Steris Reliance Eps Endoscope Processing System Operating instructions

OPERATOR MANUAL

Reliance™ EPS Endoscope Processing System

(2022-03-10) P920011-649

i

Introduction Operator Manual 920011-649

This manual contains important information on the proper use and

routine maintenance of the Reliance™ EPS Endoscope Processing

System and of the optional Automated Leak Test Assembly. All

personnel involved in the use and maintenance of this

equipment must carefully review and comply with the Safety

Precautions and instructions contained in this manual. These

instructions are important to protect the health and safety of

personnel operating this processor and should be retained in a

conveniently accessible area for quick reference.

For a 50 Hz processor, also read Operator Manual - Information

Supplement For 50 Hz Processors (P920501-322) for specific information

and features.

Complete instructions for uncrating and connecting utilities, as well

as the equipment drawing, have been provided. If they are missing,

contact STERIS for replacement copies, providing the serial number

of the processor.

STERIS provides a line of accessories and Flow Units for use with this

processor. A STERIS representative will gladly review these with you.

Please familiarize all users with this manual and store in an accessible

location.

Advisory IMPORTANT: This processor is specifically designed to only process

endoscopes as outlined in this manual and in the Endoscope Quick

Reference Guide. If there is any doubt about a specific endoscope

material or product, contact STERIS.

A listing of the Safety Precautions to be observed when operating and

servicing this processor can be found in SECTION 1 of this manual. Do

not operate the equipment until you have become familiar with this

information.

If the processor is equipped with an optional Automated Leak Test

Assembly, use this Automated Leak Test Assembly only as specified

and described in this manual.

Any alteration of this equipment not authorized or performed by

STERIS will void the warranty. Alteration of this equipment which

could adversely affect high level disinfection efficacy may violate

national, state and local laws or regulations and could jeopardize

your insurance coverage.

The protection provided by the equipment may be impaired if this

equipment is used in a manner not specified by STERIS.

Serious incidents that have occurred in relation to this medical

device should be reported to the manufacturer and competent

authority in the country where the incident occurred.

A WORD FROM STERIS

ii

920011-649 Operator Manual Introduction

To help ensure operators are adequately trained in the safe use of

this equipment, STERIS recommends:

• all personnel who operate or maintain the equipment are trained

in its operation and in its safe use.

• there is regular training of all personnel concerned with the

operation and maintenance of the equipment; attendance

records are maintained; and the evidence of understanding is

demonstrated.

• Current Safety Data Sheets (SDS) should be available to all users

in the department. For current SDS, contact STERIS.

Serious incidents that have occurred in relation to relation to this

medical device should be reported to the manufacturer and

competent authority in the country where the incident occurred.

Waste Products

Disposal

The following are waste materials associated with the processor.

When disposing of waste materials, ensure disposal is in compliance

with federal, state and local regulations.

• Printer paper – Recyclable.

• Printer ribbon – Not recyclable.

• HEPA Filter – Place HEPA filter in a large, sealable bag. Discard

the bagged HEPA filter in an outdoor waste container.

• Two Filter Cartridges from Dual Pre-Filter and Pressure Regulator

Assembly – Discard filter cartridges in an outdoor waste

container.

• 0.2 µm Bacterial-Retentive Filter Cartridge – Place filter cartridge

in a large, medical storage sealable bag. Discard the bagged

filter cartridge in a safe manner in accordance with local/national

regulations.

• Chemicals – Dispose in a safe manner in accordance with local/

national regulations and current Safety Data Sheets (SDS).

• Chemical containers – Dispose of empty containers in a safe

manner in accordance with local/national regulations.

• Entire processor (end-of-life) – Contact STERIS Corporation for

disposal or recycling recommendations.

iii

Introduction Operator Manual 920011-649

Overview Thank you for choosing

STERIS Corporation

and

The Reliance EPS Endoscope Processing System

The Reliance™ EPS Processor was designed to be versatile in meeting

the growing demands of the modern flexible endoscope processing

department, while offering patient and staff safety. The Reliance EPS

automated process, detailed below, is scientifically proven to offer

quality and outcomes you have come to expect from STERIS.

Optional Washing Phase

The Reliance EPS Processor offers a programmable washing phase.

The phase can be programmed on or off, utilizing one or two

washing phases per processing cycle, and an adjustable wash time

between five and ten minutes. The processor will automatically

dispense the correct amount of the STERIS washing detergent,

Klenzyme® Enzymatic Presoak and Cleaner, during the wash. The

Reliance washing phase does not replace manual cleaning of the

endoscopes. Please refer to endoscope manufacturer guidelines for

cleaning instructions.

High Level Disinfection

The high level disinfection portion of the cycle is a non-optional,

ten-minute, pre-programmed phase. The processor will automatically

dilute the Reliance dry chemistry, flow the high level disinfection solution

through the endoscope lumens and spray it over their external surfaces,

without user exposure to the disinfection solution. The STERIS chemical

indicator validated for use with the Reliance EPS is used as an

independent monitor of the Reliance EPS Endoscope Processing

Cycle.

Rinsing

Following high level disinfection, the Reliance EPS Processor

removes the high level disinfection solution through two rinse

phases. The processor filters the water through a 0.2 µm bacterial-

retentive filter and incorporates an automatic internal integrity

verification of this filter during each cycle.

Final Air Purge

The final stage of the Reliance EPS Cycle is an air purge phase using

HEPA-filtered air. The air purge helps to remove excess rinse water

from the processed endoscopes and accessories. This final air

purge is preset to run for four minutes; additional air purge time (up

to a total of 30 minutes) may be programmed by the supervisor. If the

endoscopes and accessories are not removed after the

programmed time, the air purge will continue to run for a maximum of

60 minutes.

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920011-649 Operator Manual Introduction

Documentation

The Reliance EPS Processor prints a detailed cycle summary at the

end of each cycle. With the optional bar code reader, these printouts

can also include the identification numbers for the operator, patient,

device, physician and procedure.

Indications for Use The Reliance Endoscope Processing System is intended for

washing and high level disinfection of up to two manually pre-

cleaned, immersible, reusable, heat-sensitive, semi-critical devices

such as bronchoscopes, GI flexible endoscopes including

duodenoscopes, and their accessories. High level disinfection is

achieved within the 50-57°C HLD phase of the endoscope

processing cycle (4-minute generation sequence followed by a

6-minute exposure sequence).

NOTE: This manual will use the general term "endoscope" for the

above-mentioned medical devices and accessories.

The Automated Leak Test Assembly is offered as an option and is

installed at the factory. The automated leak test is performed at the

start of a cycle, prior to fluid circulation within the processor.

The automated leak test is intended to detect leaks in flexible

endoscopes prior to the start of the processing cycle. The automated

leak test IS NOT a substitute for the manufacturer's manual leak test.

IMPORTANT: Operator must ensure all items have been prepared for

immersion, manually leak tested (as per the instructions of the

endoscope manufacturer) and manually cleaned before placing them

in the Reliance EPS Processor. Refer to Endoscope Quick Reference

Guide for more details.

IMPORTANT: Reliance dry chemistry and the STERIS chemical

indicator for Reliance EPS are intended to be used exclusively

within the Reliance EPS. Do not substitute any other chemistry or

chemical indicator product.

Reliance dry chemistry is a proprietary, two-part, dry, single-use

germicide, designed to deliver high level disinfection solution in the

Reliance EPS Processor.

A STERIS chemical indicator that is validated for use with the

Reliance EPS is a single use chemical indicator designed to

change from the color of the “START” reference block on the label

to the “ENDPOINT” reference block upon exposure to an effective

dose of peracetic acid generated during the Reliance EPS Cycle.

v

Introduction Operator Manual 920011-649

Service Information A thorough preventive maintenance program is essential to help

ensure safe and proper processor operation. This manual contains

maintenance schedules and procedures which should be followed

for satisfactory equipment performance.

Customers are encouraged to contact STERIS concerning our

comprehensive annual maintenance program. Under the terms of the

program, preventive maintenance, adjustments and replacement of

worn parts are performed on a scheduled basis to help ensure

equipment performance at peak capability and to help avoid untimely

or costly interruptions. STERIS maintains a global staff of well-

equipped, qualified service technicians to provide this service, as well

as expert repair services. Please contact STERIS for details.

Trademarks Please take note of the following registered trademarks that apply to

the wording used throughout the manual:

•Fujifilm is a registered trademark of FUJIFILM.

•Olympus is a registered trademark of Olympus Optical Co., Ltd.

•Pentax is a registered trademark of Pentax Imaging Company.

Certification The Reliance EPS Processor meets the applicable requirements of

the following standards:

•Underwriters Laboratories (UL) Standard 61010-1, Third

Edition

•Canadian Standards Association (CSA) CAN/CSA C22.2

No. 61010-1, Third Edition.

The Reliance EPS Processor meets the following international

standards:

•ISO 15883-1 (2006): Washer-Disinfectors – General requirements,

terms and definitions and tests.

•ISO 15883-4 (2008): Washer-Disinfectors – Requirements and

tests for washer-disinfectors employing chemical disinfection for

thermolabile endoscopes.

Governing Directive for the affixing of the CE mark:

•Medical Device Directive 93/42/EEC as amended by 2007/47/EC.

Standards applied to demonstrate conformity to the directive:

•IEC 61010-1; IEC 61010-2-040; IEC 61326-1.

vi

920011-649 Operator Manual Introduction

Manufactured by:

STERIS Canada ULC

490 boulevard Armand-Paris

Québec (Québec)

CANADA G1C 8A3

The base language of this document

is ENGLISH. Any translation must

be made from the base language

document.

European Community Representative:

STERIS Ireland Limited

IDA Business and Technology Park

Tullamore

County Offaly

R35 X865

Ireland

Sales and Service

-- Europe, Middle-East and Africa:

STERIS

116 Avenue de Magudas, 33185

Le Haillan

FRANCE

Support Service, by email:

[email protected]

All other requests, by phone: +33 5 56 93 94 94

Website:

www.steris.com

Sales and Service

-- Americas, Oceania (except Australia and New Zealand)

and Asia:

STERIS Corporation

5960 Heisley Road

Mentor, Ohio 44060

440-354-2600 • 800-548-4873

vii

Table of Contents Operator Manual 920011-649

A WORD FROM STERIS......................................................................................... -I

Advisory .......................................................................................................................................................... -i

Waste Products Disposal .............................................................................................................................. -ii

Overview........................................................................................................................................................ -ii

Indications for Use........................................................................................................................................ -iv

Service Information....................................................................................................................................... -iv

Trademarks.................................................................................................................................................... -v

Certification .................................................................................................................................................... -v

1 SAFETY PRECAUTIONS .....................................................................................1-1

2 INSTALLATION VERIFICATION ..........................................................................2-1

2.1 Technical Specifications .................................................................................................................... 2-1

2.1.1 Permissible Environmental Conditions .................................................................................2-1

2.1.2 Noise Level ........................................................................................................................... 2-1

2.1.3 Voltage, Amperage and Power Consumption ...................................................................... 2-1

2.1.4 Seismic Anchorage System (Accessory) .............................................................................2-2

2.2 Installation Verification .......................................................................................................................2-2

2.3 Chemical Additive Descriptions ........................................................................................................ 2-4

2.3.1 Washing Detergent ............................................................................................................... 2-4

2.3.2 Dry Chemistry ....................................................................................................................... 2-4

2.3.3 Decontamination Chemistry .................................................................................................. 2-4

3 COMPONENT IDENTIFICATION ..........................................................................3-1

3.1 Processor – General ..........................................................................................................................3-1

3.1.1 Chamber Door ......................................................................................................................3-1

3.1.2 Service Access Panel ........................................................................................................... 3-1

3.1.3 Base ......................................................................................................................................3-1

3.1.4 Bag-in-a-Box Compartment ..................................................................................................3-1

3.1.5 Chamber ...............................................................................................................................3-3

3.1.6 0.2 μm Bacterial-Retentive Filter ...........................................................................................3-3

3.1.7 Cleaner Injection Pumps ....................................................................................................... 3-3

3.1.8 Fresh Container Detection Meter .......................................................................................... 3-3

3.2 Endoscope Processing Support ........................................................................................................ 3-5

3.2.1 Control Handle Boots ............................................................................................................ 3-5

TABLE OF CONTENTS

Section

Number Description Page

(Continued...)

viii

920011-649 Operator Manual Table of Contents

3 COMPONENT IDENTIFICATION (Cont’d)

3.2.2 Large Mesh Basket and Accessory Basket .......................................................................... 3-5

3.2.3 Valve Irrigators ......................................................................................................................3-5

3.2.4 Reliance CDS Chemical Delivery System .............................................................................3-5

3.3 Control ...............................................................................................................................................3-7

3.3.1 Operator Mode ..................................................................................................................... 3-7

3.3.2 Supervisor Mode ................................................................................................................... 3-9

3.3.3 Service Mode ........................................................................................................................3-9

3.3.4 Display Screen ....................................................................................................................3-10

3.3.5 Audible Signal ..................................................................................................................... 3-10

3.3.6 Printer ..................................................................................................................................3-10

3.4 Reliance Dry Chemistry ................................................................................................................... 3-10

3.5 STERIS Chemical Indicator .............................................................................................................3-11

3.6 Bar Code Reader (Accessory) ........................................................................................................3-11

3.7 Dual Pre-Filter and Pressure Regulator Assembly (Required Accessory) ...................................... 3-12

3.8 Endoscope Overview and Vocabulary ............................................................................................3-13

3.8.1 Endoscope Vocabulary List ................................................................................................3-13

3.8.2 Endoscope With Biopsy/Suction System ............................................................................ 3-14

3.8.3 Endoscope With Air/Water System .....................................................................................3-15

4 PROCESSING INSTRUCTIONS ...........................................................................4-1

4.1 Principles of Operation – Overview ...................................................................................................4-1

4.1.1 Reliance EPS Endoscope Processing System ..................................................................... 4-1

4.1.2 Optional Automated Leak Test Assembly ............................................................................4-2

4.2 General Processing Guidelines .........................................................................................................4-3

4.3 Loading Endoscope Processing Support ......................................................................................... 4-3

4.4 Optional Automated Leak Test ........................................................................................................4-15

4.4.1 Preparation ......................................................................................................................... 4-15

4.4.2 Pentax Leak Test Adapter for i10c Series .......................................................................... 4-18

4.4.3 Starting Cycle .....................................................................................................................4-18

4.4.4 Status ..................................................................................................................................4-19

4.4.5 Audible Signal ..................................................................................................................... 4-22

4.4.6 Self-Diagnostic ....................................................................................................................4-23

4.5 Installing Reliance Dry Chemistry Container ................................................................................... 4-25

TABLE OF CONTENTS (Cont’d)

Section

Number Description Page

(Continued...)

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Table of Contents Operator Manual 920011-649

4 PROCESSING INSTRUCTIONS (CONT’D)

4.6 Inserting STERIS Chemical Indicator Strip ...................................................................................... 4-26

4.7 Pre-Processing Checklist ................................................................................................................ 4-27

4.8 Processing Cycle .............................................................................................................................4-28

4.8.1 Optional Testing Prior to Starting Cycle ..............................................................................4-29

4.8.2 Starting Cycle .....................................................................................................................4-30

4.8.3 Endoscope Detection ......................................................................................................... 4-33

4.8.4 Low Chemical Warning .......................................................................................................4-34

4.8.5 Monitoring Cycle .................................................................................................................4-35

4.8.6 Completing Cycle ............................................................................................................... 4-38

4.9 Process Verification and Unloading Procedure ..............................................................................4-39

4.9.1 VERIFICATION 1 – Parametric Controls ............................................................................. 4-40

4.9.2 VERIFICATION 2 – Process ................................................................................................ 4-41

4.9.3 VERIFICATION 3 – Physical................................................................................................ 4-41

4.10 Water Sampling Test .......................................................................................................................4-42

4.11 Post-Processing Checklist ...............................................................................................................4-44

4.12 Pause or Abort Cycle ....................................................................................................................... 4-44

4.13 Responding to a Fault .....................................................................................................................4-47

4.13.1 Faults ..................................................................................................................................4-47

4.13.2 Maintenance Due Faults .....................................................................................................4-49

4.14 Shutdown .........................................................................................................................................4-50

4.15 Power Failure ................................................................................................................................... 4-50

4.15.1 General ...............................................................................................................................4-49

4.15.2 Unlocking Processor Door During a Power Failure .............................................................. 4-52

4.16 Dry Chemistry Container Disposal ....................................................................................................4-53

4.17 Disposing of Expired Dry Chemistry .................................................................................................4-54

TABLE OF CONTENTS Cont’d)

Section

Number Description Page

(Continued...)

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920011-649 Operator Manual Table of Contents

5 CYCLE AND CONTROL VALUE PROGRAMMING.................................................5-1

5.1 General .............................................................................................................................................. 5-1

5.2 Supervisor Mode ...............................................................................................................................5-3

5.2.1 Accessing Supervisor Mode ................................................................................................. 5-3

5.2.2 Changing Cycle Values ........................................................................................................ 5-4

5.2.3 Setting Miscellaneous Values ............................................................................................... 5-8

5.2.4 Performing Bar Code Test and Programming Operator and Physician ID Lists ................5-16

6 ROUTINE MAINTENANCE ...................................................................................6-1

6.1 General .............................................................................................................................................. 6-1

6.2 Routine Maintenance .........................................................................................................................6-2

6.3 Debris Screen ....................................................................................................................................6-3

6.4 Drip Pan .............................................................................................................................................6-3

6.5 D-SHORT Cycle .................................................................................................................................6-4

6.6 Surfaces of Processor .......................................................................................................................6-7

6.7 Draining Holes and Punching Rods .................................................................................................. 6-7

6.8 Replacing Bag-in-a-Box Container .................................................................................................... 6-8

6.9 Changing Printer Ribbon and Paper Roll ........................................................................................ 6-12

6.10 Changing Pre-Filters ........................................................................................................................6-13

6.10.1 Dual Pre-Filter and Pressure Regulator Assembly Cartridges (Required Accessory) .......6-13

6.10.2 0.2 μm Bacterial-Retentive Filter Cartridge .........................................................................6-15

6.11 D-LONG Cycle ................................................................................................................................. 6-17

6.12 Rotary Spray Arm Assembly ............................................................................................................6-19

6.13 Lubrication of Leak Test Hose Assembly O-Ring ............................................................................ 6-20

6.14 Replacement of Leak Test Hose Assembly O-Ring ........................................................................6-20

7 TROUBLESHOOTING ..........................................................................................7-1

7.1 Troubleshooting Chart ....................................................................................................................... 7-2

7.2 Fault Chart ......................................................................................................................................... 7-5

7.3 Maintenance Due Alarm Chart ........................................................................................................7-25

8 RECOMMENDED SPARE PARTS AND CONSUMABLE PRODUCTS .....................8-1

TABLE OF CONTENTS (Cont’d)

Section

Number Description Page

xi

920011-649 Operator Manual Table of Contents

xi

List of Illustrations Operator Manual 920011-649

3 COMPONENT IDENTIFICATION

Figure 3-1. Processor With Countertop (Option) ...................................................................................... 3-2

Figure 3-2. Processor Without Countertop (Option) ................................................................................. 3-2

Figure 3-3. Chamber and Service Access Interior ................................................................................... 3-4

Figure 3-4. Endoscope Processing Support ............................................................................................ 3-6

Figure 3-5. Control Panel .......................................................................................................................... 3-8

Figure 3-6. Printer ................................................................................................................................... 3-10

Figure 3-7. Bar Code Reader (Accessory) ............................................................................................. 3-11

Figure 3-8. Dual Pre-Filter and Pressure Regulator Assembly (Required Accessory) ........................... 3-12

Figure 3-9. Example of an Endoscope With a Simple Biopsy/Suction System ...................................... 3-14

Figure 3-10. Example of an Endoscope With a Biopsy/Suction and Air/Water System ........................... 3-15

4 PROCESSING INSTRUCTIONS

Figure 4-1. Solution Flow Schematic ........................................................................................................ 4-2

Figure 4-2. Large Mesh Basket and Accessory Basket ........................................................................... 4-5

Figure 4-3. Accessory Basket Insertion From Control Side ...................................................................... 4-6

Figure 4-4. Carefully Insert Insertion Tube in Template Slot ..................................................................... 4-7

Figure 4-5. Insertion Tube Sleeves For Small Diameter Insertion Tubes .................................................. 4-8

Figure 4-6. Insert Insertion Tube Into Control Handle Boot Opening ....................................................... 4-9

Figure 4-7. Place Control Handle in Control Handle Boot ........................................................................ 4-9

Figure 4-8. Split Insertion Tube Sleeve ..................................................................................................... 4-9

Figure 4-9. Feeding Distal Tip Into Sleeve .............................................................................................. 4-10

Figure 4-10. Closing Sleeve Around Insertion Tube ................................................................................. 4-10

Figure 4-11. Coil Light Guide Cable and Connect Flow Units .................................................................. 4-11

Figure 4-12. Plug to Process Only One Endoscope ................................................................................. 4-12

Figure 4-13. Use Control Handle Boot Plug to Process Endoscope Without a Light Guide Cable .......... 4-12

Figure 4-14. Insertion Tube Sleeve ........................................................................................................... 4-14

Figure 4-15. Test Cord .............................................................................................................................. 4-14

Figure 4-16. Automated Leak Test Hose Assembly (Fujifilm Shown) ....................................................... 4-16

Figure 4-17. Connect Quick Connect Extremity of Leak Test Hose(s) to Flexible Connection(s) ............ 4-17

Figure 4-18. Connect Other Extremity of Leak Test Hose(s) to Endoscope(s) ........................................ 4-17

Figure 4-19. Pentax Venting Connector Adapter (OE-C29) ...................................................................... 4-18

Figure 4-20. Leak Test Hoses Connections Flowchart ..............................................................................4-20

Figure 4-21. Automated Leak Test Hose Assembly Plug (Olympus Shown) ............................................ 4-22

Figure 4-22. Reliance Dry Chemistry......................................................................................................... 4-24

Figure 4-23. Insertion of Chemical Indicator Strip..................................................................................... 4-25

LIST OF ILLUSTRATIONS

Figure Description Page

(Continued...)

xii

920011-649 Operator Manual List of Illustrations

4 PROCESSING INSTRUCTIONS (CONT’D)

Figure 4-24. Typical Cycle Printout ........................................................................................................... 4-36

Figure 4-25. Typical Cycle Printout – Details............................................................................................. 4-37

Figure 4-26. Door Manual Safety Latch...................................................................................................... 4-53

Figure 4-27. Insertion Tube Sleeve............................................................................................................. 4-54

Figure 4-28. Test Cord............................................................................................................................... 4-55

6 ROUTINE MAINTENANCE

Figure 6-1. D-SHORT Sample Printout ..................................................................................................... 6-6

Figure 6-2. Reliance CDS Draining Holes and Punching Rods ................................................................ 6-7

Figure 6-3. Bag-in-a-Box Compartment ................................................................................................. 6-10

Figure 6-4. Changing Bag-in-a-Box Container ....................................................................................... 6-11

Figure 6-5. Printer ................................................................................................................................... 6-12

Figure 6-6. Changing Dual Pre-Filter and Pressure Regulator Assembly Cartridges

(Required Accessory) .......................................................................................................... 6-14

Figure 6-7. Replacing 0.2 μm Bacterial-Retentive Filter Cartridge ......................................................... 6-16

Figure 6-8. Rotary Spray Arm Assembly ................................................................................................ 6-19

Figure 6-9. Endoscope Connection O-Ring ........................................................................................... 6-20

LIST OF ILLUSTRATIONS (Cont’d)

Figure Description Page

xiii

List of Tables Operator Manual 920011-649

1 SAFETY PRECAUTIONS

Table 1-1. Definition of Symbols ............................................................................................................... 1-5

Table 1-2. Definition of Symbols ............................................................................................................... 1-6

5 CYCLE AND CONTROL VALUE PROGRAMMING

Table 5-1. Reliance EPS Endoscope Processing System – Cycle Description Chart .............................. 5-2

6 ROUTINE MAINTENANCE

Table 6-1. Routine Maintenance Guide .................................................................................................... 6-2

8 RECOMMENDED SPARE PARTS AND CONSUMABLE PRODUCTS

Table 8-1. Replacement Parts ................................................................................................................... 8-1

LIST OF TABLES

Table Description Page

xiv

920011-649 Operator Manual List of Tables

Healthcare

Capital Equipment

1-1

Safety Precautions Operator Manual 920011-649

1

The following Safety Precautions must be observed when operating or servicing this equipment. WARNING

indicates the potential for personal injury and CAUTION indicates the potential for damage to equipment. For

emphasis, certain Safety Precautions are repeated throughout the manual. It is important to review ALL Safety

Precautions before operating or servicing the Reliance™ EPS Processor.

Strictly following these Safety Precautions enhances the Customer’s ability to safely and effectively utilize the unit

and helps avoid improper maintenance methods which may damage the unit or render it unsafe. It is important to

understand that these Safety Precautions are not exhaustive; Customers are encouraged to develop their own

safety policies and procedures to enhance and complement these Safety Precautions.

WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:

WARNING – ELECTRIC SHOCK AND/OR BURN HAZARD:

Bag-in-a-Box compartment door can support a maximum of 4.5 kg (10 lb). Do not place heavy objects

on Bag-in-a-Box compartment door.

In an emergency, stop cycle by pressing STOP touch pad twice to abort cycle. Wait for processor to

complete Abort sequence. Wear appropriate Personal Protective Equipment (PPE) when reaching into

chamber.

Lack of appropriate training could result in injury or equipment damage.

Regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment.

Contact STERIS to schedule preventive maintenance or obtain the necessary Maintenance Manual if

preventive maintenance is done by the Customer.

Repairs and adjustments to this equipment must be made only by STERIS or STERIS-trained service

personnel. Nonroutine maintenance performed by unqualified personnel or installation of unauthorized

parts could cause personal injury, result in improper equipment performance or result in costly damage.

Contact STERIS regarding service options.

The performance of the 510k cleared Reliance EPS Endoscope Processing System is validated as a

system including components defined by STERIS in the Operator Manual and Maintenance Manual for

the Reliance EPS Endoscope Processing System. Substitution of unauthorized components can

potentially lead to personal injury, damage or premature failure of the product and result in a unit

configuration that is inconsistent with the validated, FDA cleared product. Altering the equipment or

using unapproved component’s may void STERIS’ warranty. DO NOT USE components that are not

validated as part of the Reliance EPS Endoscope Processing System.

When working with compressed air, flying debris and particles may present a hazard to personnel in

immediate area. Personal eye protection must be worn when working with compressed air.

Disconnect all utilities to processor before servicing. Do not service processor unless all utilities have

been properly locked out. Always follow local electrical codes and safety-related work practices.

SAFETY PRECAUTIONS

1-2

920011-649 Operator Manual Safety Precautions

WARNING – ELECTRIC SHOCK AND/OR BURN HAZARD:

WARNING – BURN HAZARD:

WARNING – POSSIBLE FIRE HAZARD:

WARNING – CHEMICAL BURN AND/OR EYE INJURY HAZARD:

WARNING – EYE INJURY HAZARD:

WARNING – HEALTH HAZARD:

Fasteners and star washers are used to ensure protective bonding continuity. Always reinstall any star

washer which may have been removed during installation or servicing.

Pressing bottom portion of POWER (ON/OFF) toggle switch to turn off processor DOES NOT cut off

electrical power. Lockout/Tagout building electrical disconnect switch to turn off power to processor for

maintenance or repairs.

Allow piping to cool before inspecting and/or cleaning building supply-line strainers.

When processor is installed on a combustible floor, floor must be covered with a metal sheet extending

to outer edges of processor.

All personnel involved in the operation of this processor should be able to demonstrate the correct

procedure for disposal of Reliance dry chemistry containers.

CIP 200 Acid-Based Process and Research Cleaner is corrosive and can cause adverse effects to

exposed tissues. Do not get in eyes, on skin or swallow. Read and follow all precautions and instructions

on cleaner label and in Safety Data Sheet (SDS) prior to handling CIP 200 Acid-Based Process and

Research Cleaner Bag-in-a-Box container or servicing cleaner injection pump. Wear appropriate

Personal Protective Equipment (PPE) whenever handling detergent or servicing cleaner injection pump

and lines.

Klenzyme Enzymatic Presoak and Cleaner concentrate may cause serious damage to eyes. Product

may cause skin irritation. Do not get on skin or in eyes. Read and follow all precautions and instructions

on cleaner label and in Safety Data Sheet (SDS) prior to handling Klenzyme Bag-in-a-Box container or

servicing cleaner injection pump. Wear appropriate Personal Protective Equipment (PPE) whenever

handling cleaner or servicing cleaner injection pump and lines.

Laser radiation. Do not stare at bar code reader beam.

Before opening processor door manually, wear appropriate Personal Protective Equipment (PPE). Allow

processor to cool down. Avoid inhaling fumes from chamber and contact with any remaining solution.

1-3

Safety Precautions Operator Manual 920011-649

WARNING – INEFFECTIVE PROCESS HAZARD:

Always verify Reliance dry chemistry container is empty after cycle is completed. If undissolved powder

is present in container or Reliance CDS at the end of cycle, load cannot be considered high level

disinfected. See Troubleshooting section for procedure.

Before operating processor, always firmly push endoscope processing support into manifold connectors

at the back of chamber. If support is not positioned correctly, door will not close, damage may result and

processor will be unable to effectively process load.

Before starting a cycle, ensure to verify Reliance dry chemistry container's expiration date and STERIS

chemical indicator bottle's expiration date are valid. If expiration date is not valid, use a new Reliance

dry chemistry container or a new chemical indicator strip. Failure to do so may result in ineffective

processing.

Before starting a cycle, ensure rotary spray arms on endoscope processing support and within chamber

are not obstructed and rotate freely. If rotary spray arms are obstructed, equipment damage may result,

and processor will be unable to effectively process load.

Correct function of the system is only ensured after any diagnosed errors have been found, corrected

and a successful processing cycle has been completed.

Endoscopes and accessories are not adequately processed, rinsed and air purged when processing

cycle is aborted. REPROCESS LOAD.

Failure to process endoscopes and accessories within 30 minutes after manual cleaning may result in

ineffective processing.

Follow all applicable instructions provided by the endoscope manufacturer for preparing endoscope and

accessories for immersion. Failure to do so may result in damage to endoscope and/or ineffective

processing.

If chemical indicator strip exhibits incomplete color change, load cannot be considered high level

disinfected. If chemical indicator strip exhibits incomplete color change, call STERIS.

If chemical indicator was not used, load cannot be considered processed. Load must be reprocessed

using a new Reliance dry chemistry container and a chemical indicator strip.

Inspect Reliance dry chemistry container for damage prior to use. Do not use damaged containers; if

damage is observed, follow directions for disposal in Reliance dry chemistry package insert.

Only use Reliance dry chemistry in Reliance EPS Processor. Do not substitute any other product for

Reliance dry chemistry.

STERIS makes no claim of processing efficacy when these processing instructions are not followed.

Storage of Reliance dry chemistry container should be in a clean dry location. Reliance dry chemistry

container should not be exposed to extreme heat or humidity. Refer to package insert for instructions.

To avoid equipment damage and help ensure processing efficacy, always follow directions when loading

items in endoscope processing support.

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Steris Reliance Eps Endoscope Processing System Operating instructions

Steris Reliance Eps Endoscope Processing System Operating instructions

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