Service Manual
46 Pages
Preview
Page 1
Service Manual
RapidVac™ Smoke Evacuator
Forward 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. 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 1009803 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 Service Manual
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: ForceTriad™ Energy Platform
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
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.
RapidVac™ Smoke Evacuator Service Manual
iii
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.
iv
RapidVac™ Smoke Evacuator Service Manual
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.
RapidVac™ Smoke Evacuator Service Manual
v
Table of Contents Forward
i-ii
Chapter 1. Introducing the RapidVac Smoke Evacuator Parts Shipped with the Smoke Evacuator About the RapidVac Smoke Evacuator Features 1-3 RapidVac+ System 1-3 Operating Modes 1-3 Service Personnel Safety
1-2
1-2
1-4
General 1-4 Maintenance 1-6
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 Rear Panel
2-4
2-5
Power Cord Receptacle/Fuse Tray 2-5 Remote Activator Jack 2-5 EPROM Jack (Covered) 2-6 Equipotential Grounding Lug 2-6
Chapter 3. Technical Specifications Performance Characteristics
3-2
Dimensions and Weight 3-2 Filter 3-2 Airflow 3-2 Safety 3-2 Power 3-3 Operating Parameters 3-3 Transport and Storage 3-3 EMC for the RapidVac Smoke Evacuator 3-3 Electromagnetic Compatibility (IEC 60601-1-2) Description of Symbols 3-4 Front Panel 3-4 Rear Panel 3-5 Standards and IEC Classifications
3-3
3-5
RapidVac™ Smoke Evacuator Service Manual
vii
Chapter 4. Setup, Tests, and Maintenance Cleaning the Smoke Evacuator Testing the Smoke Evacuator
4-2 4-3
Checking the Remaining Filter Life Changing the Filter 4-4
4-3
Testing the Airflow Controls 4-4 Installing and Testing the Footswitch (optional) 4-5 Installing and Testing the Remote Switch Activator (optional) 4-5 Installing and Testing the Generator Interlink Cable (optional) 4-6 Maintenance 4-7 Motor Brush Replacement
4-7
Chapter 5. Troubleshooting Inspecting the RapidVac Smoke Evacuator Correcting Specific Malfunctions
5-2
5-2
Chapter 6. Return Policy and Procedure Responsibility of the Manufacturer
6-2
Obtaining a Return Authorization Number
6-2
Returning the Smoke Evacuator for Service 6-2 Service Centers
6-3
Chapter 7. RapidVac Schematic
viii
RapidVac™ Smoke Evacuator Service Manual
Section
1
Introducing the RapidVac Smoke Evacuator
This section provides an overview of the features and functions of the ForceTriad energy platform.
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
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 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:
1-2
•
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.
•
Stage 4 - An expanded foam used to trap activated carbon fines from migrating out of the filter.
RapidVac™ Smoke Evacuator Service Manual
About the RapidVac Smoke Evacuator
Features Introducing the RapidVac Smoke Evacuator
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.
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 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. The RapidVac Smoke Evacuator filter is disposable. Dispose of used filters according to your local codes and regulations, and follow your institutions 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 Valleylab 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.
1-4
RapidVac™ Smoke Evacuator Service Manual
Service Personnel Safety
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 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. 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 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.
RapidVac™ Smoke Evacuator Service Manual
1-5
Introducing the RapidVac Smoke Evacuator
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.
Service Personnel Safety
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.
Caution Do not reuse or resterilize 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.
1-6
RapidVac™ Smoke Evacuator Service Manual
Section
2
Controls, Indicators, and Receptacles
This section describes the front and rear panels of the smoke evacuator, including all controls, indicators, receptacles, and ports.
RapidVac™ Smoke Evacuator Service Manual
2-1
Front Panel
Front Panel
RapidVac Smoke Evacuator
+ -
1/4" 6 mm
3/8"
10 mm 7/8"
22 mm
RapidVac Smoke Evacuator Filter
1 Power On/Off switch 2 Air-flow indicators (LED) 3 Turbo button 4 Air-flow controls 5 Power on indicator (LED centered in fan symbol) 6 Filter life indicators (LED) 7 RapidVac+ button 8 Service required indicator 9 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. Accessory equipment connected to interfaces must be certified according to IEC 60601-1-1. All configurations shall comply with the system standard IEC 60601-1-1. The user is responsible for verifying that accessory equipment connections comply with the system requirements of IEC 60601-1-1. If in doubt, contact Valleylab.
The electronic system controls on the RapidVac Smoke Evacuator are easy to understand and simple to use. The control panel contains the suction on/off switch, suction power adjustment, filter life indicator, and service indicator light.
Read all instructions before installing accessories or operating this equipment. Failure to do so may result in damage to the unit and/or personal injury.
Power On/Off Switch The power switch that controls power to the RapidVac Smoke Evacuator is located in the lower-left corner of the front panel. To power up the smoke evacuator, place the power switch in the ON position ( l ). The smoke evacuator starts in standby (system power is on with no suction). When the smoke evacuator is on in standby, the LED in the center of the fan symbol on the front panel will blink continually until a fan speed is selected. Turn the system power off by placing the power switch in the OFF position ( O ).
Air Flow Controls The level of suction is controlled by the air-flow controls. up-arrow ( ) and down-arrow ( ) buttons. To start the fan from standby mode, press the up-arrow button. It starts in the lowest suction setting indicated by a single illuminated airflow indicator. The suction control should be set at the lowest practical setting to completely remove the surgical smoke from the operative site. Pressing either the up- or down-arrow buttons changes the current suction level by 20%. The selected level of suction is displayed by the air-flow indicator LEDs.
Turbo Button When increased smoke removal is necessary, the Turbo button may be pressed at anytime to increase suction. Turbo mode effectively increases the airflow to 100% suction flow to quickly remove the smoke plume from the surgical site.
RapidVac™ Smoke Evacuator Service Manual
2-3
Controls, Indicators, and Receptacles
Notice
Front Panel
Filter Life Indicator The filter life indicator provides a visual indication of the status of the life of the filter in use. Each illuminated LED represents five hours of remaining time on the 25-hour filter. The RapidVac Smoke Evacuator tracks the time each filter has been used allowing for an accurate display of remaining use for new or previously used filters. Reading the Filter Life Indicator Install an unused RapidVac filter into the system. When the smoke evacuator is on, all five of the filter life indicator LEDs illuminate indicating the new filter has 100% filter life. The indicator will regress through subsequent LEDs until the final LED is illuminated indicating less than 5 hours of filter life remaining. At one hour remaining, the LED changes to amber. When the time remaining reaches 30 minutes, the amber LED flashes slowly.
RapidVac+ Button When the smoke evacuator is connected to a generator using the Generator Interlink Cable, pressing the RapidVac+ button synchronizes the smoke evacuator with the use of an electrosurgical pencil. When a pencil is activated, the smoke evacuator activates to a preselected air flow level.
Footswitch Jack A RapidVac Footswitch (SEA3745) is available for use with the RapidVac Smoke Evacuator. A footswitch may be added to any system by simply plugging it into the footswitch jack on the front panel. The unit may be turned on or off by depressing the footswitch pedal once for each operation. For footswitching operation, the smoke evacuator should be on and the suction level to be activated from the footswitch should be selected on the control panel.
Service Required Indicator The motor powering the RapidVac Smoke Evacuator has two motor brushes that require regular maintenance every 500 hours. When the smoke evacuator has been in use for 500 hours, the Service Required Indicator illuminates. Replace the motor brushes as directed in “Motor Brush Replacement” on page 4-7. After brush replacement, reset the system by simultaneously depressing the up- and down-arrow air flow controls until the Service Required Indicator turns off.
2-4
RapidVac™ Smoke Evacuator Service Manual
Rear Panel
Rear Panel
250V, T10.0A-(100-120V) 250V, T8.0A-(220-240V)
Remote Activator
Controls, Indicators, and Receptacles
1 Cord brackets 2 Carrying handle 3 Power-cord receptacle/fuse tray 4 Remote Activator jack 5 EPROM jack 6 Equipotential grounding lug
Power Cord Receptacle/Fuse Tray 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. Two 10 AMP fuses in the 110V model (8 AMP for 220V) are located in a removable tray adjacent to the cord receptacle. Fuses electrically protect the system from damage and the operator from injury. If the system is overheated or if there is an electrical surge in the electrical system, fuses will open and the system will not operate. To re-start the system, unplug the power cord and replace the fuses.
Remote Activator Jack A Generator Interlink Cable (SEA3730) and Remote Switch Activator (SEA3740) are available for the automatic remote activation of the RapidVac Smoke Evacuator.
RapidVac™ Smoke Evacuator Service Manual
2-5
Rear Panel
The Generator Interlink Cable is compatible with the Valleylab Force FX™, ForceEZ™, and ForceTriad™ generators. It 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 is a programmable switch that plugs into the smoke evacuator jack and is attached to an electrosurgical generator. The remote switch is programmed to recognize the audible tones used by the generator. When the tone for cut or coag sounds, the remote switch automatically initiates the pre-set suction.
EPROM Jack (Covered) The EPROM jack located under the secured cover is to be used only by qualified Valleylab service technicians to update the smoke evacuator’s software.
Equipotential Grounding Lug The equipotential grounding lug provides an alternate rout for electrical energy back to ground when attached to an earth-ground cable.
2-6
RapidVac™ Smoke Evacuator Service Manual
Section
3
Technical Specifications
All specifications are nominal and subject to change without notice.
RapidVac™ Smoke Evacuator Service Manual
3-1