PREempt HLD5 (Canada)

Company: Virox

High Level Disinfectant and Sterilant for Medical Devices and Instruments

14 Day Reuse

Active Ingredient

Hydrogen Peroxide 2.0% w/w

KEEP OUT OF REACH OF CHILDREN

READ THE LABEL BEFORE USING

ACCELERATED^® HYDROGEN PEROXIDE

Licence No. 103056

TUBERCULOCIDAL • FUNGICIDAL • SPORICIDAL

A Powerful Disinfectant Effective Against:

SPORICIDAL: 6 Hrs.

Bacillus subtilis

Clostridium sporogenes

TUBERCULOCIDAL: 5 Min.

Mycobacterium terrae

FUNGICIDAL: 5 Min.

Trichophyton mentagrophytes

BACTERICIDAL: 5 Min.

Pseudomonas aeruginosa

Staphylococcus aureus

Salmonella enterica

VIRUCIDAL: 5 Min.

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

PREempt HLD5 solution has demonstrated disinfection efficacy in the presence of organic soil contamination and microbial burden during reuse.

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.

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 may not be suitable for all tools/instruments/devices. SEE NOTICE TO USER.

Directions For Use

CLEANING/DECONTAMINATION: Blood and other body fluids must be thoroughly cleaned from hard, non-porous 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 AND STERILIZATION:

1) Thoroughly clean reusable tools/instruments/devices mechanically or manually with an appropriate cleaning solution.

2) Rinse and dry tools/instruments/devices before immersion in PREempt HLD5 solution.

3) Pour PREempt HLD5 directly into suitable container, such as a soaking tray. Do not dilute.

4) Place pre-cleaned, rinsed and dried tools/instruments/devices in PREempt HLD5.

5) For high level disinfection, allow tools/instruments/devices to soak for 5 minutes. For sterilization, allow tools and instruments to soak for 6 hours.

6) Remove tools/instruments/devices from the solution and rinse. For high level disinfection, rinse with sterile or potable tap water. For sterilization, rinse with sterile water only.

REUSE PERIOD OF SOLUTION: In a suitable container, such as a soaking tray, the PREempt HLD5 solution may be reused for up to a maximum of 14 days provided the AHP2 test strips indicate a pass. Refer to test strip label for full directions.

The solution should be replaced immediately if the test strips do not indicate a pass or if the solution is visibly contaminated/cloudy. The unused PREempt HLD5 solution in its original packaging is effective until the expiry date listed on the bottle.

PREempt HLD5 is intended for use in manual (bucket & tray) systems/containers made from polypropylene, Acrylonitrile-butadienestyrene (ABS), polyethylene, polycarbonate plastics and 316 stainless steel.

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 device licence number 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 tools/instruments/devices to be disinfected are 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 equipment manufacturer before proceeding.

READ SDS BEFORE USING PRODUCT

SDS is available online at www.virox.com

DISCLAIMER: You must read and follow the instructions on the label for our product and use the product for the particular applications specified on the product label. To the full extent permitted under applicable law, Virox Technologies Inc. shall not be liable for any damages whatsoever, arising out of or otherwise in connection with any failure to follow those instructions or any use of its products which is not specified on the product’s label. The instructions on the product label are not a warranty, express or implied, and Virox Technologies, Inc. expressly disclaims any implied warranties,

including any warranty of fitness for a particular purpose. Under applicable law, some of the above waivers or disclaimers of warranty, or exclusions of liability for certain types of damages may not apply to you. In such cases, our liability will be limited to the fullest extent permitted by applicable law.

Accelerated Hydrogen Peroxide^® and Design are trademarks of Diversey Inc.

Manufactured by:

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

1-800-387-7578

virox.com

CPN: 1851004.2