STERIS VHPX10 VHP X10 Biodecontamination Unit User Manual 10087252 s06

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Document ID	2197753
Application ID	Dkv6dgRLEI16schRPjJzag==
Document Description	Updated manual pages
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
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Filesize	6.47kB (80862 bits)
Date Submitted	2014-02-21 00:00:00
Date Available	2014-02-28 00:00:00
Creation Date	2014-02-21 11:56:25
Producing Software	Acrobat Distiller 8.1.0 (Windows)
Document Lastmod	2014-02-21 11:57:28
Document Title	10087252_s06.fm
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❑
Biodecontamination Unit components are properly positioned in
relation 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 properly
connected (refer to Figure 3-4 or Figure 3-6).
❑
A Vaprox® 59 Hydrogen Peroxide Sterilant Cup is in place; if a
Cup is not in place or is empty, install a new Cup as described in
SECTION 6.6, STERILANT CUP INSTALLATION AND REMOVAL.
❑
Desiccant cartridge assembly is properly inserted
SECTION 6.7, DESICCANT INSTALLATION AND REMOVAL).
(see
6.2 Technical Data
6.2.1 Overall Size (W x H x D)
6.2.2
6.2.3
Weight
Electric Requirements
6.2.4 Environmental
Conditions
28 x 22 x 15" (711 x 559 x 381 mm)
68 lb (31 kg)
120 Vac, 50/60 Hz, 12 A, 1 Ph
230 Vac, 50/60 Hz, 7 A, 1 Ph
Temperature: 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: 2
Installation Category (Overvoltage Category): II
IP67 Rating Closed; IP20 Rating Open
IC Number: IC:11700A-VHPX10
IC 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.
Changes
or
modifications
not
expressly approved by STERIS Life
Sciences could void the user’s
authority to operate the equipment.
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 the
limits for a Class A digital device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
6-2
10087252
Operator ManualSupplemental Information
harmful interference when the equipment is operated in a commercial
environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the
instruction manual, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is
likely to cause harmful interference in which case the user will be
required to correct interference at his own expense.
6.3 Hydrogen Peroxide
Biodecontamination
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.
Figure 6-1. X10 Biodecontamination Unit
The 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 carrier
to deliver Vaprox 59 Hydrogen Peroxide Sterilant vapor to the
exposed surfaces inside a pre-cleaned, dry, sealed Enclosure (refer
to SECTION 2.1, TERMS AND DEFINITIONS). This closed loop process
allows the Biodecontamination process to take place at atmospheric
conditions. Because Biodecontamination relies only on the contact of
Sterilant with exposed surfaces, the transfer of heat and moisture
required by steam processes is not necessary.
H2O2 vapor is continuously injected for the required exposure time to
achieve Biodecontamination. The Sterilant evacuated from the
Enclosure in a closed loop operation is catalytically converted into
water vapor and oxygen.
6.4 Biodecontamination The properly installed X10 Biodecontamination Unit outside the
Cycle Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) uses STERIS’s
VHP® process technology. This process uses hydrogen peroxide vapor
as a broad-spectrum antimicrobial without condensation of active
ingredient onto surfaces. This non-condensation feature provides
additional benefit of a wide range of material compatibility.
In practice, an aqueous solution of 59% (Vaprox 59 Hydrogen Peroxide
Sterilant) hydrogen peroxide vapor is atomized and a high velocity air
stream disperses it throughout Enclosure. Relative humidity and
temperature sensor measurements ensure the vapor does not condense
on internal Enclosure surfaces.
6-3
Supplemental Information
Operator Manual10087252

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