Valleylab RapidVac User manual

User’s Guide
RapidVac™
Smoke Evacuator System

ii RapidVac™ Smoke Evacuator User’s Guide
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.
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
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.

RapidVac™ Smoke Evacuator User’s Guide iii

iv RapidVac™ Smoke Evacuator User’s Guide
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:
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.
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

RapidVac™ Smoke Evacuator User’s Guide v
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.

vi RapidVac™ Smoke Evacuator User’s Guide
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.

RapidVac Smoke Evacuator User’s Guide vii
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

viii RapidVac Smoke Evacuator User’s Guide
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

RapidVac™ Smoke Evacuator User’s Guide 1-1
1
1Introducing the
RapidVac Smoke Evacuator
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.
Chapter

Parts Shipped with the Smoke Evacuator
1-2 RapidVac™ Smoke Evacuator User’s Guide
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:
•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.

About the RapidVac Smoke Evacuator
Introducing the RapidVac
Smoke Evacuator
RapidVac™ Smoke Evacuator User’s Guide 1-3
•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.

Patient and Operating Room Safety
1-4 RapidVac™ Smoke Evacuator User’s Guide
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
Transport and Storage
Patient and Operating Room Safety
General
Ambient temperature range 10° C to 40° C (50° F to 104° F)
Relative humidity 30% to 75%, noncondensing
Ambient temperature range -34° C to 65° C (-29° F to 149° F)
Relative humidity 25% to 85%, noncondensing
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.

Patient and Operating Room Safety
Introducing the RapidVac
Smoke Evacuator
RapidVac™ Smoke Evacuator User’s Guide 1-5
Inspect the smoke evacuator before each use. If there is evidence of damage, do
not use the smoke evacuator. Call Valleylab for service assistance.
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.
Warning

Patient and Operating Room Safety
1-6 RapidVac™ Smoke Evacuator User’s Guide
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.
Warning

Patient and Operating Room Safety
Introducing the RapidVac
Smoke Evacuator
RapidVac™ Smoke Evacuator User’s Guide 1-7
Maintenance
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.
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.
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.
Notice

Patient and Operating Room Safety
1-8 RapidVac™ Smoke Evacuator User’s Guide

RapidVac™ Smoke Evacuator User’s Guide 2-1
2
2Controls, Indicators, and
Receptacles
This chapter describes the front and rear panels on the smoke
evacuator, including all controls, indicators, receptacles, and ports.
Chapter

Front Panel
2-2 RapidVac™ Smoke Evacuator User’s Guide
Front Panel
1Power On/Off switch
2Air-flow indicators (LED)
3Turbo button
4Air-flow controls
5Power on indicator (LED centered in fan symbol)
6Filter life indicators (LED)
7RapidVac+ button
8Service required indicator (LED)
9Footswitch jack
Air filter with tubing connectors
Smoke Evacuator
+
-
RapidVac
Smoke Evacuator Filter
3/8"
7/8"
1/4"
10 mm
22 mm
6 mm
RapidVac









Front Panel
Controls, Indicators, and
Receptacles
RapidVac™ Smoke Evacuator User’s Guide 2-3
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.
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 up-
arrow 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.
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.
Notice
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.

Front Panel
2-4 RapidVac™ Smoke Evacuator User’s Guide
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.