Steris SYSTEM 1 endo Manual de usuario

OPERATOR MANUAL

SYSTEM 1®endo LIQUID CHEMICAL

STERILANT PROCESSING SYSTEM

MODEL P6900

S40®STERILANT CONCENTRATE

CATALOG NO. S4000

T6900 Rev A

WARNING — COPYING PROHIBITED

This manual is protected by Federal Copyright Law, which provides for damages of up to USD $20000,

as well as criminal fines and imprisonment for unauthorized copying.

Introduction Operator Manual T6900 Rev A

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

A WORD FROM STERIS

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended

for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical

heat-sensitive medical devices and their accessories in healthcare facilities.The

SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate

to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the

load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load

with 0.2 micron ﬁltered water. The SYSTEM 1 endo Processor uses only S40

Sterilant Concentrate to liquid chemically sterilize medical devices.

After completion of a cycle in the SYSTEM 1 endo Processor (which includes

liquid chemical sterilization and rinse phases), the processed load should

be used immediately or prepared for storage according to the endoscope

manufacturer’s written instructions for drying and storage following a liquid

chemical sterilization or high-level disinfection process.

SYSTEM 1 endo Processor is to be used only by trained personnel who are fully

familiar with, and strictly comply with, the operating instructions and conditions

detailed in the Operator Manual, as well as any applicable Quick Connect

processing instructions.The warranty pertaining to equipment or products sold

by STERIS is contained in STERIS’s Terms and Conditions of Sale.

Important: Liquid chemical sterilization (LCS) of a medical device by the

SYSTEM 1 endo Processor requires that the liquid sterilant makes contact with

all exterior and interior surfaces of the device. In the case of a device having

internal channels or other interior surfaces, the device manufacturer’s instructions

should be reviewed to determine the manufacturer’s recommendations for the

preparation of the device for liquid chemical sterilization or high-level disinfection.

STERIS is not responsible for the adequacy of the device manufacturer’s

instructions or the design of a device that fails to permit liquid to contact the

surfaces of all internal channels and components of the devices. The device

will not be liquid chemically sterilized if the sterilant does not contact all interior

and exterior surfaces of the device.

Overview

T6900 Rev A Operator Manual Introduction

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

Copying, disclosure to others, or other use of this publication is prohibited without the express

written consent of STERIS Corporation. STERIS Corporation reserves the right to make

changes in speciﬁcations shown herein without notice or obligation. Contact your STERIS

representative or STERIS Customer Service for the latest information.

STERIS, SYSTEM 1, S40, VERIFY and MaxLife are registered trademarks of STERIS

Corporation.

U.S. Patents

7,135,142

7,569,182

Printed in Canada.

Manufactured exclusively by

STERIS Corporation

5960 Heisley Road

Mentor, OH 44060-1834 USA

440-354-2600 n800-548-4873

www.steris.com

Customer Service

440-354-2600

800-548-4873

Certiﬁed to ISO 9001 and 13485

Introduction Operator Manual T6900 Rev A

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

iii

A WORD FROM STERIS ...............................................................................................i

Overview .............................................................................................................................................. i

1. LISTING OF WARNINGS AND CAUTIONS................................................................. 1-1

2. SITE SPECIFICATIONS ........................................................................................... 2-1

3. S40 STERILANT CONCENTRATE ............................................................................ 3-1

Part 1: Overview ............................................................................................................................3-2

Part 2: Safety Information for Peracetic Acid ..................................................................................3-3

Part 3: Disposal .............................................................................................................................3-4

4. COMPONENT IDENTIFICATION............................................................................... 4-1

Part 1: Illustrations of Processor and Components.........................................................................4-1

Part 2: SYSTEM 1 endo Processor ................................................................................................4-4

5. GENERAL PROCESSING INSTRUCTIONS ................................................................ 5-1

Part 1: Processor with Open-Style Processing Tray........................................................................5-1

Part 2: Processor with Processing Tray and Container ...................................................................5-2

Part 3: Preparation of Devices for Liquid Chemical Sterilization ......................................................5-3

6. SPECIFIC DEVICE PROCESSING INSTRUCTIONS .................................................... 6-1

Part 1: Quick Connect Information .................................................................................................6-1

7. OPERATION OF THE PROCESSOR.......................................................................... 7-1

Part 1: LCS Cycle ..........................................................................................................................7-1

Part 2: Diagnostic Cycle...............................................................................................................7-10

Part 3: Aborting Cycles ................................................................................................................7-12

Part 4: Troubleshooting................................................................................................................7-14

8. QUALITY ASSURANCE ........................................................................................... 8-1

Part 1: Documentation...................................................................................................................8-1

9. MAINTENANCE ...................................................................................................... 9-1

Part 1: Daily Cleaning and Checks .................................................................................................9-1

Part 2: Changing 0.2 Micron MaxLife Water Filter...........................................................................9-5

Part 3: Changing Sterile Air Filter..................................................................................................9-11

Part 4: Changing the Printer Paper for the Optional Printer ..........................................................9-13

Part 5: Changing Pre-ﬁlters ..........................................................................................................9-15

Part 6: Supervisor Mode ..............................................................................................................9-17

Part 7: Replacement Parts ...........................................................................................................9-23

Part 8: Routine Maintenance Parts...............................................................................................9-24

TABLE OF CONTENTS

Section Title Page

T6900 Rev A Operator Manual Introduction

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

10. PROCESS MONITORING....................................................................................... 10-1

Part 1: Overview ..........................................................................................................................10-1

Part 2: Process Assurance Monitoring .........................................................................................10-2

11. INSERVICE........................................................................................................... 11-1

Listing of Warnings and Cautions Operator Manual T6900 Rev A

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

1-1

LISTING OF WARNINGS AND CAUTIONS 1

WARNINGS:

Do not use the SYSTEM 1 endo Processor until it has been properly installed and its electro/mechanical

performance is veriﬁed.

The SYSTEM 1 endo Processor may be used only in hospital-grade rooms when it is installed according to the

applicable speciﬁcation (VDE 0107, Class 1 Group C NFPA Rating).

The SYSTEM 1 endo Processor is not intended for operation in explosion-endangered areas.

The SYSTEM 1 endo Processor is not protected against water spillage or spray. Take precautions in the use of

liquid during cleaning or insertion of devices.

Connect the SYSTEM 1 endo Processor to hospital grade receptacle only following national and local codes

(GFCI, RCBO, etc.).

Do not attempt to access non-user serviceable components of the SYSTEM 1 endo Processor.

Failure to thoroughly clean devices, endoscopes, etc., may result in ineffective liquid chemical sterilization.

Failure to properly position devices so that all surfaces will be exposed to the liquid sterilant or overloading the

processing container may result in ineffective liquid chemical sterilization and/or damage the devices.

Always verify that the sterilant container is empty at the completion of the cycle.

Devices are not liquid chemically sterilized and/or adequately rinsed when an LCS Cycle is cancelled.

Danger: Risk of explosion if used in the presence of ﬂammable substances.

Repairs by unauthorized individuals should not be attempted and may result in damage or malfunction. Non-user

serviceable components should be serviced by an authorized STERIS Service Representative only.

Disconnect electrical power before cleaning.

The performance of the SYSTEM 1 endo Processor has been validated and optimized with components deﬁned by

STERIS in the Operator Manual for the SYSTEM 1 endo Processor. Use of pre-ﬁlters that do not meet STERIS's

speciﬁcations and have not been validated by STERIS can lead to premature failure of the MaxLife water ﬁlter

inside the processor. STERIS’s warranty will not apply to damage or early life failure of the MaxLife water ﬁlter

resulting from the use of pre-ﬁlters that do not meet STERIS’s speciﬁcations. DO NOT USE components that do

not meet STERIS’s speciﬁcations and have not been validated by STERIS.

Do not position equipment so that it is difﬁcult to disconnect the plug from the duplex receptacle.

Do not substitute any other product for S40 Sterilant Concentrate.

Contact with or inhalation of the inert powdered ingredients in the outer cup of S40 Sterilant Concentrate may

cause irritation to eye, skin or respiratory system.

Throughout this manual, WARNING statements have been included to alert the Operator to important information

regarding safety and liquid chemical sterilization efﬁcacy.

CAUTION statements advise the Operator of important information regarding processor and device safety, and proper

operating technique.

Please review and be familiar with these statements before using the SYSTEM 1 endo Processor and S40 Sterilant

Concentrate.

IMPORTANT:

These instructions are to be placed in an easily seen location.

T6900 Rev A Operator Manual Listing of Warnings and Cautions

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

1-2

S40 Sterilant Concentrate contains 35% peracetic acid in the inner cup of the container. Eye contact with the sterilant

concentrate can cause irreversible eye damage, including blindness.

Contact with 35% peracetic acid can cause destruction of skin tissue. Avoid contact with the skin.

Peracetic acid is a ﬂammable material. Do not smoke when handling, storing, transporting, or disposing of S40

Sterilant Concentrate.

To avoid accumulated concentration of peracetic acid vapor, use S40 Sterilant Concentrate in a well ventilated room

or area.

High concentrations of peracetic acid vapor will cause tearing of the eyes and irritate the nose, throat, and lungs.

Persons who are asthmatics may be more sensitive to the effects of inhaled peracetic acid vapors.

Although the use dilution of the S40 Sterilant Concentrate is not corrosive to skin or the eyes, it may cause eye

irritation.

Adequate cleaning of the medical device is required. Residual patient soil or other material or cleaning agents may

decrease effectiveness of S40 Sterilant Concentrate.

Do not use S40 Sterilant Concentrate past the expiration date printed on the carton.

Do not use partially ﬁlled, leaking, or damaged containers of S40 Sterilant Concentrate.

When disposing of S40 Sterilant Concentrate, thoroughly rinse the carton and container before attempting to

manually open the sterilant container.

Extreme care should be taken if an attempt is made to manually open a sealed container of S40 Sterilant Concentrate.

Use extreme care when cutting through the lid and the inner cup when disposing of a submerged container of S40

Sterilant Concentrate to avoid personal injury.

The SYSTEM 1 endo Processor must be installed by qualiﬁed personnel and according to correct national and local

electrical safety codes. Failure to do so can result in shock hazard that could endanger the health of the Operator.

The 0.2 micron MaxLife water ﬁlter must be changed every 180 days.

Use of a blocked or damaged aspirator may result in ineffective liquid chemical sterilization.

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

Maintenance performed by unqualiﬁed personnel or installation of unauthorized parts could cause personal injury,

result in improper equipment performance, invalidate the warranty, or result in costly damage. Contact STERIS

regarding service options.

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

STERIS Customer Service to schedule preventive maintenance.

WARNINGS (continued):

Listing of Warnings and Cautions Operator Manual T6900 Rev A

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

1-3

CAUTIONS:

Do not push the container into the sterilant compartment with excessive force. NEVER slam the container into the

sterilant compartment. Damage to the container may occur.

Do not force lid to close.

If ﬂuid remains in the chamber at the end of a cycle, call Customer Service.

Never use sterilant for the Diagnostic Cycle.

Water spills on the microcomputer housing and/or the barcode reader may result in damage to the Processor.

Do not touch the membrane of the MaxLife water ﬁlter while inserting into the ﬁlter housing.

Appropriate Personal Protective Equipment (PPE) is required when handling containers of S40 Sterilant Concentrate.

Minimally, PPE should consist of chemical-resistant gloves, apron, goggles or face shield, and any other protection

required by facility procedures.

If the carton of S40 Sterilant Concentrate is damaged, do not use the sterilant container inside the damaged carton.

T6900 Rev A Operator Manual Listing of Warnings and Cautions

SYSTEM 1 endo Liquid Chemical Sterilant Processing System

1-4

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