Steris Reliance EPS

Description

Steris Reliance EPS Endoscope Processing System Features

• Safely accelerates throughput with an easy-to-load, virtually connector-less dual scope automated processor
• No more processing scopes in the same HLD solution 2, 3 or even 40 times
• Optional washing phases augment required manual scope pre-cleaning
• Eliminate staff exposure hazards associated with toxic glutaraldehyde and other aldehyde-based HLD solutions by utilizing dry oxidizing chemistry
• Greatly diminishes chemical exposure and requires no special venting, measuring, mixing or pouring
• Helps reduce the risk of aldehyde-induced colitis
• Ensures the efficacy of every cycle by using single-use chemistry within a validated system
• Automated thermal and chemical self-decontamination cycles help prevent biofilm from forming in the processor

Steris Reliance EPS DESCRIPTION

The Steris Reliance EPS is intended to be used solely with Reliance DG and Verify® Process Indicator strips for Reliance EPS Endoscope Processing System. Reliance DG is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high-level disinfection solution within the Reliance Endoscope Processor. Do not substitute any other product for Reliance DG. The Verify Process Indicator strips are qualitative chemical indicators of the presence of the Reliance DG Dry Germicide active ingredient (peracetic acid). Only use Verify Process Indicator strips for the qualitative detection of the presence of peracetic acid in the Reliance Endoscope Processing System.

The Steris Reliance EPS is single door and designed as a freestanding unit (with accessory countertop and panels). A drop-down door facilitates the loading of the unit. The processor features a state-of-the-art microcomputer control system with a user-friendly operator interface.

The processor is pre-programmed with six complete standard cycles: SINGLE for one endoscope with or without a washing phase, DOUBLE for two endoscopes with or without a washing phase, D-SHORT, and D-LONG.

A standard printer records important in-cycle alarm and cycle value data. Voltage-specific electrical wiring and flexible hoses needed to install the endoscope processor are provided with the processor.

A bar code reader (see ACCESSORIES) can be installed to input identification numbers for the Operator ID, Patient ID, Device ID, Procedure ID, and Physician ID.

Reliance DG Dry Germicide –

• A dry, single-use, oxidative chemistry for use only in the Reliance Endoscope Processor.
• When used in the Reliance EPS this chemistry is used to high level disinfect manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes, and related accessories.

Verify Process Indicator for Steris Reliance EPS –

• Developed exclusively for the independent monitoring of the Reliance DG Dry Germicide used in the Reliance Endoscope Processing System.
• The Verify Process Indicator is used to indicate an effective dose of the peracetic acid generated during the Reliance Endoscope Processing Cycle.

Klenzyme Enzymatic Presoak and Cleaner –

• Single enzyme-based detergent for surgical instruments, flexible endoscopes, and other medical apparatus used in healthcare facilities.
• This product is provided in a special Bag-in-a-Box container developed to ease handling and installation.

CIP 200 Formulated Acid –

• A liquid, acidic detergent system specially formulated to meet unique washing demands.
• This product is provided in a special Bag-in-a-Box container developed to ease handling and installation.

Steris Reliance® EPS Endoscope Processing System Specifications

Exterior Dimensions

• (W x D x H) 38 x 32-1/2 x 47-11/16″ (965 x 825 x 1211 mm)

Interior Chamber Dimensions

• (W x D x H) 24 x 19 x 23″ (610 x 483 x 584 mm)

Load Height

• 23-15/16″ (608 mm) with drop-down door open.

Rex® Microcomputer

• This microcomputer monitor and controls the processor operations and functions. The cycle progresses automatically through the designated phases, as programmed.

Front-Loading Drop-Down Door

• A front-loading, drop-down door is provided to facilitate loading of the unit.
• The door is constructed of 316 stainless steel covered with a plastic panel.
• The panel is strong and easy to clean.
• A tempered glass window allows the operator to view the chamber interior while a cycle is in progress.
• The panel and glass window remains relatively cool to the touch.

Service Access Panel

• The front bottom service access panel provides easy access to the 0.2 μm bacterial-retentive filter, washer injection pumps, and other components for maintenance.

Interior Fluorescent Light

• A 20,000-hour life expectancy interior light allows the operator to view the process and load during the cycle.

Bag-in-a-Box Compartment

• A three-shelf compartment is provided at the right of the chamber.
• Two of the shelves are designed to receive a separate Bag-in-a-Box container provided with a specially designed connector.
• The Bag-in-a-Box compartment dropdown door is made of the same easy-to-clean plastic as the chamber door panel.

Washer Injection Pumps

• The peristaltic washer injection pumps automatically inject the correct quantity of cleaner during the appropriate cycles.
• The pumps are conveniently positioned behind the front service access panel for easy maintenance.

Endoscope Processing Support

• The endoscope processing support is designed to minimize the number of connections required to flow the endoscope channels.
• The endoscope processing support can process one or two endoscopes and their related accessories.
• The endoscope processing support includes two control handle boots, labeled “A” and “B”, for processing compatible flexible endoscopes.
• Additionally, each control handle boot can be adapted to process endoscopes that have special processing requirements (e.g., small diameters and no light guide cables).
• A dedicated process indicator clip on control handle boot A is designed to firmly hold the Verify Process Indicator in place during the cycle.
• The large mesh basket on the upper level of the endoscope processing support can hold up to two light guide cables and large compatible accessories.
• When required, fluid flow units can be connected to the two fluid flow ports in the large mesh basket.
• Bite blocks can be placed on the two accessory pegs.
• On the lid of the Chemical Delivery System are two templates for measuring insertion tube diameters.
• The small accessories basket and the cover is stored under the large mesh basket and is designed to hold small compatible accessories such as air/water valves.
• The valve irrigators have been designed to hold suction valves during the processing cycle.
• Valves are held open inside the holder to ensure solution contacts inside surfaces.

The Chamber

• The high-quality, stainless-steel chamber is insulated to reduce heat loss and noise level.
• Four-manifold connectors are provided at the back of the chamber:
  • One is the hot water inlet to the Chemical Delivery System.
  • Two are connectors for the pressure sensors.
  • One is for the endoscope processing support.
• The endoscope processing support is automatically connected to these manifold connectors when positioned correctly in the processor chamber.
• A removable debris screen at the bottom of the chamber prevents large debris from entering the piping system and pump.
• The screen is provided with a handle and is easily removed for cleaning.

0.2 μm Bacterial-Retentive Filter

• All the water supplied to the processor is filtered through a 0.2 μm bacterial-retentive filter which is conveniently positioned behind the service access panel, below the chamber door, for easy maintenance.
• To ensure parameters affecting filtration efficiency remain within specifications, a pressure holds integrity test is performed during each cycle.

Manifold Air Purge System

• This system circulates HEPA-filtered air through the endoscope processing support and inside the endoscope channels to help remove residual water.
• Room temperature air is used during the purge for safe processing.

Non-Vented System

• Air charged with humidity is evacuated out the chamber through the condenser and returned to the room.

Remote Printer

• A printer is included with the Reliance Endoscope Processor.
• The printer allows the operator to print process time, date, and unit malfunction data.
• Specific information is printed from the Operator mode (cycle parameters, cycle in process parameters, alarms) and Service mode (unit configuration values, unit setup, etc.).
• The printer can be installed at a convenient location up to 10 feet away from the processor.

Container Detection

• The Reliance Endoscope Processing System will provide the user with an indication that a new Reliance DG container has been used for each cycle.
• Components of the in-use Reliance DG solution are monitored during the disinfection phase and the control will abort any cycle where the predetermined disinfectant component level is not detected.

Countertop

• The countertop is made of a laminated wood covered with an easy-to-clean solid plastic surface. A countertop is recommended for a freestanding processor.

Air Compressor

• An air compressor is available to provide facilities that do not have a 50 psi air supply with the means to operate the required 0.2 μm bacterial-retentive filter integrity test.
• Air compressor is supplied on preferred configurations but is a base model addition on other configurations.

Steris Reliance EPS CYCLE DESCRIPTION

IMPORTANT: Items to be high level disinfected must be manually pre-cleaned according to manufacturer recommendations before being placed in the endoscope processing support.

Processing Cycles

There are four processing cycle options to choose from:

1. SINGLE Endoscope Processing Cycle With Washing Phase
   • Used to process one endoscope through washing and high-level disinfection (HLD) phases.
   • The endoscope is placed in control handle boot “A.”
2. SINGLE Endoscope Processing Cycle Without Washing Phase
   • Used to process one endoscope through a high-level disinfection phase only.
   • The endoscope is placed in control handle boot “A.”
3. DOUBLE Endoscope Processing Cycle With Washing Phase
   • Used to process two endoscopes through washing and high-level disinfection phases.
   • One endoscope is placed in the control handle boot “A” and one in control handle boot “B.”
4. DOUBLE Endoscope Processing Cycle Without Washing Phase
   • Used to process two endoscopes through a high level disinfection phase only.
   • One endoscope is placed in control handle boot “A” and one in control handle boot “B.”

• Processing Cycle Description
  • The total default cycle time with a washing phase is approximately 42 minutes.
  • The total cycle time without a washing phase is approximately 30 minutes.
  • Cycle time depends on the washing cycle settings entered in Supervisor mode.
  • Temperature, pressure, and quality of the building water supply can also influence cycle time.

1. The First Phase of the Processing Cycle is an Optional, Programmable Washing Phase
   • This phase consists of a wash with Klenzyme Enzyme Presoak and Cleaner, followed by a rinse.
   • The washing phase can be programmed ON or OFF.
   • In the ON mode, the user can choose either one or two washing phases per processing cycle.
   • Additionally, the wash segment duration can be adjusted to be between 5 and 10 minutes.
   • The Reliance Endoscope Processing System washing phase does not replace manual pre-cleaning by the user.
2. The Second Phase of the Processing Cycle
   • A required high-level disinfection phase and cannot be adjusted by the user.
   • In this phase, the single-use container Reliance DG chemistry is dissolved with water at 122°F (50°C) and circulated throughout the processor and through the device lumens.
   • During the first four minutes of this phase, peracetic acid is generated from the dry components creating the germicidal high-level disinfection solution.
   • This solution generation is followed by a six-minute high-level disinfection phase at 122°F (50°C).
3. The Third Phase of the Processing Cycle
   • A required rinse phase and cannot be adjusted by the user.
   • The Reliance Endoscope Processor removes the high-level disinfection solution using two rinses.
   • The processor filters the rinse water (as well as all of the water used throughout the cycle) through a 0.2 μm bacterial-retentive filter.
   • The processor also incorporates an automatic internal integrity check of the filter at the end of each processing cycle.
   • If the integrity check fails, the user is alerted by an alarm and the cycle printout indicates a fault code for this filter integrity failure.
4. The Fourth and Last Phase of the Processing Cycle
   • An air purge phase using HEPA-filtered air.
   • The air purge helps to remove excess rinse water from the processed devices.
   • The final air purge is preset to run for four minutes; additional air purge time may be selected by the operator for up to 30 minutes.
   • If the devices are not removed from the processor at the end of the cycle, the air purge phase will continue for up to a maximum of 60 minutes.

• Decontamination Cycles
• The processor also features Two decontamination cycles intended to prevent biofilm formation in the chamber and on the endoscope processor support.

1. The First is Called D-SHORT
   • Consists of hot water at 180°F (82.2°C) circulating through the processor for 13 minutes, followed by a 10-minute hot air purge at 240°F (115.6°C).
   • This cycle must be run every 54 hours.
   • If a D-SHORT cycle is not completed within this time interval, the processor is locked out from use until a D-LONG cycle (see below) is run.
   • D-SHORT is intended to prevent biofilm formation and contamination.
2. The Second Decontamination Cycle is Called D-LONG
   • Consists of a cycle in which CIP 200 Acid-Based Process and Research Cleaner is added to hot water at 180°F (82.2°C).
   • The washing solution is then circulated through the processor for 20 minutes; this is followed by three rinses to remove the solution from the processor and a 10-minute hot air purge at 240°F (115.6°C).
   • D-LONG is to be used on those occasions when the D-SHORT cycle has not been run within the past 54 hours.
   • D-LONG is intended to prevent biofilm formation and contamination.

• Steris Reliance EPS TEST Cycle
  • A TEST cycle program is available for service and maintenance.

Steris Reliance EPS CONTROL SYSTEM

Design Features

• Operator Interface Control Panel Consists of
  • A Display Screen
  • A Touch Pad
  • ON/OFF and UNLOCK Toggle Switches

• Display Screen –
  • The control display window features a 2-line x 16 characters, easy-to-read vacuum fluorescent display.
  • The display shows cycle status, remaining time, alarms, and instructional messages.
  • The display also indicates abnormal conditions that may occur during a cycle.
• TouchPads –
  • Membrane-type touch pads allow the operator to select, start, stop, or abort cycles.
  • An audible signal is heard to acknowledge that a pushbutton has been pressed.
• Audible Signals –
  • The audible alarm signal warns the operator that an action must be taken or when a cycle is completed.
• Cycle/Day Count Recall System –
  • A Cycle/Day Count Recall System reminds the operator when a complete preventive maintenance check is required.

Cycle Configuration

The Control System Offers Three Different Modes

1. Operator Mode
   • Allows an operator to only Start/Stop/Resume/Abort cycles.
2. Service Mode
   • Allows a service technician to perform preventive maintenance and testing.
   • The Service mode also facilitates troubleshooting.
3. Supervisor Mode
   • Allows an authorized operator to modify the time value for the Wash 1 and Air Purge phases
   • Set date and time
   • Program bar code IDs
   • Select the operating language and the “repeat washing” feature.
   • In addition to the adjustment of cycle values, the following operating parameters can also be changed in Supervisor Mode:
     • Time Display and Printout Units – Standard AM/PM or 24 hour military time (MIL).
     • Temperature Display – Fahrenheit (°F) or Celsius (°C). Temperature is set, displayed, controlled, and printed to the nearest 0.1 degrees. Recalibration is not required when changing temperature units from °F to °C and vice versa.
     • Pressures – may be programmed in psi or kPa. Recalibration is not required when changing unit pressure from psi to kPa or vice versa.

Steris Reliance EPS TECHNICAL DATA

• Control System
  • Control system consists of microcomputer control boards and peripheral function circuit boards, located within the control board housing.
• Electronic Temperature Control
  • Resistive Temperature Device (RTD) sensors are used instead of conventional thermostats, to provide accurate control inputs and readouts throughout all phases of the cycle.
• Electronic Pressure Monitoring
  • Two pressure transmitter sensors are used to provide control measurements and readouts of the pressure developed within both control handle boots during the washing (optional) and HLD phases.
  • A third pressure transmitter sensor is used to provide accurate pressure measurements during Filter Integrity Pressure Hold Test.
• Internal Battery
  • An internal battery backs up all cycle memory for up to 10 years.
  • If a power failure occurs during a cycle, the battery back-up system ensures that cycle memory will be retained and proper cycle completion will occur once power is restored.
  • When power is lost, the cycle is held in phase until power is restored.
  • Once power returns, the event is recorded on the printout and the cycle automatically resumes or is aborted, depending on which phase the cycle was in at the time of power loss.

Utility Requirements

• Size
  • Hot Water 5/8″ Barbed M
  • Cold Water 1/2″ NPT M (BSPT M)
  • Air 1/4″ OD
  • Drain 1-1/2″ ID (30 mm)
• Dynamic Pressure
  • Hot Water 40 to 50 psig (2.76 to 3.45 bar)
  • Cold Water 40 to 50 psig (2.76 to 3.45 bar)
  • Air 50 to 125 psig static (3.45 to 8.62 bar)
• Building Water Supply Temperature
  • Hot Water 110°F (43°C) to 118°F (48°C)
  • Cold Water 70°F (21°C) maximum
• Maximum Flow Rate
  • Hot Water 2.3 U.S. gal/min (8.7 L/min)
  • Cold Water 1.9 to 4.2 U.S. gal/min (7.19 to 15.9 L/min)
  • Air 0.2 cfm
  • Drain 4.0 U.S. gal/min (15.0 L/min)
• Quality
  • Hot Water Potable Water 300 ppm max CaCo3
  • Cold Water 300 ppm max CaCo3
  • Air Maximum particulate size: 5 microns.
  • Maximum dew point: 37-45°F(3-7°C).
  • Maximum oil concentration: 5 mg/m3.
• Processor Electricity
  • 208 V, 60 Hz, 3-Phase, 30 Amp
  • 230 V, 60 Hz, 1-Phase, 40 Amp
  • 460 V, 60 Hz, 3-Phase, 15 Amp
• Printer Electricity
  • 120 V, 60 Hz, 1 Amp
• Air is required without optional Air Compressor installed.
• CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH APPLICABLE LOCAL AND NATIONAL CODES AND REGULATIONS.

SAFETY FEATURES

• Safety Door Switch
  • A microswitch prevents a cycle from starting if the door is not fully closed.
• Safety Stop
  • Pressing the STOP touchpad once automatically pauses operation of the unit and pressing the STOP touchpad a second time aborts the cycle.
• Unlock Toggle Switch
  • The processor is provided with an UNLOCK toggle switch that must be pressed to open the door.
• Labeling
  • The Reliance Endoscope Processing System is labeled with safety precaution labels and equipped with wall charts to warn and inform operator and service technicians of precautions to take and proper use of the processor.
• Process Monitoring
  • The control system monitors pressures within the control handle boots and warns the operator if pressures drop below the minimum requirement or exceed the maximum requirement for safe and effective processing of the devices.
  • Water and air temperatures within the processor chamber are monitored for safe processing.
  • The rinse water quality is automatically monitored every cycle by a filter integrity pressure hold test.
  • A vacuum switch in the cleaning solution injection line signals the control when there are insufficient reserves.
  • A level float, consisting of a magnetic float switch, controls the sump water level.
  • Verify Process Indicator strips are designed to confirm an effective dose of peracetic acid during the high level disinfection process.

Steris Reliance EPS CONSTRUCTION

• Chamber
  • Chamber is constructed of 20 gauge, 316L stainless steel (#4 finish), and is seam welded.
  • Chamber inhibits corrosive action of chemicals and is easy to wash, with no enameled surfaces to chip or crack.
  • Sump capacity is four gallons (15 L).
  • Stainless steel 304 heating coils are included.
• Insulated Construction
  • Insulated construction of chamber exterior reduces heat loss and noise level for both under-counter and freestanding units.
• Piping and Recirculation System
  • All components of the recirculation system, including sump, screen, rotary spray arms, pump, Chemical Delivery System, water filter housing, piping, and endoscope processing support, are constructed of 316L stainless steel, silicone, polypropylene, and/or hydrophilic polyvinylidene fluoride (PVDF).
  • All materials are compatible with Reliance DG, Klenzyme Enzymatic Presoak and Cleaner, and CIP 200 Acid-Based Process and Research Cleaner.
• Stainless-Steel Pump
  • All phases are under pressure utilizing a 1.5 HP stainless-steel pump with a 66 U.S. gal/min at 52 ft. (249.8 L/min at 16 m) capacity.
  • Pump impeller, shaft, and casing (all stainless steel construction) are fitted with a mechanical seal.
  • The pump impeller is mounted directly on the motor shaft.
  • The pump motor is thermally protected and is equipped with a totally enclosed frame (TEFC), magnetic starter, and sealed bearings (requiring no periodic lubrication).
• Removable Debris Screen
  • The debris screen, constructed of 304L stainless steel (#4 finish), is located at the bottom of the sump and prevents large debris from entering the piping system and pump.
  • The screen can be easily removed for cleaning.

MOUNTING ARRANGEMENT

• The Steris Reliance EPS is designed as a fully enclosed unit for recessed or freestanding installation.
• Casters and flexible utility hoses are provided to allow the unit to be moved in and out of mounting location for maintenance purposes.
• The processor is inter-piped and inter-wired, requiring only one connection for each service and utility hook-up.

ACCESSORIES

• Seismic Anchorage Kit
  • A seismic anchorage kit is available and meets seismic building code requirements for high-risk seismic zones.
  • The report is supplied with the seismic kit.
• Bar Code Reader
  • Allows input and traceability of important data from printed bar codes such as:
    • Operator ID
    • Patient ID
    • Device ID
    • Procedure ID
    • Physician ID
• Automated Leak Test
  • This feature, when activated, will detect leaks in flexible Olympus®, Pentax®, and Fujinon® endoscopes prior to processing.
  • The endoscopes will be pressurized within the manufacturer’s specified ranges and leaks as low as 0.22 psig (15 mbar) will be detected.
  • Minimal pressure is maintained and monitored throughout the processing cycle.
• Dual Pre-Filter and Pressure Regulator Assembly (REQUIRED)
  • Assures hot water is supplied at optimal pressure and quality to the processor.
  • Assembly Includes:
    • One multi-layer depth media filter cartridge
    • One dual layer absolute membrane filter cartridge
    • One pressure regulator to reduce incoming water pressure to 345 kPa (50 psi)
    • One spanner wrench to easily screw and unscrew filter bowls for maintenance
• Flow Units 1-6
  1. Reliance Endoscope Processor accessory that must be used for processing Olympus®, Pentax®, and Fujinon® endoscope1 irrigation tubes.
  2. Reliance Endoscope Processor accessory that is required for processing the Olympus® 145/160/165/180 Series GI Endoscopes with an auxiliary water channel. This independent channel flows from the light guide control end connector to the distal tip without an access port on the control handle.
  3. Reliance Endoscope Processor accessory that is required for processing Pentax® P/X/00/01 Series GI Endoscopes fitted with a non-removable, mechanically actuated valve at the control handle’s auxiliary water channel port.
  4. Reliance Endoscope Processor accessory that is required for processing Pentax® 70/70K/72/72K/80K/81K/85/85K/90i/90K Series GI Endoscopes1 with a water jet channel. The independent channel flows from the light guide control connector to the distal tip.
  5. Reliance Endoscope Processor accessory that must be used when processing Cook, Medovations or CONMED esophageal dilators with a lumen (internal channel). Non-lumened dilators from Medovations, Pilling, and Rusch do not require a Flow Unit to process.
  6. Reliance Endoscope Processor accessory that is required for processing Fujinon® 530 Series Colonoscopes with Water Tank Receiver Port.

Steris Reliance EPS NOTES

1. Where required by local codes, installation of a backflow preventer, such as Wilkins 975XL 1/2″ NPT or equivalent (not provided) is recommended for hot and cold water inlets.
2. Building service lines (not provided) must supply the specified pressures and flow rates.
3. Disconnect switches (with OFF position lockout only; not provided) should be installed in electric supply lines near the equipment.
4. Clearances shown are minimal for installing and servicing the equipment. Refer to equipment drawing for specific details.
5. Customer must ensure processor stands on a noncombustible, non-slip floor.

STANDARDS

The processor meets the applicable requirements of the following standards:

• Underwriters Laboratories (UL) Standard 61010-1.
• Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 61010-1.
• Governing Directive for the affixing of the CE mark: Medical Device Directive 93/42/EEC, Annex II.
• ISO/DIS 15883-1: Washer-Disinfectors general requirements, definitions, and tests.
• ISO/DIS 15883-4: Washer-Disinfectors, using chemical disinfection for thermolabile endoscopes, requirements and tests.
• Standards applied to demonstrate conformity to the directives: IEC-61010-1; IEC-61010-2-040; IEC-61326-1.