RapidVac User Guide May 2008

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 RapidVAc Smoke Evacuator only. Additional users information is available in the RapidVac™ Smoke Evacuator Service Manual. Caution Federal (USA) law restricts this device to sale by or on the order of a physician. Equipment covered in this manual

RapidVac Smoke Evacuator-110 V and 220 V Part Number: 1008878 Effective Date: May 2008

Trademark acknowledgements

RapidVac™ is a trademark of Valleylab. All trade names referenced are the trademarks, registered trademarks, or products of their respective manufacturers.

Manufactured for:

Valleylab, a division of Tyco Healthcare Group LP Boulder, Colorado 80301-3299 USA

European representative

Tyco Healthcare UK Ltd. Gosport, PO13 0AS, UK

Device is compliant with the European Communities Council Directive 93/42/ EEC, Medical Device Directive.

Printed in USA ©2008 Valleylab. All rights reserved. For information call

1-303-530-2300 Internet address

http://www.valleylab.com

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Warranty Valleylab, a division of Tyco Healthcare Group LP, warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period(s) set forth below. Valleylab’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Valleylab’s satisfaction, that the product is defective. This warranty does not apply to any product, or part thereof, which has been repaired or altered outside Valleylab’s factory in a way so as, in Valleylab’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident. The warranty periods for Valleylab products are as follows: Microwave Ablation Generator

One year from date of shipment

Microwave Ablation Pump

One year from date of shipment

Electrosurgical Generators

One year from date of shipment

RFG-3C™ Plus Lesion Generator

One year from date of shipment

LigaSure™ Vessel Sealing System

One year from date of shipment

LigaSure™ Reusable Instruments

One year from date of shipment

Mounting Fixtures (all models)

One year from date of shipment

Footswitches (all models)

One year from date of shipment

Force Argon™ Units

One year from date of shipment

RapidVac Smoke Evacuator

One year from date of shipment

LigaSure™ Sterile Single Use Items

Sterility only as stated on packaging

Sterile Single Use Items

Sterility only as stated on packaging

Patient Return Electrodes

Shelf life only as stated on packaging

MWA Antennas

Shelf life only as stated on packaging

This warranty is in lieu of all other warranties, express or implied, including without limitation, the warranties of merchantability and fitness for a particular purpose, and of all other obligations or liabilities on the part of Valleylab. Valleylab neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Valleylab’s products. Notwithstanding any other provision herein or in any other document or communication, Valleylab’s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Valleylab to the customer. There are no warranties which extend beyond the terms hereof. Valleylab disclaims any liability hereunder or elsewhere in connection with the sale of this product, for indirect or consequential damages.

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RapidVac™ Smoke Evacuator User’s Guide

This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado, USA. The sole forum for resolving disputes arising under or relating in any way to this warranty is the District Court of the County of Boulder, State of Colorado, USA. Valleylab, its dealers, and representatives reserve the right to make changes in equipment built and/or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and/or sold by them.

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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. Notice Indicates a hazard that may result in product damage. Important Indicates an operating tip or maintenance suggestion.

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RapidVac™ Smoke Evacuator User’s Guide

Table of Contents Foreword... ii Warranty ... iv Conventions Used in this Guide ... vi

Chapter 1. Introducing the RapidVac Smoke Evacuator Parts Shipped with the Smoke Evacuator ...1-2 About the RapidVac Smoke Evacuator ...1-2 Features ...1-3 RapidVac+ System ...1-3 Operating Modes ...1-3 Power...1-4 Operating Parameters...1-4 Transport and Storage ...1-4 Patient and Operating Room Safety ...1-4 General ...1-4 Maintenance ...1-7

Chapter 2. Controls, Indicators, and Receptacles Front Panel ...2-2 Power On/Off Switch ...2-3 Air Flow Controls ...2-3 Turbo Button ...2-3 Filter Life Indicator ...2-4 RapidVac+ Button...2-4 Footswitch Jack ...2-4 Service Required Indicator ...2-4 Rear Panel ...2-5 Power Cord Receptacle/Fuse Tray...2-5 Remote Activator Jack ...2-6 EPROM Jack (Covered) ...2-6 Equipotential Grounding Lug ...2-6

Chapter 3. Before Surgery Periodic Inspection ...3-2 Initial Installation ...3-2 Checking the Smoke Evacuator ...3-4 Checking the Remaining Filter Life ...3-4 Changing the Filter ...3-5 Testing the Airflow Controls ...3-5 Installing and Testing the Footswitch (optional) ...3-6 Installing and Testing the Remote Switch Activator (optional) ...3-7 Installing and Testing the Generator Interlink Cable (optional) ...3-8 Setting Up the Smoke Evacuator ...3-9 After the initial installation, set up the smoke evacuator for use. ...3-9

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Mounting the Smoke Evacuator ... 3-9 Open Procedure-Evacuating Dry Smoke... 3-9 Open Procedure-Evacuating Smoke and Incidental Fluids ... 3-10

Chapter 4. During Surgery Initiating Airflow ... 4-2 Minimizing Noise ... 4-2 Variables Affecting Airflow ... 4-3 Changing the Airflow ... 4-3 Periodic Checks ... 4-3 Tubing ... 4-3 Sponge Guard... 4-3 Filter Life Indicator ... 4-3

Chapter 5. After Surgery Preparing the RapidVac Smoke Evacuator for Reuse... 5-2 Removing the Tubing... 5-2 Cleaning the Smoke Evacuator ... 5-2

Chapter 6. Troubleshooting Inspecting the RapidVac Smoke Evacuator ... 6-2 Correcting Specific Malfunctions ... 6-2

Chapter 7. Maintenance and Repair Routine Maintenance ... 7-2 Checking the Power Cord ... 7-2 Removing the RapidVac Filter ... 7-2 Responsibility of the Manufacturer ... 7-2 Obtaining a Return Authorization Number ... 7-3 Returning the Smoke Evacuator for Service ... 7-3 Service Centers ... 7-3

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RapidVac Smoke Evacuator User’s Guide

Chapter

1

Introducing the RapidVac Smoke Evacuator 1

This section describes the clinical applications and features of the RapidVac 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.

RapidVac™ Smoke Evacuator User’s Guide

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Parts Shipped with the Smoke Evacuator

Parts Shipped with the Smoke Evacuator When unpacking the smoke evacuator, verify that the following parts are included: •

Power cord

•

User’s guide and service manual

•

Quick reference card

Upon initial receipt, inspect the smoke evacuator for dents, cracks, or damage that may have occurred during shipment. If damage is present, notify the freight carrier for assessment. Additional items are available from Valleylab: •

Replacement RapidVac Filters

•

RapidVac Footswitch

•

RapidVac Remote Switch Activator

•

Generator Interlink Cable

•

Laparoscopic Smoke Evacuator Tubing Kit

•

Hoses, tubing, adapters, wands and other accessories

About the RapidVac Smoke Evacuator The RapidVac Smoke Evacuator captures particulates and adsorbs gases from surgical smoke. The 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. The RapidVac Smoke Evacuator is designed with a high suction, high flow rate centrifugal action pump. The ultra-quiet motor is used to draw the smoke from the surgical site through the vacuum tubing and into the system where it is processed by a series of filters. A single disposable filter is used to simplify the installation and removal during filter changes. The filter is completely enclosed to protect the healthcare personnel from potential contamination during filter changes. One SEA3700 Filter contains four filtration stages to capture the smoke plume:

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•

Stage 1 - A prefilter that traps and removes gross particulate and incidental fluid.

•

Stage 2 - An ULPA grade (Ultra Low Penetration Air) patented filter captures particulates and micro-organisms down to 0.1 µm at 99.9995% efficiency.

•

Stage 3 - The highest grade virgin activated carbon, designed specifically for Valleylab for the removal and adsorption of odors and toxic gases produced by burning tissue. These harmful gases may constitute a health hazard to healthcare professionals who are subjected to prolonged exposure. The activated carbon used in the smoke evacuation system preferentially removes toxic organic gases (rather than water vapor) and provides optimal odor removal.

RapidVac™ Smoke Evacuator User’s Guide

About the RapidVac Smoke Evacuator

•

Introducing the RapidVac Smoke Evacuator

Stage 4 - An expanded foam used to trap activated carbon fines from migrating out of the filter.

Features RapidVac Smoke Evacuator features include: •

Filter-life monitoring for its four-stage, 25-five hour filter

•

Standby, RapidVac+, footswitch, or continuous operation modes

•

Quiet operation

•

Adjustable flow

•

Compatibility with all Valleylab electrosurgery pencils and generators

RapidVac+ System The RapidVac Smoke Evacuator incorporates The RapidVac+ mode which controls the flow of the smoke evacuator when using a Valleylab electrosurgical pencil. 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. Two Valleylab accessories link the electrosurgical generator and smoke evacuator to enable the RapidVac+ mode: •

RapidVac Remote Switch Activator

•

Generator Interlink Cable

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 an 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.

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Patient and Operating Room Safety

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

Operating Parameters Ambient temperature range

10° C to 40° C (50° F to 104° F)

Relative humidity

30% to 75%, noncondensing

Transport and Storage Ambient temperature range

-34° C to 65° C (-29° F to 149° F)

Relative humidity

25% to 85%, noncondensing

Patient and Operating Room Safety General Warning Only trained personnel are to operate the RapidVac Smoke Evacuator. Operators should avail themselves of preclinical training, a review of pertinent literature, and other appropriate education before attempting to use the RapidVac. During initial set up, inspect the smoke evacuator for any damage that may have been caused during shipping. If damaged, do not use or attempt to repair. Call Valleylab for service assistance.

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Patient and Operating Room Safety

Warning

The RapidVac Smoke Evacuator filter is a disposable component that captures potentially hazardous particles. Handle used filters as you would any biohazardous material. Dispose of used filters according to your local codes and regulations, and follow your institutions procedures for disposal. The smoke evacuation filter has a life of approximately 25 hours of use and should not be used beyond the specified time. If the Replace Filter indicator illuminates during operation, the smoke evacuator will continue to run until it is turned off. Turning power off to the smoke evacuator will require replacement of the filter before subsequent use. Failure to change the filter accordingly may result in decreased efficiency in smoke evacuation and contamination of the motor, vacuum pump, and sound absorbing media within the smoke evacuator. Do not operate this device in potentially explosive environments, such as in the presence of flammable anesthetics. Refer routine servicing to qualified biomedical technical personnel. Use only with the power cord provided and always plug into a grounded outlet. Do not use two- or three-prong adapters with the smoke evacuator’s power cords. The power-cord assembly should be checked periodically for damaged insulation or connectors. Do not use damaged cords. Use of extension cords may result in fire hazards. This device is not intended for the evacuation of fluid. If fluid is expected to be aspirated to the smoke evacuation filter, a fluid collection device must be installed with the vacuum hose assembly. Failure to install a fluid collection device could cause filter blockage and electrical damage. Contact Valleylab Service for additional information. Do not connect a wet power cord to the wall receptacle. If the smoke evacuator becomes wet, either from a leaking tube or from being sprayed, unplug the smoke evacuator from the Mains outlet. Wipe dry or allow to air dry before proceeding. 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. Do not remove any covers or panels exposing the internal components of the smoke evacuator. Refer to a Valleylab representative for service. 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.

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Introducing the RapidVac Smoke Evacuator

Inspect the smoke evacuator before each use. If there is evidence of damage, do not use the smoke evacuator. Call Valleylab for service assistance.

Patient and Operating Room Safety

Warning 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 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. Use only Valleylab SEA3700 Filters in the RapidVac Smoke Evacuator. Filters from other manufacturers may cause damage to the system, thereby voiding the warranty. 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. Read all warnings, cautions, and instructions provided with the RapidVac Smoke Evacuator 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 block either the tubing or the filter. If either becomes occluded or significantly restricted, the motor/blower may overheat and cause the unit to shut down. Care must be exercised in the installation of hoses, adapters and suction canisters. Failure to follow the procedures outlined in this manual may result in overheating of the motor and may void the unit warranty. Notice Using any unapproved filter or accessory with the smoke evacuator may cause damage and will void the warranty. The RapidVac Smoke Evacuator functions properly only when the ULPA filter is correctly installed. If the filter is installed incorrectly, the amber Replace Filter indicator flashes and the Service Required indicator is illuminated. Fluids may damage the filters. When evacuating smoke and incidental fluids, always use the appropriate tubing, Connect the power cord to a wall receptacle having the correct voltage. Otherwise, product damage will result. Power line voltage below 100 VAC (110V SEA3690) and 200 VAC (220V SEA3695) will significantly reduce airflow. Connecting multiple lengths of tubing together may cause the smoke evacuator to overheat.

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RapidVac™ Smoke Evacuator User’s Guide

Patient and Operating Room Safety

Notice

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 Always turn off and unplug the smoke evacuator before cleaning. The ULPA filter captures potentially hazardous particles. Handle used filters as you would any biohazardous material. Dispose of filters with other operative waste materials according to the procedures for your institution. Do not reuse or resterilize any product labeled “DISPOSABLE” or “SINGLE USE.” Doing so may result in cross contamination, injury to the patient or medical staff, or equipment malfunction. Caution Inspect the smoke evacuator before each use. If there is evidence of damage, do not use the smoke evacuator. Call Valleylab for service assistance. 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.

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Introducing the RapidVac Smoke Evacuator

The RapidVac 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 adversely affect the stability of the cart.

Patient and Operating Room Safety

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RapidVac™ Smoke Evacuator User’s Guide

Chapter

2

Controls, Indicators, and Receptacles 2

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

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Front Panel

Front Panel

RapidVac Smoke Evacuator





  + -

1/4" 6 mm



3/8"



10 mm 7/8"



22 mm

RapidVac Smoke Evacuator Filter

1 Power On/Off switch 2 Air-flow indicators (LED) 3 Turbo button 4 Air-flow controls 5 Power on indicator (LED centered in fan symbol) 6 Filter life indicators (LED) 7 RapidVac+ button 8 Service required indicator (LED) 9 Footswitch jack Air filter with tubing connectors

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RapidVac™ Smoke Evacuator User’s Guide

Front Panel

Caution Connect accessories to the proper receptacle type. Otherwise, the smoke evacuator may not function properly. Accessory equipment connected to interfaces must be certified according to IEC 60601-1-1. All configurations shall comply with the system standard IEC 60601-1-1. The user is responsible for verifying that accessory equipment connections comply with the system requirements of IEC 60601-1-1. If in doubt, contact Valleylab.

The electronic system controls on the RapidVac Smoke Evacuator are easy to understand and simple to use. The control panel contains power and suction controls, LED indicators, and connectors. Please be sure to read all instructions before installing accessories or operating this equipment. Failure to do so may result in damage to the unit and/or personal injury.

Power On/Off Switch The power switch that controls power to the RapidVac Smoke Evacuator is located in the lower-left corner of the front panel. To power up the smoke evacuator, place the power switch in the ON position ( l ). The smoke evacuator starts in standby (system power is on with no suction). When the smoke evacuator is on in standby, the LED in the center of the fan symbol on the front panel will blink continually until a fan speed is selected. Turn the system power off by placing the power switch in the OFF position ( O ).

Air Flow Controls The level of suction is controlled by the air-flow controls. up-arrow ( ) and down-arrow ( ) buttons. To start the fan from standby mode, press the uparrow button. It starts in the lowest suction setting indicated by a single illuminated air-flow indicator. The suction control should be set at the lowest practical setting to completely remove the surgical smoke from the operative site. Pressing either the up- or down-arrow buttons changes the current suction level by 20%. The selected level of suction is displayed by the air-flow indicator LEDs.

Turbo Button When increased smoke removal is necessary, the Turbo button may be pressed at anytime to increase suction. Turbo mode effectively increases the airflow to 100% suction flow to quickly remove the smoke plume from the surgical site.

RapidVac™ Smoke Evacuator User’s Guide

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Controls, Indicators, and Receptacles

Notice

Front Panel

Filter Life Indicator The filter life indicator provides a visual indication of the status of the life of the filter in use. Each illuminated LED represents five hours of remaining time on the 25-hour filter. The RapidVac Smoke Evacuator tracks the time each filter has been used allowing for an accurate display of remaining use for new or previously used filters. Reading the Filter Life Indicator Install an unused RapidVac filter into the system. When the smoke evacuator is on, all five of the filter life indicator LEDs illuminate indicating the new filter has 100% filter life. The indicator will regress through subsequent LEDs until the final LED is illuminated indicating less than 5 hours of filter life remaining. At one hour remaining, the LED changes to amber. When the time remaining reaches 30 minutes, the amber LED flashes slowly.

RapidVac+ Button When the smoke evacuator is connected to a generator using the Generator Interlink Cable, pressing the RapidVac+ button synchronizes the smoke evacuator with the use of an electrosurgical pencil. When a pencil is activated, the smoke evacuator activates to a preselected air flow level.

Footswitch Jack A RapidVac Footswitch (SEA3745) is available for use with the RapidVac Smoke Evacuator. A footswitch may be added to any system by simply plugging it into the footswitch jack on the front panel. The unit may be turned on or off by depressing the footswitch pedal once for each operation. For footswitching operation, the smoke evacuator should be on and the suction level to be activated from the footswitch should be selected on the control panel.

Service Required Indicator The motor powering the RapidVac Smoke Evacuator has two motor brushes that require regular maintenance every 500 hours. When the smoke evacuator has been in use for 500 hours, the Service Required Indicator illuminates. Replace the motor brushes and reset the Service Required Indicator as directed in the RapidVac Smoke Evacuator Service Manual.

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RapidVac™ Smoke Evacuator User’s Guide