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The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non- metal reusable medical devices in health care facilities. The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals. Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1 [refer to continuation pages 2 - 4 of this form]. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 lb loading rack.

The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multichannel devices), and rigid-channel devices (including single-channel and double-channel rigid endoscopes). The changes to the sterilizer are component changes that were made to extend the of the hydrogen peroxide vaporization block. These changes include: 1] anodization of the hydrogen peroxide vaporization block, and 2] a reduction of the stabilizer concentration in the hydrogen peroxide solution.

The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.

The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multi-channel devices), and rigid-channel devices (including single-channel and doublechannel rigid endoscopes). Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.

The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and nonmetal reusable medical devices in health care facilities. The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, with residual hydrogen peroxide to form hydroxyl radicals. Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 1b loading rack.

The STERIZONE® VP4 Sterilizer is a versatile low temperature sterilizer using two sterilants (vaporized hydrogen peroxide [H₂O₂] and ozone [O₃]) in a multi-phase process to sterilize reusable medical instruments up to a maximum load of 75 lb. In contrast to the sterilization processes using H2O2 only and having multiple cycles, the STERIZONE® VP4 Sterilizer enables the sterilization of a wider range of instruments and load configuration with only one preset cycle. The dynamic system to distribute the sterilant ensures an adequate supply of the sterilant through multiple successive pulsed injections that adapt to the different load conditions (size, weight and temperature). The STERIZONE® VP4 Sterilizer offers a unique preset sterilization cycle (Cycle 1) to sterilize a wide range of loads consisting of general instruments, flexible endoscopes with one channel, double channels and multi-channels, and devices with rigid and semi-rigid channels, including rigid endoscopes with single or double channels.

The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.

The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, flexible endoscopes (including single, dual, and multi-channel devices), and rigid-channel devices (including single-channel and doublechannel rigid endoscopes). Lumen claims for the VP4 have been expanded to include double and multiple-channel devices with no more than four channels.

The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities. The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals. Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in seven separate validation loads, as described in Table 1. The load to be processed should be maintained between 20℃ to 26℃ (68°F to 78°F). Total load weight shall not exceed 75 lbs, inclusive of the containers/packaging weight but excluding the 25 Ibs loading rack.

The STERIZONE® VP4 Sterilizer (VP4) is a self-contained stand-alone device, using vaporized hydrogen peroxide and ozone in a multiphase process. The VP4 offers a single sterilization cycle intended for general instruments, single-channel flexible endoscopes, and rigid-channel devices including single-channel and double-channel rigid endoscopes. The VP4 has been modified in order to make it compliant with the European Directive on the Restriction Of use of certain Hazardous Substances also known as « RoHS ». In addition, device software has been modified to include a maintenance mode, among other small changes. Finally, a new sensor has been adopted for monitor and control of chamber pressure.

The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.

The STERIZONE® VP4 Sterilization chamber has a capacity of 4.4 cu. ft. (125 liters). It requires oxygen (94% pure and greater), electricity and the 125-280 Solution™ containing 50% hydrogen peroxide by weight. Both hydrogen peroxide and ozone are used in a multiphase process. The STERIZONE® VP4 Sterilizer is equipped with a factory-programmed control system offering a unique sterilization cycle. Processed medical instruments are ready to use immediately after the cycle ends; no aeration is required. Polypropylene non-woven wrapping material, non-woven polyethylene (Tyvek™) with polyester/LDPE transparent film pouches, and vaporized hydrogen peroxide compatible aluminium containers using disposable polypropylene filters, are used as packaging for medical devices to be sterilized. Plastic and metal trays are also suitable packaging means when combined with polypropylene wraps. A self-contained biological indicator containing spores of G. stearothermophilus, incorporated into a test pack, is recommended to monitor cycle performance. The STERIZONE® VP4 Sterilizer could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated.