allow the unit to stabilize to room temperature for a minimum of one hour before use.

MEGADYNE™ CONNECT CABLE, 1M REF 2403J MEGADYNE™ CONNECT CABLE, 2.1M REF 2406J (SOLD SEPARATELY)


  

  

See section on Activation Options within Chapter 5 for details regarding the connection and use of the MegadyneTM Connect Cable and/or MegadyneTM RF Sensor for automatic activation with various smoke producing energy sources.

MEGADYNE™ RF SENSOR REF 2255J (SOLD SEPARATELY)

MEGADYNE™ FLUID TRAP REF 2555J

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FILTER INSTALLATION/FILTER LIFE The MegadyneTM Filter is a highly efficient ULPA and charcoal filtration system designed to capture and filter particulates and microorganisms of 0.1 to 0.2 microns at 99.999% efficiency. • Insert the MegadyneTM Filter securely into the filter port located on the front of the MegadyneTM Smoke Evacuator • Confirm secure filter placement • One indicator light will be illuminated when the filter is secure and indicate remaining filter life •

If the filter is not securely seated, all filter lights will blink until proper installation is completed

FILTER

FILTER LIFE INDICATOR

FILTER LIFE INDICATOR The MegadyneTM Smoke Evacuator front panel display provides a visual indicator of the filter life. As the filter is used, the filter display lights will change from green to yellow and then yellow to red indicating end of filter life. Blinking filter lights indicate system does not recognize filter connection, re-seat filter into the filter port until a filter indicator light is illuminated. Green Ready for Use 100% - 25% Filter Life Yellow Ready for Use 25% - 0% Filter Life


  

  

Red End of Filter Life Change filter Once the red light is illuminated, the smoke evacuator can only be activated within a 3 hour window to complete the case. Once the system is shut off, filter replacement is required. Changing the filter when the red light indicator illuminates is preferred practice for maximum filter performance. A blinking red light indicates the filter has reached the end of its useful life and can no longer be used. The MegadyneTM Filter should be replaced if diminished performance is observed (e.g. filter gets wet, heavy use, etc.)

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Megadyne - Operator's Manual

FILTER LIFE The MegadyneTM Filter automatically measures actual activation time and FLOW use for optimal filter utilization. The expected filter life time is illustrated below.

FILTER LIFE (HOURS)* SETTING

HOURS

Minimum OPEN: 26 hrs LAP: 35 hrs

26 35

Low OPEN: 24 hrs LAP: 34 hrs

24 34

Medium OPEN: 22 hrs LAP: 32 hrs

22 32

High OPEN: 20 hrs LAP: 30 hrs

20 30

Maximum OPEN: 17 hrs LAP: 28 hrs

17 28

OPEN Mode

LAP Mode

*Actual filter life will vary within this range depending on mix of settings used over the life of the filter.

Chapter Three

MEGADYNETM FLUID TRAP (OPTIONAL)

MEGADYNETM FILTER

Ethicon recommends the use of the MegadyneTM Fluid Trap (REF 2555J) to collect moisture or fluid inadvertently suctioned during the smoke collection process.

When the filter life is exhausted (via red FILTER life light indicator), or if diminished flow is evident, follow the removal and disposal instructions below and install a new filter.

• Attach the optional MegadyneTM Fluid Trap to the MegadyneTM Filter inlet port as shown • Retain red caps for later disposal of the fluid trap • The MegadyneTM Fluid Trap is a single use, non-sterile product. It is intended for single patient use and may be used until fluids reach the replacement indicator line (Max Fill Line) on the front and/or side of the device.

• Power off smoke evacuator • Use Personal Protective Equipment (PPE) as exposure to biohazard warrants • Grasp under the filter (via the filter grip) and pull/remove from the MegadyneTM Smoke Evacuator housing • Use the biohazard bag from the new filter box to dispose of the filter as a biohazard.

Filter and Fluid Trap Disposal MEGADYNETM FLUID TRAP • The MegadyneTM Fluid Trap is full when fluids reach the Max Fill Line • Use Personal Protective Equipment (PPE) as exposure to biohazard warrants • Remove the MegadyneTM Fluid Trap • Place provided red caps on both openings as necessary • Dispose the MegadyneTM Fluid Trap as a biohazard MEGADYNE™ FILTER (REF 2550J)

MEGADYNE™ FLUID TRAP (REF 2555J)

Caution: This device is not intended for the evacuation of fluids. If fluid is expected to be aspirated to the smoke evacuation filter, a fluid trap must be installed. Failure to install the MegadyneTM Fluid Trap could cause filter blockage, reduced filter performance and result in electrical damage.


  

  

Warning: Do not allow the MegadyneTM Fluid Trap to fill over the Max Fill Line.

FOR DISPOSAL PLACE RED CAPS ON BOTH INLET AND OUTLET OF THE FLUID TRAP

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Chapter Four USE INSTRUCTIONS


  

  

INSTALL ACCESSORIES

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Megadyne - Operator's Manual

Chapter Four

Use Instructions Prior to using the MegadyneTM Smoke Evacuator, verify that system pre-procedure set-up has been completed as per the instructions in Chapter 3

1. POWER ON The power switch is located on the upper left hand section of the front panel. • Turn the system ON by pressing up on the power switch • Turn the system OFF by pressing down on the power switch

2. CONFIRM FILTER LIFE • Green or yellow filter lights indicate the filter is ready for use • Red filter light indicates change filter See sections on Filter Installation and Disposal within Chapter 3 for additional information on changing the filter.

3. AUTOMATIC ACTIVATION

SELECT PROCEDURE TYPE MegadyneTM Smoke Evacuator provides surgical smoke evacuation for both open and laparoscopic procedures. • Select the OPEN mode button located on the front panel for open procedures • Select the LAP mode button located on the front panel for laparoscopic procedures A green light will illuminate next to the mode selected.

When powered on the MegadyneTM Smoke Evacuator must also be activated to evacuate smoke. The MegadyneTM Smoke Evacuator offers both automatic and manual methods of activation. See section on Activation Options within Chapter 5 for additional information.

The MegadyneTM Smoke Evacuator offers five FLOW rate options and five RUN TIME options per mode. Pressing the OPEN or LAP mode button designates the FLOW and RUN TIME setting options specific to each mode.


  

  

The smoke evacuator will recall the previous settings when powered on after initial use.

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SET RUN TIME The MegadyneTM Smoke Evacuator offers a variety of RUN TIME options which control how long flow continues after the energy device is deactivated when utilizing one of the automatic activation methods. This feature enables evacuation of residual smoke after the surgeon discontinues activating the energy device.

SET FLOW Flow rates are controlled by the up and down arrows under the word “FLOW”. • Up arrow increases FLOW • Down arrow decreases FLOW • Each time an arrow is pressed the amount of FLOW will be adjusted accordingly • A light to the left of the FLOW control will illuminate to indicate the FLOW rate level selected • Once the maximum or minimum FLOW settings are reached, only adjustments in the opposite direction will be possible • Choose the lowest rate of FLOW possible to achieve the desired smoke removal

• RUN TIME is controlled by the up and down arrows under “RUN TIME” on the front panel • If more or less RUN TIME is desired during use, pressing the up/down arrows as indicated will achieve the desired effect • A light to the left of the RUN TIME control will illuminate to indicate the RUN TIME selected • Once the maximum or minimum RUN TIME settings are reached, only adjustments in the opposite direction will be possible

RUN TIME OPTIONS SETTING

SECONDS

#5 Max RUN TIME OPEN (seconds): 30 LAP (seconds): 10

30 10

#4 High RUN TIME OPEN (seconds): 15 LAP (seconds): 8

15 8

#3 Medium RUN TIME OPEN (seconds): 10 LAP (seconds): 6

10 6

#2 Low RUN TIME OPEN (seconds): 6 LAP (seconds): 4 #1 Minimum RUN TIME OPEN (seconds): 3 LAP (seconds): 2

6 4 3 2

FLOW OPTIONS OPEN MODE SETTING

LPM

#5 Max FLOW OPEN (LPM): 118 LAP (LPM): 41

118 41

#4 High FLOW OPEN (LPM): 106 LAP (LPM): 29

106 29

#3 Medium FLOW OPEN (LPM): 94 LAP (LPM): 18

94 18

#2 Low FLOW OPEN (LPM): 82 LAP (LPM): 11

  

#1 Minimum FLOW OPEN (LPM): 71 LAP (LPM): 5

82 11 71 5


  

OPEN MODE

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Megadyne - Operator's Manual

LAP MODE

LAP MODE

Chapter Four

Install Accessories OPEN PROCEDURES The MegadyneTM Smoke Evacuator provides evacuation of surgical smoke via a smoke evacuation device and tubing connected to the face of the filter.

OPEN PROCEDURE DEVICE AND TUBING SET-UP

LAPAROSCOPIC PROCEDURES The LAP mode is designed specifically to remove and filter surgical smoke created during laparoscopic procedures for improved visualization and particulate removal.

• Insert the proximal connection of the smoke evacuation device tubing into the MegadyneTM Filter or MegadyneTM Fluid Trap for connection to the MegadyneTM Smoke Evacuator

Utilization of the LAP mode requires use of MegadyneTM Laparoscopic Tubing (REF 2390J). The pneumoperitoneum should be insufflated as per standard protocol.

LAPAROSCOPIC PROCEDURE DEVICE AND TUBING SETUP The MegadyneTM Smoke Evacuator LAP mode is designed specifically for the unique requirements of laparoscopic procedures and regulates a lower FLOW and less RUN TIME range to maintain pneumoperitoneum pressure without overpowering the insufflator. For laparoscopic smoke removal: • Select the LAP mode button located on the front panel for laparoscopic procedures • A green light will illuminate next to the LAP button when selected • Select the desired FLOW and RUN TIME settings as noted in the previous section


  

  

Caution: Use of the OPEN mode in laparoscopic cases will deflate the pneumoperitoneum.

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GYN PROCEDURES (USING A SPECULUM)

Refer to the MegadyneTM Laparoscopic Tubing (REF 2390J) Instructions for Use

Refer to the MegadyneTM Speculum Tubing (REF 2395J) Instructions for Use

• Insert the MegadyneTM Laparoscopic Tubing (REF 2390J) into the MegadyneTM Filter or MegadyneTM Fluid Trap • Connect the luer lock connector end of the MegadyneTM Laparoscopic Tubing (REF 2390J) into the trocar cannula port • Laparoscopic tubing should be connected to the port closest to the smoke generation • Trocar placement should have sufficient room away from tissue for air FLOW • Open the trocar cannula stop cock prior to use

GYN procedures utilizing speculums are ideal for smoke evacuation using the MegadyneTM Smoke Evacuator.


  

  

LAP TUBING CONNECTION

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Megadyne - Operator's Manual

• Follow standard set-up procedures as previously outlined to connect the MegadyneTM Speculum Tubing (REF 2395J) to the filter/fluid trap face • Connect sterile MegadyneTM Speculum Tubing (REF 2395J) to the speculum port

Chapter Five ACTIVATION OPTIONS ENERGY PRODUCING DEVICE OPTIONS CONNECT CABLE RF SENSOR


  

  

MANUAL ACTIVATION

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