STERIS VHPX10 VHP X10 Biodecontamination Unit User Manual 10087252 s06

STERIS Corporation VHP X10 Biodecontamination Unit 10087252 s06

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6-210087252 Operator ManualSupplemental Information❑Biodecontamination Unit components are properly positioned inrelation to Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS)being processed, as described in SECTION 3.2, OPERATION.❑The X10 Biodecontamination Unit components are properlyconnected (refer to Figure 3-4 or Figure 3-6).❑A Vaprox® 59 Hydrogen Peroxide Sterilant Cup is in place; if aCup is not in place or is empty, install a new Cup as described inSECTION 6.6, STERILANT CUP INSTALLATION AND REMOVAL.❑Desiccant cartridge assembly is properly inserted (seeSECTION 6.7, DESICCANT INSTALLATION AND REMOVAL).6.2 Technical Data6.2.1 Overall Size (W x H x D) 28 x 22 x 15" (711 x 559 x 381 mm)6.2.2 Weight 68 lb (31 kg)6.2.3 Electric Requirements 120 Vac, 50/60 Hz, 12 A, 1 Ph 230 Vac, 50/60 Hz, 7 A, 1 Ph 6.2.4 EnvironmentalConditionsTemperature: 60 to 104°F (16 to 40°C)Maximum Humidity: 70% A-Weighted Sound Power Level: 73 dBA (mean) - 83 dBA (maximum); use earplugs.Pollution Degree: 2Installation Category (Overvoltage Category): IIIP67 Rating Closed; IP20 Rating OpenIC Number: IC:11700A-VHPX10IC Statement:This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.FCC Number: 2ABQIVHPX10.FCC Statement:This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.NOTE: This equipment has been tested and found to comply with thelimits for a Class A digital device, pursuant to part 15 of the FCC Rules.These limits are designed to provide reasonable protection againstChanges or modifications notexpressly approved by STERIS LifeSciences could void the user’sauthority to operate the equipment.
6-3Supplemental Information Operator Manual10087252harmful interference when the equipment is operated in a commercialenvironment. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with theinstruction manual, may cause harmful interference to radiocommunications. Operation of this equipment in a residential area islikely to cause harmful interference in which case the user will berequired to correct interference at his own expense.6.3 Hydrogen PeroxideBiodecontaminationFigure 6-1. X10 Biodecontamination UnitThe X10 Biodecontamination Unit (see Figure 6-1) provides a simple and reliable method for Biodecontaminating pre-cleaned, dry sealable Enclosures (refer to SECTION 2.1, TERMS AND DEFINITIONS).Effective use of H2O2 vapor for Biodecontamination requires adequate concentration and exposure time.The X10 Biodecontamination Unit typically uses a closed loop process(refer to SECTION 3, OPERATING INSTRUCTIONS) utilizing air as a carrierto deliver Vaprox 59 Hydrogen Peroxide Sterilant vapor to theexposed surfaces inside a pre-cleaned, dry, sealed Enclosure (referto SECTION 2.1, TERMS AND DEFINITIONS). This closed loop processallows the Biodecontamination process to take place at atmosphericconditions. Because Biodecontamination relies only on the contact ofSterilant with exposed surfaces, the transfer of heat and moisturerequired by steam processes is not necessary.H2O2 vapor is continuously injected for the required exposure time toachieve Biodecontamination. The Sterilant evacuated from theEnclosure in a closed loop operation is catalytically converted intowater vapor and oxygen. .6.4 BiodecontaminationCycleThe properly installed X10 Biodecontamination Unit outside theEnclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) uses STERIS’sVHP® process technology. This process uses hydrogen peroxide vaporas a broad-spectrum antimicrobial without condensation of activeingredient onto surfaces. This non-condensation feature providesadditional benefit of a wide range of material compatibility. In practice, an aqueous solution of 59% (Vaprox 59 Hydrogen PeroxideSterilant) hydrogen peroxide vapor is atomized and a high velocity airstream disperses it throughout Enclosure. Relative humidity andtemperature sensor measurements ensure the vapor does not condenseon internal Enclosure surfaces.DANGER – PERSONAL INJURY, CONTAMINATED ENCLOSURE AND/OR EQUIPMENT DAMAGE HAZARD: Use only Vaprox 59 Hydrogen Peroxide Sterilant Cups, containing STERIS-registered hydrogen peroxide which has been specially formulated, tested and approved for use in this X10 Biodecontamination Unit. Vaprox 59 Hydrogen Peroxide Sterilant has been registered by STERIS in accordance with U.S. Federal Regulations for the specific uses described in this manual. Use of other materials and/or H2O2 other than Vaprox 59 H2O2 could impair equipment operation, result in costly repairs, result in an ineffective Biodecontamination Cycle, violate federal law and void the equipment warranty.

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