Optimumm Service Manual Dec 2004

Foreword This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed., It is intended as a guide for using the Valleylab OptiMumm™ Smoke Evacuator only. A; dditional technical information is available in the OptiMumm™ Smo,ke Evacuator User’s Guide. Caution Federal (USA) law restricts this device to sale by or on the order of a physician. Equipment covered in this manual:

OptiMumm™ Smoke Evacuator – 115 V and 230 V

Part Number: 945 103 112 Effective Date: December 2004

Trademark acknowledgments:

OptiMumm™, RapidVac™, Accuvac™, and The EDGE™ are trademarks of Valleylab. Protected by U.S. Pat. Nos. 5,613,966; 5,456,248; 5,620,441; 4,658,820; 5,599,344; 5,628,745; 5,541,376; 5,702,387. Manufactured for:

Valleylab, a division of Tyco Healthcare Group LP Boulder, Colorado 80301-3299 USA For information call:

1-800-225-8522/1-303-530-2300 Distributed by:

Tyco Healthcare UK Ltd. Gosport, PO130AS, UK

Made in USA Printed in USA © 2004 Valleylab All rights reserved.

ii

OptiMumm Smoke Evacuator Service Manual

Conventions Used in this Guide Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Caution Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

Important Indicates an operating tip or maintenance suggestion.

Notice Indicates a hazard which may result in product damage.

OptiMumm Smoke Evacuator Service Manual

iii

Table of Contents Foreword

ii

Conventions Used in this Guide List of Figures

iii

vi

Section 1. Introducing the OptiMumm Smoke Evacuator Parts Shipped with the Smoke Evacuator

1-2

General Description 1-2 RapidVac System 1-3 Operating Modes 1-3 Service Personnel Safety General 1-3 Maintenance 1-5

1-3

Section 2. Controls, Indicators, and Receptacles Front Panel

2-2

Side Panel

2-3

Rear Panel

2-4

Section 3. Technical Specifications Performance Characteristics 3-1 Dimensions and Weight 3-1 Filters 3-1 Airflow 3-2 Safety 3-2 Power 3-2 Power Cord Specification 3-3 Operating Parameters 3-3 Transport and Storage 3-3 Electromagnetic Interference 3-3 Electromagnetic Compatibility (IEC 601-1-2 and IEC 601-2-2)

3-4

EMC for the OptiMumm Smoke Evacuator 3-4 Guidance and manufacturer’s declaration - electromagnetic emissions 3-4 Guidance and manufacturer’s declaration - electromagnetic immunity 3-5 Guidance and manufacturer’s declaration - electromagnetic immunity 3-6 Recommended separation distances between portable and mobile RF communication equipment and the [EQUIPMENT or SYSTEM] 3-7 Description of Symbols on Unit

3-8

Description of Symbols on Accessories Classification 3-9 Class I Equipment (IEC 601-1)

iv

3-9

3-9

OptiMumm Smoke Evacuator Service Manual

Section 4. Setup, Tests, and Adjustments Testing the Smoke Evacuator 4-2 Testing the ULPA Filter 4-2 Changing the ULPA Filter 4-3 Testing the Airflow Controls 4-4 Testing the Footswitch (optional) 4-4 Testing the Electrosurgery Sensor (optional) 4-5 Testing the Generator Interlink Cable (optional) 4-6

Section 5. Troubleshooting Inspecting the Smoke Evacuator

5-2

Correcting Specific Malfunctions

5-2

Section 6. Return Policy and Procedure Responsibility of the Manufacturer

6-1

Obtaining a Return Authorization Number Returning the Smoke Evacuator for Service Service Centers

6-2 6-2

6-3

Section 7. Board Drawings and Schematics Appendix A. Warranty

OptiMumm Smoke Evacuator Service Manual

v

List of Figures

vi

Figure 4-1.

Removing the ULPA filter 4-3

Figure 4-2.

Connecting the electrosurgery sensor to the smoke evacuator 4-5

Figure 4-3.

Connecting the generator interlink 4-6

Figure 7-1.

OptiMumm Block Diagram 7-2

Figure 7-2.

Wiring Diagram (115 V) 7-3

Figure 7-3.

Wiring Diagram (230 V) 7-4

OptiMumm Smoke Evacuator Service Manual

SECTION

1

Introducing the OptiMumm Smoke Evacuator

1

This section describes the clinical applications and features of the Valleylab OptiMumm Smoke Evacuator.

Caution Read all warnings, cautions, and instructions provided with this smoke evacuator before using. Read the instructions, warnings, and cautions provided with electrosurgical accessories before using. Specific instructions are not included in this manual.

OptiMumm Smoke Evacuator Service Manual

1-1

Parts Shipped with the Smoke Evacuator

Parts Shipped with the Smoke Evacuator When you unpack the smoke evacuator, verify that the following parts have been shipped: • Smoke evacuator • Smoke evacuator power cord • User’s guide and service manual • Quick reference card. Upon initial receipt of the smoke evacuator, inspect the smoke evacuator for dents, cracks or damage that may have occurred during shipment. If any damage is present, notify the freight carrier for damage assessment.

General Description The OptiMumm Smoke Evacuator captures particulates and adsorbs gases from surgical smoke. The OptiMumm Smoke Evacuator is specifically designed to improve visibility and reduce potential health hazards associated with surgical smoke. It can be used in both open and laparoscopic procedures. A centrifugal fan provides suction, drawing the surgical smoke into and through the system. In the first stage of filtration, a single-use prefilter captures gross particulates > 0.3 microns in size. Next, an ultra low penetration air (ULPA) filter captures submicron particulates 0.12 microns in size with 99.999% efficiency. The charcoal element in the ULPA filter adsorbs odorous gases. Features include: • Three-stage filtration process • Unique locking ULPA filter • RapidVac, footswitch, or continuous operation • Quiet operation • Filter status indicator lights • Adjustable air flow • Compatible with all Valleylab electrosurgery pencils and generators.

1-2

OptiMumm Smoke Evacuator Service Manual

Service Personnel Safety

RapidVac System The OptiMumm Smoke Evacuator incorporates a system which controls the flow of the smoke evacuator. When the electrosurgical pencil is activated, the smoke evacuator operates in the preselected flow setting. When the pencil is deactivated, the air flow reduces to a low flow purge setting. This mode is enabled by using a Valleylab electrosurgical pencil and an Electrosurgery Sensor, or a Generator Interlink connected to the smoke evacuator and to a compatible Valleylab generator.

Operating Modes Four operating modes are available: standby, footswitch, RapidVac, and continuous. • Standby mode powers up the unit without activating the motor or vacuum flow. • Footswitch mode is used to turn the smoke evacuator on or off with the optional footswitch pedal. • RapidVac mode is used to control the vacuum flow simultaneously with activation of a Valleylab electrosurgical pencil. This mode is controlled with the optional Generator Interlink or Electrosurgery Sensor. • Continuous mode is used to operate the smoke evacuator using continuous air flow.

Service Personnel Safety General Warning Electric Shock Hazard - Do not connect a wet power cord to the wall receptacle. Electric Shock Hazard - Connect the smoke evacuator power cord to a properly grounded receptacle. Plug the power cord directly into the power receptacle without any adapter plugs. Use of power plug adapters may result in electric shock. Electric Shock Hazard - Do not remove any covers or panels exposing the internal components of the smoke evacuator. Refer to a Valleylab representative for service. Fuse Replacement - Refer to a Valleylab representative for service. Fire Hazard - Use of extension cords may result in fire hazards.

OptiMumm Smoke Evacuator Service Manual

1-3

Introducing the OptiMumm Smoke Evacuator

Important The OptiMumm Smoke Evacuator is designed for use with Valleylab Electrosurgical Pencils.

Service Personnel Safety

Warning The smoke evacuator produces a strong vacuum. Adjust the airflow and the position of the inlet end of the wand or tubing to prevent patient injury and to prevent suction of surgical materials and surgical specimens. If the smoke evacuator is activated while the airflow is set to a high speed, it may produce a sudden, strong suction action. Check the airflow setting before activating the smoke evacuator to prevent patient injury and to prevent suction of surgical materials and surgical specimens.

Caution Read all warnings, cautions, and instructions provided with the OptiMumm Smoke Evacuator System before using. To maximize patient safety, the tubing or wand should not come in direct contact with tissue. Otherwise, patient injury may result. Do not stack equipment on top of the smoke evacuator or place the smoke evacuator on top of electrical equipment. These configurations are unstable and/or do not allow for adequate cooling. Provide as much distance as possible between the smoke evacuator and other electronic equipment (such as monitors). An activated smoke evacuator may cause interference with them. Notice Using any unapproved filter or accessory with the smoke evacuator may cause damage and will void the warranty. Smoke evacuator performance may be compromised if the prefilter is used for more than one surgical procedure. The OptiMumm Smoke Evacuator System functions properly only when the ULPA filter is installed properly. If the Replace Filter indicator illuminates during the filter test, remove and replace the ULPA filter. Failure to do so may reduce airflow and compromise the efficiency of the filter. Fluids may damage the filters. When evacuating smoke and incidental fluids, always use the appropriate tubing, a Valleylab E3620 Fluid Canister Ring , and E3680 Fluid Canister Kit. Check the fluid level in the canister frequently during surgery. If the fluid canister overfills, smoke evacuator damage will result. Due to the high velocity of air when using 2.2 cm (7/8 in.) tubing, the maximum fluid level in the canister should be 600 cc. To prevent clogging and/or damage to the ULPA filter, always operate the smoke evacuator with the prefilter installed. Connect the power cord to a wall receptacle having the correct voltage. Otherwise, product damage will result.

1-4

OptiMumm Smoke Evacuator Service Manual

Service Personnel Safety

Notice

When using the Electrosurgery Sensor and an electrosurgical pencil in cut or coag mode, the remote unit requires a minimum of 10 watts. Connecting multiple lengths of tubing together may cause the smoke evacuator to overheat. The OptiMumm Smoke Evacuator has been specially designed to fit on Valleylab Mounting Carts only. Do not install the smoke evacuator on a cart other than a Valleylab cart. Installing the smoke evacuator inside a cart with improper ventilation may result in overheating or may impact the stability of the cart. Periodically check the cart brackets that hold the smoke evacuator in place to ensure that the screws are securely fastened. Stacking the smoke evacuator on top of a generator may cause an unstable condition and/or cause the smoke evacuator to overheat. Do not use sterile accessory products if sterile packaging has been compromised.

Maintenance Warning Electric Shock Hazard - Always turn off and unplug the smoke evacuator before cleaning.

Caution The prefilter and ULPA filter capture potentially hazardous particles. Handle used filters as you would any biohazardous material. Dispose of the filters with other operative waste materials according to the procedures for your institution. Do not reuse or resterilize Smoke Evacuator accessories labeled “disposable,” “single use only,” or “sterile.” Notice Do not rub, touch, or clean the smoke evacuator with alcohol or caustic, corrosive, or abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the control panel or damage the smoke evacuator. Do not autoclave, pressure sterilize, or gas sterilize the smoke evacuator. Keep the smoke evacuator away from liquids. Liquids that enter the smoke evacuator will damage internal components. There are no internal user serviceable parts. For repairs, return the smoke evacuator to Valleylab.

OptiMumm Smoke Evacuator Service Manual

1-5

Introducing the OptiMumm Smoke Evacuator

Power line voltage below 100 Vac (OptiMumm 115V) and 200 Vac (OptiMumm 230V) will significantly reduce airflow.

Notes

1-6

OptiMumm Smoke Evacuator Service Manual

SECTION

2

Controls, Indicators, and Receptacles

2

This section describes the front, side, and rear panels on the smoke evacuator, including all controls, indicators, receptacles, and ports.

OptiMumm Smoke Evacuator Service Manual

2-1

Front Panel

Front Panel ULPA Filter Status Indicators When you press the Filter Test Button, the Pass indicator illuminates green if the filter is functioning properly. The Replace indicator illuminates as follows: • Red (filter warning, replace filter)

Vacuum Flow Selector Variable flow dial control with unlimited airflow settings.

Vacuum Flow Indicators Indicate selected air flow setting.

• Blinking red (ULPA filter not properly installed).

FILTER TEST

OptiMumm

TM

VACUUM

STANDBY

PASS REPLACE

SELECT

Mode Indicators

FOOTSWITCH

®

RapidVac CONTINUOUS

PUSH TO TEST

Filter Test Button Push to test the ULPA filter.

Mode Selector Dial control for operation. Each mode has its own indicator which illuminates when the mode is selected. Modes include: POWER

Power Switch This switch supplies power to the smoke evacuator. Press ( | ) to turn on the smoke evacuator. Press (O) to turn off the smoke evacuator.

2-2

FOOTSWITCH

RapidVac

• Standby • Footswitch • RapidVac

Footswitch Connection Accepts optional Valleylab E3615 Footswitch.

• Continuous. Electrosurgery Sensor Connection Accepts cable for optional Valleylab Electrosurgery Sensor.

OptiMumm Smoke Evacuator Service Manual

Side Panel

Side Panel The OptiMumm Smoke Evacuator has two small holes on the left side panel to accommodate a 1200 cc fluid canister by means of the optional Valleylab E3620 Fluid Canister Ring and E3680 Fluid Canister Kit.

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Controls, Indicators, and Receptacles

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Fluid Canister Ring Holds 1200 cc fluid canister. ER W PO

OptiMumm Smoke Evacuator Service Manual

2-3

Rear Panel

Rear Panel Generator Interlink Connection Accepts optional Valleylab Generator Interlink connection for use with compatible Valleylab generators.

Power Cord Wrap

Circuit Breaker

Carrying Handle

Locking Power Cord Connection Fits detachable power cord.

Caution Connect accessories to the proper receptacle type. Otherwise, the smoke evacuator may not function properly.

2-4

OptiMumm Smoke Evacuator Service Manual

SECTION

3

Technical Specifications

3

All specifications are nominal and subject to change without notice.

Performance Characteristics Dimensions and Weight Width

32 cm (13 3/8 in.)

Depth

43 cm (17 in.) with cord wrap and handle

Height

25 cm (9 3/4 in.)

Weight

15 kg (34 lbs) without filters

Filters Prefilter

captures medium and large particles > 0.3 micron; single use only

ULPA filter

0.12 micron particulate size at 99.999% efficiency; activated charcoal for gas and odor adsorption

OptiMumm Smoke Evacuator Service Manual

3-1

Performance Characteristics

Airflow 0–0.56 m3/min (0–20 cfm) with 2.2 cm x 3 m (7/8 in. x 10 ft) tubing with sponge guard Airflow is measured at sea level.

Safety 115 Volt

230 Volt

Circuit breaker: 8 amps (2 pole)

Circuit breaker: 3 amps

Power cord: 3-prong hospital grade plug

Power cord: 3-prong locally approved connector

Leakage current: (50/60 Hz)

Leakage current: (50/60 Hz)

Normal polarity, smoke evacuator in standby mode < 500 µA

Normal polarity, smoke evacuator in standby mode < 1000 µA

Reverse polarity, smoke evacuator in standby mode < 500 µA

Reverse polarity, smoke evacuator in standby mode < 1000 µA

Power

3-2

115 Volt

230 Volt

Input mains voltage, (nominal): 115 Vac

Input mains voltage, (nominal): 230 Vac

Input mains voltage, full regulation range: 115 Vac ± 10%

Input mains voltage, full regulation range: 230 Vac ± 10%

Mains frequency (nominal): 60 Hz

Mains frequency (nominal): 50 Hz

OptiMumm Smoke Evacuator Service Manual

Performance Characteristics

Power Cord Specification This unit was equipped from the factory with either a 110VAC hospital grade NEMA 5-15 power cord or a 220VAC CEE7/7 power cord. Should the AC power cord need to be replaced to match another plug configuration, the replacement plug/cable/receptacle configuration must meet or exceed the following specifications: 100-120VAC Cable - SJT16/3, IEC color code, maximum length 15’ (5 meters) Plug - minimum 10A 125VAC Unit receptacle - IEC female, minimum 10A 125VAC 220-240VAC Cable - H05VVF3G1.0 VDE, maximum length 15’ (5 meters) Plug - minimum 6A 250VAC Unit receptacle - IEC female, minimum 6A 250VAC

Operating Parameters Ambient temperature range

10 to 40° C (50 to 104° F)

Relative humidity

30 to 75%, noncondensing

Transport and Storage -34 to 65° C (-29 to 149° F)

Relative humidity

25 to 85%, noncondensing

Technical Specifications

Ambient temperature range

Electromagnetic Interference When placed on or beneath an activated Valleylab electrosurgical generator, the OptiMumm Smoke Evacuator operates without interference. The smoke evacuator minimizes electromagnetic interference to video equipment used in the operating room.

OptiMumm Smoke Evacuator Service Manual

3-3

EMC for the OptiMumm Smoke Evacuator

Electromagnetic Compatibility (IEC 601-1-2 and IEC 601-2-2) The OptiMumm Smoke Evacuator complies with the appropriate IEC 601-1-2 and IEC 601-2-2 specifications regarding electromagnetic compatibility. Notice The OptiMumm should not be used adjacent to or stacked with equipment other than specified in the OptiMumm User Guide and Service Manual. If adjacent or stacked use is necessary, the OptiMumm should be observed to verify normal operation in the configuration in which it will be used. The electrical surgical generator used with the OptiMumm intentionally applies RF energy for diagnosis or treatment during activation. Observe other electronic medical equipment in the vicinity during the OptiMumm activation for any possible adverse electromagnetic effects. Ensure adequate separation of electronic medical equipment based on observed reactions. The use of accessories, other than specified in the OptiMumm User Guide and Service Manual, may result in increased emissions or decreased immunity of the OptiMumm.

EMC for the OptiMumm Smoke Evacuator Guidance and manufacturer’s declaration - electromagnetic emissions The OptiMumm is intended for use in the electromagnetic environment specified below. The customer or the user of the OptiMumm should assure that it is used in such an environment.

3-4

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The OptiMumm uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

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

Voltage fluctuations/ flicker emissions IEC61000-3-3

Complies

OptiMumm Smoke Evacuator Service Manual