Steris S40 Sterilant Concentrate Operating instructions

  • Hello! I'm your chat assistant. I've analyzed the product detail for the STERIS S40 Sterilant Concentrate S4002. This document outlines the use of this single-use chemistry with SYSTEM 1 EXPRESS and SYSTEM 1 PLUS systems for sterilizing medical devices. It details storage, disposal, and safety precautions, and I'm ready to answer any questions you have about this product.
  • What should I do if the sterilant carton is damaged?
    Can I use the sterilant concentrate after the expiration date?
    What is the active ingredient in the S40 Sterilant Concentrate?
    What kind of PPE is required when handling or disposing of the concentrate?
10007435 Rev. K
DANGER
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 o 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.
DIRECTIONS FOR USE:
1 Carefully inspect the sterilant carton for evidence of damage. If the sterilant carton is damaged,
do NOT use the sterilant container inside of the damaged carton; refer to the Operator
Manual for the Processor concerning the disposal of leaking, damaged, or expired S40
Sterilant Concentrate containers.
2 Check that the manufacturer’s expiration date has not lapsed. Do NOT use the S40 Sterilant
Concentrate container past the printed manufacturer’s expiration date.
3 Do not remove sterilant container from carton until time of use. Wearing appropriate personal
protective equipment, open the carton at the tear notch and remove the sterilant container.
4 Visually check the S40 Sterilant Concentrate container. Discoloration of powders may occur; this is
acceptable and has no eect on sterilant performance. If the sterilant container is leaking or
damaged, do NOT use the sterilant container. Refer to the Operator Manual for the Processor
concerning the disposal of leaking, damaged, or expired S40 Sterilant Concentrate
containers.
5 If the container is not leaking or damaged, insert the S40 Sterilant Concentrate container into the
Processor and follow the OPERATION OF THE PROCESSOR instructions in the Operator Manual for
the Processor.
INTENDED USE
S40 Sterilant Concentrate is a single-use chemistry for use only with the SYSTEM 1® EXPRESS and
SYSTEM 1® PLUS Sterile Processing Systems to sterilize pre-cleaned immersible, reusable,
semi-critical and critical medical devices, including endoscopes and their accessories in hospitals and
medical/surgical clinics and oces. The S40 Sterilant Concentrate container holds both a liquid active
ingredient (35% peracetic acid) and powdered inert ingredients. S40 Sterilant Concentrate is
Sporicidal, Fungicidal, Bactericidal, Virucidal, & Tuberculocidal.
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 USA
800-548-4873
FOR EXPORT ONLY - NOT FOR SALE OR USE IN USA
STORAGE AND DISPOSAL:
STORAGE: The S40 Sterilant Concentrate container 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.
Do NOT use an S40 Sterilant Concentrate container after the manufacturer’s expiration date.
DISPOSAL: Dispose of spent container in proper receptacle. Refer to the Processor’s Operator
Manual for disposal instructions of leaking, damaged, or expired containers.
EXTREME CARE SHOULD BE TAKEN IF AN ATTEMPT IS MADE TO MANUALLY OPEN A SEALED
CONTAINER OF S40 STERILANT CONCENTRATE. REFER TO THE PROCESSOR’S OPERATOR
MANUAL FOR THE DISPOSAL OF LEAKING, DAMAGED, OR EXPIRED S40 STERILANT
CONCENTRATE CONTAINERS.
CAUTION: APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) IS REQUIRED WHEN
HANDLING OR DISPOSING OF PARTIALLY FILLED, LEAKING, DAMAGED, OR EXPIRED 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.
FOR EXPORT ONLY - NOT FOR SALE OR USE IN USA
Distributed by: Australia New Zealand
Company: Device Technologies Australia
Pty Ltd
Device Technologies New Zealand
Limited
ACN: 058 091 973
Address: 1 Garigal Road
BELROSE NSW 2085
AUSTRALIA
47 Arrenway Dr,
Albany, Auckland, 0632
NEW ZEALAND
Telephone No: 1300 338 423 0508 338 423
Fax No: +61 2 9975 5711 +64 9 913 2009
Emergency Telephone No: 1800 429 551 (24 hour number) 0508 338 423 (24 hour number)
S4002
S40® Sterilant Concentrate
1x
S4002
S40® Sterilant Concentrate
1x
CONTENTS:
Each cup of S40 Sterilant Concentrate contains:
ACTIVE INGREDIENT (Liquid) 35% Peracetic Acid
INERT INGREDIENTS (Powders)
Total Net Contents
SDS available at www.steris.com
76.5 g
117.7 g
194.2 g
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.
MANUFACTURED BY
27°C / 81°F
16°C / 61°F
Symbol Defi nition
Quantity per package
Do not use blades to open
Container
NOT FOR USE IN THE
SYSTEM 1 PROCESSOR
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