Steris System 1E Liquid Chemical Sterilant Processing System Operating instructions

OPERATOR MANUAL

SYSTEM 1E® LIQUID CHEMICAL STERILANT

PROCESSING SYSTEM

CATALOG NO. P6500

S40® STERILANT CONCENTRATE

CATALOG NO. S4000

T6500 Rev L

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 T6500 Rev L

SYSTEM 1E Liquid Chemical Sterilant Processing System i

A WORD FROM STERIS CORPORATION

Overview The SYSTEM 1E® Liquid Chemical Sterilant Processing System is intended for the

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

critical heat-sensitive medical devices in healthcare facilities.

The SYSTEM 1E Processor 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 extensively

treated* potable water. After completion of a cycle, critical devices should be used

immediately; semi-critical devices should be used immediately or may be handled

and stored in a manner similar to that of high level disinfected endoscopes. Critical

devices not used immediately should be processed again before use.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically

sterilize medical devices.

*The extensive treatment of EPA potable water consists of:

1. Pre-ﬁltration through two pre-ﬁlters:

• Pre-ﬁlter A is a gross depth ﬁlter that removes approximately 2.5 micron or

larger particles/contaminants.

• Pre-ﬁlter B is a surface ﬁlter that removes particles/contaminants >0.1 micron.

2. UV irradiation:

• During transit through the UV water treatment chamber, a UV dose sufﬁcient

to achieve a >6-log reduction of MS2 virus is delivered to the water.

3. 0.1 micron ﬁltration:

• The water prepared by pre-ﬁltration and UV irradiation is ﬁltered through

redundant 0.1 micron (absolute rated) membranes to remove bacteria, fungi

and protozoa > 0.1 micron.

Some devices are processed within containers that are closed with transparent

lids. The containers are not designed for device storage and should not be used

for this purpose.

NOTE: STERIS recommends that a device used in a critical application** be

processed in a container, where possible. Refer to your facility policies and

procedures for device reprocessing.

SYSTEM 1E Processors are 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 of a surgical or diagnostic device by the

SYSTEM 1E Processor requires that the liquid sterilant make 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 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.

** Due to their size, a limited number of critical devices are processed in a processing tray. Go to www.

steris.com to determine how your specific device is processed.

T6500 Rev L Operator Manual Introduction

ii SYSTEM 1E 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 1E, S40, and MaxPure are registered trademarks of STERIS Corporation.

U.S. Patents

7,135,142

7,569,182

Other U.S. and International Patents Pending

Printed in Canada.

Manufactured exclusively by

STERIS Corporation

5960 Heisley Road

Mentor, OH 44060 USA

440-354-2600 n 800-548-4873

www.steris.com

Customer Service

440-354-2600

800-548-4873

Certiﬁed to ISO 9001 and 13485

Introduction Operator Manual T6500 Rev L

SYSTEM 1E Liquid Chemical Sterilant Processing System iii

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. SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM ........................ 4-1

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

» Part 2: SYSTEM 1E Processor .....................................................................................................4-5

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

» Part 1: Processor with General Processing Tray and Container .....................................................5-1

» Part 2: Preparation of Devices for Liquid Chemical Sterilization .....................................................5-2

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

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

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

» Part 1: Operation .........................................................................................................................7-1

» Part 2: Cancelled Cycle ..............................................................................................................7-15

» Part 3: Troubleshooting a Liquid Chemical Sterilization Cycle Problem........................................7-17

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

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

» Part 2: DIAGNOSTIC Cycle ..........................................................................................................8-7

» Part 3: Troubleshooting a DIAGNOSTIC Cycle Problem ..............................................................8-13

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

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

» Part 2: Changing 0.1 Micron MaxPure Filter .................................................................................9-5

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

» Part 4: Changing the Printer Paper ............................................................................................9-13

» Part 5: Changing the Printer Ink Cartridge ..................................................................................9-19

» Part 6: Changing Pre-Filters .......................................................................................................9-21

» Part 7: Control Value Programming ............................................................................................9-23

» Part 8: Replacement Parts .........................................................................................................9-35

» Part 9: Routine Maintenance Parts .............................................................................................9-36

TABLE OF CONTENTS

Section Title Page

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

» Overview ............................................................................................................................................ i

T6500 Rev L Operator Manual Introduction

iv SYSTEM 1E Liquid Chemical Sterilant Processing System

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

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

» Part 2: Process Assurance Monitoring for the SYSTEM 1E Processor ........................................10-2

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

12. APPENDIX ........................................................................................................... 12-1

» Appendix 1: Viral Inactivation by the Water Treatment System of the SYSTEM 1E Processor ........12-1

Listing of Warnings and Cautions Operator Manual T6500 Rev L

SYSTEM 1E Liquid Chemical Sterilant Processing System 1-1

LISTING OF WARNINGS AND CAUTIONS 1

WARNINGS:

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

is veriﬁed.

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

The SYSTEM 1E 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 1E 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 1E 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 a liquid chemical sterilization 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 1E Processor has been validated and optimized with components deﬁned by

STERIS in the Operator Manual for the SYSTEM 1E 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 MaxPure Filter inside

the processor. STERIS’s warranty will not apply to damage or early life failure of the MaxPure 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.

The UV System unit may be hot to the touch!

The UV System is a non-user serviceable component of the SYSTEM 1E Processor. All installation, maintenance

work, and service must be carried out by STERIS or STERIS-trained service personnel only. Use only STERIS

approved replacement lamps, quartz sleeves, and sensor.

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

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 1E Liquid Chemical Sterilant Processing

System and S40 Sterilant Concentrate.

IMPORTANT:

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

T6500 Rev L Operator Manual Listing of Warnings and Cautions

1-2 SYSTEM 1E Liquid Chemical Sterilant Processing System

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.

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 1E Processor and UV System 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 0.1 micron MaxPure Filter must be changed every 90 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.

If a printout from the SYSTEM 1E Processor is missing for a load, the load must be reprocessed.

WARNINGS (continued):

Listing of Warnings and Cautions Operator Manual T6500 Rev L

SYSTEM 1E 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 printer or printer paper may result in damage to the processor

or create a paper jam.

Do not touch the membrane of the MaxPure 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.

T6500 Rev L Operator Manual Listing of Warnings and Cautions

1-4 SYSTEM 1E Liquid Chemical Sterilant Processing System

Site Speciﬁcations Operator Manual T6500 Rev L

SYSTEM 1E Liquid Chemical Sterilant Processing System 2-1

SITE SPECIFICATIONS 2

Water Requirements*:

Pressure: Minimum 40 psig (276 kPa), Preferred 50 - 60 psig (345 - 414 kPa), maximum

90 psig (620 kPa)

Flow Rate: Minimum 2.5 gpm (9.5 Lpm)

Temperature: 109 -140°F (43 - 60°C)

Recommended: For optimum cycle time, water temperature should be between 115 - 118°F

(46 - 48°C)

Supply Line Size: 1/2” (1.27 cm) I.D. minimum / 3/4” (1.9 cm) I.D. optimum, Backﬂow prevention by

facility

Connection: 3/4” (1.9 cm) male hose connector

Quality Potable/Tap water, ≤ 140 ppm hardness as CaCO3, transmittance ≥ 75% at 254 nm

(minimum), > 81% at 254 nm (preferred).

Drain: 1 1/4” (3.18 cm) I.D. (minimum) non-back pressuring drain

Water usage: Approximately 8.7 gal. (33 L) per processing cycle

Space and Weight Requirements:

SYSTEM 1E Processor

Width: 40” (102 cm.)

Depth: 24” (61 cm.)

Height: 38” (97 cm.)

Weight: 140 lbs. (64 kg.)

Operating Weight: 165 lbs. (75 kg.)

Electrical Requirements:

Voltage: 115 VAC 60 Hz

Load: SYSTEM 1E Processor - 15 amps

UV System - 1 amp

Service: 115 VAC, 20 amp, 60 Hz dedicated circuit, terminated in 20 amp. Hospital grade

GFCI duplex receptacle

WARNING: The SYSTEM 1E Processor and UV System 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.

NOTE: There are no special requirements for venting the drain.

WARNING: Do not position equipment so that it is difﬁcult to disconnect the plugs from the duplex

receptacle.

WARNING: Connect the SYSTEM 1E Processor to hospital grade receptacle only following national and

local codes (GFCI, RCBO, etc.).

NOTE: Back ﬂow (back siphonage) prevention provided by user (check local codes).

* Potable water should meet speciﬁcations identiﬁed in AAMI TIR 34: Water for the Reprocessing of Medical Devices.

Failure to meet these speciﬁcations may result in cancelled cycles and require the installation of additional water

treatment solutions by the health care facility.

T6500 Rev L Operator Manual Site Speciﬁcations

2-2 SYSTEM 1E Liquid Chemical Sterilant Processing System

Pre-Filter Speciﬁcations:

Pre-Filter A: Filter Rating - 2.5 micron absolute

Flow Rate – 14.5 gpm/psid

Pre-Filter B: Filter Rating - 0.1 micron nominal

Flow Rate - >1.0 gpm/psid

Water Pressure Pressure Setting - regulator pre-set to 50 psig (345 kPa) static

WARNING: The performance of the SYSTEM 1E Processor has been validated and optimized with

components deﬁned by STERIS in the operator manual for the SYSTEM 1E 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 MaxPure Filter inside the processor. STERIS’s warranty will not apply to damage or early life

failure of the MaxPure 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.

WARNING: Do not use the SYSTEM 1E Processor until it has been properly installed and its electro/

mechanical performance is veriﬁed.

WARNING: To avoid accumulated concentration of peracetic acid vapor, use S40 Sterilant Concentrate

in a well ventilated room or area.

Environmental Requirements:

Room Temperature 60 - 90°F (16 - 32°C)

Humidity: 10 - 90% relative, non-condensing

Ventilation: Recommend conformance to AAMI ST58: Chemical Sterilization and High-Level

Disinfection in Healthcare Facilities

Classiﬁcation:

Protection against electric shock: Class 1

S40 Sterilant Concentrate Operator Manual T6500 Rev L

SYSTEM 1E Liquid Chemical Sterilant Processing System 3-1

ASPIRATOR PROBE ASSEMBLY

LID

INNER CUP

OUTER CUP

STERILANT COMPARTMENT OR WELL

CUP PUNCH

DRAIN SCREEN

S40 STERILANT CONCENTRATE 3

S40 STERILANT CONCENTRATE

AND

STERILANT COMPARTMENT OF THE PROCESSOR

"POP-OUT" PLUG

T6500 Rev L Operator Manual S40 Sterilant Concentrate

3-2 SYSTEM 1E Liquid Chemical Sterilant Processing System

S40 Sterilant Concentrate is a single-use chemistry labeled exclusively for use

in the SYSTEM 1E Processor. The sterilant concentrate container holds both the

liquid active ingredient (35% peracetic acid) and the powdered inert ingredients.

Review the information provided in this section of the Operator Manual and the

package insert for S40 Sterilant Concentrate prior to use. Contact STERIS with

any questions regarding the safe and proper use of S40 Sterilant Concentrate.

Always read the package insert for S40 Sterilant Concentrate for detailed

information, including warnings and precautions, directions for use, storage

conditions and expiration date, emergency and safety information, and

sterilant container disposal instructions.

» Part 1:

Overview

S40 Sterilant Concentrate Operator Manual T6500 Rev L

SYSTEM 1E Liquid Chemical Sterilant Processing System 3-3

The 35% peracetic acid used in this product is a corrosive liquid due to its low

pH. The container is designed to minimize user contact with the contents. Care

should be taken to minimize exposure to vapors, contact with the skin, and

contact with the eyes. The following safety precautions should be taken when

handling the S40 Sterilant Concentrate:

• The sterilant concentrate should be used in a well ventilated room.

Conformance to AAMI ST58 is recommended.

• Chemical-resistant gloves should be worn to protect hands from potential

contact with the liquid portion of the sterilant concentrate.

• It is recommended that appropriate eye protection be worn to protect the

eyes from potential contact in the event of a splash. Note: This should not

occur if the integrity of the sterilant container has not been compromised

and the Operator Manual instructions for handling and inserting the

container into the processor are followed.

The peracetic acid concentrate solution is considered to have effects on the

eyes, skin, nose, throat and lungs based on acute exposure. These same sites

show signs of irritation upon repeated exposure.

Orally administered peracetic acid, in the concentrations found in the S40

Sterilant Concentrate, has been found to cause gastrointestinal tract irritation,

respiratory irritation and possible necrosis of renal tubules, in rats. Note: Orally

administered peracetic acid is classiﬁed as a GHS Category 3 material.

Inhalation of the sterilant concentrate has been shown to cause irritation of the

respiratory tract. Persons who are asthmatics may be more sensitive to the

effects of inhaled peracetic acid vapors. Note: Peracetic acid vapor is classiﬁed

as a GHS Category 1 material.

Application to the skin of a 17% peracetic acid solution is characterized by mild

skin irritation with reversible effects in dermal tissue and has caused severe

erythema, blanching of the skin, eschar formation, and exfoliation in rabbits. It

is severely irritating and corrosive to the skin. It will cause whiteness and can

cause blistering. Note: Application of a concentrated solution of peracetic acid

classiﬁes it as a GHS Category 3 material.

Application of a 17% peracetic acid solution is severely irritating and corrosive

to the eye of rabbits. Note: It is classiﬁed as a Corrosive material.

The SDS for S40 Sterilant Concentrate is available upon request from STERIS

Corporation or at www.steris.com.

WARNING: High

concentrations of peracetic

acid vapor will cause tearing

of the eyes and irritate the

nose, throat, and lungs.

WARNING: Peracetic acid

is a ﬂammable material. Do

not smoke when handling,

storing, transporting, or

disposing of S40 Sterilant

Concentrate.

WARNING: To avoid

accumulated concentration

of peracetic acid vapor, use

S40 Sterilant Concentrate

in a well ventilated room or

area.

WARNING: Persons who are

asthmatics may be more

sensitive to the effects

of inhaled peracetic acid

vapors.

WARNING: 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.

WARNING: 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.

WARNING: Contact with

35% peracetic acid can

cause destruction of skin

tissue. Avoid contact with

the skin.

» Part 2:

Safety Information

for Peracetic Acid

T6500 Rev L Operator Manual S40 Sterilant Concentrate

3-4 SYSTEM 1E Liquid Chemical Sterilant Processing System

» Part 3:

Disposal

CAUTION: 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.

WARNING: When disposing

of S40 Sterilant Concentrate,

thoroughly rinse the carton

and container before

attempting to manually

open the sterilant container.

WARNING: Extreme care

should be taken if an attempt

is made to manually open a

sealed container of S40

Sterilant Concentrate.

WARNING: 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.

WARNING: Do not use

partially ﬁlled, leaking, or

damaged containers of S40

Sterilant Concentrate.

CAUTION: If the carton of

S40 Sterilant Concentrate

is damaged, do not use the

sterilant container inside

the damaged carton.

Following a successful liquid chemical sterilization cycle, dispose of empty

sterilant containers in the trash (no special precautions are required).

To dispose of partially ﬁlled, leaking, damaged, or expired sterilant containers,

put on appropriate personal protective equipment (chemical-resistant gloves,

apron, goggles or face shield, and any other protection required by facility

procedures). Wear protective attire for the entire procedure. Perform one of the

following three disposal procedures or follow facility guidelines for disposal of

hazardous waste. To contain the powders and/or liquid until time of disposal,

place the partially ﬁlled, leaking, damaged, or expired sterilant container in a bag,

box or other suitable receptacle. Use either the automated or manual disposal

method as described below. Dispose of each sterilant container one at a time.

1. Automated Disposal (preferred method)

IMPORTANT: Automated disposal method should not be used if there are no

dry powders in the container.

a. Place the partially ﬁlled, leaking, damaged, or expired sterilant container

in the sterilant container well in the SYSTEM 1E Processor.

b. Do not place a medical device in the processor.

c. Press down until the sterilant container is ﬁrmly seated.

d. Line up the tip of the aspirator probe over the center of the sterilant

container lid. Insert the probe in a downward motion until the top of the

aspirator is resting on the lid of the container. Make sure the tubing is

not kinked.

e. Start the liquid chemical sterilization cycle according to the Operator

Manual.

f. Dispose of the empty sterilant container in the trash.

If the SYSTEM 1E Processor is unavailable, isolate the partially ﬁlled, leaking,

damaged, or expired sterilant container until the processor is available or perform

a manual disposal as described below.

2. Manual Disposal - Check facility procedures, local and state regulations

for waste disposal requirements.

a. Increase room ventilation to remove any strong, tear-producing

vapors.

b. Carefully handle the partially ﬁlled, leaking, damaged, or expired sterilant

container and place upside down on a ﬂat surface or in a sink. Note: If

the sterilant container is inside a carton, place the entire carton under

running water and remove the sterilant container from the carton. Treat

the sterilant container as instructed above. Rinse the cardboard carton

thoroughly before disposing of it in the trash.

c. In a deep sink, place a bucket ﬁlled with at least 2 gallons (8 L) of tap

water.

S40 Sterilant Concentrate Operator Manual T6500 Rev L

SYSTEM 1E Liquid Chemical Sterilant Processing System 3-5

d. With the sterilant container placed upside down on a ﬂat surface, grasp

the sterilant container ﬁrmly and, using a blunt object (brush handle,

marking pen, hemostats, etc.), push the sterilant container’s "pop out"

plug into the sterilant container. (See Figure 1)

IMPORTANT: A small puff of powder may escape from bottom of the sterilant

container.

Figure 1

Figure 2

e. Gently shake the contents (dry powders) into the bucket of water. Avoid

inhaling or contacting contents.

f. Using a long object suitable for stirring liquids (a metal/glass/plastic

rod) stir until the contents are dissolved.

g. Submerge the sterilant container into the bucket containing the dissolved

powders.

h. Using a pair of scissors, carefully cut through the lid at the center and

then into the inner cup. Allow the acid to mix with the water and dissolved

powders in the bucket. (See Figure 2)

i. Avoid standing directly over the bucket or irritation may occur

from the peracetic acid vapors. Avoid inhaling or contacting

contents.

j. With the cold water running, carefully pour the solution down the sink

drain.

k. Flush the bucket and sink with a large quantity of cold tap water.

l. Thoroughly rinse the sterilant container and inner cup and then dispose

of them in the trash.

3. Disposal When Water is Not Available

a. Increase ventilation to the area - open truck or warehouse doors, use

fans to remove any strong tear-producing vapors.

b. Shut off ignition sources and DO NOT SMOKE.

c. Seal boxes with sterilant containers into plastic bag(s) and take to a

water source.

d. When water is available, follow the procedure for manual disposal.

CAUTION: 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.

T6500 Rev L Operator Manual S40 Sterilant Concentrate

3-6 SYSTEM 1E Liquid Chemical Sterilant Processing System

SYSTEM 1E Liquid Chemical Sterilant Processing System Operator Manual T6500 Rev L

SYSTEM 1E Liquid Chemical Sterilant Processing System 4-1

SYSTEM 1E

Processor

Z

0

1

ABC

3

GHI

2

DEF

4

JKL

6

PQR

5

MNO

7

STU

9

Y

8

VWX

CHANGE

VALUES

SAVE

VALUES

ENTER PAPER

FEED

STATUS

HOME END

DIAG CANCEL

START

SYSTEM 1E LIQUID CHEMICAL

STERILANT PROCESSING SYSTEM 4

» Part 1:

Illustrations of

Processor and

Components

PRE-FILTER

ASSEMBLY (A1563)

REGULATOR

HOUSING BODY

PRE-FILTER B

PRE-FILTER A

UV SYSTEM

MONITOR

UV CHAMBER

ELECTRICAL BALLAST

PRINTER

WINDOW

CONTROL

PANEL

BALL VALVE

A1585

(OPTIONAL)

RELEASE LATCH/HANDLE

(COVERS NOT SHOWN)

UV SYSTEM NOT

SHOWN AS INSTALLED

PROCESSOR CHAMBER

(INSIDE)

SYSTEM 1E PROCESSOR

(FRONT VIEW)

T6500 Rev L Operator Manual SYSTEM 1E Liquid Chemical Sterilant Processing System

4-2 SYSTEM 1E Liquid Chemical Sterilant Processing System

SYSTEM 1E

Processor

Z

0

1

ABC

3

GHI

2

DEF

4

JKL

6

PQR

5

MNO

7

STU

9

Y

8

VWX

CHANGE

VALUES

SAVE

VALUES

ENTER PAPER

FEED STATUS

HOME END

DIAG CANCEL

START

DISPLAY PANEL GRAPHICS

CONTROL TOUCH PADS

CYCLE SELECT AND

CYCLE START

TOUCH PADS

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Steris System 1E Liquid Chemical Sterilant Processing System Operating instructions

Steris System 1E Liquid Chemical Sterilant Processing System Operating instructions

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