CER OPTIMA Users Manual Rev F

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. 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

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 ... 7 Chemicals... 8 Detergent Solution ... 8 Disinfectant Solution ... 8 Monitoring Disinfectant Potency ... 9 Endoscope Precleaning and Testing... 9 Electromagnetic Compatibility... 9 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 - INSTALLATION Installation Instructions ... 19 Water Filtration System ... 20 Reprocessor Installation ... 23 Air Filter ... 23 Barcode Reader ... 23 Data ... 23 Water ... 24 Drain ... 24 Electrical Cord ... 24 Power ... 25 Printer ... 25 Alcohol ... 25 Drain Screen/Drain Cover ... 25 Channel Connectors ... 26 Accessory Bag ... 26 Disinfectant Reservoir ... 27 Filling and Emptying the Disinfectant Reservoir ... 27 Recommended Filing Method ... 27 Alternative Filing Method ... 28 Empty the Reservoir using Transfer Pump & Tubing Set ... 29 Emptying using Manual Method ... 29 Alternative Emptying Method ... 30

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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 ... 44 Cycle Selection: Automatic or Manual ... 45 Shutdown ... 53 Quality Assurance Test ... 53 Chapter 5 - MAINTENANCE & TROUBLESHOOTING Introduction... 57 System Maintenance ... 57 Alcohol ... 57 Printer Paper ... 58 Drain Screen ... 60 Disinfectant Filter ... 62 Air Filter ... 62 Troubleshooting Guide... 63 Reprocessing Cycle Times... 66 Glossary of Terms ... 67 APPENDIX Warranty... 69

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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 describes the features of the reprocessor, how to setup and operate the reprocessor, and 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.

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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. 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® Endoscope Reprocessing System Before moving the CER OPTIMA Endoscope Reprocessing System, 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 Endoscope Reprocessing System, 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.

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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.

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.

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 bacterialretentive filter. This filter removes all microorganisms and particles greater than 0.2-micron. 7

•

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® endoscope reprocessing system 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 endoscope reprocessing system, refer to the respective chemical labeling, directions-for-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 endoscope reprocessing system 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.

!

Caution! Never use household detergent in the reprocessor.

Disinfectant Solution The CER OPTIMA endoscope reprocessing system is designed for use with RAPICIDE High-Level Disinfectant (HLD), Glutaraldehyde HLD, or Ortho-phthaladehyde (also known as OPA) HLD. 8

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. 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.

Electromagnetic Compatibility The CER OPTIMA® endoscope reprocessing system meets all safety requirements of International standard IEC 61326-1 for medical electrical equipment and is suitable for use in laboratory environments.

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!

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. 9

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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.

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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 Endoscope Reprocessing System received and 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 hook-up 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. 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. 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. •

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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 requiring 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 griping 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.

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Cleaning and Disinfection Always follow established professional guidelines while cleaning and disinfecting endoscopes. The following organizations have published recommended guidelines. Society of Gastroenterology Nurses and Associates 401 North Michigan Ave. Chicago, IL 60611-4267 TEL: (800) 245-7462 FAX: (312) 321-5194 http://www.sgna.org/

Association for Professionals in Infection Control and Epidemiology, Inc. 1275 K Street, NW, Suite 1000 Washington, DC 20005-4006 TEL: (202) 789-1890 FAX: (202) 789-1899 http://[email protected]

American Society for Gastrointestinal Endoscopy 13 Elm Street P. O. Box 1565 Manchester, MA 09144-1314 TEL: (978) 526-8330 FAX: (978) 526-4018 http://www.asge.org/

American Society for Testing and Materials 100 Bar Harbor Drive West Conshohocken, PA 19428-2959 TEL: (610) 832-9585 FAX: (610) 832-9555 http://www.astm.org/

Association of Operating Room Nurses 2170 So. Parker Rd., Suite 300 Denver, CO 80231-5711 TEL: (303) 755-6304 FAX: (303) 750-3462 http://www.aorn.org/

Canadian Society of Gastroenterology Nurses & Associates P.O. Box 366 36 Adelaide Street East Toronto, Ontario M5C 2J5 http://www.webray.com/csgna

British Society of Gastroenterology 3 St. Andrews Place Regents Park, London NW1 4LB 01144-171-387-3534 [email protected].

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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

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

Electromagnetic Environment - guidance The CER OPTIMA system 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. The CER OPTIMA system is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes, provided the following warning is 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 equipment. It maY BE NECESSARY TO TAKE MITIGATION MEASURES, SUCH AS RE-ORIENTING OR RELOCATING THE CER Optima system or shielding the location.

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. IEC 61326-1 test level

Compliance level

Electromagnetic Environment - guidance

Electrostatic discharge ± 6 kV contact (ESD) IEC 61000-4-2 ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Immunity test

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/ output lines

± 2 kV for power supply lines ± 1 kV for input/ output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

<5 % UT (>95% dip in UT) for 0,5 cycle 40 % UT (60% dip in UT) for 5 cycle 70 % UT (30% dip in UT) for 25 cycle <5 % UT (>95% dip in UT) for 5s

<5 % UT (>95% dip in UT) for 0,5 cycle 40 % UT (60% dip in UT) for 5 cycle 70 % UT (30% dip in UT) for 25 cycle <5 % UT (>95% dip in UT) for 5s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the CER OPTIMa system 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: UT is the a.c. mains voltage prior to application of the test level.

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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. Immunity test

IEC 61326-1 test level

Compliance level

Conducted RF IEC 61000-4-6

3 Vrms 3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 Vrms 3 Vrms 80 MHz to 2,5 GHz

Electromagnetic Environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the CER OPTIMA system, 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

V1

d = [ 3,5 ] √P 80 MHz to 800 MHz E1 d = [ 7 ] √P E1

800 MHz to 2,5 GHz

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. Field strengths from fixed transmitters, such as base stations fro 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 system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-or is used exceeds the applicable RF compliance level above, the CER OPTIMA system 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 system.

a

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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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. 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

3,51 ] √P d=[V

3,51 ] √P d=[E

d = [E71] √P

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.

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Specifications Dimensions Chassis Dimensions (height - width - depth) Weight CER-1 OPTIMA (120V) CER-2 OPTIMA (120V) CER-1 OPTIMA (230V) CER-2 OPTIMA (230V) Electrical Requirements Electrical Fuses Power Cord Ambient temperature range for operation Storage and Transportation Maximum Humidity Temperature Altitude

16 X 22 X 20-inches 33-inches with lid open 41 x 56 x 51cm 84cm Add 4” to width when barcode scanner mounted 71 lb 32 kg (approx) 77 lb 35 kg (approx) 75 lb 34 kg (approx) 81 lb 37 kg (approx) 120 VAC 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 50°F - 86°F (10°C - 30°C)

80%, non-condensing 41°F - 158°F (5°C – 70°C) Up to 2000 meters

Safety Classification:

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.

Installation over-voltage

Category: II

Pollution Degree

2

CER-1 OPTIMA water consumption

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

CER-2 OPTIMA water consumption

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

Basin Channels

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:

• External surface immersed in high-level disinfectant. • Internal channels purged by forced fluids.

Environmental Rating

Standard

Mode of Operation

Continuous

Degree of Mobility

Counter top or cart mount

Basin operating capacity

3.44 gallons (13L) Model CER-1 OPTIMA 4.6 gallons (17.4L) Model CER-2 OPTIMA

Reservoir operating capacity

4 gallons (15.1L) Model CER-1 OPTIMA 5 gallons (18.9L) Model CER-2 OPTIMA

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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:

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 ¾-inch male hose thread. All reprocessors and prefilter systems are supplied with a ¾-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!

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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. The drain pipe must contain an air gap at the point where the CER OPTIMA system 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 ENDOSCOPE REPROCESSING SYSTEM MODEL

VOLTAGE

CURRENT

FUSE SIZE

CER-1 OPTIMA

120 VAC

3 AMPS

(2) 4 AMP Type 3AG 250 VAC Slo-Blo, Power Inlet, PN CF02-0000 (2) 2.5 AMP 5x20mm 250V Slo-Blo, Internal Pump, PN 31600-041

CER-1 OPTIMA

230/240 VAC

1.5 AMPS

(2) 2 AMP Type 3AG 250 VAC Slo-Blo, Power Inlet, PN CF02-0003 (2) 2.5 AMP 5x20mm 250V Slo-Blo, Internal Pump, PN 31600-041

CER-2 OPTIMA

120 VAC

3 AMPS

(2) 4 AMP Type 3AG 250 VAC Slo-Blo, Power Inlet, PN CF02-0000 (2) 2.5 AMP 5x20mm 250V Slo-Blo, Internal Pump, PN 31600-041

CER-2 OPTIMA

230/240 VAC

1.5 AMPS

(2) 2 AMP Type 3AG 250 VAC Slo-Blo, Power Inlet, PN CF02-0003 (2) 2.5 AMP 5x20mm 250V Slo-Blo, Internal Pump, PN 31600-041

Disinfectant Transfer Pump (optional)

120 VAC 230/240 VAC

0.50 AMPS 0.25 AMPS

(1) 1.5 AMP, 250V Slo-Blo, PN MF02-0004 (2) 1 AMP, 250V Slo-Blo, PN 31600-003

Disinfectant Reservoir Heater (optional)

120 VAC 230/240 VAC

3.5 AMPS 1.75 AMPS

(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.

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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. Two additional holes are necessary if the water inlet and electricity are under the counter.

Cart Mounted Installation All models The design of the cart provides easy access to the disinfectant reservoir, connection tubing, and water filtration system.

Figure 1. CER OPTIMA SYSTEM

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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. Connect the water line to the female quick connect fitting on the pre-filter side of the filtration system.

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