User Manual
249 Pages
Preview
Page 1
Endoscope Reprocessor
User Manual
Endoscope Disinfection System for Multiple Use Chemistry US and Canadian Version
Clevo is a registered trademark of Clevo Corporation Epson is a registered trademark of Seiko Epson Kabushiki Kaisha Fujinon is a registered trademark of Fujinon Corporation HEPA is a registered trademark of HEPA Corporation Jun-Air is a registered trademark of Jun-Air A/S Medivators is a registered trademark of Minntech Corporation. Medivators ADVANTAGE™ is a trademark of Minntech Corporation. Olympus is a registered trademark of Olympus Corporation. Pentax is a registered trademark of Pentax Precision Instrument Corporation. Windows and Windows Explorer are registered trademarks of Microsoft Corporation. XION is a registered trademark of XION Medical GmbH.
50096-654 Rev C
© 2008, Minntech Corporation 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 Minntech Corporation. Minntech reserves the right to make changes in the specifications shown herein without notice or obligation. Contact your Medivators representative or Medivators customer service for more information.
TABLE OF CONTENTS
CHAPTER 1 - INTRODUCTION... 1-1 USING THIS MANUAL ... 1-3 MEDIVATORS ADVANTAGE SYSTEM FEATURES... 1-3 SAFETY ... 1-4 INTENDED USE ...1-4 REGULATORY COMPLIANCE ...1-4 NOTES, CAUTIONS, AND WARNINGS ...1-5 OPERATOR SAFETY ...1-6 INSTALLATION AND MAINTENANCE ...1-7 GUIDELINES FOR RELIABLE DISINFECTION ... 1-8 WATER QUALITY ...1-8 DETERGENT SOLUTION...1-8 MONITORING DISINFECTANT POTENCY ...1-8 DISINFECTANT SOLUTION ...1-9 ENDOSCOPE PRECLEANING AND TESTING ...1-9 Professional Guidelines...1-10 REPROCESSOR SPECIFICATIONS ... 1-11 GENERAL SPECIFICATIONS ...1-11 DIMENSIONS AND CLEARANCES ...1-12 INSTALLATION SPECIFICATIONS... 1-13 ELECTRICAL ...1-13 WATER ...1-13 DRAIN...1-13 ROOM VENTILATION ...1-13 AIR ...1-13 STORAGE... 1-14 TRANSPORT ... 1-14 SYMBOLS AND ICONS ... 1-15 WARNING SUMMARY... 1-16
i
Medivators ADVANTAGE System
CHAPTER 2 - OPERATOR CONTROLS ... 2-1 MAIN COMPONENTS AND THEIR FUNCTIONS... 2-3 EXTERIOR COMPONENTS ...2-3 INTERIOR COMPONENTS ...2-5 PC AND CONNECTIONS ...2-7 CONTROL PANEL...2-8 Basin Control Buttons...2-9 Touchpad and Mouse Buttons ...2-10 Function Buttons ...2-11 Selection Buttons ...2-12 CONNECTOR BLOCKS ...2-13 ACCESSORIES ...2-13 DATA ENTRY ...2-13 Bar Code Reader ...2-13 SOFTWARE SYSTEM ... 2-14 AVAILABLE PROGRAMS ...2-14 RE-STARTING LIO...2-16 USER SCREEN ...2-18 Menu Bar ...2-19 Module and Program Status...2-20 Heartbeat...2-20 Program Messages ...2-21 Reservoir Status...2-21 System Information ...2-22 LOGIN NAME AND PASSWORD ...2-22 PRINTING ...2-24 Print Service Utility ...2-24 Set the Default Printer ...2-26 BACKUPS ...2-27 Backup Utility...2-27 FLUID SYSTEM ... 2-27 FLUID RESERVOIR STATUS ...2-27 DETERGENT AND ALCOHOL ...2-28 DISINFECTANT ...2-29 Contact Time ...2-28 FLUID ...2-29 Loading Detergent...2-30 Loading Alcohol...2-31
ii
50096-654 Revision C
Table of Contents LOADING DISINFECTANT ...2-33 Disinfectant Change Utilites ...2-33 SETTING HEATER SCHEDULE ...2-48 WATER LINE AND WATER FILTER DISINFECTION ...2-50 TAKING A WATER SAMPLE ...2-55 Aseptic Collection of Water Samples from Sampling Port ...2-56 Taking a Water Sample Using the Expert Screen ...2-57 Extended Water Line Disinfect Parameter Set Disinfectant Procedure ...2-58 Reprocessor Disinfection Summary ...2-60 Automatic Start...2-60 CHAPTER 3 -OPERATION ... 3-1 STARTUP ... 3-3 DAILY SERVICE... 3-3 SYSTEM AIR PRESSURE ...3-3 O-RINGS ...3-5 DRAIN SCREENS ...3-5 CHECKING THE DISINFECTANT POTENCY LEVEL ...3-6 PREPARE THE ENDOSCOPE ... 3-9 PLACE THE ENDOSCOPE IN THE BASIN ...3-9 INSTALL THE CHANNEL SEPARATOR ...3-11 INSTALL THE CONNECTOR BLOCK ...3-12 CONNECT THE CHANNELS...3-14 DISINFECTION PROCESS SUMMARY ... 3-15 CYCLE STARTUP PHASE ...3-16 DETERGENT FLUSH PHASE ...3-16 DISINFECTANT PHASE ...3-16 RINSE PHASE...3-16 ALCOHOL PURGE PHASE (OPTIONAL)...3-16 AIR PURGE PHASE ...3-17 RUN THE DISINFECTION PROGRAM ... 3-17 NORMAL START ...3-17 DELAY START ...3-21 CYCLE INTERRUPTIONS ... 3-22 INTRODUCTION ...3-22 PROGRAM ERRORS ...3-23 Restarting a Program ...3-23 Canceling a Program...3-24 SYSTEM ERRORS ...3-25 iii
Medivators ADVANTAGE System COMPLETE THE DISINFECTION PROCESS ... 3-26 REPORTS ... 3-28 RUN DATA RECORDED ...3-28 PRINTING REPORTS ...3-29 Current Report...3-29 Earlier Reports ...3-29 SHUTDOWN ... 3-32 PROCEDURE SUMMARY... 3-33 DOWNTIME... 3-34 BRIEF DOWNTIME ...3-34 PROLONGED DOWNTIME ...3-34
CHAPTER 4 - MAINTENANCE... 4-1 WEEKLY MAINTENANCE... 4-3 INSPECTION ...4-3 O-RING LUBRICATION ...4-4 BASIN DRAIN FILTER ...4-4 AIR FILTER REPLACEMENT ... 4-4 DISINFECTANT FILTER REPLACEMENT ... 4-6 WATER FILTER REPLACEMENT ... 4-8 AIR COMPRESSOR FILTER REPLACEMENT ... 4-15 FUSE INFORMATION ... 4-18
CHAPTER 5 - TROUBLESHOOTING... 5-1 INTRODUCTION ... 5-3 ERROR REPORTS ...5-3 ONSCREEN PROGRAM PROGRESS ...5-4 PROGRAM INFORMATION ...5-5 EXPERT INFORMATION ...5-5 CYCLES AND PROGRAM ERRORS ...5-5 SYSTEM ERRORS ...5-6 SYSTEM INFORMATION ...5-6 ERROR OVERVIEW ... 5-6 SYSTEM ERRORS ...5-7 BAR CODE ERRORS ...5-7 iv
50096-654 Revision C
Table of Contents ENDOSCOPE ERRORS ...5-8 REPROCESSING CYCLE ERRORS...5-9 CONTROL ERRORS (AS-I)...5-11 WARNINGS ERRORS ...5-11 SYSTEM ERRORS ... 5-12 BAR CODE ERRORS... 5-17 ENDOSCOPE ERRORS... 5-18 REPROCESSING CYCLE ERRORS ... 5-24 CONTROL ERRORS (AS-I)... 5-34 WARNING ERRORS ... 5-39
CHAPTER 6 - SYSTEM ADMINISTRATION ... 6-1 MEDIVATORS ADVANTAGE SYSTEM SOFTWARE ... 6-5 SERVER SOFTWARE ... 6-6 GENERAL INFORMATION ...6-6 FINDING THE SERVER ...6-6 HOSPITAL ADMINISTRATOR LOGIN ...6-7 MANAGEMENT PROGRAM ... 6-8 STRUCTURE ...6-8 GENERAL APPLICATIONS ...6-9 CONFIGURATION APPLICATIONS ...6-9 SETUP ...6-9 NAVIGATION ...6-10 PRINTING ...6-10 DATA MANAGEMENT ...6-11 Backups...6-11 Importing Data ...6-11 Exporting Data...6-12 STANDARD CODING... 6-13 DEVELOPING A SYSTEM ...6-13 BAR CODES (OPTIONAL)...6-14 ENDOSCOPE REGISTRATION ... 6-14 CATEGORIZING ENDOSCOPES ...6-14 ENTERING DATA...6-15 Data Fields ...6-15 Adding Endoscope Types ...6-16 v
Medivators ADVANTAGE System Adding Parameter Sets ...6-17 Adding a New Endoscope ...6-18 Endoscope Sets ...6-18 Endoscope Replacement ...6-19 Editing Data ...6-20 Deleting Data...6-20 USER (OPERATOR) REGISTRATION ... 6-21 USERS/OPERATORS ...6-21 USER GROUPS...6-21 ENTERING DATA...6-22 Adding a New User ...6-22 Changing User Data...6-23 Deleting User Data ...6-23 PHYSICIAN/ASSISTANTS REGISTRATION ... 6-24 GENERAL INFORMATION ...6-24 ADDING PHYSICIAN INFORMATION ...6-25 CHANGING PHYSICIAN INFORMATION ...6-25 DELETING PHYSICIAN INFORMATION ...6-25 REPORTS ... 6-26 INTRODUCTION ...6-26 SELECTING REPORT CRITERIA ...6-27 Time Period Selection ...6-27 Narrow Criteria ...6-27 RUN REPORT ...6-29 RUN DETAILS ...6-29 EVENTS ... 6-30 SYSTEM... 6-32 LIO EXPERT OPERATION... 6-36 INTRODUCTION ...6-36 SYSTEM ...6-37 ASI MASTER (ASC) ...6-38 INPUTS/OUTPUTS ...6-39 TAG ...6-39 NETWORKING ... 6-40 NETWORK SETUP ...6-41 Server (Database PC) ...6-41 Client (Medivators ADVANTAGE System)...6-42 Both PCs (Server and Client ...6-42 vi
50096-654 Revision C
Table of Contents Server (Database PC) ...6-43 Client (Medivators ADVANTAGE System)...6-43
APPENDIX A ... A-1 INSTRUMENT REGISTRATION FORM ... A-3 OPERATOR REGISTRATION FORM ... A-5 PHYSICIAN REGISTRATION FORM... A-7 APPENDIX B ...B-1 REPLACEMENT PART NUMBERS ...B-1 APPENDIX C ... C-1 I.
LIMITED WARRANTY ... C-2
II.
LIMITATION OF REMEDY ... C-2
III. WARRANTY DISCLAIMER... C-3
vii
Medivators ADVANTAGE System
NOTES
viii
50096-654 Revision C
Chapter 1
INTRODUCTION This chapter describes the Medivators ADVANTAGE™ System endoscope reprocessor.
CONTENTS USING THIS MANUAL ...1-3 MEDIVATORS ADVANTAGE FEATURES ...1-3 SAFETY ...1-4 INTENDED USE...1-4 REGULATORY COMPLIANCE...1-4 NOTES, CAUTIONS, AND WARNINGS ...1-5 OPERATOR SAFETY ...1-6 INSTALLATION AND MAINTENANCE ...1-7 GUIDELINES FOR RELIABLE DISINFECTION ...1-8 WATER QUALITY ...1-8 DETERGENT SOLUTION ...1-8 MONITORING DISINFECTANT POTENCY ...1-8 DISINFECTANT SOLUTION ...1-9 ENDOSCOPE PRECLEANING AND TESTING...1-9 Professional Guidelines ...1-10 REPROCESSOR SPECIFICATIONS ...1-11 GENERAL SPECIFICATIONS ...1-11 DIMENSIONS AND CLEARANCES ...1-12 INSTALLATION SPECIFICATIONS...1-13 ELECTRICAL ...1-13
Medivators ADVANTAGE System
WATER ...1-13 DRAIN ...1-13 ROOM VENTILATION ...1-13 AIR ...1-13 STORAGE ...1-14 TRANSPORT...1-14 SYMBOLS AND ICONS ...1-15 WARNING SUMMARY...1-16
1-2
50096-654 Revision C
Chapter 1: Introduction
USING THIS MANUAL This manual describes the features of the Medivators ADVANTAGE 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 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.
M E D I V A T O R S A D VA N TA G E F E A T U R E S The Medivators ADVANTAGE System was designed for ease of use and maintenance in the disinfection of endoscopes. Features include: •
Individual channel connectivity and channel blockage monitoring.
•
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-fill detergent and alcohol reservoirs
•
Hook-up blocks dedicated to a family of endoscopes ensure correct connectivity and flow rates to meet manufacturers’ specifications
•
Diagnostics for operator assistance and troubleshooting
1-3
Medivators ADVANTAGE System
SAFETY Intended Use The Medivators ADVANTAGE System is intended for the high level disinfection of flexible endoscopes. Only use high level disinfectants that are labeled to provide high level disinfection when used according to the manufacturer’s specified conditions and contact times. The Medivators ADVANTAGE System has been validated by Medivators for use with Cidex® OPA and Rapicide High-Level Disinfectants. The use of any other disinfectant requires validation by the user.
Caution
Prior to placing used endoscopes into the Medivators ADVANTAGE system, they must be precleaned and manually cleaned according to the endoscope manufacturers and professional organization guidelines and your facility procedures.
Regulatory Compliance The Medivators ADVANTAGE System complies with EN 60601-1-2 Electromagnetic Compatibility (EMC) Standards, and also meets the IEC 61010-1 electrical safety requirements for laboratory equipment. The reprocessor is ETL and cETL certified and listed, and conforms to UL Standards 61010-1 and CAN/CSA Standard 61010-1.
1-4
50096-654 Revision C
Chapter 1: Introduction
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.
1-5
Medivators ADVANTAGE System
Operator Safety •
Equipment must be operated solely by qualified personnel, and used for its intended use only.
WARNING:
1-6
To avoid biological contamination and chemical burns, always wear appropriate personal protective equipment (PPE) when handling endoscopes or disinfectant solutions.
•
Cleansing 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.
•
For glutaraldehyde disinfectant handling guidelines refer to the American National Standard Safe use and handling of glutaraldehyde-based products in health care facilities (AAMI/ANSI ST 58:2005).
•
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.
50096-654 Revision C
Chapter 1: Introduction
Installation and Maintenance Proper maintenance ensures effective disinfection and prolongs the life of the reprocessor. •
The Medivators ADVANTAGE System must be grounded in accordance with applicable regulations.
•
The system default is factory-set for a specific disinfectant immersion time. This time may only be changed in the system parameters by a qualified individual. Verify the program is appropriate for the disinfectant used.
•
All pressure regulators are factory-preset. Do not adjust the settings. Contact your Technical Support representative for assistance.
•
Do not allow the cleaning solution to contact metal components.
•
Do not use alcohol or alcohol-based products to clean the reprocessor cabinet.
•
The Medivators ADVANTAGE must be used on a level surface only.
•
Medivator endoscope hook-ups 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.
•
Do not disable temperature sensors in heated reservoirs.
•
Ensure that the power supply connection is accessible in the event that emergency disconnection is necessary.
For service or service-related questions, contact Medivators Technical Support at 1-800-444-4729. 1-7
Medivators ADVANTAGE System
GUIDELINES FOR RELIABLE DISINFECTION Water Quality Potable water is the minimum standard, Medivators recommends the use of a high quality water pre filtration system that filters incoming water to a minimum of 0.2 micron. A typical water pre-filtration system, such as the one offered by Medivators, filters incoming water through a 1 micron, 0.45 micron, and 0.2 micron series of filters. •
The high performance 0.2 micron (absolute rated) water filter included with the reprocessor is highly effective at removing microorganisms and particles larger than 0.2 microns. Appropriate pre-filtration and regular disinfection are required to maintain the performance of this filter.
• The routine maintenance schedule recommends replacing the 0.2 micron water filter every six months or sooner, depending on the pre-filtration system and the quality of the incoming water. If the filter clogs to the point of non effectiveness, the reprocessor will alarm and will not continue until the filter is replaced.
Detergent Solution Medivators recommends the use of a detergent solution that is low-foaming and formulated to use with medical instruments. The detergent should have a neutral pH and also bacteriostatic properties to inhibit bacterial growth in the detergent reservoir and detergent lines.
Monitoring Disinfectant Potency The efficacy of a disinfection procedure is directly related to the disinfectant solution used, and the amount of time the endoscope is exposed to that solution.
1-8
•
Disinfectants must be monitored for potency every reprocessing cycle. Consult the disinfectant manufacturer recommendations for monitoring guidelines and procedure.
•
Use the manufacturer’s test strips to test the potency of the solution. If the potency of the solution is below its minimum recommended concentration (MRC), discard and replace it with fresh solution.
•
Never use disinfectant beyond the manufacturer’s recommended reuse life, even if the potency levels is acceptable. 50096-654 Revision C
Chapter 1: Introduction •
Never use disinfectant with unacceptable potency levels, even if the reuse date is unexpired.
Disinfectant Solution A high-level disinfectant specifically manufactured for high-level medical instrument disinfection. The product must be capable of destroying M. tuberculosis. Consult the product label and verify that the Medivators ADVANTAGE System contact time and temperature is correctly configured for the disinfectant solution. The Medivators ADVANTAGE System can only be reconfigured by a service technician.
Endoscope Precleaning and Testing The Medivators ADVANTAGE System may be used with all makes and sizes of flexible, 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 flushing of all endoscope channels, valves and fittings where contamination can occur. Preclean and manually clean used endoscopes to the endoscope manufacturers guidelines and your internal facility procedures prior to disinfection. Leak test all endoscopes prior to disinfection. Follow the endoscope manufacturer’s instructions and established professional guidelines while cleaning and disinfecting endoscopes. Note: that endoscopes with an elevator wire channel requires additional manual cleaning and disinfection steps.
1-9
Medivators ADVANTAGE System
PROFESSIONAL GUIDELINES The following organizations have published recommended guidelines for cleaning and disinfecting endoscopes.
1-10
Society of Gastroenterology Nurses and Associates, Inc. 401 North Michigan Ave. Chicago, IL 60611-4267 USA Tel: 800-245-7462 Fax: 312-527-6658 www.sgna.org
Assoc. for Professionals in Infection Control and Epidemiology, Inc. 1275 K Street NW, Suite 1000 Washington, DC 20005-4006 USA Tel: 202-789-1890 Fax: 202-789-1899 www.apic.org
American Society for Gastrointestinal Endoscopy 1520 Kensington Rd., Suite 202 Oak Brook, IL 60523-2141 USA Tel: 630-573-0600 Fax: 630-573-0691 www.asge.org
American Society for Testing and Materials 100 Barr Harbor Dr. West Conshohocken, PA 19428-2959 USA Tel: 610-832-9585 Fax: 610-832-9555 www.astm.org
Association of periOperative Registered Nurses, Inc. 2170 S. Parker Rd., Suite 300 Denver, CO 80231-5711 USA Tel: 800-755-2676 Fax: 303-750-3462 www.aorn.org
Canadian Society of Gastroenterology Nurses & Associates 27 Nicholson Dr. Lakeside, NS B3T 1B3 CANADA Fax: 902-473-4406 www.csgna.com
British Society of Gastroenterology 3 St. Andrews Place Regents Park London NW1 4LB ENGLAND Tel: (+44) (0)20 7387 3534 www.bsg.org.uk
Société Française d’Hygiène Hospitalière S.F.H.H. Hôpital de la Croix-Rousse Unité d’Hygiène Hospitalière-Épidémiologie 93 Grande Rue de la Croix-Rousse 69317 Lyon Cdx04 FRANCE Tél: 04 72 07 19 83 Fax: 04 72 07 19 85 www.sfhh.net 50096-654 Revision C