This biodecontamination unit using the Flexible Cycle can
biodecontaminate single or dual lumen flexible instruments in
either of the two configurations:
1.
Two flexible instruments with a light cord (if not integral to
instrument) and mat with no additional load.
instruments may contain either:
1
The validation studies were conducted with two flexible instruments, each
packaged into a tray with silicone mat and light cord (if not integral to
instrument).
» A single lumen with an inside diameter of ≥ 1 mm
(~3/64") and a length of ≤ 1050 mm (41")
» Or two lumens with:
• One lumen with an inside diameter of ≥ 1 mm
(~3/64") and a length of ≤ 998 mm (39")
• And the other lumen with an inside diameter of
≥ 1 mm (~3/64") and a length of ≤ 850 mm (33")
2.
One flexible instrument with a light cord (if not integral to
instrument) and mat and additional non-lumened
instruments including instruments with diffusion-restricted
areas such as the hinged portion of forceps and scissors.
The flexible instrument may contain either:
» A single lumen with an inside diameter of ≥ 1 mm
(~3/64") and a length of ≤ 1050 mm (41")
» Or two lumens with:
• One lumen with an inside diameter of ≥ 1 mm
(~3/64") and a length of ≤ 998 mm (39")
• And the other lumen with an inside diameter of
≥ 1 mm (~3/64") and a length of ≤ 850 mm (33")
2
The validation studies were conducted with a flexible instrument in a tray with
silicone mat and light cord (if not integral to instrument). Also included in the
load were an additional instrument tray and one pouch for a total weight of
24 lb (11 kg).
The VHP MD140X Biodecontamination Unit also features:
• Unit operates on 208/230 Vac, three-phase electrical
service.
• Unit is equipped with a printer located on front of unit (right
side while facing unit). This alphanumeric impact printer
provides an easy-to-read permanent record of
Biodecontamination Cycle. Printer provides a 2-1/4"
(5.7 mm), 24-character wide cycle tape and paper take-
up.
• Unit utilizes specially designed, disposable, multi-use
cups (available separately) containing 0.03 gal (113 mL)
Vaprox 59 Hydrogen Peroxide Sterilant, a broad-spectrum
anti-microbial. Proprietary cup is equipped with a data
matrix code to ensure correct cup is used in unit and cup
contents are not expired; no cup code (or other
information) needs to be entered by user.
• Unit verifies expiration date of sterilant, tracks days it has
been opened and tracks number of cycles per cup that
have been performed. Ready, Status, Standby and Cup
Empty screens include a cup level indicator in lower right
corner. Each bar represents approximately four cycles.
• Unit is available with single door in either a freestanding or
recessed configuration.
• Unit installation requires no plumbing, ventilation or air
supply – only a dedicated electrical connection is needed.
A power cord is supplied for this connection.
• Unit is equipped with a racking system for articles to be
biodecontaminated.
• Unit is equipped with automated control enabling cycle to
be started and monitored by operator. Control touch
screen is user friendly and easy to operate.
STANDARDS
The flexible
1
This VHP MD140X Biodecontamination Unit meets the
applicable requirements of the following standards:
• Underwriters Laboratories (UL) Standard UL 61010-1
Second Edition as certified by INTERTEK Testing
Services
• Canadian Standards Association (CSA): Standard
C22.2 No. 61010-1 Second Edition
• Pollution Degree: 2
• Installation Catagory (OverVoltage Protection): II
SIZE (W X H X L)
Overall Dimensions:
2
• 33 x 75-1/8 x 38-5/16" (838 x 1908 x 973 mm)
Chamber Size:
• 17 x 15 x 32-1/2" (432 x 381 x 826 mm)
Chamber Volume:
• 4.8 cubic feet (136 L)
CONSTRUCTION
Chamber and door assembly are aluminum equipped with a
silicone rubber gasket for door and a welded backhead for
chamber.
Insulation fitted on chamber wall exterior, door and backhead
is 1" (25 mm) thick (nominal), held in place with hook-and-loop
closures and is constructed of asbestos-free spin-glass, sealed
in an oil and water resistant outer jacket.
Automatic door locking mechanism keeps door locked during
entire Biodecontamination Cycle. After cycle completion, air
pressure is used to unlock door. This door cannot be opened if
either electrical power or air pressure is lost during unit operation.
When unit is in Standby mode, there are no door opening
restrictions.
Chamber heating is achieved through electric strip heaters
attached to chamber sides, bottom wall, door and backhead.
Operating temperature is approximately 122°F (50°C)
Sterilant cup interface only accepts Vaprox 59 Hydrogen
Peroxide Sterilant Cups. System control automatically tracks
amount of sterilant used and sterilant expiration date. Control
prompts user via control display when new cup is needed.
Catalytic converter receives outflow from chamber during all
cycle phases. Catalytic converter converts hydrogen peroxide
into water vapor and oxygen.
Air Supply and Vacuum Filters are supplied to ensure air
entering chamber is HEPA (High Efficiency Particulate Air)
filtered (prevent chamber recontamination) and air exhausted
from vacuum pump is free of entrapped oil and odor.
Unit Panels are constructed of plastic and stainless steel.
Unit Frame and support system is constructed of welded
carbon steel with protective paint.
2
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