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The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack. The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures. Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended for use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and “Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices. The Sterilucent SCBI is to be used in a test pack configuration, with a different test pack (Process Challenge Device) used for each sterilization cycle. Each Process Challenge Device (PCD) is designed to have greater resistance than the worst-case sterilization load, allowing for survival beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle. The Sterilucent SCBI provides information on whether necessary conditions were met to kill a specified number of microorganisms upon exposure to either cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.

A chemical indicator for monitoring all cycles within the Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer (Lumen & Flexible), STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® VPRO™ 1, V-PRO™ 1 Plus (Lumen & Non-Lumen), VPRO® maX (Flexible, Lumen & Non-Lumen) and Sterilucent PSD-85 (Lumen & Non-Lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

The Sterilucent VH2O2 Chemical Indicator is a Class 1/Type 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1:2014, and is intended to be used with currently cleared hydrogen peroxide sterilizers (STERRAD® 100S, 200, 100NX, NX, STERIS® VPRO™ 1, V-PRO™ 1 Plus, VPRO® maX and the Sterilucent PSD-85) and the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and "Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices. The Sterilucent VH2O2 Chemical Indicator is provided in two different formats: Strip and Label. Both formats consist of a polymeric material on which indicator ink is deposited. A pressure-sensitive adhesive is provided on the back of the Label, which allows the process indicator to be adhered to various substrates including containers, pouches, tamper-proof arrows or locks, etc. The Sterilucent VH2O2 Chemical Indicator provides a visual indication that a sterilization load has been exposed to the VHP sterilization process. The indicator works by means of a chemical reaction, which results in a recognizable color change from red to blue.

The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycle and the Flexible Cycle, operate at low temperature and are thus suitable for processing medical devices that are sensitive to heat and moisture. The HC 80TT Lumen Cycle can sterilize: o Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hinged portion of forceps and scissors; O Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are: - · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or - · ≥ 1.33 mm ID and ≤ 430 mm long; and, o Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are: - ≥ 1.00 mm ID and ≤ 310 mm long. The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using two (2) separate validation loads as described in the following table. The HC 80TT Flexible Cycle can sterilize: - · Rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors; - · Single channel flexible endoscopes with flexible lumens that are: - · ≥ 1.00 mm ID and ≤ 1280 mm long; and, - · Dual channel flexible endoscopes with flexible lumens that are: - · ≥ 0.80 mm ID and ≤ 1000 mm long.

The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (HC 80TT) is a self-contained standalone device, using vaporized hydrogen peroxide as the sterilant. The HC 80TT is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and non-metal medical device used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures and is therefore suitable for processing medical devices that are sensitive to heat and moisture. The hydrogen peroxide vapor is generated by heating aqueous hydrogen peroxide and injecting into a chamber.

The Sterilucent Sterilization Container System is a device intended 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 container system is intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen Cycles. The sterility maintenance period has been validated for a period of up to 180 days. Reusable baskets and accessory items (clips, posts, pins, dividers, bars and mats) are intended to organize and secure enclosed medical devices during sterilization, transport, and storage of the container. Consumable accessory items (filter media, data card and tamper evident arrows) provide a range of functions and are indicated as single-use devices. Filter media allows ingress of sterilant while providing a microbial barrier. Data cards are used to record information regarding a specific sterilization process load. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains an external process indicator that serves as a visual indication that the system has been exposed to the Sterilization process.

The Sterilucent Sterilization Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of those devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses reusable baskets of varying depths and organizing accessory items that are used to organize and secure surgical instrumentation and/or other medical devices.

The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the hydrogen peroxide sterilization process in the Sterilizer Lumen and Non-Lumen cycles. It is intended for use solely in a test pack. The Sterilucent Biological Indicator Monitoring System is intended for incubating and monitoring of the Sterilucent Self-Contained Biological Indicator.

The Sterilucent Self-Contained Biological Indicator is a self-contained biological indicator (SCBI) designed for use in monitoring the efficacy of the Sterilucent PSD-85 Sterilizer Lumen and Non-Lumen cycles. The SCBI consists of Geobacillus stearothermophilus bacterial spores, inoculated on a stainless steel carrier, and placed into a thermoplastic vial that serves as a culture tube. A small glass ampoule containing sterile culture medium (soybean casein digest formulation) and pH color indicator (Bromocresol Purple) is also contained in the vial. The user places the Sterilucent SCBI into the Sterilucent PSD-85 sterilizer load and initiates a sterilization cycle appropriate for the particular type of load. After cycle completion, the SCBI is retrieved and activated by breaking the glass ampoule which contains a growth media. The activated SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates conditions for sterilization were achieved (a passing result). The Sterilucent Biological Indicator Monitoring System is a biological indicator incubator which monitors for the presence and condition (growth [as indicated by a yellow color in the growth media] or no-growth [as indicated by purple growth media]) of Sterilucent SCBI. When an activated Sterilucent SCBI is placed into one of the incubation cavities, the LED in front of the cavity will illuminate amber. The incubator maintains the operating temperature specifications under all potential loading conditions over the recommended incubation time. It can incubate and monitor up to ten (10) Sterilucent SCBI plus one control unit.

The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles, the Lumen Cycles, operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. The PSD-85 Lumen Cycle can sterilize*: - · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors - · Medical devices with a single stainless steel lumen with: - o An inside diameter of 1 mm or larger and a length of 60 mm or shorter - o An inside diameter of 2 mm or larger and a length of 250 mm or shorter o An inside diameter of 3 mm or larger and a length of 350 mm or shorter *The validation testing for all lumen sizes was conducted using a maximum of ten (10) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray with a total weight of 10.4 lbs. The PSD-85 Non-Lumen Cycle can sterilize**: · Non-lumen instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. ** The validation studies were conducted using a validation load consisting of one instrument tray with a total weight of 25.3 lbs.

The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) is a self contained stand alone device, using vaporized hydrogen peroxide as the sterilant. The PSD-85 is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and non-metal medical device used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices that are sensitive to heat and moisture. The hydrogen peroxide vapor is generated by heating aqueous hydrogen peroxide and injecting into a chamber.

The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation, after relocation, major repairs or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle. The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 Sterilizer during initial installation, after relocation, major repairs or after sterilization process failures. The Sterilucent PCD-NL may also be used for routine monitoring of the PSD-85 Sterlizer Non-Lumen Cycle.

The Sterilucent PCD-L and PCD-NL are pre-assembled devices that consist of a Sterilucent Self-Contained Biological Indicator (SCBI), a vial, a vial cap containing a challenge tube, and a Chemical Indicator (CI) Label. The design of the PCD is such that it creates a challenge at least as challenging as the most difficult to sterilize item routinely processed in the PSD-85 sterilizer. The PCDs are used by healthcare providers for qualification testing of the Sterilucent PSD-85 sterilizer and for routine monitoring of the PSD-85 sterilizer Lumen and Non-Lumen Cycles. The user places the Sterilucent PCD into the Sterilucent PSD-85 along with a load and initiates a sterilization cycle. After cycle completion, the PCD is retrieved. The Cl is immediately accessed for a passing color change from pink to blue. If the CI is blue, the SCBI is removed from the PCD vial and activated by breaking the glass ampoule which contains a growth media. The SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates adequate sterilization (a passing result).