PREempt CS 20 (Canada)

Company: Virox

Sterilant and High Level Disinfectant for Medical Devices and Instruments

14 Day Reuse

ACCELERATED^® HYDROGEN PEROXIDE

Patented

Active Ingredient

Hydrogen Peroxide 7.0% w/w

PREempt CS 20 Caution

CORROSIVE

READ THE LABEL BEFORE USING

Licence No. 103055

FUNGICIDAL • TUBERCULOCIDAL • SPORICIDAL

A Powerful Disinfectant Effective Against

SPORICIDAL: 20 Min.

Bacillus subtilis (ATCC 19659)

Clostridium sporogenes (ATCC 7955)

TUBERCULOCIDAL: 20 Min.

Mycobacterium terrae (ATCC 15755)

FUNGICIDAL: 20 Min.

Trichophyton mentagrophytes (ATCC 9533)

Germicidal activity of this product was determined in accordance with the Canadian General Standards Board’s standard CAN/CGSB-2.161-97.

Indications For Use

PREempt CS 20 is a sterilant and high level disinfectant for processing heat sensitive medical devices for which heat sterilization is not suitable, when used according to the directions for use. PREempt CS 20 is intended for use in manual (bucket & tray) systems made from polypropylene, acrylonitrile-butadienestyrene (ABS), polyethylene, polycarbonate plastics and 316 stainless steel. PREempt CS 20 is not intended for use on flexible endoscopes. PREempt CS 20 may not be suitable for all instruments. SEE NOTICE TO USER.

SEMI-CRITICAL DEVICES: High Level Disinfection is required for medical devices and instruments that come in contact with non-intact skin or mucous membranes during use but do not usually penetrate normally sterile areas of the body such as respiratory equipment and surgical mirrors.

CRITICAL DEVICES: Sterilization is required for medical devices and instruments that come in contact with sterile tissue and the blood stream and recirculating Sterilant and High Level Disinfectant body fluids such as surgical instruments, implants and laparoscopes.

Disinfectant Use Directions

SEMI-CRITICAL DEVICES: Thoroughly clean the medical instruments and equipment mechanically or manually with an appropriate cleaning solution. Rinse and dry objects before immersion in PREempt CS 20 solution. Place pre-cleaned, rinsed and dried instruments and devices in solution of undiluted PREempt CS 20. Allow devices to soak for at least 20 minutes. Rinse with sterile or potable tap water. PREempt CS 20 may not be suitable for all instruments. SEE NOTICE TO USER.

CRITICAL DEVICES: Thoroughly clean the medical instruments and equipment mechanically or manually with an appropriate cleaning solution. Rinse and dry objects before immersion in PREempt CS 20 solution. Place pre-cleaned, rinsed and dried instruments and devices in solution of undiluted PREempt CS 20. Allow devices to soak for at least 20 minutes. Remove and rinse with sterile water. PREempt CS 20 may not be suitable for all instruments. SEE NOTICE TO USER.

REUSE PERIOD FOR DISINFECTION: PREempt CS 20 solution has demonstrated disinfection efficacy in the presence of organic soil contamination and microbial burden during reuse. The Hydrogen Peroxide concentration of PREempt CS 20 solution during its use-life can be verified by the 7% Hydrogen Peroxide Test Strips (Part No. AHP7). PREempt CS 20 may be used and reused for up to a maximum of 14 days provided the 7% Hydrogen Peroxide test strip indicates a pass according to the instructions. The unused PREempt CS 20 solution in its original packaging is good until date expiry.

Precautionary Statements

KEEP OUT OF REACH OF CHILDREN. CAUTION: Corrosive material. May cause burns. Avoid contact with eyes and skin. Wear suitable protective clothing. Avoid contamination of food in the use and storage of this product. Store in dry, well ventilated areas away from chemicals, direct light, heat or open flame. Do not mix with other cleaning or disinfecting products.

FIRST AID: If in contact with eyes, immediately flush with water for 15 minutes. Call a physician. If in contact with skin, flush with water for 15 minutes. Wash thoroughly with soap and water. Call a physician if irritation persists. If ingested, do not induce vomiting. Call a physician or a poison control centre immediately. Take Product label or DIN with you when seeking medical attention.

Disposal

Triple rinse the container with water. Dispose of the container in accordance with federal, provincial and municipal requirements. Do not re-use the empty container. For information on the disposal of unused, unwanted product and the clean up of spills, contact the local waste management office or the manufacturer for guidance.

NOTICE TO USER: Please ensure the instruments, equipment or device material to be disinfected is compatible with PREempt CS 20. Compatible materials include acrylic, silicone rubber, low and high density plastics, and stainless steel (visit the Compatibility section on www.virox.com for a list of compatible materials). PREempt CS 20 is contraindicated for use on copper, brass, carbon tipped devices and anodized aluminum. If you are uncertain as to material composition of your item, confirm with the manufacturer before proceeding. PREempt CS 20 is not intended for use on flexible endoscopes.

SPOT VARNISH

READ S.D.S. BEFORE USING PRODUCT.

S.D.S. is available on line at www.virox.com

For relevant patents, visit:

virox.com/patents

Manufactured by: Virox Technologies Inc., 2770 Coventry Road, Oakville, ON Canada L6H 6R1

1-800-387-7578

virox.com

CPN: 1851005.1