Covidien RapidVac Smoke Evacuator Service Manual

Service Manual
RapidVac
TM
Smoke Evacuator
Part Number: 1075303
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 servicing the RapidVac Smoke Evacuator only. Additional
users information is available in the RapidVac Smoke Evacuator User’s Guide.
Equipment covered in this manual:
RapidVac Smoke Evacuator—110 V and 220 V
Device is compliant with the European Communities Council Directive 93/42/EEC,
Medical Device Directive.
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 which may result in product damage.
Important
Indicates an operating tip or maintenance suggestion.
ii
RapidVac Smoke Evacuator Service Manual
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.
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 Service Manual
iii
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Table of Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Chapter 1. Introduction
Parts Shipped with the Smoke Evacuator. . . . . . . . . . . . . . . . . .
About the RapidVac Smoke Evacuator . . . . . . . . . . . . . . . . . . . .
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RapidVac+ System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Service Personnel Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-2
1-2
1-3
1-3
1-3
1-4
1-4
1-6
Chapter 2. Controls, Indicators, and Receptacles
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power On/Off Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Airflow Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Turbo Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Filter-Life Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RapidVac+ Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Footswitch Jack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Service-Required Indicator . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power-Cord Receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Remote Activator Jack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equipotential Grounding Lug . . . . . . . . . . . . . . . . . . . . . . . .
2-2
2-3
2-3
2-3
2-4
2-4
2-4
2-4
2-5
2-5
2-5
2-6
Chapter 3. Technical Specifications
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dimensions and Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Airflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transport and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
EMC for the RapidVac Smoke Evacuator . . . . . . . . . . . . . . . . . .
Electromagnetic Compatibility (IEC 60601-1-2) . . . . . . . . . .
RapidVac Smoke Evacuator Service Manual
3-2
3-2
3-2
3-2
3-2
3-3
3-3
3-3
3-4
3-4
v
Summary of EMC Immunity Test Results . . . . . . . . . . . . . . .
FCC Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Description of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Front Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Standards and IEC Classifications . . . . . . . . . . . . . . . . . . . . .
3-4
3-6
3-7
3-7
3-8
3-9
Chapter 4. Setup and Tests
Cleaning the Smoke Evacuator . . . . . . . . . . . . . . . . . . . . . . . . . .
Testing the Smoke Evacuator . . . . . . . . . . . . . . . . . . . . . . . . . . .
Checking the Remaining Filter Life . . . . . . . . . . . . . . . . . . .
Changing the Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Testing the Airflow Controls. . . . . . . . . . . . . . . . . . . . . . . . .
Installing and Testing the Footswitch (optional). . . . . . . . .
Installing and Testing the Remote Switch
Activator (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Installing and Testing the RapidVac Interlink
Cable (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4-2
4-3
4-3
4-4
4-4
4-5
4-5
4-6
Chapter 5. Troubleshooting
Inspecting the RapidVac Smoke Evacuator . . . . . . . . . . . . . . . . 5-2
Correcting Specific Malfunctions . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Chapter 6. Return Policy and Procedure
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . .
Obtaining a Return Authorization Number . . . . . . . . . . . . . . . .
Returning the Smoke Evacuator for Service. . . . . . . . . . . . . . . .
Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6-2
6-2
6-3
6-3
Chapter 7. RapidVac Schematic
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RapidVac Smoke Evacuator Service Manual
C h a p te r 1
Introduction
This chapter provides an overview of the features and functions of the RapidVac
Smoke Evacuator.
Caution
Read all warnings, cautions, and instructions provided with this system before use.
Read the instructions, warnings, and cautions provided with smoke evacuator accessories before
use. Specific instructions are not included in this manual.
RapidVac Smoke Evacuator Service Manual
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Parts Shipped with the Smoke Evacuator
Parts Shipped with the Smoke Evacuator
When unpacking the smoke evacuator, verify that the following parts are included:
• Power cord
• User’s guide and service manual
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 available from Covidien:
• Replacement RapidVac Filters
• RapidVac Footswitch
• RapidVac Remote Switch Activator
• RapidVac Interlink Cable
• Laparoscopic Smoke Evacuator Tubing Kit
• Hoses, tubing, adapters, wands and other accessories
• Smoke pencil
About the RapidVac Smoke Evacuator
Indications for use for the RapidVac Smoke Evacuator include:
To remove and filter smoke and aerosols from a surgical site produced during
electrosurgical and laser procedures.
The RapidVac Smoke Evacuator is designed with a vacuum motor. The motor is used to
draw 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 SEA3700 filter contains four different stages within to capture the smoke
plume:
• The first stage filtration is a prefilter whose function is to trap and remove gross
particulate.
• The second stage filtration is ULPA (Ultra Low Penetration Air) grade filter whose
high-tech design captures particulates and micro-organisms from .1 to .2 microns at
an efficiency of 99.999%.
• The third stage filtration is comprise 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.
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RapidVac Smoke Evacuator Service Manual
About the RapidVac Smoke Evacuator
RapidVac Smoke Evacuator features include:
• Filter-life monitoring for its four-stage, 25-hour filter
Introduction
Features
• Standby, RapidVac+, footswitch, or continuous operation modes
• Adjustable flow
• Compatibility with all Covidien 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 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:
• RapidVac Remote Switch Activator
• RapidVac 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 interlink cable
or electrosurgery sensor.
• Continuous mode is used to operate the smoke evacuator using continuous airflow.
RapidVac Smoke Evacuator Service Manual
1-3
Service Personnel Safety
Service Personnel Safety
General
Warning
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.
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 institution’s 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, and sound absorbing media within the smoke evacuator.
The RapidVac Smoke Evacuator filter is disposable. Dispose of used filters according to your local
codes and regulations, and follow your institution’s procedures for disposal.
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 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 Covidien Service for additional information.
Do not connect a wet power cord to the wall receptacle.
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.
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.
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RapidVac Smoke Evacuator Service Manual
Service Personnel Safety
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.
Introduction
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 RapidVac SEA3700 ULPA 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 installed properly.
If the filter is installed incorrectly, the amber replace-filter indicator flashes and the Service
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.
RapidVac Smoke Evacuator Service Manual
1-5
Service Personnel Safety
Notice
Power line voltage below 100 VAC (110 V SEA3690) and 200 VAC (220 V SEA3695) will
significantly reduce airflow.
Connecting multiple lengths of tubing together may cause the smoke evacuator to overheat.
The RapidVac 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.
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
biohazard material. Dispose of filters with other operative waste materials according to the
procedures for your institution.
Do not reuse or re-sterilize smoke evacuator accessories labeled “disposable,” “single use only,”
or “sterile.”
Notice
Do not rub, touch, or clean the smoke evacuator with alcohol or caustic, corrosive, or abrasive
cleaning or disinfectant compounds, solvents, or other materials that could scratch the control
panel or damage the smoke evacuator.
Do not autoclave, pressure sterilize, or gas sterilize the smoke evacuator.
Keep the smoke evacuator away from liquids. Liquids that enter the smoke evacuator will damage
internal components.
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RapidVac Smoke Evacuator Service Manual
C h a p te r 2
Controls, Indicators, and Receptacles
This chapter describes the front and rear panels of the RapidVac Smoke Evacuator
Service Manual smoke evacuator, including all controls, indicators, receptacles,
and ports.
RapidVac Smoke Evacuator Service Manual
2-1
Front Panel
Front Panel
+
-
1/4"
6 mm
3/8"
10 mm
7/8"
22 mm
 Power on/off switch
 Airflow indicators (LED)
 Turbo button
 Airflow controls
 Power-on indicator (LED centered in fan symbol)
 Filter-life indicators (LED)
 RapidVac+ button
 Service-required indicator
 Footswitch jack
 Air filter with tubing connectors
2-2
RapidVac Smoke Evacuator Service Manual
Front Panel
Caution
Connect accessories to the proper receptacle type. Otherwise, the smoke evacuator may not
function properly.
The electronic system controls on the RapidVac Smoke Evacuator are easy to understand
and simple to use. The control panel contains the suction on/off switch, suction power
adjustment, filter-life indicator, and service indicator light.
Notice
Power On/Off Switch
The power switch that controls power to the RapidVac Smoke Evacuator is 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.
Controls, Indicators, and
Receptacles
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.
Turn the system power off by placing the power switch in the off position (O).
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. 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 effectively increases the airflow to 100% suction flow to
quickly remove the smoke plume from the surgical site.
RapidVac Smoke Evacuator Service Manual
2-3
Front Panel
Filter-Life Indicator
The filter-life indicator provides a visual indication of the status of the life of the filter in
use. Each illuminated LED represents five hours of remaining time on the 25-hour filter.
The RapidVac Smoke Evacuator tracks the time each filter has been used allowing for an
accurate display of remaining use for new or previously used filters.
Reading the Filter-Life Indicator
Install an unused RapidVac filter into the system. When the smoke evacuator is on, all five
of the filter-life indicator LEDs illuminate indicating the new filter has 100% filter life. The
indicator will regress through subsequent LEDs until the final LED is illuminated indicating
less than 5 hours of filter life remaining. At one hour remaining, the LED changes to
amber. When the time remaining reaches 30 minutes, the amber LED flashes slowly.
RapidVac+ Button
When the smoke evacuator is connected to a generator using the RapidVac 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 RapidVac Footswitch (SEA3745) is available for use with the RapidVac Smoke
Evacuator II.
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 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 Service Manual
Rear Panel
Rear Panel
1
1
3
5
Controls, Indicators, and
Receptacles
4
2
 Cord brackets
 Carrying handle
 Power-cord receptacle
 Remote Activator jack
 Equipotential grounding lug
Power-Cord Receptacle
The cord receptacle provides power to the smoke evacuator using a removable cord
appropriate for regional power supplies. Cord can be wound on the cord brackets to
store with the smoke evacuator.
Remote Activator Jack
A RapidVac Interlink Cable (SEA3730) and Remote Switch Activator (SEA3741) are
available for the automatic remote activation of the RapidVac Smoke Evacuator.
The RapidVac Interlink Cable is compatible with the Covidien Force FXTM, Force EZTM and
ForceTriadTM generators. The cable attaches to a generator’s RF activation port and 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.
RapidVac Smoke Evacuator Service Manual
2-5
Rear Panel
Equipotential Grounding Lug
The equipotential grounding lug provides an alternate route for electrical energy back to
ground when attached to an earth-ground cable.
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C h a p te r 3
Technical Specifications
All specifications are nominal and subject to change without notice.
RapidVac Smoke Evacuator Service Manual
3-1
Performance Characteristics
Performance Characteristics
Dimensions and Weight
Width
14” (36 cm)
Depth
18.75” (48 cm) with cord wrap and handle
Height
8” (20.5 cm)
Weight
20.5 lb (9.9 kg) 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 7/8” x 10’ (2.2 cm x 3 m) tubing with sponge guard.
Airflow measured at sea level.
Safety
3-2
110 Volt
220 Volt
Fuse: 10 AMPS, 250 V (Slo-Blo™*)
Fuse: 8 AMP, 250 V (Slo-Blo)
Power cord:
3-prong hospital grade plug
Power cord:
3-prong locally approved connector
Leakage current: (50/60 Hz)
Leakage current: (50/60 Hz)
Normal polarity, smoke evacuator in
standby mode < 300 µA
Normal polarity, smoke evacuator in
standby mode < 300 µA
Reverse polarity, smoke evacuator in
standby mode < 300 µA
Reverse polarity, smoke evacuator in
standby mode < 300 µA
RapidVac Smoke Evacuator Service Manual
Performance Characteristics
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
Power Cord - SJT, No. 16AWG, 3 Conductor, IEC Female, 125VAC-13A, UL/IEC
Approvals
220 - 240 VAC
Power Cord - HOVV-F3G1.00, IEC Female, 250VAC-10A, EU Approvals
Operating Parameters
Ambient temperature range
50 °F to 104 °F (10 °C to 40 °C)
Relative humidity
30% to 75%, noncondensing
Ambient temperature range
-29 °F to 149 °F (-34 °C to 65 °C)
Relative humidity
25% to 85%, noncondensing
RapidVac Smoke Evacuator Service Manual
Technical Specifications
Transport and Storage
3-3
EMC for the RapidVac Smoke Evacuator
EMC for the RapidVac Smoke Evacuator
Electromagnetic Compatibility (IEC 60601-1-2)
The RapidVac Smoke Evacuator complies with the appropriate IEC 60601-1-2
specifications regarding electromagnetic compatibility.
The RapidVac Smoke Evacuator meets the following requirements:
• ESD Immunity (IEC 60601-1-2 sub-clause 36.202 and IEC 61000-4-2)
• Radiated Immunity (IEC 60601-1-2 sub-clause 36.202.2 and
IEC 61000-4-3)
• Electrical Fast Transient/Burst (IEC 60601-1-2 sub-clause 36.202.3.1 and IEC 61000-44)
• Surge Immunity (IEC 60601-1-2 sub-clause 36.202.3.2 and
IEC 61000-4-5)
• Emissions (IEC 60601-1-2 sub-clause 36.201.1)
• Harmonic distortion (IEC 60601-1-2 sub-clause 36.201.3.1 and IEC 61000-3-2)
• Conducted disturbances (IEC 60601-1-2 sub clause 36.202.6 and IEC 61000-4-6)
• Power frequency magnetic fields (IEC 60601-1-2 sub-clause 36.202.8.1 and IEC
610004-8)
• Voltage dips, short interruptions and variations (IEC 60601-1-2 sub-clause 36.202.7
and IEC 61000-4-11)
Summary of EMC Immunity Test Results
Standard
IEC 61000-4-2
EN 6100-4-2
IEC 61000-4-3
EN 6100-4-3
ENV 50204
IEC 61000-4-4
EN 6100-4-4
IEC 61000-4-5
EN 6100-4-5
3-4
Description
Electrostatic
Discharge
Radiated RF
Immunity
Electrical Fast
Transient
Surge Withstand
Severity Required
•
Performance
Criteria Met
±2kV; ±6kV Discharge
(Directed and Indirect)
• ±2kV; ±4kV; ±8kV
3 V/m, 80–2700 MHz, 2 Hz,
80% AM modulation (Dwell
Time is 1 second for 1kHz
modulation)
• ±2kV on Power Supply
Lines
• ±0.5kV on I/O Lines
• ±2kV on Power Supply
Lines
• ±1kV on I/O Lines
(1)
Performance
Criteria
Allowed
A
A
A
A
A
A
A
A
A
A
A
A
A
A
RapidVac Smoke Evacuator Service Manual
EMC for the RapidVac Smoke Evacuator
Standard
Description
IEC 61000-4-6
EN 6100-4-6
Conducted RF
Immunity
IEC 61000-4-8
EN 6100-4-8
IEC 61000-4-11
EN 6100-4-11
Magnetic Field
Immunity
Dips
Dips
Dropout
Interrupts
IEC 61000-3-2
EN 6100-3-2
IEC 61000-3-3
EN 6100-3-3
Performance
Criteria Met
(1)
Performance
Criteria
Allowed
3V, 150 MHz–80 MHz, 1k
Hz or 2 Hz, 80% AM
modulation (Calibration
required level set to 0–25%
of target voltage.) Patient
coupled leads are tested
with current clamp.
50 and 60 Hz, 3 A/m
A
A
A
A
•
<60% UT (>95%dip in
UT) for 0.5 cycles for 3
times
• 30% 25 cycles for 3
times
• Drop-outs >0.5 cycles
for 3 times
• Interrupts <95% UT
(>95% cycles for 5
times)
Class A
A
A
A
A
A
A
C
C
Pass
Pass
Voltage Fluctuation and
Flicker
Pass
Pass
Variation of power
Pass
Pass
frequency at ±49 Hz,
Dell Time 3 min.
• 61 Hz 3 min. & 61 Hz
for min.
*Note: Applicable to all life support equipment and any equipment with less than 1kVA input power,
equipment with input power above 1kVA and below 16A per phase need only meet criteria B.
(1) Allowed performance criteria is specified in the individual basic standard.
RapidVac Smoke Evacuator Service Manual
•
Technical Specifications
EN 60601-1-2
Clause 6.2.14
Harmonic Current
Emissions
Voltage Fluctuation
and Flicker in LowVoltage Supplies
Variations of power
frequencies
Severity Required
3-5
EMC for the RapidVac Smoke Evacuator
FCC Compatibility
The RapidVac Smoke Evacuator:
• Complies with Part 15 of the FCC rules. Operation is subject to the following two
conditions:
–
(1) This device may not cause harmful interference.
–
(2) This device must accept any interference received, including interference that
may cause undesired operation.
• Has been tested and found to comply with the limits for a Class A digital device,
pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instruction
manual, may cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference, in which case
the user will be required to correct the interference at their expense.
• Utilizes mobile RF communications equipment that can affect medical electrical
equipment.
• Operates in the following radio frequency specifications:
3-6
–
RX modulation: Pulse-width coded, AM 100% modulation
–
TX frequencies: Manchester encoded, A = fc =/-423.75 kHz, B = fc+/-484.29 kHz
Low bit: transition A to B
High bit: transition B to A.
RapidVac Smoke Evacuator Service Manual
Description of Symbols
Description of Symbols
Front Panel
Power Off/On
Turbo Button. Press to jump to maximum suction at 100%
motor speed.
Airflow Control. Press up-arrow button (+) to increase flow
20%, or down-arrow button (-) to decrease flow by 20%.
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,
it signifies the filter has 100% of its filter life remaining.
RapidVac+ Button. Remote Switch Activator cord is attached
to a generator. Electrosurgery sensor will activate the smoke
evacuator.
Footswitch Jack. Attach pneumatic footswitch.
Technical Specifications
Replace Filter. With its position next to the bottom filter-life
indicator, it signifies the filter has no filter life remaining and
needs to be replaced.
Service-required Indicator. After 500 hours of use, the LED
illuminates indicating the motor needs to be serviced.
RapidVac Smoke Evacuator Service Manual
3-7
Description of Symbols
Rear Panel
Remote Activator Connector
Manufacturer
Authorized European Representative
Do not dispose of in unsorted, municipal trash
Date of Product Manufacture, Year - Month
3-8
RapidVac Smoke Evacuator Service Manual
Description of Symbols
Standards and IEC Classifications
Type CF applied part. Complies with IEC 60601-1
IPX1
Protect against dripping water
Non-ionizing electromagnetic radiation
Alternating current
Danger, explosion risk if used with flammable anesthetics
Consult instructions for use (Symbol is white with blue background)
Technical Specifications
To reduce the risk of electric shock, do not remove the cover. Refer
servicing to qualified service personnel. (Symbol is black with yellow
background)
Caution, consult accompanying documents
Product complies with European Product Directives
Indicates the presence of an RFID tag or RFID interrogator
RapidVac Smoke Evacuator Service Manual
3-9
Description of Symbols
MEDICAL - GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL 60601-1, ANSI/AAMI ES60601-1 (2005, 3rd ed.),
CAN/CSA C22.2 NO. 601.1, AND CAN/CSA-C22.2 No. 60601-1 (2008)
9D93
E351320
3-10
RapidVac Smoke Evacuator Service Manual
C h a p te r 4
Setup and Tests
After unpacking the RapidVac Smoke Evacuator, set it up and verify that it
functions correctly by performing the tests described in this chapter.
RapidVac Smoke Evacuator Service Manual
4-1
Cleaning the Smoke Evacuator
Cleaning the Smoke Evacuator
Clean the smoke evacuator before servicing or testing to minimize the risk of coming in
contact with contaminants present from previous use.
Warning
Always turn off and unplug the smoke evacuator before cleaning.
The tubing and filter capture potentially hazardous particles. When removed, handle as you
would any biohazardous material. Dispose of these items with other operative waste materials
according to the procedures for your institution.
Wear appropriate protective gear when cleaning the filter ports and covering flap to avoid coming
in contact with incidental contaminants on these surfaces.
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. Do not spray liquid cleaner into the filter ports.
1. Ensure the power switch on the front panel is off (O).
2. Disconnect the power cord from the wall receptacle.
3. Thoroughly wipe all external surfaces with a mild detergent or disinfectant.
4. Thoroughly clean both sides of the flap covering the filter ports. Do not spray liquid
cleaner into the filter ports.
5. Clean 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 infectioncontrol procedure.
Warning
Wear protective gloves when cleaning around filter ports. Do not place fingers into ports or touch
the internal surface of the ULPA filter. Contaminants may be present.
6. Ensure the smoke evacuator is completely dry before use.
4-2
RapidVac Smoke Evacuator Service Manual
Testing the Smoke Evacuator
Testing the Smoke Evacuator
This section provides instructions for setting up and testing the following smoke
evacuator components:
• RapidVac ULPA Filter
• Airflow controls
• RapidVac footswitch (as applicable)
• RapidVac Remote Switch Activator (as applicable)
• RapidVac Interlink Cable (as applicable)
Checking the Remaining Filter Life
RapidVac Smoke Evacuator filters have a use duration of 25 hours. As a filter is used,
information about the amount of time the individual filter has been used is stored in 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.
1. Turn on the smoke evacuator and insert a filter.
2. Check the filter-life indicators on the front panel to verify the filter has ample
remaining time to complete a procedure.
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
Important
Replace the filter when indicated. Failure to replace the filter may reduce airflow and compromise
the efficiency of the filter.
RapidVac Smoke Evacuator Service Manual
Setup and Tests
Illuminated Filter-Life
Indicators
4-3
Testing the Smoke Evacuator
Changing the Filter
Warning
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.
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 this filter with other operative waste materials according to the procedures
for your institution.
3. Install a new filter in the smoke evacuator as described earlier in this chapter.
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
down-arrow (
) increases or decreases suction.
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.
2. Ensure 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. 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 (
4-4
) button repeatedly to regress through the settings to the lowest setting.
RapidVac Smoke Evacuator Service Manual
Testing the Smoke Evacuator
Installing and Testing the Footswitch (optional)
Use only the RapidVac 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 on the front panel.
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 RapidVac Remote Switch Activator (RSA) 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 is to be mounted.
2. Clean 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 on the back panel of the
smoke evacuator.
6. Turn on the smoke evacuator and press the up-arrow (
) button twice to illuminate
the first two airflow indicators.
7. Press the RapidVac+ button.
8. Set up the surgical pencil and generator as instructed in their user documentation.
9. Drape the ESU wire into the RSA cradle. More than one ESU wire may be placed in
this cradle. 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.
10. An optional delayed stop can be set for the smoke evacuator once deactivation of the
RapidVac Smoke Evacuator Service Manual
Setup and Tests
pencil occurs. Press and hold the button located on the front of the RSA for the
desired amount of delay. This delay can be set from 0-10 seconds. To return to delay
of 0 seconds, tap the button once.
4-5
Testing the Smoke Evacuator
Installing and Testing the RapidVac Interlink
Cable (optional)
The RapidVac Interlink Cable attaches to a RapidVac Smoke Evacuator and a compatible
Covidien generator to synchronize smoke evacuation with the activation of the
generator. The cable is compatible with the Covidien Force FX, Force EZ,
and ForceTriad generators.
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 back panel to access
optional ports.
3. Plug the interlink cable into the generator RF Activation port.
4. Plug the interlink cable into the Remote Activator jack on the back panel of the
smoke evacuator.
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 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 pre-set suction level. When the pencil is deactivated, the smoke
evacuator will return to minimal suction.
4-6
RapidVac Smoke Evacuator Service Manual
C h a p te r 5
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
chapter to assist in identifying and correcting the malfunction.
RapidVac Smoke Evacuator Service Manual
5-1
Inspecting the RapidVac Smoke Evacuator
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 identify and
correct specific malfunctions. After correcting the malfunction, verify that the smoke
evacuator is working properly.
Situation
Possible Cause
Recommended Action
Smoke evacuator is on but
there is minimal or no
vacuum or airflow at the
wand or tubing
Improperly installed ULPA filter
Ensure the ULPA filter is
properly installed. Reposition it
if necessary.
Clogged tubing
Unclog/replace the tubing.
Clogged ULPA filter
Replace the filter.
Obstructed or malfunctioning
motor and/or blower
Contact Covidien service for
assistance.
Disconnected or faulty power
cord
Check and correct the power
cord connections. Check the
cord for damage. Replace cord
if needed.
No power from wall receptacle
(power cord is connected to
wall receptacle, but mode
indicator is not illuminated)
Check the power at the wall
receptacle. Connect power
cord to a functional wall
receptacle.
Power switch on the front
panel is off (O)
Turn the power switch on (|).
Fuses damaged
Contact Covidien service.
Smoke evacuator does not
operate
5-2
RapidVac Smoke Evacuator Service Manual
Correcting Specific Malfunctions
Possible Cause
Recommended Action
Footswitch does not
activate smoke evacuator
when footswitch mode is
selected
Improperly connected
footswitch
Check that the footswitch is
securely connected at the
front of the smoke evacuator.
Malfunctioning footswitch
Replace the footswitch.
Incorrect footswitch
connected to the smoke
evacuator
Connect the RapidVac
Footswitch (SEA3745) to the
smoke 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
evacuator
Contact Covidien service.
No electrical power
Refer to electrical utility
maintenance.
Fuses damaged
Contact Covidien service.
Malfunction in the smoke
evacuator
Contact Covidien service.
Filter incorrectly installed
Reinstall the filter. Ensure the
filter is fully seated in the
smoke evacuator and the
securing tab locks into place.
Malfunction in smoke
evacuator
Contact Covidien service.
RapidVac Interlink cable
incorrectly installed
Ensure the RapidVac Interlink
is properly connected to the
rear panel of the smoke
evacuator and the Covidien
generator.
Remote Switch Activator
incorrectly installed
Ensure the Remote Switch
Activator is connected to the
rear of the smoke evacuator.
Indicator LEDs do not
illuminate
Motor does not run, but
power-on LED illuminates
ESU remote does not
activate when RapidVac
mode is selected
Troubleshooting
Situation
or
Check the ESU pencil lead
installation on the
electrosurgery sensor bobbin.
ULPA filter incorrectly installed
RapidVac Smoke Evacuator Service Manual
Reinstall the filter. Ensure the
filter is fully seated in the
smoke evacuator and the
securing tab locks into place.
5-3
C h a p te r 6
Return Policy and Procedure
Refer to this chapter for information about:
• The manufacturer’s responsibility
• Returning the smoke evacuator for service
• Technical service
RapidVac Smoke Evacuator Service Manual
6-1
Responsibility of the Manufacturer
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 Covidien instructions for use.
For warranty information, refer to the Limited Warranty at the beginning of this guide.
Obtaining a Return Authorization Number
Notice
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
6-2
RapidVac Smoke Evacuator Service Manual
Returning the Smoke Evacuator for Service
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 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 (i.e., hospital, phone number, etc.).
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.
Return Policy and Procedure
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.
Technical Service
For service information, please refer to the Covidien web site: http://
surgical.covidien.com/service-centers
RapidVac Smoke Evacuator Service Manual
6-3
C h a p te r 7
RapidVac Schematic
This chapter contains a schematic drawing for the RapidVac Smoke Evacuator.
RapidVac Smoke Evacuator Service Manual
7-1
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