Steris System 1E Liquid Chemical Sterilant Processing System Operating instructions

Brand: Steris

Model: System 1E Liquid Chemical Sterilant Processing System

Type: Operating instructions

This manual is also suitable for

S40® Sterilant Concentrate

Package Insert

A. Indications for Use

SYSTEM 1E® Liquid Chemical Sterilant Processing System

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for 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.

SYSTEM 1® endo Liquid Chemical Sterilant Processing System

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.

B. DANGERS, PRECAUTIONARY STATEMENTS and ADDITIONAL PRECAUTIONS

DANGERS:

• Flammable liquid and vapour.

• Heating may cause a ﬁre.

• Harmful if swallowed, in contact with skin or inhaled.

• May cause respiratory irritation.

• Causes severe skin burns and eye damage.

• Very toxic to aquatic life.

PRECAUTIONARY STATEMENTS:

• Keep away from heat, hot surfaces, sparks, open ﬂames and other ignition sources. No smoking.

• Do not breathe dust, fumes, vapours, mist, spray.

• IF INHALED: Remove person to fresh air and keep comfortable for breathing.

• IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

• IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

• IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

• Call a POISON CENTER or physician if you feel unwell.

• Wear protective clothing, protective gloves, eye and face protection.

• Avoid release to the environment. Refer to special disposal instructions in the Processor’s Operator Manual and the safety data sheet.

ADDITIONAL PRECAUTIONS:

• Do not substitute any other product for S40 Sterilant Concentrate.

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

• 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.

• 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.

Net contents 194.2 g

Active Ingredient:

Peracetic Acid (35%) 39%

Inert Ingredients 61%

Total 100%

P/N 10004334 Rev E

3. Disposal When Water is Not Available

a. Increase ventilation to the area.

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 in this package insert.

H. Storage Conditions and Expiration Date

S40 Sterilant Concentrate must be stored at 16-27°C (61-81°F), upright, away from sunlight and not near heat or open ﬂame, in a dry environment, until ready

to use.

The expiration date is printed on the sterilant carton: EXP YYYY MM DD

I. Statement of Practical Treatment

Sterilant Container Contents (Dry Powders)

Inert powdered ingredients are contained in the outer cup. Under normal use conditions, users are not exposed to the dry powder contents of the sterilant

container. In the unlikely event that the user is exposed to the dry powders the following ﬁrst aid is recommended:

• In case of eye contact, ﬂush eyes immediately with copious amounts of water for at least 15 minutes, holding eyelids open. Seek medical attention.

• In case of skin contact, rinse with plenty of water.

• If inhaled, seek fresh air. If irritation persists or other symptoms develop such as difﬁculty breathing, obtain immediate medical attention.

• If swallowed, the contents of the sterilant container may be harmful; do not induce vomiting.

Sterilant Container Contents (Liquid)

The active ingredient, 35% peracetic acid, is contained in the inner cup. Under normal use conditions, users are not exposed to the liquid contents of the

sterilant container. In the unlikely event that the user is exposed to the acid the following ﬁrst aid is recommended:

• In case of eye contact, ﬂush eyes immediately with copious amounts of water for at least 15 minutes, holding eyelids open. Seek medical attention.

• In case of skin contact, rinse with plenty of water. Seek medical attention.

• If vapors inhaled, seek fresh air. If irritation persists or other symptoms develop such as difﬁculty breathing, obtain immediate medical attention. If not

breathing, apply artiﬁcial respiration.

• If swallowed, do not induce vomiting. Drink large quantities of water and get medical attention. Immediately call a poison center or hospital emergency

department and follow their instructions. Do not give anything by mouth to an unconscious person.

Use Dilution of S40 Sterilant Concentrate

In the diluted form as used in the SYSTEM 1E or SYSTEM 1 endo Processor, use dilution of S40 Sterilant Concentrate is only minimally irritating to the eyes

and would not be expected to cause signiﬁcant adverse effects if contact or other exposure occurs.

• If contact with the use dilution occurs, rinse the exposed area thoroughly with water.

J. Emergency and Technical Product Information

For detailed information, refer to the Safety Data Sheet (SDS). Emergency or safety information can be obtained from STERIS Corporation at 1-800-548-

4873, or at www.steris.com.

K. Operator Training

The operator should be adequately trained in the reprocessing of medical devices and in the correct use of S40 Sterilant Concentrate and the SYSTEM 1E or

SYSTEM 1 endo Liquid Chemical Sterilant Processing System.

L. Reorder Information

Reorder Description Contents

S4000 S40 Sterilant Concentrate 20 sterilant containers per case

S40 Sterilant Concentrate is manufactured in the USA by:

STERIS Corporation

5960 Heisley Road

Mentor, OH 44060-1834, USA

1-800-548-4873

www.steris.com

C. General Information on Selection and Use of Germicides for Medical Device Reprocessing

Choose a germicide with the level of microbicidal activity appropriate for the reusable device and its intended clinical application. Follow the reusable device

labeling and standard institutional practices. In the absence of complete instructions, use the following guidance:

First, for patient contacting devices determine whether the reusable device to be reprocessed is a critical or semi-critical device.

• Critical Device: Presents a high risk of infection if not sterile. Routinely penetrates the skin or mucus membranes during use or is otherwise used in

normally sterile tissue of the body.

• Semi-critical Device: Makes contact with mucus membranes, but does not ordinarily penetrate sterile areas of the body.

Second, determine if sterilization is required. A sterilant is an agent that destroys all viable forms of microbial life, when used according to labeling.

• Critical Reusable Devices: Must be sterilized between uses.

• Semi-critical Reusable Devices: Should also be sterilized between uses whenever practical, but at a minimum, high level disinfection is acceptable.

Third, select a germicide that is labeled for the appropriate microbicidal activity level and is compatible with the reusable device. Follow directions for the

germicide.

D. Microbicidal Activity of S40 Sterilant Concentrate

Peracetic acid, the active ingredient in S40 Sterilant Concentrate, has been shown to attack and inactivate many different cellular mechanisms to achieve its

microbicidal activity1. It is thought to act primarily as an oxidizing agent. Its activity was demonstrated under worst case conditions in performance and simulated-

use testing. S40 Sterilant Concentrate has been shown to be effective against the following organisms:

1Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001

Spores: Vegetative Organisms: Fungi: Viruses:

• Bacillus subtilis • Mycobacterium terrae • Trichophyton mentagrophytes • Herpes simplex Type 1

• Clostridium sporogenes • Staphylococcus aureus • Adenovirus Type 5

• Geobacillus stearothermophilus • Salmonella enterica • Poliovirus Type 1

• Pseudomonas aeruginosa

The sterilant has also been shown to be effective in clinical (in-use) studies.

E. Device Compatibility

With S40 Sterilant Concentrate, when used in the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing System, the processed devices,

including heat-sensitive ﬂexible and rigid endoscopes, cameras, and light guide cables, were tested for material compatibility. These devices were composed

of the following materials:

• Polyurethane • Teﬂon® (DuPont Company) • Nickel-plated brass • Viton® (DuPont Performance Elastomers)

• Rubber • Polyethylene • Silicon • Acetal

• Glass • Stainless steel • Polyvinyl chloride • Acrylonitrile butadiene styrene (ABS)

• Anodized aluminum • Polycarbonate • Polypropylene • Adhesives

The devices were subjected to 300 standard liquid chemical sterilization cycles. The devices were then evaluated visually for any change, damage, or corrosion,

and tested for loss of functionality (for example, optical bundle integrity, optical image, distal tip angulation, leak testing, and ability to provide light).

Exposure to 300 liquid chemical sterilization cycles had no effect on the functionality of the representative ﬂexible endoscopes, rigid endoscopes, cameras, or

light cables tested. The following cosmetic change was noted: progressive loss of black anodized aluminum coloration without underlying damage to the base

metal.

Because working devices were evaluated, the testing supports the compatibility of the use dilution of S40 Sterilant Concentrate with ﬁnished devices.

Material compatibility testing by STERIS with S40 Steriliant Concentrate is ongoing. Contact endoscope manufacturers regarding compatibility of their devices

and device materials with S40 Sterilant Concentrate. For a current list of devices that are compatible with the SYSTEM 1E or SYSTEM 1 endo Processor, see

the Device Compatibility Matrix at www.steris.com.

F. Directions for Use

1. Operators must follow all instructions provided in the following:

• The Operator Manual for the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing System for use and routine maintenance of the

system.

• The Quick Connect Processing Instructions for the liquid chemical sterilization of speciﬁc lumened devices using the indicated Quick Connect.

• The reusable device manufacturer’s labeling for recommendations on disassembly, cleaning, leak testing, and reprocessing methods.

• OSHA’s Bloodborne Pathogens Universal Precautions when cleaning and placing medical devices in the Processor.

Medical devices MUST BE THOROUGHLY CLEANED and RINSED according to manufacturers’ recommendations prior to liquid chemical sterilization.

2. Operators must observe the following safety measures for peracetic acid:

• 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,

but PPE should be used when handling the sterilant concentrate.

• The sterilant concentrate should be used in a well ventilated room. Conformance to AAMI ST58: Chemical Sterilization and High-Level Disinfection in

Healthcare Facilities is recommended.

3. Prior to Insertion of S40 Sterilant Concentrate:

• Carefully inspect the sterilant carton for evidence of damage. If damaged, follow the disposal instructions listed in this package insert.

• Check that the manufacturer’s expiration date has not lapsed.

• Open the carton at the tear notch and remove the sterilant container.

• Visually check the sterilant container. If leaking or damaged, follow the disposal instructions in this package insert.

4. Insert S40 Sterilant Concentrate into the Processor and Process the Load:

• S40 Sterilant Concentrate is a single use sterilant. A new container of S40 Sterilant Concentrate must be used for each liquid chemical sterilization

cycle.

• Install the appropriate processing tray needed for the type of devices to be liquid chemically sterilized into the chamber of the Processor.

• Insert S40 Sterilant Concentrate into the sterilant container well located in the lower right-hand corner of the processing tray.

• Press down ﬁrmly until the sterilant container is seated. Never slam the container into the sterilant compartment.

• 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.

• Start the liquid chemical sterilization cycle according to the Operator Manual for the Processor.

• The processed devices are automatically rinsed during the liquid chemical sterilization cycle.

G. Sterilant Container Disposal Information

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 sink, 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 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 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 diposal 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.

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)

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

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

k. Thoroughly rinse the sterilant container and inner cup and then dispose of them in the trash.

FIGURE 2

FIGURE 1

IMPORTANT: A small

puff of powder may

escape from bottom of

the sterilant container.