❑
Biodecontamination Unit components are properly positioned in
relation to Enclosure (refer to
SECTION 2.1, TERMS AND DEFINITIONS
being processed, as described in
❑ 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
S
ECTION 6.6, STERILANT CUP INSTALLATION AND REMOVAL.
❑ Desiccant cartridge assembly is properly inserted (see
S
ECTION 6.7, DESICCANT INSTALLATION AND REMOVAL).
6.2 Technical Data
6.2.1 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
SECTION 3.2, OPERATION
)
.
6.2.4 Environmental
Conditions
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.
FCC Statement:
Changes or modifications not
expressly approved by STERIS Life
Sciences could void the user’s
authority to operate the equipment.
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
6.3 Hydrogen Peroxide
Biodecontamination
DANGER – PERSONAL INJURY,
CONTAMINATED ENCLOSURE
AND/OR EQUIPMENT DAMAGE
HAZARD: Use only
Hydrogen Peroxide Sterilant Cups,
containing STERIS-registered
hydrogen peroxide which has
been specially formulated, tested
and approved for use in this X10
Biodecontamination Unit. V
Hydrogen Peroxide Sterilant
59
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 H
than V
aprox 59
equipment operation, result in
costly repairs, result in an
ineffective Biodecontamination
Cycle, violate federal law and void
the equipment warranty.
Vap rox 5 9
H2O2 could impair
2O2
aprox
other
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.
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 S
Effective use of H
concentration and exposure time.
The X10 Biodecontamination Unit typically uses a closed loop process
(refer to S
ECTION 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 S
ECTION 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.
ECTION 2.1, TERMS AND DEFINITIONS).
vapor for Biodecontamination requires adequate
2O2
H
vapor is continuously injected for the required exposure time to
2O2
achieve Biodecontamination. The Sterilant evacuated from the
Enclosure in a closed loop operation is catalytically converted into
water vapor and oxygen. .
6.4 Biodecontamination
Cycle
The properly installed X10 Biodecontamination Unit outside the
Enclosure (refer to
®
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.
Supplemental Information Operator Manual10087252
SECTION 2.1, TERMS AND DEFINITIONS
) uses STERIS’s
6-3
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