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Steris VHP MD140X Manual

Steris VHP MD140X Manual

Biodecontamination unit

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APPLICATION
The VHP MD140X Biodecontamination Unit is designed for the
application of Vaprox
®
59 Hydrogen Peroxide Sterilant to
properly prepared (cleaned, rinsed and dried) reusable metal
and nonmetal instruments
1
using STERIS's VHP process
technology, vacuum conditions and Vaprox 59 Hydrogen
Peroxide Sterilant
. The low temperature Biodecontamination
2
Cycles are suitable for biodecontaminating instruments
sensitive to heat and moisture.
1
Not for use to reprocess reusable instruments for human use.
2
When using VHP MD140X Biodecontamination Units with Vaprox 59 Hydrogen
Peroxide Sterilant in the United States of America (USA), the term
biodecontamination referred to in this document is defined as sterilization of
exposed porous and non-porous surfaces of precleaned, dry, instruments and
reusable instruments for non-human use. Any reference to biodecontamination
as it relates to the use of this equipment in the USA does not impart additional
claims of effectiveness beyond that approved in the USA Environmental
Protection Agency (EPA) registered labeling of Vaprox 59 Hydrogen Peroxide
Sterilant (EPA Reg. No. 1043-123).
DESCRIPTION
The VHP MD140X Biodecontamination Unit uses STERIS's
patented VHP process technology. The biodecontamination
process is fully automated, is compatible with a broad range of
materials and has rapid Biodecontamination Cycle times. There
are no toxic by-products created by the Biodecontamination
Cycle – only water vapor and oxygen are produced.
The VHP MD140X Biodecontamination Unit performs three
programmed Biodecontamination Cycles:
• Lumen Cycle (approximately 55 minutes to complete)
• Non Lumen Cycle (approximately 28 minutes to complete)
• Flexible Cycle (approximately 35 minutes to complete)
This biodecontamination unit using the Lumen Cycle can
biodecontaminate
the following:
3
1.
Rigid instruments, with diffusion-restricted spaces such
as the hinged portion of forceps and scissors.
2.
Single, dual and triple channeled rigid instruments, with
the following configurations:
• Single channeled instruments with a stainless lumen that
is ≥ 0.77 mm (~1/32") internal diameter (ID) and
≤ 500 mm (19-11/16") in length
• Dual channeled instruments with stainless lumens that
are ≥ 0.77 mm (~1/32") ID and ≤ 527 mm (20-3/4") in
length
3
Validation testing was conducted for all lumen sizes using a maximum of 20
lumens per load. Loads should not exceed this validated number of lumens.
Validation studies conducted using validation load of two instrument trays and
two pouches for a total weight of 19.65 lb (9.0 kg)
ACCESSORIES
❑ Seismic Tie Down Kit
❑ Trays And Organizer Clips
❑ Tray Mats
❑ Pouches
.
The Selections Checked Below Apply To This Equipment
MOUNTING
❑ Single Door, Cabinet
❑ Single Door, Recessed
BIODECONTAMINATION UNIT
(Typical only - some details may vary.)
• Triple channeled instruments with stainless lumens that
are either:
» ≥ 1.2 mm (~3/64") ID and ≤ 310 mm (12-13/64") in length
OR
» ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
This biodecontamination unit using the Non Lumen Cycle can
biodecontaminate
non-lumened instruments (both non-lumened
4
rigid and those with stainless-steel diffusion-restricted areas such
as the hinged portion of forceps or scissors).
4
Validation studies conducted using validation load of two instrument trays and two
pouches for a total weight of 19.65 lb (9.0 kg).
VHP
MD140X
®
Item ________________________
Location(s)___________________
____________________________
SD980 (03/01/13)

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Summary of Contents for Steris VHP MD140X

  • Page 1 Not for use to reprocess reusable instruments for human use. When using VHP MD140X Biodecontamination Units with Vaprox 59 Hydrogen Peroxide Sterilant in the United States of America (USA), the term biodecontamination referred to in this document is defined as sterilization of exposed porous and non-porous surfaces of precleaned, dry, instruments and reusable instruments for non-human use.
  • Page 2 The flexible instruments may contain either: This VHP MD140X Biodecontamination Unit meets the The validation studies were conducted with two flexible instruments, each applicable requirements of the following standards: packaged into a tray with silicone mat and light cord (if not integral to instrument).
  • Page 3: Control Description

    1043-123). Order PB033US (950 mL). CONTROL DESCRIPTION Steraffirm NB305 Process Indicator – Chemical indicator ® designed for use with hydrogen peroxide vapor. The VHP MD140X Biodecontamination Unit is equipped with Steraffirm PCC051 Process Indicator – Chemical indicator ® an Allen-Bradley Compact Logix (PanelView Plus 6 1000 ™...
  • Page 4 NOTES 1. Unit is only to be operated by Trained and Certified Applicators who have successfully completed both STERIS Vaprox Training and Certification Course and MD140X Biodecontamination Unit Operator Course. Certification must be active and in force for all Applicators of Vaprox 59 Hydrogen Peroxide Sterilant.
  • Page 6 EQUIPMENT DRAWINGS (REQUIRED FOR INSTALLATION) Equipment Drawing Part Number Equipment Drawing Title 387358-924 Single Door, Recessed 387358-923 Single Door, Cabinet Dimensions are typical. Drawing is not to scale. 30 1/2 [775] DOOR SWING Dimensions are in inches [mm] PLAN VIEW FRONT VIEW SIDE VIEW SINGLE DOOR, RECESSED MODEL SHOWN...
  • Page 7 EQUIPMENT DRAWINGS (REQUIRED FOR INSTALLATION) Equipment Drawing Part Number Equipment Drawing Title 387358-924 Single Door, Recessed 387358-923 Single Door, Cabinet Dimensions are typical. Drawing is not to scale. 30 1/2 [775] DOOR SWING Dimensions are in inches [mm] PLAN VIEW FRONT VIEW SIDE VIEW SINGLE DOOR, CABINET MODEL SHOWN...
  • Page 8 Mentor, OH 44060-1834 • USA 440-354-2600 • 800-444-9009 www.STERISLifeSciences.com This document is intended for the exclusive use of STERIS Customers, including architects or designers. Reproduction in whole or in part by any party other than a Customer is prohibited. SD980 ©2013, STERIS Corporation. All rights reserved. (03/01/13)