Cantel Medical MEDIVATORS CER OPTIMA User Manual
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Cantel Medical MEDIVATORS CER OPTIMA User Manual

Endoscope reprocessing system
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Summary of Contents for Cantel Medical MEDIVATORS CER OPTIMA

  • Page 1 User Manual...
  • Page 2 MEDIVATORS , RAPICIDE , CER OPTIMA are registered trademarks of Medivators Inc. ® ® ® CIDEX is a registered trademark of Advance Sterilization Products. ® 50097-776-EN Rev F © 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.

  • Page 3: Table Of Contents

    TABLE OF CONTENT Chapter 1 - INTRODUCTION Using this Manual ..........................5 Indications for Use ........................5 Safety .............................. 6 Intended Use ..........................6 Operator Safety ......................... 6 Moving the CER OPTIMA Endoscope Reprocessing System ............6 ® Installation and Maintenance ..................... 7 Water Quality and Filtration ......................
  • Page 4 Chapter 4 - OPERATION Power ............................32 Water Supply ..........................32 Heated Disinfectant Reservoir ....................... 32 Control Panel ..........................34 Function Keys ..........................34 Prepare Endoscopes for Reprocessing ..................41 Place Endoscopes into Reprocessor ....................41 Endoscope Hookups ........................43 Power CER OPTIMA Endoscope Reprocessing System On ............

  • Page 5: Chapter 1 - Introduction

    An example of each is illustrated below. Indications for Use MEDIVATORS CER OPTIMA Endoscope Reprocessing System, washes, disinfects and rinses flexible endoscopes, including fiberoptic, ultra-sound and video endoscopes between patient uses. The CER OPTIMA System is indicated to provide high level disinfection, using RAPICIDE High-Level Disinfectant, Glutaraldehyde ®...

  • Page 6: Safety

    Safety This section outlines general safety guidelines for proper operation and service of the reprocessor. Failure to follow these guidelines may result in severe injury or death to the patient and/or operator. Read and understand all operating and service procedures before attempting to operate the reprocessor. If the equipment is not used as specified, the the ability of the equipment to high level disinfect an endoscope may be at risk.

  • Page 7: Installation And Maintenance

    Note: Prior to undertaking any service or maintenance operation, or when resetting the GFI ensure that the CER OPTIMA system is disconnected from the ® main power supply. If service or maintenance operations are to be conducted on the water system, ensure that the CER OPTIMA system is isolated from the main water supply.

  • Page 8: Chemicals

    • The routine maintenance schedule recommends replacing the 0.2-micron water filter every 6 months or sooner, depending on the pre-filtration system and the quality of the incoming water. Never use a nominal 0.2 micron water filter. • Incoming water supplied (upstream of the external pre-filtration system) should be shut-off at the end of every work day.

  • Page 9: Monitoring Disinfectant Potency

    Medivators only recommends the use of the HLD that is legally marketed and FDA cleared as a high-level disinfectant/sterilant for use on flexible endoscopes and medical devices/instruments. Refer to the FDA website to confirm the HLD is cleared for use. It is the user’s responsibility to ensure the HLD used per the disinfectant manufacturer’s instructions, including the proper contact time, use temperature, and post rinses.

  • Page 10: Endoscope Hookups

    Caution! The use of accessories, components and cables other than those specified by Medivators, as replacement parts for internal components or for external accessories and connections, may result in increased emissions or decreased immunity of the CER OPTIMA Endoscope Reprocessing System. ®...
  • Page 11 • Endoscopes must be inspected for damage and verified to be in proper working order prior to hookup connection. If cleaning or leak testing identifies endoscope damage or channels that may be restricted or obstructed, the endoscope should be repaired before further reprocessing. Connection of hookups to damaged endoscopes, or endoscopes with restricted or obstructed channels may result in inadequate high level disinfection.

  • Page 12: Cleaning And Disinfection

    Cleaning and Disinfection Always follow established professional guidelines while cleaning and disinfecting endoscopes. The following organizations have published recommended guidelines. Society of Gastroenterology Association for Professionals in Nurses and Associates Infection Control and Epidemiology, Inc. 401 North Michigan Ave. 1275 K Street, NW, Suite 1000 Chicago, IL 60611-4267 Washington, DC 20005-4006 TEL: (800) 245-7462...
  • Page 13 Guidance and Manufacturer’s declaration - electromagnetic emissions The CER OPTIMA Endoscope Reprocessing System is intended for use in the electromagnetic environment specified below. The customer or ® the user of the CER OPTIMA system should assure that it is use in such an environment. Emissions test Compliance Electromagnetic Environment - guidance...
  • Page 14 Guidance and Manufacturer’s declaration - electromagnetic immunity The CER OPTIMA Endoscope Reprocessing System is intended for use in the electromagnetic environment specified below. The customer or ® the user of the CER OPTIMA system should assure that it is use in such an environment. IEC 61326-1 Compliance Immunity test...
  • Page 15 Recommended separation distance between portable and mobile RF communications equipment and the CER OPTIMA Endoscope Reprocessing ® System The CER OPTIMA system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CER OPTIMA system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and CER OPTIMA system as recommended below, according to the maximum output power of the communications equipment.

  • Page 16: Specifications

    Specifications Dimensions Chassis Dimensions 16 X 22 X 20-inches 33-inches with lid open (height - width - depth) 41 x 56 x 51cm 84cm Add 4” to width when barcode scanner mounted Weight CER-1 OPTIMA (120V) 71 lb 32 kg (approx) CER-2 OPTIMA (120V) 77 lb 35 kg (approx) CER-1 OPTIMA (230V)

  • Page 17: Water Supply

    CHAPTER 2 PLUMBING & ELECTRICAL SPECIFICATIONS Reference the “CER OPTIMA Pre-site Installation Instructions” the “CER OPTIMA Installation Instructions” ® and the “CER OPTIMA Water Filtration Installation Instructions” for further CER OPTIMA Installation details. Water Supply Water flow rate into reprocessor is a minimum of 2 to 3 gallons (7.6 L to 11.3 L) /minute. Water pressure: Minimum 40 psi (2.8 bar) Maximum 60 psi (4.1 bar) Temperature:...

  • Page 18: Drain

    Drain A facility drain pipe having a minimum 1-1/2 inch diameter must be placed at least 1 foot below the CER OPTIMA Endoscope Reprocessing System drain fitting to ensure complete draining of fluids from the unit. ® The drain fitting on the reprocessor is 1 1/4-inch OD with ¾-inch ID pipe thread. It is recommended that the reprocessor be installed with the 4-foot flexible drain hose supplied with each reprocessor.

  • Page 19: Chapter 3 - Installation

    CHAPTER 3 INSTALLATION Installation Instructions Reference the “CER OPTIMA Pre-site Installation Instructions”, the “CER OPTIMA Installation ® Instructions” and the “CER OPTIMA Water Filtration Installation Instructions” for further CER OPTIMA Installation details. Counter Top Installations All models Counter top must be a minimum of 24-inches (61cm) deep. It is necessary to cut two, 2-inch (5.1cm) holes in the counter top to allow passage of the drain pipe and disinfectant reservoir tubing from under the counter.

  • Page 20: Water Filtration System

    Water Filtration System Connection of Filtration System to the Water Source. IN Port ¾-inch hose connection OUT Port Quick connect fitting 0.2 micron absolute 1 micron nominal Post-filter Pre-filter Figure 3. Water Filtration Unit Figure 2. Water Filtration Unit Tap into the water line. This must be done by qualified personnel. Attach the provided male quick connect to the water line.
  • Page 21 Connection of the filtration system hose to the reprocessor. • Connect the provided stainless steel hose between the hose fitting on the post filter side and the blue hose fitting on the back of the reprocessor. Installation, Sanitization and Maintenance of Water Filtration System. Note: Water filters must be replaced every three to six months depending on water quality.
  • Page 22 Transfer Pump Filtration One Gallon System Disinfectant Container Figure 3. Transfer Pump Connected to Prefilter and Solution • Insert the inlet tubing of the transfer pump into a one gallon disinfectant container. • Press START on the reprocessor. • Turn the transfer pump ON until the pre-filter canister is filled up and the disinfectant solution starts flowing continuously in the basin.

  • Page 23: Reprocessor Installation

    Without using the Disinfectant Transfer Pump. • Fill each housing with approximately 40-ounces of high level disinfectant. • Screw the housings into the bracket. Make sure that the filters are well seated into the peg in the lid of the housing. If the pre-filter and the gasket are not properly seated, the housing will not screw into the bracket.

  • Page 24: Water

    Reservoir tubing Figure 4. Rear of Model CER-2 OPTIMA Reprocessor Water See Water Supply Section Drain Connect the flexible drain hose to the fitting labeled “DRAIN” fitting on the back of the reprocessor and attach the screw clamp. The drain must be 12-inches below the drain fitting on the reprocessor. Eliminate all loops in the drain hose in order for fluids to drain completely.

  • Page 25: Power

    Use the supplied plug, to block off the unused connection point located on the disinfectant reservoir. For all reprocessor models, plug the electrical cord FIRMLY into the power entry module on the right side of the reprocessor. Plug the other end into a standard AC power outlet. Caution! Only outlets outfitted with a ground fault interrupter (GFI) can be used.

  • Page 26: Channel Connectors

    Channel Connectors Attach the channel connectors to the quick-release connections in the basin. Be sure to attach them firmly until they “click” in. Accessory Bag Place the accessory bag with drawstring into the basin. Caution: DO NOT place the accessory bag over drain screen. Incomplete draining could result.

  • Page 27: Disinfectant Reservoir

    Disinfectant Reservoir The reservoir can be installed: • Under the counter. • On the bottom of the custom cart. Caution! Do not put the reservoir next to the reprocessor. The HLD may seep back into the basin overnight. The reservoir must be lower than the basin. Filling and Emptying the Disinfectant Reservoir Caution! Always use personal protective clothing when handling and transferring disinfectant.

  • Page 28: Alternative Filing Method

    Place the rigid end of tube “A” into the disinfectant container and the opposite end to the inlet of the transfer pump. Connect tube “B” between the outlet of the pump and the reservoir. Connect tube “B” between the outlet of the pump and the adapter. •...

  • Page 29: Empty The Reservoir Using Transfer Pump & Tubing Set

    Figure 7. Disinfectant Transfer Pump Empty the reservoir using Transfer Pump and Tube set Note: Some local, regional, or national agencies require neutralization of the solution prior to disposal. Use the MEDIVATORS MediNewt™ system if disinfectant neutralization is required. 1. Plug the Transfer Pump into a standard power outlet. 2.

  • Page 30: Emptying Using Manual Method

    5. Continue to pump until all of the disinfectant has been pumped out of the reservoir. (You might need to lift one end of the reservoir to remove all disinfectant.) 6. Turn the pump OFF. 7. Flush the Transfer Pump with clear water. Refer to “Flushing the Transfer Pump and all tubing”. Alternative Emptying Method Emptying using Manual Method 1.

  • Page 31: Chapter 4 - Operation

    CHAPTER 4 OPERATION Note: Effective endoscope reprocessing can only be accomplished by a complete and thorough manual precleaning process. This process must be completed prior to the immersion of an endoscope in disinfectant solution using the automated endoscope reprocessor. The CER OPTIMA Endoscope Reprocessing System will effectively reprocess immersible endoscopes available ®...

  • Page 32: Power

    Power The power switch for all models of the endoscope reprocessor is located on the right side of the unit. Caution: Turning the power ON and then OFF during a cycle will reset the reprocessor. To avoid an overflow, any fluids remaining in the basin must be either returned to the reservoir or manually drained before restarting.
  • Page 33 3. To confirm the actual temperature of the disinfectant in the reservoir, the CER OPTIMA system front ® panel LCD will display the disinfectant temperature during the HLD reprocessing cycle step. It will also document this information on the cycle printout. 4.

  • Page 34: Control Panel

    Control Panel The control panel allows the operator to select a cycle, adjust cycle settings, view system and cycle status, view alarm conditions, and fully operate the reprocessor. Figure 10. Control Panel Function Keys The function keys control the operation of the CER OPTIMA endoscope reprocessor.
  • Page 35 • The ALCOHOL volume is selectable from: • CER-1 OPTIMA: 0, 30, and 60cc’s • CER-2 OPTIMA: 0, 30, 60 and 120cc’s • HLD/RINSE Cycle: Sets the reprocessing cycle to automatically provide a 1 minute water purge, HLD exposure, post-rinses (HLD dependent) and air and alcohol endoscope flushing (if selected). •...
  • Page 36 • AIR: Shutting of all AUTOMATIC and MANUAL functions and then pressing the AIR button alone, allows a separate AIR cycle to be performed. The AIR time is pre-selected by the operator from 0, 3, 5, and 10 minutes, prior to starting the cycle. •...
  • Page 37 ALARM RESET The ALARM RESET key allows cycle alarms to be reset. The CER OPTIMA system continuously monitors for alarm conditions during a reprocessing cycle. This ® includes sensor monitoring and also electronic software monitoring for cycle anomalies. The cycle alarm feature detects and then alerts the operator by an audible alert tone, and also a visual notification on the display screen.
  • Page 38 Arrow & Enter Keys The ARROW and ENTER keys provide operator access to special CER OPTIMA Endoscope Reprocessing ® System sub-menus. These menus allow the CER OPTIMA unit to run, display and print a reprocessing cycle custom configured by an operator. With all AUTOMATIC and MANUAL functions turned off, press the ↓...
  • Page 39 Automatic (Full) Cycles AUTOMATIC FULL CYCLE HLD/Rinse Wash Alcohol Start/Stop Reprocessing Step Full LED Air LED Wash (Fill/Circulation/Drain) Blinking Blinking On - Green Rinse (Drain/Air) Blinking On - Green HLD Disinfect Blinking On - Green Rinse 1 (Fill/Drain/Air) Blinking On - Green Rinse 2 (Fill/Drain/Air) Blinking On - Green...
  • Page 40 MANUAL FUNCTIONS Basin to Reservoir Basin Start/Stop HLD to Wash Alcohol Function Reservoir to Basin to Drain Air LED Drain LED Basin to Reservoir On - Green Blinking Basin to Reservoir Completion Off - Red HLD to Drain On - Green Blinking HLD to Drain Completion Off - Red...

  • Page 41: Prepare Endoscopes For Reprocessing

    Prepare Endoscopes for Reprocessing A manual, thorough cleaning of endoscopes is always necessary immediately after each patient use. Clean within 5-minutes to prevent blood, mucous or other debris from drying. Follow the instructions in the current ASTM guideline, for reprocessing of flexible endoscopes. Always wear the recommended personal protective gear when reprocessing endoscopes.
  • Page 42 Note: In order to immerse some video endoscopes, it is necessary to place the head of the first endoscope with the control wheels up at the left rear of the basin. The second endoscope can be placed with the head at the left front of the basin with the control wheels down.

  • Page 43: Endoscope Hookups

    Figure 12. One and Two endoscopes loaded into the CER-2 OPTIMA basin Endoscope Hookups Endoscopes attach to the CER OPTIMA basin connectors using specific tubing hookups. For proper ® endoscope hookup identification, use the online interactive “Hookup Guide” located on the Medivators website at: http://www.medivators.com/HookupLookup/.

  • Page 44: Power Cer Optima ® Endoscope Reprocessing System On

    CAUTION! EACH ENDOSCOPE HOOKUP IS INTENDED ONLY FOR CONNECTION WITH SPECIFIC ENDOSCOPE MODELS IDENTIFIED IN THE MEDIVATORS ONLINE HOOKUP. PROPER ENDOSCOPE MODEL AND HOOKUP COMBINATIONS, INCLUDING CONNECTIONS FOR ALL APPROPRIATE ENDOSCOPE CHANNELS THAT REQUIRE A SEPARATE REPROCESSING CONNECTION, MUST BE VERIFIED PRIOR TO CONNECTION. Power CER On Using the power switch located on the right side of the unit, turn the CER OPTIMA Endoscope Reprocessing...

  • Page 45: Cycle Selection: Automatic Or Manual

    Cycle Selection: Automatic or Manual Use the control panel keys to select the cycle to be run on the CER OPTIMA endoscope reprocessor. ® Selecting an AUTOMATIC Cycle The CER OPTIMA system allows for either an AUTOMATIC “FULL” or “HLD/RINSE” cycle. The difference between the two cycles is the WASH phase;...
  • Page 46 • If detergent is preferred for the wash phase, then manually add the detergent when the “WASH” led light is blinking and the display screen shows WASH. • During the HLD phase, the basin disinfectant temp will be displayed in Celsius ±1°C. •...
  • Page 47 • Press the ALCOHOL key multiple times to cycle through and select the desired alcohol flush volume of: • CER-1 OPTIMA: 0, 30, and 60cc’s • CER-2 OPTIMA: 0, 30, 60 and 120cc’s • Press START/STOP key to begin the HLD/RINSE cycle. •...
  • Page 48 Caution! An endoscope having a loose or disconnected hookup tubing at the completion of a reprocessing cycle must be treated as still being contaminated and cannot be used for a patient procedure. The endoscope reprocessing cycle must be repeated. Do not use this endoscope on a patient. •...
  • Page 49 • MANUAL “HLD to DRAIN” Cycle: Sets the reprocessing cycle to transfer disinfectant from the reservoir into the basin and immediately down the drain, all in one step. Note: The HLD CYCLE COUNT will be rest to “0” when the START key is pressed. This allows the operator to easily replace the high-level disinfectant, and automatically reset the cycle counter at the same time.
  • Page 50 • MANUAL “BASIN to DRAIN” Cycle: Sets the reprocessing cycle to transfer basin solutions to drain. • Press the MANUAL “BASIN to DRAIN” key, and the LED light will now illuminate. • Press START/STOP key to begin transferring basin solutions from the basin to drain. The START/ STOP light will illuminate green, the BASIN to DRAIN key will begin blinking, and the display screen will show BASIN to DRAIN.
  • Page 51 • MANUAL “AIR” Cycle: Sets the reprocessing cycle to perform a separate Air purge cycle. • Press the MANUAL “AIR” key multiple times to cycle through and select the desired air purge time of 0, 3, 5 and 10 minutes. The Air LED light will now illuminate. •...
  • Page 52 • Combination MANUAL “WASH, AIR and/or ALCOHOL” Cycle: Sets the reprocessing cycle to perform any combination of Wash, Air and Alcohol cycles. • Press the MANUAL “WASH”, “AIR” and/or “ALCOHOL” keys to select the desired cycle. • Pressing the MANUAL “WASH” key multiple times to cycle through and select the desired cycle wash time: •...

  • Page 53: Shutdown

    Shutdown Use the following process to shutdown the reprocessor at the end of the day. 1. Close the incoming water line shutoff valve. 2. Wipe out the CER OPTIMA unit basin using a lint-free cloth only. Do not use gauze, cotton swab, towel ®...
  • Page 54 Reinsert the basin drain screen over the CER OPTIMA unit drain opening, ensuring it is securely in ® place. Press the ENTER arrow key to continue the test. Caution! A basin drain screen must always be in place. Failure to use this item could result in unexpected servicing of the CER OPTIMA unit, due to small endoscope components getting inside the internal working hydraulics and mechanisms of the CER OPTIMA unit.
  • Page 55 Quality Assurance Test Completion The CER OPTIMA Endoscope Reprocessing System will automatically generate a printout upon completion ® of the QA test. Note: Contact your local representative or MEDIVATORS Customer Support (1-800-444-4729) if water or air does not flow through all of the channel connectors.
  • Page 56 6. Accessory Bag Endoscope accessories such as buttons and valves may be disinfected in the CER OPTIMA endoscope ® reprocessing system using the supplied accessory bag. Never place small items directly in the basin, as it could result in damage to the CER OPTIMA system. Also, never place the accessory bag near or over the CER OPTIMA drain which will block fluid flow.

  • Page 57: Chapter 5 - Maintenance & Troubleshooting

    CHAPTER 5 MAINTENANCE & TROUBLESHOOTING Introduction If a problem occurs, please use this section to locate the cause. It is best to review main topics to help identify the problem. Listed below are possible solutions to problems which might occur. Note: Contact your local representative or Medivators Customer Support (1-800-444-4729) if problem is not resolved after using the Troubleshooting Guide.

  • Page 58: Printer Paper

    Remove and replace, or refill, the alcohol bottle. Step 4: Reinsert the uptake tube into the alcohol bottle, tighten the alcohol Step 5: bottle cap, and place the full alcohol bottle back into the alcohol compartment. Close the alcohol compartment door. Step 6: Printer Paper Figure 16...
  • Page 59 To replace the printer paper Pull the lever on the front of the printer door upwards, until the door is released from its locked Step 1: position (to avoid damage, do not use excessive force). Remove the empty paper spindle. Figure 18 Locate a new paper roll and reel off about 2 inches of paper.
  • Page 60 Printer Paper Storage Conditions The printer paper has a shelf life based upon its storage conditions. It is important to understand and follow these storage conditions for both opened and unopened printer paper, to ensure a long printed cycle retention. For optimal printer paper storage, the following conditions should be followed as closely as possible: Unopened printer paper rolls •...

  • Page 61: Drain Screen

    Basin Drain Screen Confirm the basin drain screen is in place and in use at all times. The basin drain screen is to be inspected daily during every Quality Assurance Test, and replaced it worn, damaged or clogged. Changing the Basin Drain Screen Step 1: Verify the basin drain screen is positioned over the CER OPTIMA endoscope reprocessing system ®...

  • Page 62: Air Filter

    Air Filter Changing the Air Filter: The CER OPTIMA Endoscope Reprocessing System uses an air filter to ensure only filtered air is delivered ® into the unit and into the endoscope. The air filter condition is to be monitored weekly and replaced every three (3) months.

  • Page 63: Troubleshooting Guide

    Troubleshooting Guide Problem Cause Corrective Action Rinse alarm triggered Water valve is closed Open water valve Main water pressure is low Increase water pressure to 40 – 60 psi Water filters clogged Replace filters Water hose is kinked Remove kink Inlet valve screen is plugged Clean screen Float tower is covered...
  • Page 64 Problem Cause Corrective Action Solution out solenoid is leaking water Contact Medivators Customer Support for (Only applies to overfilling reservoir) replacement/repair Drain screen is plugged Clean or replace drain screen Water pressure is too high Verify water pressure is set between 40 and 60 PSI Losing HLD during cycles HLD lost in the drain Contact Medivators Customer Support for...
  • Page 65 Problem Cause Corrective Action No power to ASW Contact Medivators Customer Support for replacement/repair Loose internal air pump tubing Contact Medivators Customer Support for replacement/repair No fluid flowing through Kink in channel connector tubing Remove kink in tubing channel connectors Channel connectors not fully inserted Reinsert channel connectors until they “clicks”...

  • Page 66: Reprocessing Cycle Times

    Reprocessing Cycle Times Note: All reprocessor models are capable of using EITHER the full automatic cycle OR the HLD/rinse cycle. Note: If using RAPICIDE or Glutaraldehyde high-level disinfectants, then the CER ® OPTIMA system will use 2 post rinses immediately following the HLD step. If using ®...

  • Page 67: Glossary Of Terms

    Glossary of Terms basin ......chamber into which the endoscope is placed for disinfection. cleaning ......physical removal of organic debris from an endoscope. control panel ....operator interface used to program and operate the reprocessor. custom program .... disinfection program other than the default program. cycle ......

  • Page 69: Appendix

    APPENDIX WARRANTIES Limited Warranty Subject to the terms below, Medivators Inc. (the “Company”) warrants that its products (the “Products”) will conform to the Company’s written specifications (where applicable) and will be free from defects in material and workmanship under normal use and service for the following periods (the “Warranty Period”): Endoscope reprocessors and associated equipment, and Irrigation Pumps: fifteen (15) months from date of shipment from the Company or one (1) year from the date of installation, whichever occurs first.
  • Page 70 Manufactured in the USA by: Medivators Inc. Medivators BV Cantel Medical Asia/Paci c Pte. Ltd. Cantel Medical Devices (China) Co. Ltd. 1A International Business Park 14605 28th Avenue North Sourethweg 11 Unit 804-805, Innov Tower Block A, 6422PC Heerlen #05-01 Singapore 609933...

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