Medivators ADVANTAGE PLUS User manual

1
User
Manual
Endoscope Cleaning and Disinfection System
(With optional cleaning cycle that eliminates manual cleaning)

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CLEVO®is a registered trademark of Clevo Corporation
EPSON®is a registered trademark of Seiko Epson Kabushiki Kaisha
FUJIFILM™ is a trademark of Fujilm Corporation
HEPA®is a registered trademark of HEPA Corporation
JUN-AIR®is a registered trademark of Gast Manufacturing, Inc.
MEDIVATORS®is a registered trademark of Medivators Inc.
ADVANTAGE PLUS®and RAPICIDE®are registered trademarks of Medivators Inc.
INTERCEPT®is a registered trademark of Medivators Inc.
OLYMPUS®is a registered trademark of Olympus Corporation.
PENTAX®is a registered trademark of Hoya Corporation.
WINDOWS®and WINDOWS EXPLORER®are registered trademarks of MICROSOFT Corporation.
XION®is a registered trademark of XION Medical GmbH.
50097-429 REV E– ADVANTAGE PLUS 2.0
© 2016 Medivators Inc.
All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or the use of
this publication is prohibited without the express written consent of Medivators Inc.
Medivators reserves the right to make changes in the specications shown herein without notice or
obligation. Contact your Medivators representative or Medivators customer service for more information.

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TABLE OF CONTENTS
CHAPTER 1
Using this manual ...................................................................................................................5
Safety ......................................................................................................................................6
Operator Safety .......................................................................................................................7
Installation and Maintenance ..................................................................................................9
Guidelines for Reliable Disinfection ....................................................................................10
Professional Guidelines ........................................................................................................12
Reprocessor Specications ...................................................................................................13
Dimensions and Clearances ..................................................................................................14
Installation Specications .....................................................................................................15
Storage ..................................................................................................................................16
Transport ...............................................................................................................................16
Symbols and Icons ................................................................................................................17
Warning Summary ................................................................................................................18
CHAPTER 2
Main Components.................................................................................................................22
Software System ...................................................................................................................33
Printing ................................................................................................................................ 41
Backup ................................................................................................................................ 43
Fluid System .........................................................................................................................44
CHAPTER 3
System Startup ......................................................................................................................54
Daily Service.........................................................................................................................54
Prepare the Endoscope..........................................................................................................62
Disinfection Process Summary.............................................................................................68
Run the Disinfection Program ..............................................................................................69
Cycle Interruptions................................................................................................................74
Taking a Sample of Disinfectant – Check MRC...................................................................77
Complete the Disinfection Process .......................................................................................79
Reports ..................................................................................................................................81
Shutdown ..............................................................................................................................85
Procedure Summary..............................................................................................................86
Downtime..............................................................................................................................86
CHAPTER 4
Daily Maintenance................................................................................................................88
Weekly Maintenance.............................................................................................................88
Monthly Maintenance ...........................................................................................................89
Air Filter Replacement..........................................................................................................89
Water Filter Replacement......................................................................................................92
CHAPTER 5
Introduction.........................................................................................................................100
Error Overview ...................................................................................................................104
System Errors......................................................................................................................109
Barcode Errors ....................................................................................................................113
Endoscope Errors................................................................................................................114

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Reprocessing Cycle Errors..................................................................................................119
Control Errors (SCU)..........................................................................................................126
Warning Errors....................................................................................................................130
CHAPTER 6
MEDIVATORS®ADVANTAGE PLUS®Automated Endoscope Reprocessor Software...138
Management Program.........................................................................................................140
Endoscope Registration ......................................................................................................145
User (operator) Registration ...............................................................................................150
Physician/Assistant Registration.........................................................................................153
Reports ................................................................................................................................155
Events..................................................................................................................................159
Systems ...............................................................................................................................161
LIO Expert Operations........................................................................................................163
Networking .........................................................................................................................167
APPENDIX A .......................................................................................................................171
Registration Forms
APPENDIX B .......................................................................................................................179
Replacement Part Numbers
APPENDIX C .......................................................................................................................181
Warranty

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CHAPTER 1
INTRODUCTION
This chapter describes the MEDIVATORS®ADVANTAGE PLUS®Automated Endoscope Reprocessor.
Using This Manual
This manual describes the features of the MEDIVATORS ADVANTAGE PLUS endoscope reprocessor,
including the hardware, software, setup, operation, safety, maintenance, and troubleshooting procedures. It
is important to follow the instructions provided to keep the MEDIVATORS ADVANTAGE PLUS System
in proper operating order and to ensure that endoscopes receive adequate disinfection.
This is not a service manual and does not provide detailed instructions for service beyond general
maintenance. See Service Manual for servicing instructions. Contact your service representative for
additional service information.
Medivators ADVANTAGE PLUS Features
The MEDIVATORS ADVANTAGE PLUS System was designed for ease of use and maintenance in the
disinfection of endoscopes. Features include:
• Individual channel connectivity and channel blockage monitoring.
• Single use germicide: fresh disinfectant solution for each endoscope.
• Asynchronous operation of dual reprocessing basins with transparent glass lids.
• A dedicated personal computer (PC) for system operation of reprocessing cycle, cycle recording,
powerful quality assurance reporting, easy backups, networking availability, and remote diagnostics
• Easy-to-ll detergent and alcohol reservoirs
• Hookup blocks dedicated to a family of endoscopes ensure correct connectivity and ow rates to meet
manufacturers’ specications
• Diagnostics for operator assistance and troubleshooting
• Cleaning phase validated to eliminate manual cleaning of endoscopes prior to reprocessing (endoscopes
must be pre-cleaned immediately after procedures).

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Safety
Intended Use
The MEDIVATORS®ADVANTAGE PLUS®Automated Endoscope Reprocessor is intended for the
cleaning and high level disinfection of endoscopes and endoscope accessories.
The MEDIVATORS ADVANTAGE PLUS System has been validated by MEDIVATORS for use only
with RAPICIDE®PA High-Level Disinfectant or INTERCEPT®Detergent.
Indications for Use of the ADVANTAGE PLUS System:
MEDIVATORS ADVANTAGE PLUS Endoscope Reprocessing System tests, cleans, disinfects and rinses
endoscopes, such as beroptic and video endoscopes between patient uses. The ADVANTAGE PLUS
system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related
accessories. Manual cleaning of endoscopes is not required prior to placement in the ADVANTAGE PLUS
system. The endoscopes must be pre-cleaned immediately after use.
The ADVANTAGE PLUS Endoscope Reprocessing System uses RAPICIDE PA High Level Disinfectant
to provide high level disinfection of endoscopes when used according to the directions for use. The system
uses INTERCEPT Detergent in its cleaning cycle at a concentration of 0.5%.
RAPICIDE PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is at or
above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the
disinfectant was above MRC during the entire disinfection cycle. RAPICIDE PA should be used in the
ADVANTAGE PLUS System under the following contact conditions*:
Contact Time: 5 minutes
Temperature: 30°C
MRC: 850 ppm
Use-conditions may vary by country. Please contact your MEDIVATORS representative for information.
Caution: When using the cleaning cycle, endoscopes must be precleaned according to SGNAand facility
guidelines. Manual cleaning of the endoscopes is not required. It is recommended that reprocessing
using the cleaning cycle be performed within one hour after the procedure. If the cleaning cycle is not
chosen, endoscopes must be manually cleaned before placing in the Reprocessor for disinfection.

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Regulatory Compliance
The MEDIVATORS®ADVANTAGE PLUS®Automated Endoscope Reprocessor complies with EN
60601-1-2 Electromagnetic Compatibility (EMC) Standards.
The reprocessor is ETL and cETL certied and listed for safety per IEC Standard IEC 61010-1, UL
Standard UL 61010-1 and Canadian Standard CAN/CSA-C22.2 No. 61010-1 for laboratory equipment.
Notes, Cautions, and Warnings
Throughout the manual are notes, service notes, cautions, and warnings. These provide important
information and you should pay special attention to them. Examples are shown below.
Note: A note refers to important information to which you should pay special attention.
Service: A service note refers to operations or repairs that only a trained service technician may
perform.
Caution A caution describes actions or conditions that may cause damage to or destruction of the
equipment.
WARNING A warning describes actions and conditions that may cause severe personal injury
or death to the operator or patient.
Operator Safety
• Equipment must be operated solely by qualied personnel, and used for its intended use only. Never
use the reprocessor for any purpose other than the manufacturer’s specic intended purpose.
WARNING: To avoid biological contamination and chemical burns, always wear appropriate
personal protective equipment (PPE) when handling endoscopes or disinfectant solutions.
• Cleaning and disinfectant solutions must be used according to the regulations governing their use,
safety, and shelf life.
• Do not attempt to open the reprocessor lid during operation.
• Do not place heavy objects on the glass covers.

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• For peracetic acid (PAA) disinfectant handling guidelines, refer to the American National Standard
recommended practice titled, Chemical Sterilants and High Level Disinfectants: A Guide to Selection
and Use (AAMI TIR7:1999) and/or Safe Handling and Biological Decontamination of Reusable
Medical Devices in Health Care Facilities and in Nonclinical Settings (AAMI/ANSI ST35:2003). The
documents are available from the Association for the Advancement of Medical Instrumentation.
• In the event of a disinfectant or other chemical leak, use personal protective equipment (clothing, gloves
& safety glasses) & follow the disinfectant manufacturer’s guidelines for spill clean-up procedures.
• Place guidelines for disinfectant clean-up in an easily visible area near the reprocessor to ensure users
will have access to the information when needed.
• It is recommended that the facility conduct regular training of all personnel concerned with the
operation and maintenance of this equipment, including emergency procedures for toxic, ammable
or pathogenic material released into the environment. Records of attendance at training should be
maintained and evidence of understanding demonstrated.
Handling and storage of 70% Isopropyl Alcohol.
Handling
Avoid prolonged or repeated contact with skin. Extinguish any naked ames. Remove ignition sources.
Avoid sparks. Do not smoke. Take precautionary measures against static discharges. Earth all equipment.
Do not empty into drains.
Handling Temperatures
Ambient.
Storage
Keep away from direct sunlight and other sources of heat or ignition. Do not smoke in storage areas. Keep
container tightly closed and in a well-ventilated place.
Storage Temperatures
Ambient.
Product Transfer
Take precautionary measures against static discharges. Earth all equipment. Avoid splash lling.
Respiratory Protection
No specic measures.
Eye Protection
Monogoggles.
Body Protection
Standard issue work clothes. Safety shoes or boots – chemical resistant.

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Installation and Maintenance
Proper maintenance ensures effective disinfection and prolongs the life of the reprocessor.
• The MEDIVATORS®ADVANTAGE PLUS®Automated Endoscope Reprocessor must be grounded
in accordance with applicable regulations.
• The system default is factory-set for the specic disinfectant immersion time for RAPICIDE®PA.
• All pressure regulators are factory-preset. Do not adjust the settings. Contact your Technical Support
representative for assistance.
• Do not allow the washing solution to contact metal components.
• Do not use alcohol or alcohol-based products to clean the reprocessor cabinet.
• MEDIVATOR endoscope hookups are not autoclavable. The hookups are automatically disinfected
with each use due to their exposure to the entire disinfection cycle; no further disinfection or rinsing
is required prior to their next use.
• Do not remove covers, doors, or panels fastened with screws while the reprocessor is in use.
• Replacement parts must be ordered from the manufacturer to maintain the warranty.
• Do not block ventilation openings.
• Regularly check all cables, tubing, and drains for damage or leaks.
• Do not carry out any maintenance that is not described in this manual.
• Ensure that the power supply connection is accessible in the event that emergency disconnection is
necessary.
• Prior to undertaking any service or maintenance operations or when resetting the GFI, ensure that the
MEDIVATORS ADVANTAGE PLUS System is disconnected from the main power supply. If service
or maintenance operations are to be conducted on the water system, ensure that the MEDIVATORS
ADVANTAGE PLUS System is isolated from the main water supply.
For service or service-related questions, contact MEDIVATORS Technical Support at 1-800-444-4729 in
the United States or your local MEDIVATORS Distributor.

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Guidelines for Reliable Disinfection
Water Quality
Potable water is the minimum standard, Medivators recommends the use of a high quality water pre
ltration system that lters incoming water to a minimum of 0.1 micron. A typical water pre-ltration
system, such as the one offered by Medivators, lters incoming water through a 1 micron, 0.4 micron, and
0.1 micron series of lters.
• The high performance 0.1 micron (absolute rated) water lter included with the reprocessor is highly
effective at removing microorganisms and particles larger than 0.1 microns. Appropriate pre-ltration
and regular disinfection are required to maintain the performance of this lter.
• The routine maintenance schedule recommends replacing the 0.1 micron water lter every six months
or sooner, depending on the pre-ltration system and the quality of the incoming water. If the lter
clogs to the point of non effectiveness, the reprocessor will alarm and will not continue until the lter
is replaced.
Detergent Solution
INTERCEPT®Detergent must be used in the cleaning phase of the reprocessing cycle. INTERCEPT
Detergent is low-foaming and formulated to use with medical instruments. INTERCEPT Detergent has
a neutral pH and also bacteriostatic properties to inhibit bacterial growth in the detergent reservoir and
detergent lines.
Monitoring Disinfectant Potency
The efcacy of a disinfection procedure is directly related to the disinfectant solution used, and the amount
of time the endoscope is exposed to that solution.
• RAPICIDE®PA must be monitored for potency every reprocessing cycle according to the instructions
in this manual.
• Use the RAPICIDE PA test strips to test the potency of the solution. If the potency of the solution is
below MRC minimum recommended concentration (MRC), discard and replace it with fresh solution.
• Never use disinfectant with unacceptable potency levels.
Disinfectant Solution
Use only with RAPICIDE PA High Level Disinfectant (Part A & Part B).

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Endoscope Cleaning and Testing
The MEDIVATORS®ADVANTAGE PLUS®Automated Endoscope Reprocessor may be used with all
makes and sizes of exible, immersible endoscopes that can be internally and externally disinfected.
Proper endoscope disinfection is required because endoscopes have multiple internal valves and channels
that have the potential to harbor microorganisms that could cross-contaminate patients. Reprocessing
quality depends largely on a thorough ushing of all endoscope channels, valves and ttings where
contamination can occur.
This reprocessor includes a cleaning cycle that may be used to eliminate manual cleaning of the endoscopes.
Used endoscopes must be pre-cleaned according to manufacturers, guidelines and your internal facility
procedures before reprocessing. Follow the endoscope manufacturer’s, instructions and established
professional guidelines while pre-cleaning and disinfecting endoscopes. Leak test all endoscopes prior to
disinfection.
If the cleaning cycle is not chosen, endoscopes must be manually cleaned before placing in the reprocessor
for disinfection.
Only INTERCEPT®detergent has been validated for use in the cleaning cycle. It is recommended that
cleaning and reprocessing take place within one hour after the procedure is completed.

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Professional Guidelines
The following organizations have published recommended guidelines for cleaning and disinfecting
endoscopes.
Society of Gastroenterology Assoc. for Professionals in Infection
Nurses and Associates, Inc. Control and Epidemiology, Inc.
401 North Michigan Ave. 1275 K Street NW, Suite 1000
Chicago, IL 60611-4267 Washington, DC 20005-4006
USA USA
Tel: [phone] Tel: [phone]
Fax: [phone] Fax: [phone]
www.sgna.org www.apic.org
American Society for American Society for
Gastrointestinal Endoscopy Testing and Materials
1520 Kensington Rd., Suite 202 100 Barr Harbor Dr.
Oak Brook, IL 60523-2141 West Conshohocken, PA 19428-2959
USA USA
Tel: [phone] Tel: [phone]
Fax: [phone] Fax: [phone]
www.asge.org www.astm.org
Association of periOperative Canadian Society of Gastroenterology
Registered Nurses, Inc. Nurses & Associates
2170 S. Parker Rd., Suite 300 27 Nicholson Dr.
Denver, CO 80231-5711 Lakeside, NS B3T 1B3
USA CANADA
Tel: [phone] Fax: [phone]
Fax: [phone] www.csgna.com
www.aorn.org
British Society of Société Française d’Hygiène Hospitalière S.F.H.H.
Gastroenterology Hôpital de la Croix-Rousse
3 St. Andrews Place Unité d’Hygiène Hospitalière-Épidémiologie
Regents Park 93 Grande Rue de la Croix-Rousse
London NW1 4LB 69317 Lyon Cdx04
ENGLAND FRANCE
Tel: (+44) (0)20 7387 3534 Tél: [phone]
www.bsg.org.uk Fax: [phone]
www.sfhh.net

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Reprocessor Specications
General Specications
The basic reprocessor specications required for installation and operation of the MEDIVATORS®
ADVANTAGE PLUS®Automated Endoscope Reprocessor are summarized in Table 1 .
Table 1 Reprocessor Specications
Equipment Type Laboratory Equipment
Electrical rating 100-240 VAC, 50/60 Hz
Power rating 1000 Watts
Air pressure range 87 – 145 psi (6 - 10 bar)
Water pressure range 35 - 87 psi (2 - 6 bar)
Water ow range 2 – 8 Liters/minute
Water temperature operating range 30ºC – 40ºC, set mixing valve to 35ºC
Humidity range for operation 20–80%, non-condensing
Temperature range for operation 50°F – 80.6°F (10°C - 27°C)
Environment Indoor use only
Installation/Over voltage category II
Pollution degree 2
Connection to power supply Cord connection
Dimensions 45”W X 31” D X 62” H (inches)
114 W X 79 D X 157 H (cm)
Weight 400 lbs. (182 kg)

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Dimensions and Clearances
Figure 1 Front Dimensions
Figure 2 Side Dimensions & Clearance

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Installation Specications
Electrical
The MEDIVATORS®ADVANTAGE PLUS®Automated Endoscope Reprocessor must be connected to a
single electrical outlet capable of supplying 1000 watts at 100-240 volts AC, 50/60 Hz. The outlet must
be properly grounded.
Water
Potable water is the minimum standard. For optimum performance, water must be delivered at a minimum
ow rate of 5 L/min (1.32 gpm) at a dynamic pressure of 30 psi (2 bar) during the basin ll. For optimum
performance water must be delivered at 35ºC by use of a mixing valve (required). The mixing valve
must be purchased separately and installed by the facility. A back siphonage prevention device must be
purchased separately and installed between the water line & the reprocessor to prevent contamination of
the water supply in the event of a sudden drop in water pressure.
Drain
For optimum performance the MEDIVATORS ADVANTAGE PLUS System should be connected to a
vented sanitary drain system capable of draining at a minimum rate of 12 L/min (3.17 gpm).
Room Ventilation
The MEDIVATORS ADVANTAGE PLUS System must be installed in a room with a ventilation system
capable of delivering a minimum of 10 air exchanges per hour.
An optional vapor management system is available for ductless fume removal.
Air
The MEDIVATORS ADVANTAGE PLUS System must be connected to an air supply for proper
operation. The ADVANTAGE PLUS system includes an air compressor that requires a dedicated 120
VAC, 20 Ampere service or 230 VAC, 10 Ampere service. The air compressor delivers proper air ows
and pressure for correct system operation.
If the ADVANTAGE PLUS model purchased did not include the air compressor, the system may utilize
house compressed air (dry, oil free) which must meet these required air pressure specications : 58 to 125
PSI with a minimum ow volume of 1.5 CFM, maximum particle size is 5 microns, maximum dew point
is 7°C (45°F), maximum oil concentration is 5 mg/m3.

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Storage
If the MEDIVATORS®ADVANTAGE PLUS®Automated Endoscope Reprocessor will be out of service
for an extended period of time, the following steps must be followed:
• Remove the side covers, purge all liquids from the system, and then replace the covers.
• Place a covering over the unit to protect it from dust and moisture.
• The storage temperature must not go below 0°C (32°F), or exceed 60°C (140°F).
• The maximum relative humidity must not exceed 80% during storage.
Transport
The MEDIVATORS ADVANTAGE PLUS System can be safely moved on a smooth, level oor. However,
if you encounter any thresholds or oor level changes, the base cover must be removed to avoid damage.
For all other moves, place the MEDIVATORS ADVANTAGE PLUS System on a pallet with a kraft liner.
Before moving MEDIVATORS ADVANTAGE PLUS System, ensure the electrical cord, drain line and
water supply are either disconnected or are appropriate lengths to accommodate the relocation of the
machine.

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Symbols and Icons
Symbol Symbol Meaning Symbol Symbol Meaning
LIO software shortcut Cancel
Management software
shortcut
Next
Server software shortcut Release All
Expert Operation Start
Cancel Stop
Menu Active report, lter applied.
Open/Close Edit
OK/Enter Expand
Scroll Down Export data
Scroll Up Filter data
Start Generate report
Stop Minimize report details
Import data New
The icons in the grayed area are only used by Service Personnel.

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Warning Summary
WARNING Portable and mobile communication devices can affect electrically-operated medical
equipment
WARNING Connecting a chemical container with the incorrect uid may cause the endoscope to
be improperly disinfected. Do not use the endoscope on a patient if this occurs.
WARNING Wear personal protective equipment (PPE) (clothing, mask, gloves & eye wear).
WARNING All endoscope hookups must be periodically inspected for wear. Discard and replace
damaged hookups otherwise it could result in an endoscope that is not disinfected and therefore
should not be used on a patient.
WARNING Verify all connections to the endoscope are secure and tubing is not linked. Failure
to do so could result in an endoscope which is not disinfected and therefore should not be used
on a patient.
WARNING Verify the connection tubing does not interfere with the spray head and conrm that
the spray function is working during the cycle. Failure to do this could result in an endoscope
that is not disinfected and therefore should not be used on a patient.
WARNING Before removing the endoscope, verify all connections to the endoscope are secure.
If an adapter is loose or disconnected, the disinfection was not complete and must be repeated.
Failure to do so could result in an endoscope which is not disinfected and therefore should not
be used on a patient.
WARNING Report all system errors to your supervisor.
WARNING Wear clean gloves to prevent soiling of the disinfected endoscope.
If a run error was generated, a channel is blocked, or the endoscope is leaking, the endoscope
must not be released for patient use. If there is any doubt as to whether an endoscope is
correctly disinfected, it must be disinfected again before use. Contact your supervisor for further
instructions.
Verify all endoscope connections are secure. Failure to do so could result in an endoscope which
is not disinfected and therefore should not be used on a patient.
WARNING Avoid possible chemical burns. Wear personal protective equipment (clothing, mask,
gloves & eye wear).

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WARNING Use only uids approved by Medivators Inc.
Check the expiration date of the disinfectant in the reprocessor each day.
Never use disinfectant beyond the manufacturer’s expiration date, even if the MRC level is
acceptable.
Never use disinfectant that tests below the acceptable MRC level, even if it has not yet reached
the expiration date.
When replacing disinfectant, wear personal protective equipment (clothing, mask, gloves & eye
wear). The disinfectant and detergent manufacturers may recommend additional protection.
If leaking liquid is present and you suspect it is disinfectant, read and follow the disinfectant
instructions before attempting a cleanup.
WARNING Ensure that the reprocessor is installed and maintained in a position that allows
access to the power cord for emergency disconnection if necessary.
Never use the equipment in a manner inconsistent with the manufacturer’s guidelines. Using
the equipment in a manner inconsistent with the manufacturer’s guidelines may impair the
protections that are designed into the device and may cause injury to the user.
RAPICIDE®PA containers must be triple rinsed before disposal.

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NOTE