Valleylab RapidVac User manual
User’s Guide
RapidVac™
Smoke Evacuator System
Foreword
This manual and the equipment it describes are for use only by qualified medical
professionals trained in the particular technique and surgical procedure to be performed.
It is intended as a guide for using the RapidVAc Smoke Evacuator only. Additional
users information is available in the RapidVac™ Smoke Evacuator Service
Manual.
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.
Equipment covered in this manual
RapidVac Smoke Evacuator—110 V and 220 V
Part Number: 1008878
Effective Date: May 2008
Trademark acknowledgements
RapidVac™ is a trademark of Valleylab. All trade names referenced are the
trademarks, registered trademarks, or products of their respective manufacturers.
Manufactured for:
Valleylab, a division of Tyco Healthcare Group LP
Boulder, Colorado 80301-3299 USA
European representative
Tyco Healthcare UK Ltd.
Gosport, PO13 0AS, UK
Device is compliant with the European Communities Council Directive 93/42/
EEC, Medical Device Directive.
Printed in USA
©2008 Valleylab. All rights reserved.
For information call
1-303-530-2300
Internet address
http://www.valleylab.com
ii RapidVac™ Smoke Evacuator User’s Guide
RapidVac™ Smoke Evacuator User’s Guide iii
Warranty
Valleylab, a division of Tyco Healthcare Group LP, warrants each product
manufactured by it to be free from defects in material and workmanship under
normal use and service for the period(s) set forth below. Valleylab’s obligation
under this warranty is limited to the repair or replacement, at its sole option, of
any product, or part thereof, which has been returned to it or its Distributor within
the applicable time period shown below after delivery of the product to the
original purchaser, and which examination discloses, to Valleylab’s satisfaction,
that the product is defective. This warranty does not apply to any product, or part
thereof, which has been repaired or altered outside Valleylab’s factory in a way so
as, in Valleylab’s judgment, to affect its stability or reliability, or which has been
subjected to misuse, neglect, or accident.
The warranty periods for Valleylab products are as follows:
Microwave Ablation Generator One year from date of shipment
Microwave Ablation Pump One year from date of shipment
Electrosurgical Generators One year from date of shipment
RFG-3C™ Plus Lesion Generator One year from date of shipment
LigaSure™ Vessel Sealing System One year from date of shipment
LigaSure™ Reusable Instruments One year from date of shipment
Mounting Fixtures (all models) One year from date of shipment
Footswitches (all models) One year from date of shipment
Force Argon™ Units One year from date of shipment
RapidVac Smoke Evacuator One year from date of shipment
LigaSure
Sterile Single Use Items Sterility only as stated on packaging
Patient Return Electrodes Shelf life only as stated on packaging
MWA Antennas Shelf life only as stated on packaging
™ Sterile Single Use Items
Sterility only as stated on packaging
This warranty is in lieu of all other warranties, express or implied, including
without limitation, the warranties of merchantability and fitness for a particular
purpose, and of all other obligations or liabilities on the part of Valleylab.
Valleylab neither assumes nor authorizes any other person to assume for it any
other liability in connection with the sale or use of any of Valleylab’s products.
Notwithstanding any other provision herein or in any other document or
communication, Valleylab’s liability with respect to this agreement and products
sold hereunder shall be limited to the aggregate purchase price for the goods sold
by Valleylab to the customer. There are no warranties which extend beyond the
terms hereof. Valleylab disclaims any liability hereunder or elsewhere in
connection with the sale of this product, for indirect or consequential damages.
iv RapidVac™ Smoke Evacuator User’s Guide
This warranty and the rights and obligations hereunder shall be construed under
and governed by the laws of the State of Colorado, USA. The sole forum for
resolving disputes arising under or relating in any way to this warranty is the
District Court of the County of Boulder, State of Colorado, USA.
Valleylab, its dealers, and representatives reserve the right to make changes in
equipment built and/or sold by them at any time without incurring any obligation
to make the same or similar changes on equipment previously built and/or sold by
them.
RapidVac™ Smoke Evacuator User’s Guide v
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.
vi RapidVac™ Smoke Evacuator User’s Guide
Table of Contents
Foreword................................................................................................................................................................... ii
Warranty ..................................................................................................................................................................iv
Conventions Used in this Guide .......................................................................................................................... vi
Chapter 1. Introducing the RapidVac Smoke Evacuator
Parts Shipped with the Smoke Evacuator........................................................................................................ 1-2
About the RapidVac Smoke Evacuator ............................................................................................................ 1-2
Features ....................................................................................................................................................... 1-3
RapidVac+ System.....................................................................................................................................1-3
Operating Modes ........................................................................................................................................1-3
Power............................................................................................................................................................1-4
Operating Parameters................................................................................................................................1-4
Transport and Storage...............................................................................................................................1-4
Patient and Operating Room Safety .................................................................................................................1-4
General.........................................................................................................................................................1-4
Maintenance................................................................................................................................................1-7
Chapter 2. Controls, Indicators, and Receptacles
Front Panel............................................................................................................................................................2-2
Power On/Off Switch..................................................................................................................................2-3
Air Flow Controls ........................................................................................................................................2-3
Turbo Button................................................................................................................................................2-3
Filter Life Indicator ......................................................................................................................................2-4
RapidVac+ Button.......................................................................................................................................2-4
Footswitch Jack ..........................................................................................................................................2-4
Service Required Indicator........................................................................................................................2-4
Rear Panel ............................................................................................................................................................ 2-5
Power Cord Receptacle/Fuse Tray.......................................................................................................... 2-5
Remote Activator Jack...............................................................................................................................2-6
EPROM Jack (Covered) ............................................................................................................................ 2-6
Equipotential Grounding Lug ....................................................................................................................2-6
Chapter 3. Before Surgery
Periodic Inspection...............................................................................................................................................3-2
Initial Installation...................................................................................................................................................3-2
Checking the Smoke Evacuator ........................................................................................................................3-4
Checking the Remaining Filter Life.......................................................................................................... 3-4
Changing the Filter .....................................................................................................................................3-5
Testing the Airflow Controls...................................................................................................................... 3-5
Installing and Testing the Footswitch (optional) ....................................................................................3-6
Installing and Testing the Remote Switch Activator (optional)............................................................ 3-7
Installing and Testing the Generator Interlink Cable (optional)...........................................................3-8
Setting Up the Smoke Evacuator ......................................................................................................................3-9
After the initial installation, set up the smoke evacuator for use......................................................... 3-9
RapidVac Smoke Evacuator User’s Guide vii
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
viii RapidVac Smoke Evacuator User’s Guide
Chapter
1Introducing the
RapidVac Smoke Evacuator
This section describes the clinical applications and features of the
RapidVac Smoke Evacuator.
1
Caution
Read all warnings, cautions, and instructions provided with this smoke evacuator
before using.
Read the instructions, warnings, and cautions provided with electrosurgical
accessories before using. Specific instructions are not included in this manual.
RapidVac™ Smoke Evacuator User’s Guide 1-1
Parts Shipped with the Smoke Evacuator
Parts Shipped with the Smoke Evacuator
When unpacking the smoke evacuator, verify that the following parts are
included:
• Power cord
• User’s guide and service manual
• Quick reference card
Upon initial receipt, inspect the smoke evacuator for dents, cracks, or damage that
may have occurred during shipment. If damage is present, notify the freight
carrier for assessment.
Additional items are available from Valleylab:
• Replacement RapidVac Filters
• RapidVac Footswitch
• RapidVac Remote Switch Activator
• Generator Interlink Cable
• Laparoscopic Smoke Evacuator Tubing Kit
• Hoses, tubing, adapters, wands and other accessories
About the RapidVac Smoke Evacuator
The RapidVac Smoke Evacuator captures particulates and adsorbs gases from
surgical smoke. The smoke evacuator is specifically designed to improve
visibility and reduce potential health hazards associated with surgical smoke. It
can be used in both open and laparoscopic procedures.
The RapidVac Smoke Evacuator is designed with a high suction, high flow rate
centrifugal action pump. The ultra-quiet motor is used to draw the smoke from the
surgical site through the vacuum tubing and into the system where it is processed
by a series of filters. A single disposable filter is used to simplify the installation
and removal during filter changes. The filter is completely enclosed to protect the
healthcare personnel from potential contamination during filter changes.
One SEA3700 Filter contains four filtration stages to capture the smoke plume:
• 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.
1-2 RapidVac™ Smoke Evacuator User’s Guide
About the RapidVac Smoke Evacuator
• Stage 4 - An expanded foam used to trap activated carbon fines from
migrating out of the filter.
Features
RapidVac Smoke Evacuator features include:
• Filter-life monitoring for its four-stage, 25-five hour filter
• Standby, RapidVac+, footswitch, or continuous operation modes
• Quiet operation
• Adjustable flow
• Compatibility with all Valleylab electrosurgery pencils and generators
RapidVac+ System
The RapidVac Smoke Evacuator incorporates The RapidVac+ mode which
controls the flow of the smoke evacuator when using a Valleylab electrosurgical
pencil. When the electrosurgical pencil is activated, the smoke evacuator operates
in the preselected flow setting. When the pencil is deactivated, the air flow
reduces to a low-flow purge setting.
Introducing the RapidVac
Smoke Evacuator
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.
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.
100-120 VAC
Cable - SJT16/3, IEC color code, maximum length 15 ft. (5m)
Plug - minimum 10A 125 VAC
Unit receptacle - IEC female, minimum 10A 125 VAC
220-240 VAC
Cable - H05VVF3G1.0 VDE, maximum length 15 ft. (5m)
Plug - minimum 6A 250 VAC
Unit receptacle - IEC female, minimum 6A 250 VAC
Operating Parameters
Ambient temperature range 10° C to 40° C (50° F to 104° F)
Relative humidity 30% to 75%, noncondensing
Transport and Storage
Ambient temperature range -34° C to 65° C (-29° F to 149° F)
Relative humidity 25% to 85%, noncondensing
Patient and Operating Room Safety
General
Warning
Only trained personnel are to operate the RapidVac Smoke Evacuator. Operators
should avail themselves of preclinical training, a review of pertinent literature, and
other appropriate education before attempting to use the RapidVac.
During initial set up, inspect the smoke evacuator for any damage that may have
been caused during shipping. If damaged, do not use or attempt to repair. Call
Valleylab for service assistance.
1-4 RapidVac™ Smoke Evacuator User’s Guide
Patient and Operating Room Safety
Warning
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.
Introducing the RapidVac
Smoke Evacuator
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.
RapidVac™ Smoke Evacuator User’s Guide 1-5
Patient and Operating Room Safety
Warning
If the smoke evacuator is activated while the airflow is set to a high speed, it may
produce a sudden, strong suction action. Check the airflow setting before
activating the smoke evacuator to prevent patient injury and to prevent suction of
surgical materials and surgical specimens.
Caution
Do not stack equipment on top of the smoke evacuator or place the smoke
evacuator on top of electrical equipment. These configurations are unstable and/
or do not allow for adequate cooling.
Use only Valleylab SEA3700 Filters in the RapidVac Smoke Evacuator. Filters
from other manufacturers may cause damage to the system, thereby voiding the
warranty.
Provide as much distance as possible between the smoke evacuator and other
electronic equipment (such as monitors). An activated smoke evacuator may
cause interference with them.
Read all warnings, cautions, and instructions provided with the RapidVac Smoke
Evacuator before using.
To maximize patient safety, the tubing or wand should not come in direct contact
with tissue. Otherwise, patient injury may result.
Do not block either the tubing or the filter. If either becomes occluded or
significantly restricted, the motor/blower may overheat and cause the unit to shut
down.
Care must be exercised in the installation of hoses, adapters and suction
canisters. Failure to follow the procedures outlined in this manual may result in
overheating of the motor and may void the unit warranty.
Notice
Using any unapproved filter or accessory with the smoke evacuator may cause
damage and will void the warranty.
The RapidVac Smoke Evacuator functions properly only when the ULPA filter is
correctly installed. If the filter is installed incorrectly, the amber Replace Filter
indicator flashes and the Service Required indicator is illuminated.
Fluids may damage the filters. When evacuating smoke and incidental fluids,
always use the appropriate tubing,
Connect the power cord to a wall receptacle having the correct voltage.
Otherwise, product damage will result.
Power line voltage below 100 VAC (110V SEA3690) and 200 VAC (220V
SEA3695) will significantly reduce airflow.
Connecting multiple lengths of tubing together may cause the smoke evacuator
to overheat.
1-6 RapidVac™ Smoke Evacuator User’s Guide
Patient and Operating Room Safety
Notice
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.
Maintenance
Warning
Always turn off and unplug the smoke evacuator before cleaning.
The ULPA filter captures potentially hazardous particles. Handle used filters as
you would any biohazardous material. Dispose of filters with other operative
waste materials according to the procedures for your institution.
Introducing the RapidVac
Smoke Evacuator
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.
RapidVac™ Smoke Evacuator User’s Guide 1-7
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