Medtronic SE3690 Instructions for Use

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User’s Guide

RapidVac

Smoke Evacuator System and Accessories

SE3690

SE3695

SEA3730

SEA3741

SEA3745

User’s Guide

RapidVac

Smoke Evacuator System and Accessories

SE3690

SE3695

SEA3730

SEA3741

SEA3745

Part Number: PT00073377

Preface

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 information is available in the RapidVac

Equipment covered in this manual

smoke evacuator only. Additional users

Smoke Evacuator Service Manual.

SE3690 RapidVac

SE3695 RapidVac

SEA3745 Footswitch

SEA3741

SEA3730

Remote switch activator

Interlink cable

smoke evacuator—110 V Not for distribution in the European Union

smoke evacuator—220 V

SE3695, SEA3745, SEA3741, and SEA3730 are compliant with Regulation (European Union) 2017/745 of the European Parliament and of the Council on medical devices.

To request a hard copy of the service manual, please call:

• USA and Canada: +1 800 255 8522, option 2

• International: +1 303 476 7996

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.

Note: Indicates a hazard which may result in product damage, an operating tip, or maintenance suggestion.

ii RapidVac™ Smoke Evacuator User's Guide

Limited Warranty

Covidien warrants each covered product listed below to be free from defects in material and workmanship for normal use and service for the period(s) set forth below. Covidien’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 authorized distributor) within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Covidien’s satisfaction, that the product is defective. This limited warranty does not apply to any product, or part thereof, which has been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.

The warranty periods for Covidien products are as follows:

RapidVacTM Smoke Evacuator One year from date of shipment

Notwithstanding any other provision herein or in any other document or communication, Covidien’s liability with respect to this limited warranty and the products sold hereunder shall be limited to the aggregate purchase price for the products sold to the customer. This limited warranty is non-transferable and runs only to the original purchaser of the covered product(s). There are no warranties which extend beyond the terms hereof. Covidien disclaims any liability hereunder or elsewhere in connection with the sale of products and for any form of indirect, tort, or consequential damages.

Limited Warranty

This limited 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 limited warranty is the District Court of the County of Boulder, State of Colorado, USA.

Covidien reserves the right to make changes in covered products built or sold by it at any time without incurring any obligation to make the same or similar changes to equipment previously built or sold by it.

THE OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT IS THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS

EXPRESSLY PROVIDED HEREIN, COVIDIEN DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

RapidVac™ Smoke Evacuator User's Guide iii

Table of Contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii

Symbol Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ix

Standard and IEC Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ix

Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii

Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

Symbol Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv

Chapter 1. Introduction

Parts Shipped with the RapidVac™ Smoke Evacuator . . . . . . . . . . . . . . . . . . 1-2

About the RapidVac™ Smoke Evacuator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Clinical Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

RapidVac+ System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Patient and Operating Room Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Chapter 2. Controls, Indicators, and Receptacles

Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Power On/Off Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Airflow Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Turbo Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Filter-Life Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

RapidVac+ Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Footswitch Jack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Service-Required Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Power-Cord Receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Remote Activator Jack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

RapidVac™ Smoke Evacuator User’s Guide v

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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Installing and Testing the Interlink Cable (optional) . . . . . . . . . . . . . 3-8

Setting Up the Smoke Evacuator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Mounting the Smoke Evacuator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Evacuating Surgical Smoke . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Evacuating Surgical Smoke and Incidental Fluids. . . . . . . . . . . . . . . . 3-9

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

Chapter 6. Troubleshooting

Inspecting the RapidVac™ Smoke Evacuator . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Correcting Specific Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Chapter 7. Maintenance and Repair

General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Servicing the Motor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Checking the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Removing the RapidVac™ ULPA Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Optional Maintenance of the Smoke Evacuator . . . . . . . . . . . . . . . . . . . . . . . 7-3

Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Obtaining a Return Authorization Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Returning the Smoke Evacuator for Service . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Chapter 8. Accessories

vi RapidVac™ Smoke Evacuator User’s Guide

Chapter 9. Technical Specifications

Performance Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Dimensions and Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Airflow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Operating and Storage Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Transportation Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

EMC for the RapidVac™ Smoke Evacuator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Electromagnetic Compatibility (IEC 60601-1-2) . . . . . . . . . . . . . . . . . . 9-4

Electromagnetic Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

Cables & Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9

FCC Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

Radio Frequency Identification (RFID) . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

Industry Canada Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

RF Exposure Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10

European Conformity (220 V device only) . . . . . . . . . . . . . . . . . . . . . . 9-11

China Conformity (220 V device only) . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

RapidVac™ Smoke Evacuator User’s Guide vii

Symbol Glossary

Single use

Standard and IEC Classification

Non-sterile product

Not made with natural rubber latex

Symbol Glossary

Single use

For prescription use only

Consult the instructions for use

Caution! Read all warnings and cautions in instructions for use

Follow instructions for use.

Product is a medical device

RapidVac™ Smoke Evacuator User's Guide ix

Symbol Glossary

4UPSBHF

5SBOTQPSU

Temperature limitations for storage

Temperature limitations for transportation



Humidity limitations

Keep product dry

Product contains waste from electrical and electronic equipment, and should be separately collected and not disposed of as unsorted municipal waste

Type CF applied part

Danger, explosion risk if used with flammable anesthetics

IPX1 Protect against dripping water

Non-ionizing electromagnetic radiation

Alternating current

x RapidVac™ Smoke Evacuator User's Guide

Warning, electricity

GOST R

AU/NZ RF Compliance

Symbol Glossary

NOM RF Compliance

Vietnam RF Compliance

EurAsian Conformity (EAC) Mark

Caution, consult accompanying documents

CE mark

Authorized representative in the European Community

RapidVac™ Smoke Evacuator User's Guide xi

Symbol Glossary

Catalog number

Manufacturer

Lot number

Front Panel

Serial number

Date of Manufacture

Power off/on

Turbo Button: Press to jump to maximum suction at 100%

motor speed.

Airflow Control: Press up-arrow button (+) to increase flow by 20%, or down-arrow button (-) to decrease flow by 20%.

xii RapidVac™ Smoke Evacuator User's Guide

Power-on Indicator: LED at the center of the fan illuminates when power to the smoke evacuator is on. A flashing LED indicates the smoke evacuator is in standby mode.

New Filter: With its position next to the top filter-life indicator, signifies the filter has 100% of its filter life remaining.

Replace Filter: With its position next to the bottom filter-life indicator, signifies the filter has no filter life remaining and needs to be replaced.

Symbol Glossary

Rear Panel

RapidVac+ Button: Remote Switch activator cord is attached

to a generator. Electrosurgery sensor will activate the smoke evacuator.

Footswitch Jack: Attachment to pneumatic footswitch or receptacle.

Service Required Indicator: After 500 hours of use, the LED illuminates indicating the motor needs to be serviced.

Remote Activator Connector

Remote Switch Activator Time Delay

RapidVac™ Smoke Evacuator User's Guide xiii

Symbol Glossary

Symbol Matrix

Symbol SE3690 SE3695 SEA3730 SEA3741 SEA3745 E3655

Non-sterile product X

Not made with natural rubber latex

Single use X

For prescription use only X X X X X X

Consult the instructions for use

Caution! Read all warnings and cautions in instructions for use

Follow instructions for use

Product is a medical device

Temperature limitations for storage

Temperature limitations for transportation

XX X X XX

XX X XX

XX X X XX

XXXX

Humidity limitations X X

Keep product dry X X X X

Waste from electrical and electronic equipment

XX X

xiv RapidVac™ Smoke Evacuator User's Guide

Symbol SE3690 SE3695 SEA3730 SEA3741 SEA3745 E3655

Type CF applied part X X

Danger, explosion risk if used with flammable anesthetics

Symbol Glossary

Protect against dripping water

Non-ionizing electromagnetic radiation

Alternating current X X

Warning, electricity X X

GOST R X X

AU/NZ RF Compliance X

NOM RF Compliance X

Vietnam RF Compliance X

EurAsian Conformity (EAC) Mark

Caution, consult accompanying documents

CE Mark X X X X X

Authorized representative in the European Community

XX X XX

Catalog number X X X X X X

Manufacturer X X X X X X

Lot number X X X X

Serial number X X

Date of manufacture X X X X X X

Power off/on X X

Turbo Button X X

Airflow Control X X

Power-on Indicator X X

RapidVac™ Smoke Evacuator User's Guide xv

Symbol Glossary

Symbol SE3690 SE3695 SEA3730 SEA3741 SEA3745 E3655

New Filter X X

Replace Filter X X

RapidVac+ Button X X

Footswitch Jack X X

Service Required Indicator

Remote Activator Connector

Remote Switch Activator Time Delay

xvi RapidVac™ Smoke Evacuator User's Guide

Chapter 1

Introduction

This section describes the clinical applications and features of the RapidVacTM 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 for electrosurgical instruments and energy platforms are not included in this manual.

RapidVac™ Smoke Evacuator User's Guide 1-1

Parts Shipped with the RapidVac™ Smoke Evacuator

When unpacking the smoke evacuator, verify that the following parts are included:

•Power cord

• User’s Guide and Service Manual

Note: 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 Covidien:

• Replacement filters—SEA3700

• Laparoscopic smoke evacuator tubing kit with valve—SEA3720

• Tubing and wand—SEA3705, SEA3710, SEA3715, and SEA3725

•RapidVac

fluid trap—RVFT10

• OptiMumm™ smoke reducer fitting—E3655

Contact your Covidien representative for ordering information and a complete list of compatible products.

About the RapidVac™ Smoke Evacuator

Indications for Use

The indications for use of the RapidVacTM smoke evacuator system (SE3690, SE9695, SEA3730, SEA3741, SEA3745) are to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

Clinical Benefits

The smoke evacuation system, including the smoke evacuator and accessories, will provide the ability to remove surgical smoke at the source; thereby reducing the patients’ and clinicians’ exposure to harmful surgical smoke and enhancing surgeon visibility.

The RapidVac draw the surgical smoke from the surgical site through the vacuum tubing and into the filter where the surgical smoke 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 RapidVac

smoke evacuator is designed with a vacuum motor. The motor is used to

SEA3700 filter contains four different stages to capture the smoke plume:

1-2 RapidVac™ Smoke Evacuator User's Guide

About the RapidVac™ Smoke Evacuator

• The first stage filtration is a prefilter whose function is to trap and remove gross particulate.

• The second stage filtration is a ULPA (Ultra Low Penetration Air) grade filter whose hightech design captures particulates and micro-organisms from 0.1 to 0.2 microns at an efficiency of 99.999%.

• The third stage filtration is composed of virgin activated carbon.

• The fourth stage filtration is a woven fiberglass filtration media used to reduce the amount of activated carbon fines from migrating out of the filter.

Features

RapidVacTM smoke evacuator features include:

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

• Standby, RapidVac+, footswitch, or continuous operation modes

Introduction

• Adjustable flow

• Compatibility with all Covidien and Valleylab

electrosurgery pencils and generators

RapidVac+ System

The RapidVacTM smoke evacuator incorporates the RapidVac+ mode which controls the flow of the smoke evacuator when using a Covidien electrosurgical pencil. When the electrosurgical pencil is activated, the smoke evacuator operates in the preselected flow setting. When the pencil is deactivated, the airflow reduces to a low-flow purge setting.

Two Covidien accessories link the electrosurgical generator and smoke evacuator to enable the RapidVac+ mode:

• Remote switch activator—SEA3741

•Interlink cable—SEA3730

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 interlink cable or remote switch activator.

• Continuous mode is used to operate the smoke evacuator using continuous airflow.

RapidVac™ Smoke Evacuator User's Guide 1-3

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.

SE3690 100 – 120 VAC

Power Cord—Type SJT, No. 16AWG, 3 Conductor, IEC Female, 125VAC-13A, UL/IEC Approvals

• Not for distribution in the European Union

SE3695 220 – 240 VAC

Power Cord—Type HOVV-F3G1.00, IEC Female, 250VAC-10A, European Union Approvals

Patient and Operating Room Safety

General

Warning

This device is for use only by trained licensed physicians. Use of this device without proper training can result in serious unintended patient injury.

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 Covidien for service assistance.

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

Do not modify this equipment in any way.

Do not operate this device in potentially explosive environments, including in the presence of flammable anesthetics or oxidizing gases, such as nitrous oxide (N proximity to volatile solvents, such as ether or alcohol, as explosion may occur.

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.

O) and oxygen (O2), or in close

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.

1-4 RapidVac™ Smoke Evacuator User's Guide

Patient and Operating Room Safety

Warning

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 (such as the RVFT10 fluid trap) must be installed with the vacuum hose assembly. Failure to install a fluid-collection device could cause filter blockage and electrical damage. Contact Covidien 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 or allow to air dry before proceeding.

Refer routine servicing to qualified biomedical technical personnel.

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.

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

Introduction

Accessible conductive parts cannot become live in the event of basic insulation failure because of the way in which they are connected to the protective earth conductor.

Do not position the equipment so that it is hard to disconnect the power cord.

Do not remove any covers or panels exposing the internal components of the smoke evacuator. Refer to a Covidien 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.

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.

The RapidVacTM smoke evacuator has been specially designed to fit on Covidien mounting carts only. Do not install the smoke evacuator on a cart other than a Covidien cart. Installing the smoke evacuator inside a cart with improper ventilation may result in overheating or may adversely affect the stability of the cart.

Do not use sterile accessory products if sterile packaging has been compromised.

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 RapidVacTM SEA3700 ULPA filters in the RapidVacTM smoke evacuator. Filters from other manufacturers may cause damage to the system, thereby voiding the warranty.

RapidVac™ Smoke Evacuator User's Guide 1-5

Patient and Operating Room Safety

Caution

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.

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.

Note: Failure to change the filter accordingly may result in decreased efficiency in smoke evacuation and contamination of the motor and sound absorbing media within the smoke evacuator.

Note: Using any unapproved filter or accessory with the smoke evacuator may cause damage and will void the warranty.

Note: The RapidVac correctly installed. If the filter is installed incorrectly, the amber replace-filter indicator flashes and the service-required indicator is illuminated.

smoke evacuator functions properly only when the ULPA filter is

Note: Fluids may damage the filters. When evacuating smoke and incidental fluids, always use the appropriate tubing.

Note: Connect the power cord to a wall receptacle having the correct voltage. Otherwise, product damage will result.

Note: Power line voltage below 100 VAC (110 V SE3690) and 200 VAC (220 V SE3695) will significantly reduce airflow.

Note: Periodically check the cart brackets that hold the smoke evacuator in place to ensure that the screws are securely fastened.

Residual Risk Statement

While every attempt has been made to reduce patient and user risks, all surgeries using this system carry some residual risk, even when used by trained physicians. The potential adverse events associated with the use of RapidVac includes, but are not limited to the following risks:

•Air embolism

• Airway obstruction

•Burn

• Cross patient exposure to body fluids

• Electric shock

smoke evacuation system and its accessories

•Fall

1-6 RapidVac™ Smoke Evacuator User's Guide

Patient and Operating Room Safety

• Foreign body reaction

•Infection

Serious Incidents Statement

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and necessary regulatory authority (if European Union, the competent authority of the Member State) in which the user and/or patient is established.

Disposal

Introduction

Warning

Do not dispose of electrical appliances as unsorted mun icipal waste. Use separate collection facilities. Electrical appliances that are incorrectly disposed in dumps or landfills can leach dangerous substances causing contamination of soil and groundwater, and damaging the environment. Contact your local government or point of sale for information regarding the collection of waste electrical appliances.

At the end of the product's life, discard biologically contaminated devices in accordance with your institution's hazardous medical waste procedures and local regulatory requirements.

RapidVac™ Smoke Evacuator User's Guide 1-7

Chapter 2

Controls, Indicators, and Receptacles

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

RapidVac™ Smoke Evacuator User's Guide 2-1

Front Panel

3/8"

7/8"

1/4"

10 mm

22 mm

6 mm





















Front Panel

Figure 1

① Power on/off switch

② Airflow indicators (LED)

③ Turbo button

④ Airflow 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

⑩ Air filter with tubing connectors

Caution

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

2-2 RapidVac™ Smoke Evacuator User's Guide

The control panel contains the turbo button, airflow adjustment button, filter-life indicator, and service indicator light.

Note: 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.

Note: Do not position the RapidVac the disconnection device (keep plug connected).

smoke evacuation unit so that it is difficult to operate

Power On/Off Switch

The power switch that controls power to the RapidVacTM smoke evacuator is located in the lower-left corner of the front panel (Figure 1). 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 (Figure 1) will blink continually until a fan speed is selected.

Turn the system power off by placing the power switch in the OFF position (O).

Front Panel

Controls, Indicators, and

Receptacles

Airflow Controls

The level of suction is controlled by the airflow controls: up-arrow ( ) and down-arrow ( ) buttons. To start the fan from standby mode, press the up-arrow button. It starts in the lowest suction setting indicated by a single illuminated Airflow 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. The selected level of suction is displayed by the airflow indicator LEDs.

Turbo Button

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

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 accurate display of remaining use for new or previously used filters.

smoke evacuator tracks the time each filter has been used allowing for an

RapidVac™ Smoke Evacuator User's Guide 2-3

Front Panel

Reading the Filter-Life Indicator

Install an unused RapidVacTM 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 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 airflow level.

Footswitch Jack

A footswitch (SEA3745) is available for use with the RapidVacTM smoke evacuator.

A footswitch may be plugged into the system by inserting the plug into the footswitch port on the front panel (Figure 1). The unit may be turned on or off by depressing the footswitch pedal once for each operation. For footswitching operation, turn on smoke evacuator, select suction level on control panel, and depress footswitch which will turn suction off. Depress the footswitch again to turn suction on.

Service-Required Indicator

The motor powering the RapidVacTM smoke evacuator requires regular maintenance every 500 hours. When the smoke evacuator has been in use for 500 hours, the service-required indicator illuminates. Contact the Covidien customer service department and return the smoke evacuator for service.

2-4 RapidVac™ Smoke Evacuator User's Guide

Rear Panel

1 1

Figure 2

Rear Panel

Controls, Indicators, and

Receptacles

① Cord brackets

② Carrying handle

③ Power-cord receptacle

④ Remote activator jack

⑤ Equipotential grounding lug

Power-Cord Receptacle

The cord receptacle (Figure 2) provides power to the smoke evacuator using a removable cord appropriate for regional power supplies. Cord can be wound on the cord brackets (Figure 2) to store with the smoke evacuator.

RapidVac™ Smoke Evacuator User's Guide 2-5

Rear Panel

Remote Activator Jack

An interlink cable (SEA3730) and remote switch activator (SEA3741) are available for the automatic remote activation of the RapidVac

The interlink cable is compatible with the Covidien Force FX generators, and Valleylab

FX8 and FT10. It attaches to a generator’s RF activation port and

smoke evacuator.

, Force EZTM, ForceTriadTM

to the smoke evacuator’s remote activator jack. When the generator is activated, the smoke evacuator automatically initiates the pre-set suction.

The remote switch activator (RSA) is programmed to recognize cut and coag activation currents emitted from the generator. The recognized current initiates activation of the smoke evacuator.

Equipotential Grounding Lug

The equipotential grounding lug (Figure 2) provides an alternate route for electrical energy back to ground when attached to an earth-ground cable.

2-6 RapidVac™ Smoke Evacuator User's Guide

Chapter 3

Before Surgery

This chapter contains procedures for:

• Periodic inspection

• Initial installation

• Checking and testing the smoke evacuator prior to use

• Preparing for evacuation of surgical smoke

• Preparing for evacuation of surgical smoke and incidental fluids

Caution

Read all warnings, cautions, and instructions provided with this smoke evacuator before using.

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

RapidVac™ Smoke Evacuator User's Guide 3-1

Periodic Inspection

3/8"

7/8"

1/4"

10 mm

22 mm

6 mm

Periodic Inspection

The RapidVacTM smoke evacuator and accessories should be visually inspected at least every year. This inspection should include checks for:

• Damage to the power cord

• Damage to the power plug

• Tightness of the power plug

• Proper mating, absence of damage, and contamination to the filter inlet

• Obvious external or internal damage to the system or accessories

Warning

Do not use if products are damaged.

Initial Installation

To prepare the RapidVacTM smoke evacuator for use, you must verify that the filter is installed, connect the appropriate tubing, and check the performance of the smoke evacuator indicators and controls.

Caution

Stacking the smoke evacuator on top of a generator may cause an unstable condition or cause the smoke evacuator to overheat.

Figure 3

1. Inspect the power cord for any signs of visible damage. If it is in good condition, plug the power cord into a grounded wall receptacle.

3-2 RapidVac™ Smoke Evacuator User's Guide

Warning

1 1

Interlink

Monopolar1Monopolar

U.S. and foreign pate

Valleylab™ FX8

Force FX™

Force EZ™

Valleylab™ FT10

ForceTriad™

Connect the smoke evacuator power cord to a properly grounded, hospital-grade receptacle of the correct voltage. Plug the power cord directly into the power receptacle without any extension cords and/or adapter plugs.

2. Insert a RapidVac

SEA3700 ULPA filter into the square opening on the right side of the smoke evacuator. Slide the filter into place until it is fully seated and the locking mechanism clicks into place (Figure 3).

3. Turn on power to the smoke evacuator by pressing the on switch (I) located on the front panel (Figure 1). The smoke evacuator performs a self test. Verify all LEDs are illuminated during the test. When the test is complete, the RapidVac

is placed in standby mode

signified by an illuminated power on LED within the fan symbol and no active suction.

4. (Optional) Connect the remote switch activator (SEA3741) to the remote switch jack on the rear panel of the smoke evacuator (Figure 2). Use only the remote switch activator. Other remote units are not compatible.

Initial Installation

5. (Optional) Connect the interlink cable (SEA3730) to the remote switch jack on the rear panel of the smoke evacuator (Figu re 2) and to the rear panel of the compatible Covidien or Valleylab not be compatible. There are two external system receptacles on the back of the Valleylab

generator (Figure 4). Use only the SEA3730 interlink cable. Other cables may

FT10 and FX8 energy platforms that can signal RF activation. These

receptacles are labeled Monopolar 1 and Monopolar 2.

6. (Optional) Connect the footswitch (SEA3745) to the front panel (Figure 1) of the smoke evacuator. Use only the SEA3745 footswitch with the RapidVac

Figure 4

smoke evacuator.

Before Surgery

RapidVac™ Smoke Evacuator User's Guide 3-3

Checking the Smoke Evacuator

Before each use, test the following smoke evacuator components to verify performance:

•RapidVac

• Airflow controls

• Footswitch (as applicable)

• Remote switch activator (as applicable)

•RapidVac

If the system does not respond as indicated below, refer to Chapter 6, Troubleshooting.

Checking the Remaining Filter Life

RapidVacTM smoke evacuator filters have a use duration of up to 25 hours (refer to Filter Life Indicators Table on page 3-4). As a filter is used, information about the amount of time the

individual filter has been used is stored on the filter’s RFID tag. Whenever a new or previously used filter is inserted, the smoke evacuator reads the stored information from the tag. The remaining filter life is visually displayed by the corresponding number of filter-life indicators on the smoke evacuator front panel (Figure 1).

ULPA filter

interlink cable (as applicable)

1. Turn on the smoke evacuator and insert a filter.

2. Check the filter life indicators on the front panel (Figure 1) to verify the filter has ample remaining time to complete a procedure.

Filter Life Indicators Table

Illuminated filter life indicators Remaining use

All 25 to 20 hours

4 20 to 15 hours

3 15 to 10 hours

2 10 to 5 hours

1 (green) 5 hours to 1 hour

1 (amber) less than 1 hour

1 (flashing amber) less than 30 minutes

Note: Replace the filter when indicated. Failure to replace the filter may reduce airflow and compromise the efficiency of the filter.

3-4 RapidVac™ Smoke Evacuator User's Guide

Checking the Smoke Evacuator

Changing the Filter

Warning

The ULPA filter captures potentially hazardous particles. Handle used filters as you would any biohazard material. Dispose of filters with other operative waste materials according to the procedures for your institution.

1. Remove the filter by depressing the locking tab on the top edge of the filter while pulling the filter straight out of the opening.

2. Dispose of the filter with other operative waste according to the procedures for your institution.

3. Install a new filter in the smoke evacuator as described earlier in this section.

Testing the Airflow Controls

Warning

The smoke evacuator produces a strong vacuum. Properly 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.

You can start, stop, and change the vacuum airflow rate when the smoke evacuator is on. Illuminated LEDs display the airflow setting. Each pressing of the up-arrow ( ) or downarrow ( ) increases or decreases suction. Refer to Figure 1 for more information on button controls.

There are five suction flow indicator LEDs that light in succession. Turbo mode illuminates the sixth LED next to the Turbo button.

1. Verify that the filter is installed properly (Figure 3).

2. Ensure that the power cord is plugged into a hospital-grade power receptacle.

3. Turn on the smoke evacuator by pressing the power on switch (|) on the lower left of the front panel (Figure 1). The smoke evacuator powers up with the fan motor off (standby mode). The LED in the center of the fan symbol blinks indicating power is on.

4. Press the up-arrow( )button once to start suction at the lowest airflow setting.

5. Press the up-arrow ( ) button and pause briefly to progress to the next level of suction. Verify that the level of suction noticeably increases with each progression.

6. When all suction flow LEDs are lit steadily (100% motor speed), press the down-arrow ( ) button repeatedly to regress through the settings to the lowest setting.

Before Surgery

RapidVac™ Smoke Evacuator User's Guide 3-5

Checking the Smoke Evacuator

Installing and Testing the Footswitch (optional)

Only use the RapidVacTM footswitch with the smoke evacuator. Other footswitches are not compatible.

1. Turn on the smoke evacuator.

2. Connect the footswitch cord to the footswitch jack (port) on the front panel (Figure 1).

3. Turn on the airflow to any setting.

4. Press the footswitch once to turn off the airflow.

5. Press the footswitch again to activate the airflow.

Installing and Testing the Remote Switch Activator (optional)

Use the RapidVacTM remote switch activator (RSA) (SEA3741) with any of Covidien’s electrosurgical pencils and generators.

1. Select a space on the front of the generator or generator cart near the 3 prong ESU pencil cable input where the remote switch activator (RSA) will be mounted.

2. Wipe the surface of the selected area with alcohol. Allow the alcohol to evaporate.

3. Remove the backing from the gasket on the RSA.

4. Affix the RSA to the generator or generator cart.

5. Plug the RSA connector into the remote activator jack (1) located on the back panel of the RapidVac

Figure 5

smoke evacuator (Figure 5).

250V, T10.0A-(100-120V)

250V, T8.0A-(220-240V)

Remote Activator

3-6 RapidVac™ Smoke Evacuator User's Guide

Checking the Smoke Evacuator

6. Plug the generator and smoke evacuator into outlets of the proper voltage.

7. Attach hoses, surgical pencil, patient return electrode, and any other accessories to be used.

Warning

When activating an electrosurgical pencil for set up, the operator must be properly grounded to avoid unintended surgical affect. A patient return electrode connected to the generator and properly adhered to the operator (that is, on the arm opposite the hand holding the pencil) provides a safe path for electrical current from the pencil back to the generator.

8. Turn the power on to both devices by turning their respective main power switches to on (I).

9. When the devices have completed their self tests, set the smoke evacuator suction level to 40%.

• Press the up-arrow ( ) button twice to illuminate the first two airflow indicators.

• Press the RapidVac+ button

The suction reduces to a minimal level and the pre-set suction is set at 40%.

10. Drape the electrosurgical unit (ESU) wire into the RSA cradle (2) as shown in Figure 6. More than one ESU wire may be placed in this cradle (Figure 6).

Figure 6

11. Test the connectivity of the RSA by depressing the cut or coag button on the electrosurgical pencil. The smoke evacuator should start. Deactivate the pencil.

12. An optional delayed stop can be set for the smoke evacuator once deactivation of the pencil occurs. Press and hold the button located on the front of the RSA for the desired amount of delay.

Before Surgery

This delay can be set from 0-10 seconds. To return to delay of 0 seconds, tap the button once.

Note: If both the cut and coag modes are not activating the smoke evacuator, disconnect the RSA cord from the smoke evacuator. Reinsert the connector and repeat step 5.

The RSA is now programmed to activate the smoke evacuator when the cut and coag modes are emitted from a generator.

RapidVac™ Smoke Evacuator User's Guide 3-7

Checking the Smoke Evacuator

Note: If the attached smoke evacuator is to be separated from the generator, unplug the RSA from the smoke evacuator. The RSA should remain affixed to the generator to which it was programmed. The RapidVac™ smoke evacuator cannot be operated manually or with a footswitch while the RSA is plugged into the smoke evacuator.

Note: If the RSA is moved to another generator, it must be reprogrammed using the steps in this section.

Installing and Testing the Interlink Cable (optional)

• The interlink cable attaches to a RapidVacTM smoke evacuator and a compatible Covidien or Valleylab generator. The cable is compatible with the Covidien generator models Force FX

, ForceTriadTM, and ValleylabTM FT10 and FX8 (Figure 4).

generator to synchronize smoke evacuation with the activation of the

, Force

1. Turn power off and unplug the smoke evacuator and generator from the power source.

2. Remove the metal cover plate in the center of the generator rear panel to access optional ports.

• Note: This step is not required on the FX8 or FT10

• Force FX

only: A replacement cover is provided for the Force FXTM to allow access to

the RF activation port. Cut out the ECG section on the replacement cover and secure it to the replacement port using the screws removed from the original cover plate.

• Note: Replacement covers are not provided for the Force EZ

or the ForceTriadTM.

Covers are not required for operation.

3. Plug the interlink cable into the generator RF activation port (Figure 4).

4. Plug the interlink cable into the remote activator jack on the rear panel of the smoke evacuator (Figure 5).

5. Plug the generator and smoke evacuator into outlets of proper voltage.

6. Turn power on to both devices.

7. When the generator and smoke evacuator have completed their self tests, set the level of suction to be used when the smoke evacuator is activated.

8. Press the up-arrow ( ) button until reaching the desired pre-setting.

9. Press the RapidVac+ button

The pre-set suction level is now selected. The smoke evacuator continues to run and suction reduces to a minimal level. Use of the surgical pencil will automatically activate the RapidVac

to the preset suction level. When the pencil is deactivated, the smoke evacuator

will return to minimal suction.

3-8 RapidVac™ Smoke Evacuator User's Guide

Setting Up the Smoke Evacuator

Warning

Use of extension cords may result in fire hazards.

After the initial installation, set up the smoke evacuator for use.

Mounting the Smoke Evacuator

The smoke evacuator may be mounted in the following locations:

• UC8009 Valleylab

•FT900 ForceTriad

• VLFTCRT Valleylab

universal mounting cart—primary, secondary, or suspended shelf

energy platform cart

universal generator cart

• Boom systems

• Stable, flat surfaces

Evacuating Surgical Smoke

Caution

Connecting multiple lengths of tubing together may cause the smoke evacuator to overheat.

1. Verify the installed filter has enough available filter life to complete the procedure.

2. Connect your choice of tubing to the corresponding filter tubing connection.

Note: Do not connect more than one set of tubing to the smoke evacuator filter at one time. Suction levels and airflow will be adversely affected.

Evacuating Surgical Smoke and Incidental Fluids

The primary function of the smoke evacuator is to evacuate surgical smoke. A fluid canister (such as the RVFT10 fluid trap) is recommended to prevent the filters from getting wet when evacuating smoke that may contain incidental fluids.

Caution

Connecting multiple lengths of tubing together may cause the smoke evacuator to overheat.

Before Surgery

Note: Fluids may damage the filters. When evacuating smoke and incidental fluids, always use the appropriate tubing and fluid canister.

RapidVac™ Smoke Evacuator User's Guide 3-9

Setting Up the Smoke Evacuator

Note: Check the fluid level in the canister frequently during surgery. If the fluid canister overfills, damage to the smoke evacuator will result.

1. Verify the installed filter has enough available filter life to complete the procedure.

2. Insert a fluid trap in-line with the smoke evacuator tubing.

3-10 RapidVac™ Smoke Evacuator User's Guide

Chapter 4

During Surgery

This chapter covers the following topics:

• Minimizing airflow noise

• Changing and adjusting airflow

• Checking the tubing

• Checking the filter

• Checking the sponge guard

RapidVac™ Smoke Evacuator User's Guide 4-1

Initiating Airflow

Warning

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.

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 Covidien Service for additional information.

Caution

To maximize patient safety, the tubing or wand should not come in direct contact with tissue. Otherwise, patient injury may result.

Connecting multiple lengths of tubing together may cause the smoke evacuator to overheat.

1. Verify that all tubing is connected.

2. Turn on the smoke evacuator by pressing the power-on switch (|) on the front panel (Figure 1). The smoke evacuator powers up with the fan motor off. The smoke evacuator is in standby mode which is indicated by a blinking LED in the center of the fan symbol.

3. Press the up-arrow ( ) button once to start suction at the lowest airflow setting.

Minimizing Noise

The higher the suction setting, the greater the noise. Minimize noise by using a lower suction setting. Effectiveness of a lower suction setting can be maximized by using a larger diameter tubing or positioning the tubing closer to the source of smoke or both.

4-2 RapidVac™ Smoke Evacuator User's Guide

Variables Affecting Airflow

The following factors may affect airflow:

• Diameter of the tubing—with larger diameter tubing, airflow improves

• Airflow settings

• Attachments

Changing the Airflow

You can change the airflow while the smoke evacuator is in use.

1. Adjust the airflow by pressing the up-arrow ( ) to increase or the down-arrow ( ) button to decrease.

2. Verify that the indicator illuminates for the speed setting you selected.

Periodic Checks

During surgery periodically check the accessories described below.

Tubing

Check for clogged, occluded, or kinked tubing during surgery.

Sponge Guard

If a sponge guard is in use, ensure it is fully attached to the sterile tubing to prevent suction of surgical materials.

Filter-Life Indicator

Monitor the remaining life of the filter by viewing the filter-life-indicator LEDs on the smoke evacuator front panel (Figure 1).

During Surgery

RapidVac™ Smoke Evacuator User's Guide 4-3

Chapter 5

After Surgery

This chapter covers the following topics:

• Preparing the smoke evacuator for reuse

RapidVac™ Smoke Evacuator User's Guide 5-1

Preparing the RapidVac™ Smoke Evacuator for Reuse

After surgery, prepare the smoke evacuator for reuse by performing the following procedures:

• Remove the tubing

• Wipe the smoke evacuator

Caution

Do not reuse or re-sterilize accessories labeled “disposable” or “single use only.”

Removing the Tubing

Caution

Discard biologically contaminated devices in accordance with your institution’s hazardous medical waste procedures and local regulatory requirements.

1. Press the power switch (O) on the front panel (Figure 1) to turn off the smoke evacuator.

2. If applicable, disconnect the tubing from any reusable instrument that will not be discarded with the tubing.

3. Disconnect the tubing from the smoke evacuator.

5-2 RapidVac™ Smoke Evacuator User's Guide

Chapter 6

Troubleshooting

This chapter describes solutions to problems that may occur when operating the smoke evacuator.

If the smoke evacuator is not functioning properly, use the information in this section to help identify and correct the malfunction.

RapidVac™ Smoke Evacuator User's Guide 6-1

Inspecting the RapidVac™ Smoke Evacuator

If there is a problem with the operation of the smoke evacuator, inspect the unit for obvious conditions that can cause a malfunction:

• Check for visible signs of damage

• Verify the connections of all cables and tubing

• Verify proper filter installation

• Verify that the power switch is on and the power-on indicator LED in the center of the fan symbol is blinking

• Check the filter life indicators to ensure the filter has available filter time remaining

Correcting Specific Malfunctions

If a solution to the problem is not readily apparent, use the following table to help identify and correct specific malfunctions. After you correct the malfunction, verify that the smoke evacuator is in proper working order.

Situation Possible cause Recommended action

Smoke evacuator is on but there is minimal or no vacuum or airflow at the wand or tubing

Smoke evacuator does not operate

Improperly installed ULPA filter

Clogged tubing Unclog/replace the tubing.

Clogged ULPA filter Replace the filter.

Obstructed or malfunctioning motor and/or blower

Disconnected or faulty power cord

No power from wall receptacle (power cord is connected to wall receptacle, but mode indicator is not illuminated)

Ensure the ULPA filter is properly installed. Reposition if necessary.

Contact Covidien service for assistance.

Check and correct the power cord connections. Check the cord for damage. Replace cord if needed.

Check the power at the wall receptacle. Connect power cord to a functional wall receptacle.

Power switch on the front panel (Figure 1) is off (O)

Fuses damaged Contact Covidien service.

Turn the power switch on (|).

6-2 RapidVac™ Smoke Evacuator User's Guide

Situation Possible cause Recommended action

Correcting Specific Malfunctions

Footswitch does not activate smoke evacuator when footswitch mode is selected

Indicator LEDs do not illuminate

Motor does not run, but Power On LED illuminates

Improperly connected footswitch

Check that the footswitch is securely connected at the front of the smoke evacuator.

Malfunctioning

Replace the footswitch.

footswitch

Incorrect footswitch connected to the smoke

Connect the RapidVac (SEA3745) to the smoke evacuator.

footswitch

evacuator

Filter incorrectly installed Reinstall the filter. Ensure that the filter

is fully seated in the smoke evacuator and the securing tab locks into place.

Malfunction in the smoke

Contact Covidien service.

evacuator

No electrical power Refer to electrical utility maintenance.

Fuses damaged Contact Covidien service.

Malfunction in the smoke

Contact Covidien service.

evacuator

Filter incorrectly installed Reinstall the filter. Ensure the filter is

fully seated in the smoke evacuator and the securing tab locks into place.

Troubleshooting

ESU remote does not activate when RapidVac mode is selected

Malfunction in smoke evacuator

RapidVacTM interlink cable

incorrectly installed

Remote switch activator incorrectly installed

ULPA filter incorrectly installed

Contact Covidien service.

Ensure the RapidVacTM interlink cable is properly connected to the rear panel (Figure 2) of the smoke evacuator and the Covidien generator.

Ensure the remote switch activator is connected to the rear of the smoke evacuator.

Check the ESU pencil lead installation on the electrosurgery sensor bobbin.

Reinstall the filter. Ensure the filter is fully seated in the smoke evacuator and the securing tab locks into place.

RapidVac™ Smoke Evacuator User's Guide 6-3

Chapter 7

Maintenance and Repair

Refer to this chapter for information about:

• Maintenance

• Routine maintenance

• Optional maintenance of the smoke evacuator

• Manufacturer’s responsibility

• Returning the smoke evacuator for service

•Technical service

RapidVac™ Smoke Evacuator User's Guide 7-1

General Warnings and Cautions

Warning

Always turn off and unplug the smoke evacuator before wiping.

Do not reuse or re-sterilize 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 Covidien for service assistance.

Note: Do not rub, touch, or wipe 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.

Note: Do not autoclave, pressure sterilize, or gas sterilize the smoke evacuator.

Note: Keep the smoke evacuator away from liquids. Liquids that enter the smoke evacuator

will damage internal components.

Routine Maintenance

The RapidVacTM smoke evacuator requires very little maintenance. Periodically, you must check the power cord and replace the filter. Periodic inspections and performance tests are recommended by a qualified biomedical technician to ensure safe and efficient operation.

Servicing the Motor

The motor powering the RapidVacTM smoke evacuator requires regular maintenance every 500 hours. When the smoke evacuator has been in use for 500 hours, the service-required indicator illuminates. Contact the Covidien Customer Service Department and return the smoke evacuator for service.

Checking the Power Cord

Inspect the power cord each time you use the smoke evacuator, or at intervals recommended by your institution. Make sure the power cord is in good working condition, without exposed wires, cracks, or frayed areas.

7-2 RapidVac™ Smoke Evacuator User's Guide

Optional Maintenance of the Smoke Evacuator

Removing the RapidVac™ ULPA Filter

The ULPA filter removes smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

Warning

Note: If the replace-filter indicator illuminates, remove and replace the filter. Failure to do so may reduce airflow and compromise the efficiency of the filter.

1. Ensure that the smoke evacuator power switch on the front panel (Figure 1) is off (O).

2. Depress the locking tab on the top edge of the filter and pull straight out of the smoke evacuator.

3. Dispose of the filter with other operative waste materials according to the procedures for your institution.

Optional Maintenance of the Smoke Evacuator

Warning

Always turn off and unplug the smoke evacuator before wiping.

Discard biologically contaminated devices in accordance with your institution’s hazardous medical waste procedures and local regulatory requirements.

Wear appropriate protective gear when cleaning the filter ports and covering flap to avoid coming in contact with incidental contaminants on these surfaces.

Note: Do not rub, touch, or wipe 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.

Note: Do not autoclave, pressure sterilize, or gas sterilize the smoke evacuator.

Note: Keep the smoke evacuator away from liquids. Liquids that enter the smoke evacuator

will damage internal components. Do not spray liquid cleaner into the filter ports.

1. Ensure that the power switch on the front panel (Figure 1) is off (O).

2. Disconnect the power cord from the wall receptacle.

3. Disconnect tubing as directed in the previous section.

4. Thoroughly wipe all external surfaces with a mild detergent or disinfectant.

Maintenance and Repair

5. Thoroughly wipe both sides of the flap covering the filter ports. Do not spray liquid cleaner into the filter ports.

RapidVac™ Smoke Evacuator User's Guide 7-3

Optional Maintenance of the Smoke Evacuator

6. Wipe the surface around the filter ports. Do not spray liquid cleaner into the filter ports. Follow procedures approved by your institution, or use a validated infection-control procedure.

Warning

Wear protective gloves when wiping around filter ports. Do not place fingers into ports or touch the internal surface of the ULPA filter. Contaminants may be present.

7. Ensure the smoke evacuator is completely dry before use.

8. Reconnect the power cord to the wall receptacle.

7-4 RapidVac™ Smoke Evacuator User's Guide

Responsibility of the Manufacturer

Covidien is responsible for the safety, reliability, and performance of the smoke evacuator only under the following circumstances:

• Installation and setup procedures in this manual are followed.

• Readjustments, modifications, or repairs to the unit are carried out by persons authorized by Covidien.

• The electrical installation of the relevant room complies with local codes and regulatory requirements, such as UL.

• The accessories are used in accordance with the instructions found within this user’s guide or specific product’s instructions for use, if applicable.

For warranty information, refer to the Limited Warranty at the beginning of this guide.

Obtaining a Return Authorization Number

Note: For repairs, return the smoke evacuator to Covidien.

Before you return the smoke evacuator, call the Covidien Customer Service Department (+1 800 255 8522) for a Return Authorization Number or call your Covidien Representative for assistance.

Have the following information ready when you call:

• Hospital/clinic name/customer number

• Telephone number

• Department/address, city, state, and zip code

• Model number

•Serial number

• Description of the problem

Maintenance and Repair

RapidVac™ Smoke Evacuator User's Guide 7-5

Returning the Smoke Evacuator for Service

Follow this procedure when returning the smoke evacuator for service. Service center information is provided below.

1. Remove the ULPA filter and any attached tubing and fluid container.

Warning

2. Clean the smoke evacuator thoroughly. Follow the procedures approved by your institution or use a validated infection control procedure.

3. Attach a tag to the smoke evacuator that includes the Return Authorization Number and the information listed above (that is, hospital, phone number, and so forth).

4. Be sure the smoke evacuator is completely dry. Then, package the smoke evacuator in its original shipping container, if available.

5. When you receive the Return Authorization Number, ship the smoke evacuator prepaid according to Covidien's instructions.

Tec hnical Service

For service information, please refer to the Covidien web site: https://www.medtronic.com/ covidien/en-us/support.html

7-6 RapidVac™ Smoke Evacuator User's Guide

Chapter 8

Accessories

The accessories listed in this chapter are recommended for use with the RapidVacTM smoke evacuator. Accessories can be ordered through your Covidien sales representative.

Product Catalog number

ULPA filter SEA3700

Smoke tubing, 6 mm x 3 m (1/4 in. x 10 ft), sterile SEA3705

Smoke tubing, 10 mm x 3 m (3/8 in. x 10 ft), sterile SEA3710

Smoke sponge guard tubing, 22 mm x 3 m (7/8 in. x 10 ft), sterile SEA3715

Smoke lap tubing kit with valve, 0.6 cm x 3 m (1/4 in. x 10 ft) SEA3720

Smoke wand, 2.2 cm x 20.3 cm (7/8 in. x 8 in.) SEA3725

Fluid trap RVFT10

Interlink cable SEA3730

Remote switch activator SEA3741

Footswitch SEA3745

OptiMumm

smoke reducer fitting, 2.2 cm to 1 cm (7/8 in. to 3/8 in.) E3655

RapidVac™ Smoke Evacuator User's Guide 8-1

Chapter 9

Technical Specifications

All specifications are nominal and subject to change without notice.

RapidVac™ Smoke Evacuator User's Guide 9-1

Performance Characteristics

Dimensions and Weight

Width 36 cm (14 in.)

Depth 48 cm (18.75 in.) with cord wrap and handle

Height 20.5 cm (8 in.)

Weight 9.9 kg (20.5 lb) without filter

Filter

ULPA filter 0.1-0.2 micron particulate size at 99.999% efficiency; activated charcoal

Airflow

0-1.25 m3/min (0-44 cfm) with 2.2 cm x 3 m (7/8 in. x 10 ft) tubing with sponge guard.

Airflow measured at sea level.

Safety

110 Volt (for the SE3690) 220 Volt (for the SE3695)

Fuse 10 AMPS, 250 V (Slo-Blo

Power cord 3-prong hospital-grade plug 3-prong locally approved connector

Leakage current (50/60 Hz) (50/60 Hz)

Normal polarity Smoke evacuator in standby

mode < 300 μA

Reverse polarity Smoke evacuator in standby

mode < 300 μA

*) 8 AMPS, 250 V (Slo-BloTM*)

Smoke evacuator in standby mode < 300 μA

9-2 RapidVac™ Smoke Evacuator User's Guide

Performance Characteristics

Power

SE3690 100 – 120 VAC

Power Cord—Type SJT, No. 16AWG, 3 Conductor, IEC Female, 125VAC-13A, UL/IEC Approvals

SE3695 220 – 240 VAC

Power Cord—Type HOVV-F3G1.00, IEC Female, 250VAC-10A, European Union Approvals

Reading the Filter-Life Indicator

Technical Specifications

Operating and Storage Parameters

Ambient temperature range 10°C to 40°C (50°F to 104°F)

Relative humidity 20% to 90%, non-condensing

Transportation Parameters

Ambient temperature range -30°C to 60°C (-22°F to 140°F)

Relative humidity 15% to 90%, non-condensing

RapidVac™ Smoke Evacuator User's Guide 9-3

EMC for the RapidVac™ Smoke Evacuator

Warning

The SE3690/SE3695 RapidVacTM requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Valleylab RapidVacTM Service Manual.

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.

Note: Portable and mobile RF communication equipment can affect the RapidVacTM smoke evacuation unit. Refer to the EMC information provided below for more information.

Electromagnetic Compatibility (IEC 60601-1-2)

The RapidVacTM smoke evacuator complies with the appropriate clauses and sub-clauses of IEC 60601-1-2 specifications regarding electromagnetic compatibility.

The RapidVac

• ESD Immunity (IEC 60601-1-2 and IEC 61000-4-2)

• Radiated Immunity (IEC 60601-1-2 and IEC 61000-4-3)

• Electrical Fast Transient/Burst (IEC 60601-1-2 and IEC 61000-4-4)

• Surge Immunity (IEC 60601-1-2 and IEC 61000-4-5)

• Emissions (IEC 60601-1-2)

• Harmonic distortion (IEC 60601-1-2 and IEC 61000-3-2)

• Conducted disturbances (IEC 60601-1-2 and IEC 61000-4-6)

• Power frequency magnetic fields (IEC 60601-1-2 and IEC 610004-8)

• Voltage dips, short interruptions and variations (IEC 60601-1-2 and IEC 61000-4-11)

smoke evacuator meets the following requirements:

9-4 RapidVac™ Smoke Evacuator User's Guide

EMC for the RapidVac™ Smoke Evacuator

Electromagnetic Environment

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The SE3690/SE3695 RapidVac electromagnetic environment specified below. The customer or the user of the RapidVacTM smoke evacuation system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

Group 1 The SE3690/SE3695 RapidVac

CISPR 11

RF emissions

CLASS A The SE3690/SE3695 RapidVac

CISPR 11

Harmonic emissions

CLASS A

IEC 61000-3-2

smoke evacuation system is intended for use in the

smoke evacuation system 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.

smoke evacuation system is suitable for use in all establishments and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes.

Technical Specifications

Voltage fluctuations/

Complies

flicker emissions

IEC 61000-3-3

The essential performance requirement per IEC 60601-1 does not apply to SE3690/SE3695 RapidVac

smoke evacuation system. Basic safety is the performance requirement used during

immunity testing.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The SE3690/SE3695 RapidVac

smoke evacuation system is intended for use in the electromagnetic environment specified below. The customer or the user of the RapidVac smoke evacuation system should assure that it is used in such an environment.

Immunity test IEC 60601 test

level

Electrostatic Discharge (ESD)

± 8 kV contact

± 15 kV air

IEC 61000-4-2

Compliance level Electromagnetic environment

- guidance

± 8 kV contact

± 15 kV air

Floors should be wood, concrete or tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst

IEC 61000-4-4

± 2 kV for power supply lines

± 1 kV for input/ output lines

± 2 kV for power supply lines

± 1 kV for input/ output lines

Mains power quality should be that of a typical commercial or hospital environment.

RapidVac™ Smoke Evacuator User's Guide 9-5

EMC for the RapidVac™ Smoke Evacuator

d=1.2 P

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The SE3690/SE3695 RapidVac electromagnetic environment specified below. The customer or the user of the RapidVacTM smoke evacuation system should assure that it is used in such an environment.

smoke evacuation system is intended for use in the

Immunity test IEC 60601 test

level

Surge

Withstand IEC

61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

± 1 kV differential mode

± 2 kV common mode

for 0.5 cycles

0% U

(0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°)

for 1 cycle (0°)

0% U

(30% dip in

70% U

) for 25/30 cycles

(0°)

for 250/300

0% U

cycles (0°)

Power

30 A/m 30 A/m Power frequency magnetic frequency (50/60 Hz) magnetic field

IEC 61000-4-8

1 cycle is at 50 Hz or 20 ms.

NOTE: U

is the a.c. mains voltage prior to the application of the test level.

Compliance level Electromagnetic environment

- guidance

± 1 kV differential mode

± 2 kV common

Mains power quality should be that of a typical commercial or hospital environment.

mode

for 0.5 cycles

0% U

(0°, 45°, 90°, 135°, 180°, 225°, 270°,

Mains power quality should be that of a typical commercial or hospital environment.

315°)

for 1 cycle (0°)

0% U

(30% dip in

70% U

) for 25/30 cycles

(0°)

for 250/300

0% U

cycles (0°)

fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Conducted RF

IEC 61000-4-6

3 V

rms

150 kHz to 80 MHz

3 V

rms

Portable and mobile RF communications equipment should be used no closer to any part of the RapidVac

smoke evacuation system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

9-6 RapidVac™ Smoke Evacuator User's Guide

EMC for the RapidVac™ Smoke Evacuator

d=1.2 P 80 MHz to 800 MHz

d=2.3 P 800 MHz to 2.7 GHz

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The SE3690/SE3695 RapidVac electromagnetic environment specified below. The customer or the user of the RapidVacTM smoke evacuation system should assure that it is used in such an environment.

smoke evacuation system is intended for use in the

Technical Specifications

Immunity test IEC 60601 test

level

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.7 GHz

Compliance level Electromagnetic environment

- guidance

3 V/m

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol.

RapidVac™ Smoke Evacuator User's Guide 9-7

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RapidVac

smoke evacuation system is used exceeds the applicable RF compliance level above, the RapidVacTM smoke evacuation system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the RapidVac

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

smoke evacuation system.

EMC for the RapidVac™ Smoke Evacuator

d = 1.2x P

d = 2.3x P

Recommended Separation Distances between Portable and Mobile RF Communication Equipment and the RapidVac

smoke evacuation system

The RapidVacTM smoke evacuation system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.

Rated maximum

Separation distance according to frequency of transmitter (m) output power of transmitter (W)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

9-8 RapidVac™ Smoke Evacuator User's Guide

EMC for the RapidVac™ Smoke Evacuator

Cables & Accessories

Warning

The use of cables and accessories, other than those specified in the RapidVacTM User Guide and Service Manual, may result in increased emissions or decreased immunity of the system.

Technical Specifications

Model type Description Shielded Maximum

length

0Type SJT, No. 16AWG, 3 Conductor, IEC Female

Type HOW-F3G1.00, IEC Female

N/A Equipotential ground

SEA3730 RapidVac

SEA3741 RapidVacTM remote switch

Power cord - 125VAC-13A No 4.6 m (15 ft.) Rear panel

Power cord - 250VAC-10A No 4.6 m (15 ft.) Rear panel

No 4.6 m (15 ft.) Rear panel

cable

system

interlink cable

activator

No 1.4 m (4.5 ft.) Rear panel

No 3.1 m (10 ft.) Rear panel

Location

RapidVac™ Smoke Evacuator User's Guide 9-9

EMC for the RapidVac™ Smoke Evacuator

FCC Compatibility

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

1) This device may not cause harmful interference, and;

2) This device must accept any interference received, including interference that may cause undesired operation.

Changes or modifications to this equipment not expressly approved by the manufacturer may void the user’s authority to operate this equipment.

Contains FCC ID: Y92-BF0002

Radio Frequency Identification (RFID)

The RFID module is located on the RF circuit board. The intended use of the RFID module is to insure the correct RFID tagged filter is used and monitor filter life.

Transmit/receive frequency range 13.56 MHz

RF output power -4.61 dBuA/m at 10 meters

Type of antenna Integral loop antenna

Modulation Amplitude-shift keying (ASK)

Mode of operation (simplex/duplex) Duplex

Contains Module FCC ID Y92-BF0002

Contains IC ID 9532A-BF0002

Industry Canada Statement

This device complies with Innovation, Science and Economic Development Canada’s license exempt RSS(s). Operation is subject to the following two conditions:

1) This device may not cause interference.

2) This device must accept any interference, including interference that may cause undesired operation of the device.

Contains IC ID: 9532A-BF0002

RF Exposure Statement

This device meets the requirements for RF exposure when operated at a minimum distance of 20 cm from the user or nearby persons.

9-10 RapidVac™ Smoke Evacuator User's Guide

EMC for the RapidVac™ Smoke Evacuator

European Conformity (220 V device only)

This product operates at 13.56 MHz with an H-field strength of -4.61μ A/m at 10 meters.

Hereby, Covidien declares that RapidVac EU. The full text of the European Union declaration of conformity is available at: www.MedtronicCompliance.eu

SE3695 is in compliance with Directive 2014/53/

China Conformity (220 V device only)

1) This micro-powered short-range radio transmitting equipment complies with "The catalog and technical requirements for micro-powered short-range radio transmitting equipment".

2) The following are the micro-power short-range radio transmitting equipment operating parameters:

Technical Specifications

Operating frequencies Field strength/power Modulation Antenna type

13.56 MHz -4.61 dBA/m at 10 m Amplitude shift keying Integral loop

3) Do not change the use environment or use conditions. Do not modify the transmission frequency, do not increase its range, increase the transmission power (including adding additional RF power amplifiers, or change the transmission antenna without authorization.

4) This micro-power short-range radio transmitting equipment shall not cause harmful interference to other legal radio (station) or claim protection from harmful interference.

5) This micro-power short-range radio transmitting equipment shall accept any interference received, including interference from industrial, scientific and medical (ISM) applications or any legal radio stations. If harmful interference is caused to other legitimate radio stations, stop using the micro-power short-range radio transmitting equipment immediately and take measures to eliminate interference before continuing to use it.

6) The use of micro-power equipment in electromagnetic environmental protected areas such as radar stations, satellite earth stations (including measurement and control, ranging, reception, and navigation stations), military and civilian radio stations, airports, and so forth shall comply with electromagnetic environmental protection and relevant industry supervisors’ departmental regulations.

7) It is prohibited to use any type of remote controllers in an area within a radius of 5000 meters from an airport location.

8) Environmental conditions (for example, temperature, humidity, and pressure) within the micro-power equipment information for use shall not be exceeded. Refer to the instructions for use and/or product collateral material for environmental conditions.

RapidVac™ Smoke Evacuator User's Guide 9-11

] ]

Consult

instructions

for use

Part No. PT00073377

COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company.

Made in Mexico. May be covered by U.S. Patents: www.covidien.com/patents

Manufactured for Covidien llc, 15 Hampshire Street,

Mansfield, MA 02048 USA.

Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The

Netherlands.

www.covidien.com +1 303 530 2300 [T

+1 800 255 8522 [T

REV 04/2020

Medtronic SE3690 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual