CER OPTIMA. Service Manual. Endoscope Reprocessing System. CER OPTIMA Service Manual

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CER OPTIMA Endoscope Reprocessing System Service Manual CER OPTIMA Service Manual 1

50098-027 Rev B 1.20.2014 2014 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. MEDIVATORS 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. 2 CER OPTIMA Service Manual

Table of Contents Chapter 1 - INTRODUCTION Using this Manual...5 Indications for Use... 5 Safety...6 Intended Use... 6 Operator Safety... 6 Moving the CER OPTIMA... 6 Installation and Maintenance...7 Water Quality and Filtration...8 Chemicals... 8 Detergent Solution...8 Disinfectant Solution... 9 Monitoring Disinfectant Potency...9 Endoscope Precleaning and Testing...9 Electromagnetic Compatibility...10 Endoscope Hookups... 10 Cleaning and Disinfection...12 Specifications... 16 Chapter 2 - PLUMBING AND ELECTRICAL SPECIFICATIONS Water Supply...17 Drain...18 Electrical Requirements... 18 Chapter 3 General Machine Layout... 19 Chapter 4 - SERVICE Power Entry Module... 23 Channel Pump Fuses... 25 Printer Replacement... 27 24VDC Power Supply Replacement... 29 Power Supply Replacement Procedure... 29 Barcode Scanner Replacement... 30 CPU Replacement... 31 Removal Procedure... 32 Installation Procedure... 32 CPU Jumper Location... 32 Channel Pump... 34 Channel Pump Replacement... 34 Transfer Pump... 36 Transfer Pump Replacement... 36 CER OPTIMA Alcohol System... 38 Perastaltic Pump... 38 To Access the Pump... 38 Perastaltic Pump Head Housing Replacement... 39 CER OPTIMA Service Manual 3

Replacing the Alcohol Sensor... 40 Changing Disinfectant Type... 41 Disinfectant Options... 41 Change the Disinfectant Type... 41 Setting Date & Time... 42 Error & Warning Messages... 44 OPTIMA Diagnostics... 60.Introduction... 60 To Access Diagnostics... 61 Warranty... 71 4 CER OPTIMA Service Manual

CHAPTER 1 Introduction Using this Manual This manual is for the MEDIVATORS CER OPTIMA automatic endoscope reprocessor which is available in the following models: CER-1 OPTIMA, Single endoscope reprocessing capability CER-2 OPTIMA, Single or dual endoscope reprocessing capability This manual covers maintenance and troubleshooting procedures to keep the reprocessor in good operating order. Throughout the manual are notes, service notes, cautions, and warnings which provide additional important information. 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 disinfectant or Ortho-phthaladehyde (also known as OPA) disinfectant, for heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the CER OPTIMA system. Note: A note refers to relevant information not covered in the main body of the text. Service: A service note refers to operations or repairs only a trained service technician may perform.! Caution! A caution describes actions and 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. CER OPTIMA Service Manual 5

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 ability of the equipment to high level disinfect an endoscope may be at risk. Contact your MEDIVATORS representative if you have any questions regarding the safe and correct way to operate and service this equipment. Intended Use Only properly trained individuals may operate or service the reprocessor. Never use the reprocessor for any purpose other than the manufacturer s specific indications for use. It is the responsibility of the facility to maintain and ensure that adequate training is provided to operators. 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 safe handling of an accidental chemical spill. Attendance records of the training should be maintained and evidence of understanding demonstrated. Operator Safety Avoid biological contamination and chemical burns always wear appropriate personal protective equipment when handling endoscopes or disinfectant solutions. Never open the reprocessor lid during operation. Moving the CER OPTIMA Before moving the CER OPTIMA, ensure the electrical cord, disinfectant tubing, drain line and water supply line are either disconnected or are appropriate lengths to accommodate the relocation of the machine. Failure to do so may result in damage to the machine. While moving the CER OPTIMA, ensure the machine remains in an upright position. Moving or resting the machine in any orientation other than an upright position may result in damage to the machine. Take precautions to ensure the machine does not tip over which could result in damage to the machine or personal injury. The machine may be placed upon a mobile cart or dolly. When loading or unloading the machine onto or off of a cart or dolly, utilize appropriate lifting equipment or manpower to avoid damage to the machine or personal injury. Note: To avoid injury or death from an electrical insulation breakdown within the unit, the GFI (ground fault interrupter) circuit breaker should be checked for proper operation on an annual basis. Note: If during the use of this equipment you see or smell smoke, immediately disconnect the unit from the power supply, discontinue use and call MEDIVATORS Technical Support at 1-800-444-4729. 6 CER OPTIMA Service Manual

Note: Prior to undertaking any service or maintenance operation, or when resetting the GFI ensure that the CER OPTIMA 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 is isolated from the main water supply. Warning! The reprocessor must be protectively grounded. Installation and Maintenance For complete system installation instructions and details, refer to the: CER OPTIMA Pre-site Installation Instructions CER OPTIMA Water Filtration Installation Instructions CER OPTIMA Installation Instructions Upon installation, position the equipment so the power on/off switch is readily accessible by the operator. Ensure compliance with the installation documents before operating the system. The reprocessor must be properly grounded. The disinfectant immersion period (contact time) is fixed in the CER OPTIMA s software, specific to the high level disinfectant that is displayed on the screen at the start of the cycle. All pressure regulators are factory-preset. Do not adjust the settings. Contact MEDIVATORS Technical Support for assistance. Do not use alcohol or alcohol-based products to clean the reprocessor cabinet. The hook-ups are not autoclavable and must be reprocessed by low temperature disinfection only. Replacement parts must be ordered from the manufacturer to maintain the warranty. Regularly inspect reprocessor for basin damage, pipe and tubing damage, which may result in leaks. Ensure CER OPTIMA unit is level prior to operation. Place a bubble level on the front and side edges of the basin. Level the unit using the four (4) adjustable feet on the bottom of the reprocessor. To adjust the level of the reprocessor, rotate the foot clockwise to raise up, or counterclockwise to lower the corner. When the basin is full of liquid, the level of the liquid should be even around the top of the basin. Proper maintenance will ensure effective disinfection and prolong the life of the reprocessor. CER OPTIMA Service Manual 7

Water Quality and Filtration Potable water is the minimum standard. Incoming water must be pre-filtered to a minimum of 1 micron. Use a cold water line with a pressure of 40 to 60 PSI that will supply a flow rate of 2.5 to 3 GPM (9.4 LPM to 11.4 LPM) to the water filtration system. The cold water supply should not exceed 104 F (40 C). The high performance 0.2-micron absolute water filter included with the reprocessor is a bacterial-retentive filter. This filter removes all microorganisms and particles greater than 0.2-micron. 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. Ensure this water supply is turned on prior to operating the reprocessor. The pre-filtration system should be monitored for excessive pressure drop indicating blocked filter membranes. If this occurs replace the water filter. Chemicals The CER OPTIMA is designed for use with RAPICIDE High-Level Disinfectant, Glutaraldehyde disinfectant, or Ortho-phthaladehyde (also known as OPA) disinfectant. 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). These documents are available from the Association for the Advancement of Medical Instrumentation. The CER OPTIMA also allows the use of detergents for endoscope washing, or 70% Ethyl Alcohol and Isopropyl Alcohol for end-of-cycle endoscope drying. For all chemicals used within the CER OPTIMA, refer to the respective chemical labeling, directionsfor-use (DFU) and/or material safety data sheet (MSDS) for chemistry constituents, as well as for safety and handling guidelines. These documents should be displayed and stored near the CER OPTIMA for easy access in the event of a chemical spill or emergency resulting in contact with any chemical that is considered hazardous. In case of an emergency in which eye or skin contact, or inhalation occurs, such as release of toxic or pathogenic material, or leakage from a disinfectant container, or detergent (alkaline, acidic, non-enymatic or enzymatic) container, always refer to the manufacturer s labeling, directions for use and/or Materials Safety Data Sheet (MSDS), for first aid measures, accidental release measures and exposure controls/ personal protection. Call the emergency telephone number located on the MSDS if additional manufacturer s information is needed. Detergent Solution If the user decides to incorporate a pre-wash in the reprocessing cycle, MEDIVATORS recommends the use of a medical-grade detergent solution which is bacteriostatic, low foaming, free-rinsing and having a neutral ph. 8 CER OPTIMA Service Manual

! Caution! Never use household detergent in the reprocessor. Disinfectant Solution The CER OPTIMA is designed for use with RAPICIDE High-Level Disinfectant (HLD), Glutaraldehyde HLD, or Ortho-phthaladehyde (also known as OPA) HLD. MEDIVATORS only recommends the use of the HLD that is legally marketed and FDA cleared as a highlevel 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 is used per the disinfectant manufacturer s instructions, including the proper contact time, use temperature, and post rinses. Refer to the high level disinfectant manufacturer s directions for use for further instructions. Monitoring Disinfectant Potency High Level Disinfectant (HLD) testing must be performed before each reprocessing cycle. The minimum required concentration (MRC) testing of the high level disinfectant (HLD), ensures the HLD is at an effective level of potency, so that it can be used to disinfect an endoscope or medical device. Testing the potency prior to starting a reprocessing cycle, confirms the disinfectant s MRC potency, and that it can be used to achieve high level disinfection of an endoscope or medical device. Use only the disinfectant manufacturer s recommended test strips to test the potency of the HLD. If the high level disinfectant is below the minimum required concentration, then discard the used disinfectant and replace it with new disinfectant, prior to initiating a reprocessing cycle. Refer to the test strip manufacturer s instructions, for further details and step-by-step use instructions. Endoscope Precleaning and Testing All endoscopes must be manually precleaned prior to disinfection. Follow the endoscope manufacturer s instructions and established professional guidelines to properly preclean the endoscope. Endoscopes with elevator wire channels require additional manual cleaning and disinfection steps. Leak test endoscopes prior to disinfection procedures. CER OPTIMA Service Manual 9

Electromagnetic Compatibility The CER OPTIMA meets all safety requirements of International standard IEC 60601-1-2 for medical electrical equipment and is suitable for use in laboratory environments.! Caution! Portable and mobile communication devices can affect electrically-operated medical equipment.! Caution! Medical Electrical Equipment needs special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in the accompanying document.! 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 Optima.! Caution! The pins of any connectors identified with an ESD warning symbol should not be touched. Connections, with this symbol, should not be made unless ESD precautionary procedures are used. Note: All personnel involved in the operation, installation and or maintenance of the CER OPTIMA received an explanation of the ESD warning symbol and training in ESD precautionary procedures. Endoscope Hookups Endoscopes attach to the CER OPTIMA basin connectors using specific tubing hookups. For proper endoscope hookup identification, refer to the interactive Hookup Guide located on the MEDIVATORS website at www.medivators.com. MEDIVATORS Customer Support can also assist in endoscope hookup identification by calling 1-800-444-4729. EACH ENDOSCOPE HOOKUP IS INTENDED ONLY FOR CONNECTION WITH SPECIFIC ENDOSCOPE MODELS IDENTIFIED IN THE MEDIVATORS ONLINE HOOKUP GUIDE. PROPER ENDOSCOPE MODEL AND HOOKUP COMBINATION, INCLUDING CONNECTIONS FOR ALL APPROPRIATE ENDOSCOPE CHANNELS THAT REQUIRE A SEPARATE REPROCESSING CONNECTION, MUST BE VERIFIED PRIOR TO CONNECTION. 10 CER OPTIMA Service Manual

The online hookup guide is available at: http://www.medivators.com/hookuplookup. Refer to the online hookup guide for additional notes and considerations specific to individual endoscope models. Endoscopes must be thoroughly cleaned according to the manufacturer s instructions and established professional society guidelines prior to hookup connection. Failure to properly clean and prepare endoscopes may result in inadequate high level disinfection and/or damage to the endoscope. 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. Users operating MEDIVATORS AERs and hookups must be trained and competent in the understanding of endoscope channel systems. Prior to hookup connection, users must verify that the hookup used contains connections for all appropriate endoscope channels that require a separate reprocessing connection. Ensure proper alignment of all connectors with the endoscope mating parts prior to attachment. Misalignment may cause damage to hookup components and/or mating parts. All connectors and adapters must remain firmly attached and unrestricted for the entire disinfection cycle to ensure adequate high level disinfection. Users must inspect the endoscope and hookup combination to verify proper connection and flow. Remove connectors from mating parts by gripping the connector directly and detaching from the endoscope. Do not remove connectors by pulling on tubing. Hookups must be periodically checked to ensure their functionality is not impaired. Hookups should be inspected for damaged or worn connectors, missing components, kinked/blocked tubing or other signs of deterioration. If signs of damage or deterioration are found, the hookup should be replaced. Modifications or repairs to hookups which do not correspond to the manufacturer s specifications may result in inadequate high level disinfection and/or damage to endoscopes. Leak testing should be carried out in accordance with endoscope manufacturer s recommendations prior to hookup connection. Install all necessary waterproof caps, plugs and cleaning adapters prior to immersion. Do NOT autoclave MEDIVATORS hookups. Avoid biological contamination. Always wear personal protective equipment when handling endoscopes. MEDIVATORS makes no claim of high-level disinfection efficacy when these instructions are not followed, or when this hookup is used with endoscopes other than those specified in the online hookup guide. CER OPTIMA Service Manual 11

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 TEL: (202) 789-1890 FAX: (312) 321-5194 FAX: (202) 789-1899 http://www.sgna.org/ http://www.apicinfo@apic.org American Society for American Society for Gastrointestinal Endoscopy Testing and Materials 13 Elm Street 100 Bar Harbor Drive P. O. Box 1565 West Conshohocken, PA 19428-2959 Manchester, MA 09144-1314 TEL: (610) 832-9585 TEL: (978) 526-8330 FAX: (610) 832-9555 FAX: (978) 526-4018 http://www.astm.org/ http://www.asge.org/ Association of Operating Canadian Society of Gastroenterology Room Nurses Nurses & Associates 2170 So. Parker Rd., Suite 300 P.O. Box 366 Denver, CO 80231-5711 36 Adelaide Street East TEL: (303) 755-6304 Toronto, Ontario M5C 2J5 FAX: (303) 750-3462 http://www.webray.com/csgna http://www.aorn.org/ British Society of Gastroenterology 3 St. Andrews Place Regents Park, London NW1 4LB 01144-171-387-3534 BSG@mailbox.u2cc.ac.uk. 12 CER OPTIMA Service Manual

Guidance and Manufacturer s declaration - electromagnetic emissions The CER OPTIMA is intended for use in the electromagnetic environment specified below. The customer or the user of the CER OPTIMA should assure that it is use in such an environment. Emissions test Compliance Electromagnetic Environment - guidance RF emissions CISPR 11 Group 1 The CER OPTIMA uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class A The CER OPTIMA is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply Harmonic emissions IEC network that supplies buildings used for domestic purposes, provided the following warning is 61000-3-2 Class A heeded: WARNING! This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby Voltage fluctuations/flicker equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating emissions IEC 61000-3-3 Complies the CER OPTIMA or shielding the location. Guidance and Manufacturer s declaration - electromagnetic emissions The CER OPTIMA is intended for use in the electromagnetic environment specified below. The customer or the user of the CER OPTIMA should assure that it is use in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 60601 test level ± 6 kv contact ± 8 kv air ± 2 kv for power supply lines ± 1 kv for input/ output lines ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth <5 % U T (>95% dip in U T ) for 0,5 cycle 40 % U T (60% dip in U T ) for 5 cycle 70 % U T (30% dip in U T ) for 25 cycle <5 % U T (>95% dip in U T ) for 5s Compliance level ± 6 kv contact ± 8 kv air ± 2 kv for power supply lines ± 1 kv for input/ output lines ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth <5 % U T (>95% dip in U T ) for 0,5 cycle 40 % U T (60% dip in U T ) for 5 cycle 70 % U T (30% dip in U T ) for 25 cycle <5 % U T (>95% dip in U T ) for 5s Electromagnetic Environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the CER Optima requires continued operation during power mains interruptions, it is recommended that the CER Optima be powered from an uninterruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field IEC 61000-4-6 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: U T is the a.c. mains voltage prior to application of the test level. CER OPTIMA Service Manual 13

Guidance and Manufacturer s declaration - electromagnetic immunity The CER OPTIMA is intended for use in the electromagnetic environment specified below. The customer or the user of the CER OPTIMA should assure that it is used in such an environment. Immunity test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 test level 3 Vrms 150 khz to 80 MHz 3 Vrms 80 MHz to 2,5 GHz Compliance level 3 Vrms 3 Vrms Electromagnetic Environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the CER OPTIMA, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = [ 3,5 ] P V 1 d = [ 3,5 ] P 80 MHz to 800 MHz E 1 d = [ 7 ] P 800 MHz to 2,5 GHz E 1 where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations from radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CER OPTIMA is used exceeds the applicable RF compliance level above, the CER OPTIMA should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the CER Optima. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than [V 1 ] V/m. 14 CER OPTIMA Service Manual

Recommended separation distance between portable and mobile RF communications equipment and the CER OPTIMA The CER OPTIMA is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CER OPTIMA can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and CER OPTIMA as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter (m) Rated maximum output power of transmitter (W) 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = [ 3,5 ] P V 1 d = [ 3,5 ] P E 1 d = [ 7 ] P E 1 0,01 0.12 0.12 0.23 0,1 0.37 0.37 0.74 1 1.2 1.2 2.3 10 3.7 3.7 7.4 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. CER OPTIMA Service Manual 15

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) CER-2 OPTIMA (120V) CER-1 OPTIMA (230V) CER-2 OPTIMA (230V) Electrical Requirements Electrical Fuses Power Cord Storage and Transportation Maximum Humidity Temperature Altitude Safety Classification: Installation over-voltage 71 lb 32 kg (approx) 77 lb 35 kg (approx) 75 lb 34 kg (approx) 81 lb 37 kg (approx) 120 VAC 50/60 Hz, 1Φ, 360 WATTS 230/240 VAC 50/60 Hz, 1Φ, 360 WATTS Two 4.0 AMP Slo Blo Fuses (120VAC CER OPTIMA) Two 2.0 AMP Slo Blo Fuses (230/240 CER OPTIMA) Hospital grade 10 feet (2.4m) Removable 80%, non-condensing 41 F - 158 F (5 C 70 C) Up to 2000 meters 1, Ordinary protection The reprocessor is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. Category: II Pollution Degree 2 CER-1 OPTIMA water consumption CER-2 OPTIMA water consumption Basin Channels HLD/RINSE cycle with 2 final rinses: 11 gal (42 liters) FULL cycle with 2 final rinses: 16 gal (60 liters) *For machines running OPA disinfectant, add 4 gal (15 liters) for third rinse HLD/RINSE cycle with 2 final rinses: 13 gal (49 liters) FULL cycle with 2 final rinses: 20 gal (75 liters) * For machines running OPA, add 5 gal (19 liters)/cycle for third rinse 8-10 psi per channel 8.5-10 ml/sec flow rate Electrical Safety Certifications: ETL Intertek Listed #75811, UL Standard 61010-1, EN Standard 61010-1, Laboratory Equipment: CAN/CSA Standard C22.2, No. 61010-1, CE 0050 Method of Reprocessing Endoscopes: Environmental Rating Mode of Operation Degree of Mobility Basin operating capacity Reservoir operating capacity External surface immersed in high-level disinfectant. Internal channels purged by forced fluids. Standard Continuous Counter top or cart mount 3.44 gallons (13L) Model CER-1 OPTIMA 4.6 gallons (17.4L) Model CER-2 OPTIMA 4 gallons (15.1L) Model CER-1 OPTIMA 5 gallons (18.9L) Model CER-2 OPTIMA 16 CER OPTIMA Service Manual

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: Temperature: Minimum 40 psi (2.8 bar) Maximum 60 psi (4.1 bar) Water supply [not to exceed 104 F (40 C)] Note: Endoscope manufacturers recommend that endoscopes not be exposed to temperatures above 130 F (55 C). A shut off valve is required. The water inlet fitting on the reprocessor and on the pre-filter side (water inlet side) of the water filtration system is 3/4-inch male hose thread. All reprocessors and prefilter systems are supplied with a 3/4-inch female thread, 5-foot, flexible, stainless hose. All tubing necessary to connect the water filtration system to the reprocessor is included with the system. The water filtration system can be installed in-line. The water supply can tee off the supply under a counter or can be a dedicated line. Local plumbing regulations vary regarding installation of: Vacuum breakers for the water inlet. Backflow protection for the drain. Note: MEDIVATORS recommends that the user check local regulations regarding anti siphon valves and vacuum breakers before attempting to install any reprocessor models. Note: Always TURN OFF the water supply at the end of the day! CER OPTIMA Service Manual 17

Drain A facility drain pipe having a minimum 1-1/2 inch diameter must be placed at least 1 foot below the CER OPTIMA drain fitting to ensure complete draining of fluids from the system. 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. The drain pipe must contain an air gap at the point where the CER drain tubing enters it. The facility drain must be capable of handling a discharge rate of 5 gallons per minute (19L per minute). A facility drain having a dishwasher type drain Y is not an acceptable drain method and cannot be used. The drain Y does not provide adequate drain flow rates and must not be used. Consult with local plumbing regulations for information regarding backflow protection for drain. Electrical Requirements All Reprocessor models: The following power is required for each of the following: CER OPTIMA MODEL VOLTAGE CURRENT FUSE SIZE CER-1 OPTIMA 120 VAC 3 AMPS (2) 4 AMP, Power Inlet, PN CF02-0000 (2) 2.5 AMP, 250V Slo-Blo, Internal Pump, PN 31600-041 CER-2 OPTIMA 120 VAC 3 AMPS (2) 4 AMP, Power Inlet, PN CF02-0000 (2) 2.5 AMP, 250V Slo-Blo, Internal Pump, PN 31600-041 Disinfectant Transfer Pump (optional) Disinfectant Reservoir Heater (optional) 120 VAC 230/240 VAC 120 VAC 230/240 VAC 0.50 AMPS 0.25 AMPS 3.5 AMPS 1.75 AMPS (1) 1.5 AMP, 250V Slo-Blo, PN MF02-0004 (2) 1 AMP, 250V Slo-Blo, PN 31600-003 (1) 5 AMP, 250V Slo-Blo, PN 31600-025 (2) 2.0 AMP, 250V Slo-Blo, PN CF02-0003 Total current draw for one CER OPTIMA model and all 120 VAC attachments is 7 AMPs. Note: For maximum safety, MEDIVATORS recommends the CER OPTIMA system only be connected to an electrical outlet containing a ground fault interrupter (GFI) or residual current device (RCD). A Hospital Grade electrical cord is supplied with each machine. 18 CER OPTIMA Service Manual

CHAPTER 3 General Machine Layout Barcode Scanner Alcohol bottle access door Thermal Printer Front View Touch Pad and Display CER OPTIMA Service Manual 19

CPU Access panel Power Entry Module Right Side View Connection for bar code Water Inlet 24V Power Supply Access Panel Air Filter Connector HLD In Connection for Data Management HLD Return Drain to sewer Rear View 20 CER OPTIMA Service Manual

Basin Vent Basin Overflow Basin Level Switch Water & disinfectant inject port (only front port used) Channel ports (Four ports for OPTIMA 1, Eight ports for OPTIMA 2) Basin Drain Top View CER OPTIMA Service Manual 21

22 CER OPTIMA Service Manual

CHAPTER 4 Service Power Entry Module Replacing Power Inlet Fuses 1. Turn off the reprocessor at the power switch. 2. Unplug the reprocessor from the AC power receptacle. 3. Remove the power cord plug from the power inlet. See figure 1. 4. Using a small blade screw driver, pry down the cover of the power inlet. See figure 2. 5. Two fuses are located inside. Carefully pull out each fuse holder. See figure 3. 6. Utilize a volt ohm meter to determine if fuse is defective. 7. Replace defective or blown fuses with same rated fuses. 8. Close the power inlet fuse cover. 9. Plug the power cord into the power inlet. 10. Plug the power cord into the AC receptacle. 11. Power machine back up. NOTE: All fuses are slow blow. Do not use any other type. 120VAC 230VAC F1 (Left fuse) 4.0 AMP Slow blow 2.0 AMP Slow blow F2 (Right fuse) 4.0 AMP Slow blow 2.0 AMP Slow blow CER OPTIMA Service Manual 23

Figure 1 Figure 2 Figure 3 24 CER OPTIMA Service Manual

Channel Pump Fuses The Channel Pump is a 120VAC pump and each leg is protected by a 2.5 AMP Slow Blow fuse. Replacing Channel Pump Fuses 1. The CER OPTIMA must be drained of all fluids. 2. Set the CER OPTIMA on its left side. Hoses may have to be disconnected from the rear of the machine. 3. Remove the bottom cover. 4. Locate the fuse holders. See figure 4 and 5 Figure 4 Figure 5 CER OPTIMA Service Manual 25

Figure 6 5. The fuse holder twists open. Replace fuse and retighten. 6. Replace bottom plate and set machine upright. 26 CER OPTIMA Service Manual

Printer Replacement Use the following procedure to replace the printer. Only use MEDIVATORS supplied printer for replacement. 1. Power down the machine. 2. Raise the paper compartment cover by lifting up on the front tab. See figure 7. 3. Remove the paper and set aside. 4. Remove the two 3/16-inch nuts. See figure 8. 5. Gently pull printer out. Disconnect the cables on the printer, making note of the proper location. Please note there are unused connectors on the printer. See Figure 9. 6. Reattach the cables to the new printer. 7. Insert the printer into the printer compartment and attach the retaining nuts. 8. Insert paper. Refer to the CER OPTIMA User Manual PRINTER PAPER REPLACEMENT SECTION for instructions. 9. Power up the CER OPTIMA. 10. The green ready light on the printer should be a solid green. See Figure 10. 11. The printer is now ready for normal use. CER OPTIMA Service Manual 27

Figure 7 Figure 8 Green Light Figure 9 Figure 10 28 CER OPTIMA Service Manual

24V DC Power Supply Replacement The CER OPTIMA utilizes a dual voltage input power supply. The power supply is located under a panel at the rear of the machine. Power Supply Replacement Procedure 1. Power down the CER OPTIMA. 2. Remove the five screws that retain the right panel. See figure 11. Figure 11 3. Remove the two power supply retention screws. See figure 12. Gently pull out to access the power supply terminals. See figure 13. Figure 12 CER OPTIMA Service Manual 29

Figure 13 4. Make note of the proper wire positions prior to removal. 5. Attach power supply cables to replacement power supply. Verify terminal screws are sufficiently tightened. 6. Mount power supply back into compartment. 7. Replace cover. 8. Power up and test functionality of machine. Barcode Scanner Replacement The CER OPTIMA is equipped with an optional barcode scanner. After the replacement of the barcode scanner, the scanner needs to be programmed. 1. Connect the barcode reader to the USB port on the back of the reprocessor. 2. Scan all seven barcodes in the order shown, making sure the barcode reader beeps after each read. Once the scanning of all seven barcodes has been completed, the scanner is ready to use. 30 CER OPTIMA Service Manual

CPU Replacement CER OPTIMA Service Manual 31

Removal Procedure Remove power to the machine. Remove the five screws retaining the cover plate. Disconnect all cable harnesses. To gain better access to the ribbon cables, it may be necessary to set the machine on its side and remove the lower panel for better access. Remove the six board retaining screws Installation Procedure Wearing an ESD strap to eliminate electrostatic, remove the CPU from the packaging. Note the position of the jumper on CN14. Set the jumper for the proper configuration of the machine CPU Jumper Location For CER-1 OPTIMA For CER-2 OPTIMA CN14 Pins 1 and 2 (Left two pins) CN14 Pins 2 and 3 (Right two pins) Carefully attach the ribbon cables at the left side of the board and any other cable that may be easier to attach prior to inserting the six retaining screws. This jumper is on Pins 2-3, configured for CER-2 OPTIMA 32 CER OPTIMA Service Manual

Insert and tighten the six retaining screws. Connect any other cables that have not yet been reattached. Replace all covers. Power up the machine and test. Set the time and date. Refer to user functions in the CER OPTIMA operation manual. CER OPTIMA Service Manual 33

Channel Pump The CER OPTIMA internal channel pump performs various duties in the cycle of the reprocessor. The pump pushes fluid through the endoscope connectors during various phases of the cycle and also assists the disinfectant back to the reservoir and rinse water to the drain. Please note, the pump only assists and draining is dependent on gravity. The pump is not designed to pump fluid higher than the bottom of the reprocessor. This is the reason that the reservoir return hoses and drain lines must go down from the back of the machine, and never loop above the drain fittings. The Channel pump is a 120VAC pump that has two line fuses in the chassis. Refer to the section on fuse replacement for further details Channel Pump Replacement 1. Verify all fluid has been drained from the basin. 2. Remove the power to the machine. 3. Set the CER OPTIMA on its left side. Depending on the plumbing situation, hoses may need to be disconnected to allow for this to occur. 4. Remove the bottom cover from the reprocessor. 5. Locate the Channel pump. See figure 14. 34 CER OPTIMA Service Manual

Disconnect silicone hose (Step 7) Mounting Screws Disconnected T fitting from pump (Step 9) Fuses for channel pump Disconnect this elbow (Step 8) Channel pump Figure 14 6. Disconnect the electrical connection from pump. 7. Disconnect the silicone drain hose from the input of the pump. Have a rag ready to catch any excess fluid remaining in the tubing. 8. Using a John Guest tool, disconnect the tube from the elbow shown in figure 14. This will allow easier access for the removal of the fitting from the pump in step 9. Have a rag ready to catch any excess fluid remaining in the tubing. 9. Using a John Guest tool, disconnect the white Tee fitting from the gray output fitting. 10. Remove the four mounting screws using a 5/32 Allen wrench. See circled items in figure 14. The pump is mounted to an L shaped bracket, remove the entire bracket with the pump attached. 11. Remove pump from bracket and replace pump. 12. Reattach new pump and reconnect tubing and electrical connectors. CER OPTIMA Service Manual 35

Transfer Pump The purpose of the transfer pump is to move the disinfectant from the reservoir to the reprocessor basin. The pump is 24 VDC. Transfer Pump Replacement 1. Verify all fluid has been drained from the basin. 2. Remove the power to the machine. 3. Set the CER OPTIMA on its left side. Depending on the plumbing situation, hoses may need to be disconnected to allow for this to occur. 4. Remove the bottom cover from the reprocessor. 5. Locate the Transfer pump. See figure 15. 6. Disconnect the power connection 7. Using a John Guest tool, disconnect the outside hose connection. Once the pump mounting screws, the inside hose will be accessible. 8. The pump is mounted to an L shape mounting bracket. This bracket with the pump mounted to it, will be removed in this process. Remove the four 5/16 Allen head mounting screws as shown, carefully pull out, then disconnect the backside hose connection. 9. Remove old pump from bracket and attach the new pump to the bracket. 10. While remounting the new pump, attach the rear hose to the pump head before inserting the mounting screws. 11. Attach all screw and tighten. 12. Attach hose and power connection. 13. Attach bottom cover and test. 36 CER OPTIMA Service Manual

Transfer pump Mounting screws Power connection Hose input/out connections Figure 15 CER OPTIMA Service Manual 37

CER OPTIMA Alcohol System The CER OPTIMA Alcohol system is comprised of a perastaltic pump, which pumps alcohol into the manifold for distribution to the individual basin connectors. The alcohol is drawn out of the alcohol container located at the left front corner of the machine behind a small access door. The flow of alcohol is monitored by a proximity sensor. The sensor will trigger a Low Alcohol Alarm when no alcohol is detected, indicating the alcohol bottle is empty. Perastaltic Pump The Perastaltic pump is comprised of a length of tubing located in the pump head housing. The tubing is squeezed by a rotating cam in the pump head housing. The cam action on the tubing creates suction and pumping motion that transports the alcohol from the holding bottle to the manifold. To Access the Pump The pump is located behind the left side access panel. Power down the reprocessor, remove the six retaining screws and remove the cover plate. See figure 16. Hose to main manifold Hose from alcohol supply bottles Perastaltic pump Figure 16 Pump tubing 38 CER OPTIMA Service Manual

Perastaltic Pump Head Housing Replacement 1. Grasp the two release tabs and squeeze to release the lock. See figure 17 2. Pull the Pump head out from the pump motor. See figure 18. 3. Disconnect the two hose fittings. Remove the gray fitting on the alcohol tubing from the white elbow with a John Guest tool. Be sure to note correct location of each hose in relationship to the pump head (suction vs. output). 4. Obtain the new pump head. 5. Connect the new pump head. 6. Reconnect the two hose fittings to the pump head. 7. Reattach the pump to the motor. Figure 17 Figure 18 CER OPTIMA Service Manual 39

Replacing the Alcohol Sensor The alcohol sensor is located on the supply line to the manifold and detects the presence of alcohol. The sensor has a green LED adjacent to the cable connection. When illuminated, this indicates the sensor detects the presence of Alcohol in the supply tube. When the LED is off, no alcohol is being detected. See figure 19. 1. Verify all fluid has been drained from the basin. 2. Remove the power. 3. Set the CER OPTIMA on its left side. Depending on the plumbing situation, hose may need to be disconnected to allow for this to occur. 4. Remove the bottom cover from the reprocessor. 5. Locate the alcohol sensor. See figure 19. Figure 19 1. Cut the two wires ties, and unplug the sensor. 2. Replace with new sensor. 3. Attach the sensor to the same location using wire ties. The wire ties should be snug, but not tight enough to crush the tubing. 4. Reconnect the cable. 5. Replace the bottom cover. 40 CER OPTIMA Service Manual

Changing the Disinfectant Type The CER OPTIMA ships from the factory programmed for RAPICIDE High-Level Disinfectant. If the CER OPTIMA is to be used with a different disinfectant type (such as OPA or Glutaraldehyde), follow the instructions below to reprogram the machine. Changing the type of high-level disinfectant used by the CER OPTIMA can be performed anytime the machine is in an idle state. The Quality Assurance test does not need to be performed prior to making this change. Each program is fixed. Disinfectant contact time, number of rinses and temperature alarms cannot be modified. User selectable options (Incremental Air, Alcohol inject and washes prior to disinfection) are adjustable. Refer to operations manual for further details on these functions. Disinfectant options North American Options International Options DISINFECTANT TYPE SPECIFICATIONS DISINFECTANT TYPE SPECIFICATIONS RAPICIDE 5 min, 35ºC 2 rinses RAP OPA INT 5 min, 20ºC 2 rinses RAP OPA/28 5 min, 25ºC 2 rinses ADASPOR RTU 5 min, 20ºC 1 rinses RAP OPA/28 10 min, 20ºC 2 rinses ADASPOR RTU 10 min, 20ºC 1 rinses OPA 12 min, 20ºC 3 rinses ADASPOR RTU 10 min, 20ºC 2 rinses GLUT 20 min, 20ºC 2 rinses PERASCOPE 10 min, 20ºC 2 rinses GLUT 20 min, 25ºC 2 rinses ANIOXIDE 10 min, 20ºC 2 rinses GLUT 45 min, 20ºC 2 rinses STERANIOS 10 min, 20ºC 2 rinses To Change the Disinfectant Type: 1. To place the CER OPTIMA into an idle state, deselect/shut off the AUTOMATIC FULL and HLD/ RINSE touch pads, and also the four MANUAL touch pads, so their respective green lights are OFF. 2. Press the arrow until SERVICE MENU is displayed. 3. To access the SERVICE MENU, press and hold the arrow and then press the arrow. 4. The current programmed disinfectant type will now appear on the screen. Note: The factory default is set for RAPICIDE High-Level Disinfectant. For North America: Proceed to line 5. For International: Press the arrow key one time and INT L DISINFECTANT should be displayed. Press the arrow until the desired disinfectant type is displayed. Proceed to step 6. 5. Press the arrow until the desired disinfectant type is displayed. CER OPTIMA Service Manual 41

6. Press ENTER to select the disinfectant: the CER OPTIMA is now programmed to this disinfectant. 7. Use the arrow to scroll through the remaining user-selectable menu screens. 8. EXTENDED RINSES: If extended rinse times are required, press to select YES and press ENTER to change. Press to move to next function. 9. CONTINUOUS RUN: This funtion should always set to NO. 10. SPECIAL TESTING: This function should always be set to OFF. 11. MACHINE CYCLE RESET: This value displayed is the overall machine cycle count. This value should never be reset. Press to move to the next function. 12. SCAN SERIAL NUMBER: The machine serial number will be displayed. Consult MEDIVATORS Technical Support before attempting to change this value. 13. Press will exit the SERVICE MENU and return to the CER OPTIMA s idle state. Setting Date and Time The CER OPTIMA CPU utilizes a capacitor for providing power for retention of the Time and Date. All other parameters are stored on an EPROM and will not be lost during long periods of no power. To change the date and time parameters: The lights on the FULL, HLD/RINSE and MANUAL buttons must not be illuminated. Press until the following is displayed: SET DATE 01/01/12 Press to change the date Once the current date is selected, press SET MONTH MONTH =01 Press to change the month. Once the current month is selected, press SET DAY Day =01 42 CER OPTIMA Service Manual

Press to change the day. Once the current day is selected, press SET YEAR Year =2014 Press to change the year. Once the current year is selected, press SET TIME 15:54 Press to change the time. Once the current time is selected, press SET HOUR Hour = 15 Press to change the hour. Once the current hour is selected, press SET MINUTES MINUTES= 54 Press to change the minutes. Once the current minutes is selected, press Press until you exit the menu options CER OPTIMA Service Manual 43

Error and Warning Messages Error messages are displayed on the LCD screen to alert the operator of operational malfunctions and/or operational warnings (see the Appendix for message definitions). If the suggested solutions do not correct the problem or if the problem reoccurs contact customer support. LOW WATER LEVEL - If the basin is NOT full of water at the time of the alarm Problem Solution Incoming water pressure is too low Verify water pressure is between 40 and 60 PSI: This pressure must be present at the post (0.2µ) filter of the filter unit, see figure 20. The CER OPTIMA is designed to operate within this pressure range. Water pressure outside of this range can cause operational errors. If pressure is outside this range, contact a qualified plumber to obtain water pressure within this range. If using pressure regulators or booster pumps, these devices require periodic (typically yearly) maintenance to continue to operate at optimum specifications. Water Filters clogged Replace water filters: To verify if the filters are clogged, a simple check of the pressure differential is made. The pressure differential must be checked when water is flowing (Dynamic pressure). Even with clogged filters, if pressure is checked when no water is flowing (Static pressure), the water pressure can appear to be correct, but is not. To check the pressure, simply start a cycle and observe the three pressure gauges during the initial fills. If the pressure differential from the first to the last gauge is greater than 5 PSI, the filters should be changed. IMPORTANT, the incoming pressure cannot be lower than 40 PSI into the filter unit. The 0.2 micron filter (CF01-0018) must be changed at least once every six (6) months and the 1 micron filter (MF01-0014) at least once every three (3) months. 44 CER OPTIMA Service Manual

40-60 PSI must be seen at this Post Filter Gauge If not, but the pressure is correct at the # 3 gauge, check the pressure drop. Greater than 5 PSI, the filters need to be changed. 1 2 3 The pressure at Gauge 3 must be between 40 and 60 PSI for the reprocessor to function optimally. Filtered water to the reprocessor Connect to Water supply Post Filter 0.2 micron CF01-0018 Pre-Filter 1 micron MF01-0014 Direction of water flow Figure 20 If the pressure at gauge 1 is 5 PSI less than at gauge 3, this pressure drop indicates one of the filters is starting to become clogged and requires replacement. Remember to always read the pressure only when water is flowing. CER OPTIMA Service Manual 45

LOW WATER LEVEL - If the basin is FULL of water at the time of the alarm. Note, even though the basin is full, the reprocessor has detected the fill time as exceeded the maximum allowed time limits. Problem Solution Reprocessor is out of level Verify the level of the unit: See figure 21 and 22. If the machine is biased to a specific side, the water level sensor may not be able to detect the basin is full. Level sensor is not detecting correct fluid level in the basin Water filters clogged Verify the level sensor is not obstructed and is functioning correctly. See figure 23 Replace water filters. Even though the basin is filled, if the fill rate is below minimum requirements, the reprocessor will alarm for LOW WATER LEVEL. To verify if the filters are clogged, a simple check of the pressure differential is made. The pressure differential must be checked when water is flowing (Dynamic pressure). Even with clogged filters, if pressure is checked when no water is flowing (Static Pressure), the water pressure can appear to be correct, but is not. To check the pressure, simply start a cycle and observe the three pressure gauges. If the pressure differential is from the first to the last gauge is greater than 5 PSI, the filters should be changed. Remember, the incoming pressure cannot be lower than 40 PSI into the filter unit. The 0.2 micron filter (CF01-0018) must be changed at least once every six (6) months and the 1 micron filter (MF01-0014) at least once every three (3) months. Figure 21 Figure 22 46 CER OPTIMA Service Manual

Overflow port. Fluid should not be going down this port at anytime if the reprocessor is operating properly. The most common cause is machine level, improper endoscope placement or unused endoscope connectors left connected in the basin. Basin level sensor. Verify the two holes in the body are not obstructed and that the cover is not tipped or out of place. Drain Screen Figure 23 Problem Solution Insufficient HLD in reservoir Verify the reservoir has a minimum of 4 gallons of HLD in the reservoir for OPTIMA CER-1 and a minimum of 5 gallons for the OPTIMA CER-2. See figure 24. Disinfectant being sprayed down the overflow port in the back left portion of the basin. Chemical inlet hose is kinked Only endoscope hookups that are attached to the endoscope should be connected to the basin connector channel ports. Any unused basin connector ports should have a right-angled basin connector inserted. See figure 23A and 23B. Fluid from the distal tip may also be sprayed into the overflow drain. Make sure the distal tip is not facing the back left corner and that it is tucked under the body of the scope. Verify the chemical inlet hose has not been kinked or squeezed if the reservoir has recently been accessed, such as refilling or cleaning purposes. If reprocessor is on a movable cart, hoses can easily become entangled and kinked. See figure 25 CER OPTIMA Service Manual 47

Disinfectant filter is clogged Dirty drain screen Drain covered by objects Internal Transfer pump is not functioning Bottles or containers being reprocessed in OPTIMA If the hose is removed for any reason, the correct orientation of the hose is imperative when reattaching. The hose contains a check valve in line with the disinfectant filter. If this hose is reversed, no fluid will flow. Always connect the 90 degree elbow fitting to the back of the reprocessor and the straight fitting on the hose to the reservoir. Refer to figure 26 If the drain is clogged and restricts the draining of disinfectant, this can cause a loss of disinfectant because not all may return to the reservoir prior to the end of the disinfectant cycle affecting the next cycle in the form of a LOW HLD LEVEL alarm. If the drain is covered by an object(s) that restricts the draining of disinfectant, this can cause a loss of disinfectant because not all may return to the reservoir prior to the end of the disinfectant cycle, affecting the next cycle in the form of a LOW HLD LEVEL alarm. See figure 23C Check and verify pump operation. Change disinfectant filter (possible clogged filter). Water bottles, suction bottles or any container CANNOT be reprocessed in a MEDIVATORS reprocessor. These items can retain fluid and cause either a loss of disinfectant or a gain of water in the disinfectant. Refer to the directions for proper cleaning of these items from the manufacture of the items. Refer to Figure 23D 48 CER OPTIMA Service Manual

Right-angled basin connectors (shown in this figure) should be inserted in any basin channel port that are not being used. NEVER leave unused endoscope hookups in the basin that are not connected to an endoscope. This practice can lead to disinfectant being sprayed down the overflow drain. Figure 23A Do not leave endoscope hook ups in the basin that are not attached to an endoscope. The spray or turbulence caused by this loose hook up can cause HLD loss. Figure 23B CER OPTIMA Service Manual 49

Button bags should not be placed over the drain. This can reduce the flow to the drain. Always place button bags in a location away from the drain. Keep the drain area clear. Figure 23C Figure 23D 50 CER OPTIMA Service Manual

Note that for the CER-1 OPTIMA the disinfectant must be AT OR ABOVE the 4 gallon mark and for the CER-2 OPTIMA the disinfectant must be AT OR ABOVE the 5 gallon mark. If using an CER-2 OPTIMA and fluid is between the 4 and 5 gallon mark, a LOW HLD LEVEL alarm will be the result. Disinfectant filter MUST be changed with every disinfectant change to prevent LOW HLD LEVEL Alarm. A clogged filter will slow the fill rate of the disinfectant into the basin. If the HLD does not fill within the specific period, it will alarm. LOW HLD LEVEL Figure 24 CER OPTIMA Service Manual 51

Scanner connection Chemical inlet hose. This hose has the disinfectant filter connected in line. The 90 elbow fitting attaches to the reprocessor and the straight fitting to the reservoir. If reversed, no fluid will flow. Figure 25 LOW HLD LEVEL - If basin is full of disinfectant, but still alarms Problem Reprocessor is not level Level sensor is not detecting correct fluid level in the basin Disinfectant filter is clogged Solution Verify machine is properly leveled. Refer to figures 21 & 22. Verify the level sensor is not obstructed and functioning correctly. See figure 23 The filter must be changed every time the disinfectant is changed. Failure to do so will cause the LOW HLD LEVEL alarm. A clogged filter will slow the fill rate of the disinfectant to the basin. The machine will alarm LOW HLD LEVEL after a specific time period if the basin is not filled in that specified time period. CHECK WATER FLOW Problem Solution Incoming water pressure is too low Verify water pressure is between 40 and 60 PSI. Refer to figure 20 Water filters clogged Replace water filters Drain Screen clogged Clean drain screen in basin. The unit draws water through this screen if clogged or obstructed, the reprocessor will sense as low flow. 52 CER OPTIMA Service Manual

CYCLE CANCELED Problem Cycle was canceled by pressing stop Lid was not closed for more than 2 minutes during the cycle Power Interruption Solution Pressing stop cancels the cycle. Do not press stop unless canceling the cycle is required. The reprocessor is constantly monitoring the lid to verify it is closed. If the lid is detected to be open for more than 2 minutes, the cycle will automatically cancel as a safety precaution. If the lid is closed, but not latched, the lid may not be detected as closed, even though it appears closed. Always latch the lid when in use to prevent this from occurring. This error can occur if a power interruption occurs during reprocessing. BASIN FULL - This error is indicating the basin is not draining when it should be. The issue relates completely to the draining of the basin Problem Drain screen clogged HLD Line return line restriction Power Interruption Pressure Sensor Failure Solution Clean the basin drain screen. Verify nothing is occluding the drain such as a button bag. See Figure 23C Verify that return line is not kinked or pinched. If recently removed verify the hose is connected correctly. This hose only allows flow in one direction. This error can occur if a power interruption occurs during reprocessing. Replace Pressure Sensor. Consult MEDIVATORS Technical Service BASIN LEVEL LOW (DURING RINSE CYCLE) - Water filled initially, but there is a loss of fluid during the cycle that has caused this alarm. Problem Solution Water supply rate to low Verify the water pressure is between 40-60 PSI Water filters clogged Replace water filter(s) Internal drain valve defective Verify valve is properly sealing. During the rinse cycle, no water should be seen flowing back to the drain. If so, this is an indication the valve is not sealing properly. Remove all unused hook ups from the basin and replace with right-angled basin connectors, refer to figure 23A. CER OPTIMA Service Manual 53

BASIN LEVEL LOW - Disinfectant is being lost after the initial fill of the basin. Problem Disinfectant is flowing down the overflow. Disinfectant shooting down drain from endoscope Level sensor is not detecting the level of the fluid correctly Internal drain valve defective Solution Verify level of machine, see figures 21 & 22 Verify the distal tip of the endoscope is not spraying towards the overflow. Always tuck the tip of the endoscopes under the body of the endoscope. Verify operation of the level sensor. See figure 23 Verify valve is properly sealing. During the rinse cycle, no water should be seen flowing back to the drain. If so, this is an indication the valve is not sealing properly. Remove all unused hook ups from the basin and replace with right-angled basin connectors, refer to figure 23A. TEMPERATURE ERROR - This alarm indicates the disinfectant temperature is either below the minimum basin temperature called out by the program setting or above 42 C Problem Disinfectant reservoir temp too low Disinfectant reservoir temp >42 C Solution Verify reservoir temp is set correctly for the specific disinfectant and reservoir is connected to power Verify reservoir temp is set correctly and reservoir is connected to power. See figure 26. 54 CER OPTIMA Service Manual

The dial gauge is the actual temperature of the solution. If temperature is below the minimum basin temp for the selected disinfectant or above 42 C a TEMPERATURE ERROR will occur. The temperature displayed is the SET temperature, not the actual. If the display is not illuminated, the unit is not receiving power. Check the cord or fuse. Figure 26 TEMP SENSOR ERROR - This is only referring to a failure of the actual sensors Problem The temp is monitored by two separate sensors. When the temperature difference between the two probes is >3, then this alarm will occur Solution The temperature probe S4 or S5 (probes located in the drain) may be defective. Review sensor wire harness connections. In diagnostics, review the temp readings for S4 and S5. If the difference is greater than 3º, the temp probe is defective. Note: Temperature is displayed without decimal points. 350 = 35.0. S4 is the temperature used for the displayed temperature. CER OPTIMA Service Manual 55

BASIN DRAIN TIMEOUT - Only occurs when BASIN TO DRAIN button is pressed Problem Drain screen clogged HLD line restriction Pressure sensor is defective Channel Pump is defective Solution Clean drain screen or remove any object that maybe covering the drain screen. Verify there are no kinks in HLD hose Possible defective pressure sensor Verify pump operation. Repair/Replace if necessary LOW CHAN PRESSURE - During the rinse cycle Problem Drain screen clogged Water supply is turned off Pressure sensor defective Channel pump is not pumping Solution Clean drain screen. Prevent endoscopes or other objects from covering the drain. Turn on water supply Possible defective pressure sensor Inspect Channel Pump. Verify the Chemical inlet hose is not kinked or disconnected. LOW CHAN PRESSURE - During HLD portion of cycle Problem Drain screen clogged Disinfectant reservoir empty Disinfectant supply line restriction Disinfectant filter clogged Channel pump not pumping Pressure sensor defective Solution Clean drain screen. Prevent endoscopes or other objects from covering the drain. Fill reservoir Remove restriction from line; verify the supply line is connected and that the disinfectant filter is properly connected. Replace disinfectant filter. Change after every disinfectant change. Inspect channel pump Possible defective pressure sensor NVRAM - This error can occur at any point in the cycle Problem Internal Communication fault. May occur during a power fluctuation Solution If either the FULL or HLD RINSE button is illuminated, press it to turn it off. Press the down arrow until you see HLD CYCLE CNT RESET. Press the arrow. Then press ENTER to accept the change. Reselect the FULL or HLD RINSE cycle and run a test cycle. The customer may need to power the unit up and down. 56 CER OPTIMA Service Manual

Error Conditions Not tied to a specific error AFTER THE COMPLETION OF ONE CYCLE, ANOTHER CYCLE IMMEDITALY STARTS Problem The CONTIUNOUS RUN function has been activated SCANNER DOES NOT READ BAR CODES Problem Scanner not activated Scanner not plugged in Solution In the SERVICE MENU this option should be set to NO. If not changed from YES to NO. Refer to the OPTIMA USER manual for details Solution Verify in the sub menu that the scanner is activated. Refer to the OPTIMA USER manual for details Verify the scanner is plugged in to the back of the reprocessor. Refer to figure 25. Scanner requires reprogramming Refer to the BARCODE SCANNER REPLACEMENT section of the repair manual. RESERVOIR GAINING VOLUME Problem Water in basin at the end of the initial rinse cycle. Fluid remaining in basin at end of cycle Obstruction in basin Bottles or containers being reprocessed in OPTIMA Unauthorized items in basin and items covering the drain Solution If using HLD Rinse and water pressure is too great. If pressure is too high, water can be carried over from the initial rinse into the disinfectant. Check machine level. If out of level, fluid cannot completely return to the drain. Clean the drain screen Water bottles, suction bottles or any container CANNOT be reprocessed in a MEDIVATORS reprocessor. These items can retain fluid and cause either a loss of disinfectant or a gain of water in the disinfectant. Refer the directions for proper cleaning of these items from the manufacture of the items. Refer to figure 23B Only endoscopes and their related accessories (buttons and caps) are to be reprocessed at the same time. The reprocessing of inappropriate items with endoscopes can, depending on the circumstance cause either gain or loss. There are a certain number of soak only devices that can be reprocessed, but must be reprocessed independently of endoscopes and adhering to the guidelines outlined in the document SOAK ONLY DEVICES MAY BE REPROCESSED IN MEDIVATORS AER S. Bulletin number 50097-478 found at www.medivators.com. CER OPTIMA Service Manual 57

RESERVOIR LOSING VOLUME Problem Reservoir level dropping over time Loss of up to 1 gallon per cycle Constant loss Disinfectant being sprayed down the drain. Dirty Drain screen Drain covered by objects Bottles or containers being reprocessed in OPTIMA Solution There is a typical loss of disinfectant up to 20 ml per endoscope per cycle. If the loss is at a low rate, it may simply be normal loss. Verify the distal tip of the endoscope is tucked under the body of the endoscope preventing the fluid from shooting towards the overflow drain Verify the level of the machine. If out of level the fluid will go down the overflow drain. Only hook ups that are attached to the endoscope should be connected to the basin channel ports. Any unused basin connector ports should have a rightangled basin connector inserted. See figure 23A & 23B. A clogged drain screen will prevent the proper return of HLD in the prior cycle. This loss will affect this next cycle in the form of a LOW HLD LEVEL alarm. If the drain is covered by an object(s) that restrict the draining of fluid, this can cause a loss of disinfectant because not all may return to the reservoir in the prior cycle, affecting the next cycle in the form of a LOW HLD LEVEL alarm. See figure 23C Water bottles, suction bottles or any container CANNOT be reprocessed in a MEDIVATORS reprocessor. These items can retain fluid and cause either a loss of disinfectant or a gain of water in the disinfectant. Refer the directions for proper cleaning of these items from the manufacture of the items. Refer to figure 23D 58 CER OPTIMA Service Manual

FLUID LEAKING FROM MACHINE Problem Fluid found behind machine and over the back side of the machine Fluid found around the unit Fluid leaking from hoses Solution Moisture will build up on the bottom side of the reprocessor lid. When the lid is lifted up, condensation can flow down the lid and down the back of the machine if the lid is not fully opened. Always open the lid to the full, upright position quickly. If endoscope hook ups are allowed to drape over the side of the machine, fluid may flow out of these connections, especially if still connected to the basin connectors. Many times, simply disconnecting the hose and wiping the O-ring on the connector and reconnecting can rectify the situation. Recovering from a Power Outage If a power outage should occur during a reprocessing cycle, the cycle must be aborted and a new reprocessing cycle must be performed. After the power outage, the operator must determine where in the cycle the outage occurred. If the basin contains disinfectant, the fluid must be manually drained back to the reservoir using the BASIN to RSVR manual function. If the outage is for a prolonged period, verify the disinfectant is at the proper temperature prior to stating the new cycle. If the basin contains rinse water, the fluid must be manually pumped to the drain using the manual function BASIN to DRAIN. Refer to the OPTIMA USER manual for details on how to operate the manual functions. CER OPTIMA Service Manual 59

CER OPTIMA Diagnostics Introduction The diagnostic functions can be utilized to verify proper component operation when troubleshooting a reprocessor issue. Precautions Always refer to the Safety section in the Introduction chapter before attempting to service the reprocessor. Descriptions of valves, pumps and sensors accessible through diagnostics Diagnostic Code CER-1 OPTIMA CER-2 OPTIMA V1 Channel Port Channel Port V2 Channel Port Channel Port V3 Channel Port Channel Port V4 Channel Port Channel Port V5 Water Inlet Valve Water Inlet Valve V6 HLD Return Valve HLD Return Valve V7 Drain Valve Drain Valve V8 NA Channel Port V9 NA Channel Port V10 NA Channel Port V11 NA Channel Port P1 Channel Pump Channel Pump P2 Transfer Pump Transfer Pump P3 Alcohol Pump Alcohol Pump P4-7 Air Pumps for Channels Air Pumps for Channels P8 Air Pump for Purging Air Pump for Purging S1 Basin Level Sensor Basin Level Sensor S2 Channel Pressure Sensor Channel Pressure Sensor S3 Cover Sensor Cover Sensor S4 Temp Probe 1 Temp Probe 1 S5 Temp Probe 2 Temp Probe 2 S6 Alcohol Low Sensor Alcohol Low Sensor 60 CER OPTIMA Service Manual

To Access Diagnostics Figure 27 1. The Automatic Cycle lights on the FULL and HLD buttons should be extinguished. Refer to figure 27. 2. The display must be in an idle state as in the below example, if not, the diagnostic functions may not be accessible 5/13/201308:30 HLD Cycle Count 25 3. Hold the and press ENTER 4. At this point all lights on the function buttons will be extinguished NOTE: The diagnostic menu is structured in a linear flow. To access various menus requires the operator to scroll down through the options from the beginning to end. The first diagnostic to be displayed is: Diagnostics Front Panel Test Press to access This function tests all the panel buttons. Press the indicated button as requested by the display. All the lights in the function buttons will be illuminated. The machine will display a button description on the display. As each button that is called out is pressed, the corresponding light on the button will extinguish. All buttons must be pressed in the order requested to complete the function. There is no other means to exit the function. If a key is found to not respond, power down the machine and contact Technical Support. CER OPTIMA Service Manual 61