PREempt HLD5 (Canada)

Company: Virox

High Level Disinfectant and Sterilant for Medical Devices and Instruments

14 Day Reuse

ACCELERATED^® HYDROGEN PEROXIDE

Patented

Active Ingredient: Hydrogen Peroxide 2.0% w/w

KEEP OUT OF REACH OF CHILDREN

READ THE LABEL BEFORE USING

Licence No. 103056

TUBERCULOCIDAL • FUNGICIDAL • SPORICIDAL

A Powerful Disinfectant Effective Against

SPORICIDAL: 6 Hrs.

Bacillus subtilis (ATCC 19659)

Clostridium sporogenes (ATCC 7955)

TUBERCULOCIDAL: 5 Min.

Mycobacterium terrae (ATCC 15755)

FUNGICIDAL: 5 Min.

Trichophyton mentagrophytes (ATCC 9533)

BACTERICIDAL: 5 Min.

Pseudomonas aeruginosa (ATCC 15442)

Staphylococcus aureus (ATCC 6538)

Salmonella enterica (ATCC 10708)

VIRUCIDAL: 5 Min.

Poliovirus, Sabin strain type 1 (ATCC VR-192), which allows for a Broad-Spectrum Virucide claim against most enveloped and non-enveloped viruses.

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 HLD5 is a high level disinfectant and sterilant for processing heat sensitive medical devices for which heat sterilization is not suitable, when used according to the Directions for Use. PREempt HLD5 is intended for use in manual (bucket & tray) systems made from polypropylene, Acrylonitrilebutadienestyrene (ABS), polyethylene, polycarbonate plastics and 316 stainless steel. PREempt HLD5 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 (which are not normally considered to be sterile) 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 body fluids such as surgical instruments, implants and laparoscopes.

Directions For Use

CLEANING/DECONTAMINATION: Blood and other body fluids must be thoroughly cleaned from hard, nonporous surfaces of medical devices and instruments before application of the disinfectant or sterilant. For complete disinfection or sterilization of medical instruments and equipment, thoroughly clean, rinse and dry objects before immersion in PREempt HLD5 solution.

HIGH LEVEL DISINFECTION: Place pre-cleaned, rinsed and dried medical devices and instruments in solution of undiluted PREempt HLD5. Allow devices to soak for at least 5 minutes. Rinse with sterile water or potable tap water. PREempt HLD5 may not be suitable for all instruments. SEE NOTICE TO USER.

STERILIZATION: Place pre-cleaned, rinsed and dried medical devices and instruments in solution of undiluted PREempt HLD5. Allow devices to soak for at least 6 hours. Remove and rinse with sterile water. PREempt HLD5 may not be suitable for all instruments. SEE NOTICE TO USER.

REUSE PERIOD FOR DISINFECTION: PREempt HLD5 solution has demonstrated disinfection efficacy in the presence of organic soil contamination and microbiological burden during reuse. The Hydrogen Peroxide concentration of PREempt HLD5 solution during its use-life can be verified by the 2% AHP test strip (Part No. AHP2). PREempt HLD5 may be used and reused for up to a maximum of 14 days provided the 2% AHP test strip indicates a pass according to the instructions. The unused PREempt HLD5 solution in its original packaging is good until date of expiry.

Precautionary Statements

KEEP OUT OF REACH OF CHILDREN. CAUTION: 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. Do not store in food processing areas. Store in dry, well ventilated area 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 plenty of water. 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 HLD5. 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 HLD5 is contraindicated for use on copper, brass, carbon tipped devices and anodized aluminum. If you are uncertain as to the material composition of the device or instrument, confirm with the manufacturer before proceeding.

READ S.D.S. BEFORE USING PRODUCT.

SPOT VARNISH

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: 1851004.1