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The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.

The STERIZONE® VP4 Test Pack is a Process Challenge Device (PCD) designed to have greater resistance than the worst-case sterilization load of the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to simulate products to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process. The STERIZONE® VP4 Test Pack (subject device) is composed of a Self-contained Biological Indicator (the Terragene's Bionova® BT96), a 10 mL syringe and its plunger, and a diffusion restrictor. A STERIZONE® CI+ Chemical Indicator is also added, external to the syringe, to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.

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 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 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.

The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle ("Cycle 1"). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration.

The STERIZONE® BI+ Self-contained Biological Indicator (TSO3 product code 42602) consists of at least 106 Geobacillus stearothermophilus viable spores, known to be the reference microorganism for the STERIZONE® VP4 Sterilizer sterilization process, grouped on a stainless steel carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. The presence of G. stearothermophilus spores is detected by a visual color change (media turns yellow). The yellow color change indicates bacterial growth. No change of color indicates that the process achieved the conditions necessary to kill at least 1 × 106 viable spores of G. stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier. The final readout of a negative result (media remains purple) is made after 18 hours of incubation when using a dry-bath type incubator. The STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Selfcontained Biological Indicator (TSO3 product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). A STERIZONE® CI+ Chemical Indicator (TSO3 product code 43810) is also added, external to the syringe, to allow differentiating processed test packs. All components of the Test Pack are single-use, disposable items.

The STERIZONE® CI+ Chemical Indicator is a single-use process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle ("Cycle 1"). Critical process parameters for Cycle 1 are summarized in Table 1. The red stripe chemical indicator is located above the peach-colored stripe labeled as the "REFERENCE". After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).

The STERIZONE® CI+ Chemical Indicator (CI+) is a Class 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1: 2005(R)2010, and is intended to only be used with the STERIZONE® VP4 Sterilizer. The single pre-set cycle (Cycle 1) of the STERIZONE® VP4 Sterilizer utilizes vaporized hydrogen peroxide and ozone in a multiphase process, to rapidly sterilize a variety of reusable medical devices. The CI+ chemical indicator consists of a polymeric material strip on which an indicator ink, a reference color and a varnish coating have been deposited. The CI+ provides a visual indication that a sterilization load has been exposed to the STERIZONE® VP4 Sterilizer Cycle 1. The indicator works by means of a chemical reaction, which results is a recognizable color change from red to peach (or lighter).

TSO3 125L Ozone Sterilizer is intended for use in the sterilization processing of reusable medical devices in health care facilities. TSO 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures. TSO3 125L Ozone Sterilizer has the ability to sterilize successfully packaged rigid and flexible lumen medical devices, including single and multi channel flexible endoscopes such as fiberoptic and video endoscopes.

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned. The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.). It requires USP grade oxygen, water and electricity. TSO3 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. By-products are oxygen and low humidity water vapor. Model 125L is equipped with a unique factory-programmed control system. Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized. OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance. TSO3 Chemical Indicators are available for this process. No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use with TSO3 Ozone Sterilization process.

The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use in the TSO3 Ozone Sterilization process. The TSO3 Ozone Sterilization Wrap is a 2 layer laminate consisting of an ePTFE membrane and a 100% Polyethylene/Polyester (PE/PET) bi-component nonwoven backer.

The TSO3 Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in health care facilities. The TSO3 Ozone Sterilizer, Movol 1252. is designed for sterilization of both metal and non-metal medical devices at low temperatires. The sterilization cycle operates at very low pressure and low temperature, consequently it is suitable for processing medical devices sensitive to heat and moisture. The TSO3 Ozone Sterilizer, Model 125L, is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and sciators.

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned. The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.). It requires USP grade oxygen, water and electricity. Model 125L 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. By-products are oxygen and low humidity water vapor. Model 125L is equipped with a unique factory-programmed control system. Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized. OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance. TSO3 Chemical Indicators are available for this process. No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.