Steris VHP X10 User manual

OPERATOR MANUAL
X10™Biodecontamination Unit
(TEAM) 10087252

i
Introduction Operator Manual 10087252
A WORD FROM STERIS CORPORATION
©2014, STERIS Corporation. All rights reserved. Printed in U.S.A.
Thank you for choosing this fine STERIS Life Sciences product. STERIS
is committed to ensuring your continued satisfaction. This manual
contains important information on proper use and maintenance of the
X10
™
Biodecontamination Unit. All personnel involved in the use
and maintenance of this equipment must carefully review and
comply with the SAFETY PRECAUTIONS and instructions contained
in this manual and the
Vaprox
®
59 Hydrogen Peroxide Sterilant
Safety Data Sheet (SDS), product label and package insert.
These
instructions are important to protect the health and safety of personnel
operating the X10 Biodecontamination Unit and should be retained in a
conveniently accessible area for quick reference.
Complete instructions for uncrating and installing this unit, as well as
equipment drawings, have been furnished. If missing, contact
STERIS Life Sciences for replacement copies, giving the serial,
equipment and model numbers of the Biodecontamination Unit.
NOTE: Refer to SECTION 2of this manual for a listing of Terms,
Definitions and Symbols that may appear in this manual or on your
equipment.
Advisory A listing of the SAFETY PRECAUTIONS to be observed when operating
and servicing this X10 Biodecontamination Unit and/or handling the
Sterilant is found in SECTION 1 of this manual or on the container
label. Do not operate or service the equipment or handle the Sterilant
until you have become familiar with this information.
Any alteration of the unit not authorized or performed by STERIS Life
Sciences voids the warranty, could adversely affect Biodecontamination
efficacy, and could violate national, state and local regulations.
Vaprox 59 Hydrogen Peroxide Sterilant have been EPA registered by
STERIS in accordance with Federal Regulations for the specific uses
described in this manual. The X10 Biodecontamination Unit must be
used only on Enclosures (refer to SECTION 2.1, TERMS AND
DEFINITIONS) that have been pre-cleaned and dried per facility
process and current protocols. Please refer to the Vaprox 59
Hydrogen Peroxide Sterilant package insert for additional
information and application instructions.
IMPORTANT: A listing of the SAFETY PRECAUTIONS to be observed when operating and servicing this
equipment and/or handling Vaprox 59 Hydrogen Peroxide Sterilant can be found in
SECTION 1 of this
manual. Do not operate or service the equipment or handle the Sterilant until you have been trained
and certified on this information as well as the information on the Vaprox 59 Hydrogen Peroxide
Sterilant product label and package insert.
IMPORTANT: Please refer to SECTION 2.1, TERMS AND DEFINITIONS, for a list of terminology used in
this document. This manual describes the STERIS Biodecontamination Process using
Vaprox 59
Hydrogen Peroxide Sterilant. The U.S. EPA has registered Vaprox 59 Hydrogen Peroxide Sterilant
(EPA Reg. No. 1043-123) and its use. Refer to either the Vaprox 59 Hydrogen Peroxide Sterilant
label and package insert for detailed Safety Precautions and application instructions.

ii
10087252 Operator Manual Introduction
Intended Use NOTE: The X10 Biodecontamination Unit is to be used by Trained
and Certified Applicators who have successfully completed both the
STERIS Training and Certification Course for Applicators of Vaprox
Hydrogen Peroxide Sterilant and the X10 Biodecontamination Unit
Operator Course. Certification must be active and in force for all
Applicators of Vaprox 59 Hydrogen Peroxide Sterilant.
The X10 Biodecontamination Unit is designed for mobile
Biodecontamination of clean, dry, sealed Enclosures (refer to
SECTION 2.1, TERMS AND DEFINITIONS) of three, four, five and six foot
widths with corresponding internal volumes from 15.6 - 31.2 ft3(.44 -
.88 m3) using STERIS’s patented VHP®Process Technology and
using Vaprox 59 Hydrogen Peroxide Sterilant.
Uses other than as specified and described in this manual are not
recommended and may not be effective or safe in operating the
Biodecontamination Unit. Consult this manual or STERIS Life
Sciences for further information.
The Biodecontamination Unit utilizes specially designed disposable
70 mL Cups* of Vaprox 59 Hydrogen Peroxide Sterilant.
*Available separately for purchase.
Introduction The STERIS X10 Biodecontamination Unit offers fast, economical
Biodecontamination of Enclosures (refer to SECTION 2.1, TERMS AND
DEFINITIONS).
The Biodecontamination Unit uses STERIS's patented VHP Process
Technology. This process utilizes hydrogen peroxide vapor as a
broad spectrum anti-microbial without condensation of the active
ingredient onto surfaces with good material compatibility.
The Biodecontamination Unit comes with two programmed cycles
designed to achieve a minimum of a 6-log bioburden reduction in a
Class II Type A2 Biological Safety Cabinet:
1. Cycle 1 for 3 - 4'(0.9 - 1.2 m)
2. Cycle 2 for 5 - 6'(1.5 - 1.8 m)
The X10 features X-Phase hardware technology and VaproxLink
software technology. X-Phase hardware technology features a
rotating cylinder design that enables heating, dehumidification,
conditioning, Biodecontamination and aeration for an All-In-One unit
design while VaproxLink software technology automatically identifies
Vaprox 59 Hydrogen Peroxide Sterilant Cup and verifies expiration
date.
With 0.5-2.5 g/min of Sterilant injection, the Biodecontamination Unit
is capable of Biodecontaminating a single Class II Type A2 cabinet
from 3 - 6'(0.9 - 1.8 m) with internal cabinet volume up to 31.2 ft3
(.88 m3).
The X10 Biodecontamination Unit is multi-lingual (English, French,
Spanish, Italian and German) and available in either 120 or 230 Vac,
single phase, electrical service.
DANGER – FIRE AND
EXPLOSION HAZARD:
• Verify all materials coming
in contact with hydrogen
peroxide are compatible
with oxidizers. Contact
STERIS Life Sciences or
the material manufacturer
for information on material
compatibility.
• This Biodecontamination
Unit is not designed to
process flammable liquids.
Do not process liquids,
linens, powders or any
cellulose materials.
Process only those
materials compatible with
hydrogen peroxide.

iii
Introduction Operator Manual 10087252
Service Information
A thorough preventive maintenance program is essential to safe and
proper equipment operation. Comprehensive instructions for monthly,
quarterly and semi-annual preventive maintenance can be found in the
Maintenance Manual (available from STERIS Life Sciences).
Only STERIS-trained personnel should attempt to perform maintenance
on the X10 Biodecontamination Unit to avoid personal injury, improper
equipment performance, invalidation of the warranty or other costly
damage.
Customers are encouraged to contact STERIS Life Sciences concerning
our annual maintenance program. Under the terms of the program,
preventive maintenance, adjustments and replacement of worn parts are
provided on a scheduled basis to help ensure optimal equipment
performance and to help minimize untimely or costly schedule
interruptions. STERIS Life Sciences maintains a worldwide staff of well-
equipped, factory-trained technicians to provide these services, as well
as on-site installation, training and expert repair services. Contact
STERIS Life Sciences** for details.
**1 [phone] or www.sterislifesciences.com.

iv
10087252 Operator Manual Introduction
The base language of this document is
ENGLISH. Any translations must be
made from the base language document.
EC Authorized Re
p
resentative
STERIS Ltd.
Chancery House
190 Waterside Road
Hamilton Industrial Park
Leicester LE5 1QZ UK
STERIS Cor
p
oratio
n
5
960 Heisle
y
Roa
d
Mentor,
O
H 44060-1834 U
SA
44
0
-
3
54-
2600
•
800
-444-
9009
www.
s
t
e
r
is
.
com
STERIS CORPORATION
6515 Hopkins Road
Mentor, OH 44060 • USA

v
Table of Contents Operator Manual 10087252
TABLE OF CONTENTS
Section
Number Description Page
1 Safety Precautions ........................................................................................................................ 1-1
2 Terms, Definitions and Symbols.................................................................................................. 2-1
2.1 Terms and Definitions ............................................................................................................................ 2-1
2.2 Symbols ................................................................................................................................................. 2-3
3 Operating Instructions .................................................................................................................. 3-1
3.1 Introduction ............................................................................................................................................ 3-1
3.2 Operation ............................................................................................................................................... 3-2
3.2.1 Attach to Enclosure .................................................................................................................. 3-2
3.2.2 Prepare Enclosure and Biodecontamination Unit..................................................................... 3-4
3.2.3 Cycle Completion ..................................................................................................................... 3-6
4 Troubleshooting ............................................................................................................................ 4-1
4.1 Troubleshooting ..................................................................................................................................... 4-1
5 Routine Maintenance..................................................................................................................... 5-1
5.1 Read Before Performing Routine Maintenance ..................................................................................... 5-1
5.2 Clean Biodecontamination Unit ............................................................................................................. 5-2
5.3 Clean Hoses .......................................................................................................................................... 5-3
5.4 Cleaning Touch Screen ......................................................................................................................... 5-4
5.5 Replacement Parts and Supplies .......................................................................................................... 5-4
5.5.1 Ordering Information ................................................................................................................ 5-4
5.5.2 Supply Products ....................................................................................................................... 5-5
5.5.3 Recommended Spare Parts ..................................................................................................... 5-5
5.6 Associated Publications ........................................................................................................................ 5-6
6 Supplemental Information ............................................................................................................ 6-1
6.1 Installation Verification........................................................................................................................... 6-1
6.1.1 Installation Checklist................................................................................................................. 6-1
6.1.2 Pre-Operation Checklist ........................................................................................................... 6-1
6.2 Technical Data ....................................................................................................................................... 6-2
6.2.1 Overall Size (W x H x D) .......................................................................................................... 6-2
6.2.2 Weight ...................................................................................................................................... 6-2
6.2.3 Electric Requirements .............................................................................................................. 6-2
6.2.4 Environmental Conditions ........................................................................................................ 6-2
6.3 Hydrogen Peroxide Biodecontamination ............................................................................................... 6-3
6.4 Biodecontamination Cycle ..................................................................................................................... 6-3
6.5 Hydrogen Peroxide Handling Precautions ............................................................................................. 6-5

vi
10087252 Operator Manual Table of Contents
Section
Number Description Page
TABLE OF CONTENTS (CONT’D)
6.6 Sterilant Cup Installation and Removal................................................................................................. 6-6
6.6.1 Cup Installation......................................................................................................................... 6-7
6.6.2 Cup Removal............................................................................................................................ 6-7
6.6.3 Disposal of Sterilant From Cup ................................................................................................ 6-8
6.7 Desiccant Installation and Removal....................................................................................................... 6-8
6.8 Sterilant Container Storage .................................................................................................................. 6-9
6.9 General Component Identification ......................................................................................................... 6-9
6.10 Operation ............................................................................................................................................. 6-10

vii
Table of Contents Operator Manual 10087252
LIST OF FIGURES
Description Page
Figure 3-1. VHP X10 Biodecontamination Unit in Cases ..............................................................................3-3
Figure 3-2. Open Biodecontamination Unit Case..........................................................................................3-3
Figure 3-3. Accessory Case Components ....................................................................................................3-3
Figure 3-4. Connect Biodecontamination Unit to Enclosure .........................................................................3-4
Figure 3-5. Open Supply Door ......................................................................................................................3-5
Figure 3-6. Connecting X10 Biodecontamination Unit and AR60 Aerator to Enclosure ...............................3-6
Figure 6-1. X10 Biodecontamination Unit .....................................................................................................6-3
Figure 6-2. Typical Biodecontamination Cycle..............................................................................................6-4
Figure 6-3. Typical Sterilant Cup...................................................................................................................6-6
Figure 6-4. Sterilant Cup in Biodecontamination Unit (Typical) ....................................................................6-7
Figure 6-5. Carefully Insert Draw Tube (Typical) ..........................................................................................6-7
Figure 6-6. Desiccant Cartridge (Typical) .....................................................................................................6-8
Figure 6-7. Place Desiccant Cartridge in Biodecontamination Unit ..............................................................6-9
Figure 6-8. Component Identification ..........................................................................................................6-10

viii
129396-083 Operator Manual Table of Contents
Life
Sciences

xi
Table of Contents Operator Manual 10087252
LIST OF TABLES
Table
Number Description Page
Table 2-1 Definition of Symbols....................................................................................................................... 2-3
Table 4-1 Alarm/Abort Actions......................................................................................................................... 4-1
Table 4-2 Power Interruption/Power-Up Actions ............................................................................................. 4-1
Table 4-3 Troubleshooting Guide .................................................................................................................... 4-2
Table 5-1 VHP X10 Biodecontamination Unit Selected Supply Products ....................................................... 5-5
Table 5-2 Recommended Spare Parts ............................................................................................................ 5-5
Table 5-3 Associated Publications .................................................................................................................. 5-6

xii
10087252 Operator Manual Table of Contents
Life
Sciences

1-1
Safety Precautions Operating Manual 10087252
1
NOTE: Refer to SECTION 2 of this manual for a listing of Terms, Definitions and Symbols that may appear in this
manual or on your equipment.
The following Safety Precautions must be observed when operating or servicing this STERIS X10™
Biodecontamination Unit and when handling Vaprox®59 Hydrogen Peroxide Sterilant Cups. Safety Precautions
are divided as follows:
•DANGER indicates personal injury or substantial property damage results if proper precautions are not
taken.
•WARNING indicates the potential for personal injury and/or potential for property damage may result if proper
precautions are not taken.
•CAUTION indicates the potential for damage to equipment may result if proper precautions are not taken.
For emphasis, certain Safety Precautions are repeated throughout the manual. It is important to review ALL
Safety Precautions before operating or servicing the unit. Also read the Vaprox 59 Hydrogen Peroxide
Sterilant SDS for additional information on the proper use and handling of hydrogen peroxide.
STERIS recommends that all operators should be regularly trained in the operation and safe usage of the
equipment, including emergency procedures for any harmful material released into the environment. Records of
attendance at training shall be maintained and evidence of understanding shall be demonstrated.
NOTE:
Disregarding the presented safety information is considered ABNORMAL USE of this product. If the
equipment is used in a manner not specified by STERIS, the protection provided by the equipment may be impaired.
DANGER – SLIPPING HAZARD:
DANGER – FIRE AND EXPLOSION HAZARD:
Water or hydrogen peroxide spilled on the floor presents a slipping hazard – promptly clean up the spill.
If in doubt whether the liquid is water or hydrogen peroxide, test the liquid using a Liquid Hydrogen
Peroxide Test Strip (follow manufacturer's instructions), before wiping up. If the liquid is hydrogen
peroxide, contain the spill and dilute with water (at least 20 parts water to one part H2O2) prior to wiping
up. Observe all hydrogen peroxide handling precautions. Refer to the Vaprox 59 Hydrogen Peroxide
Sterilant SDS for spill containment and cleanup.
Liquid hydrogen peroxide is a strong oxidant and poses a FIRE, EXPLOSION OR CONTAINER
RUPTURE HAZARD. Avoid excessive heat, contamination or contact with combustible materials.
Clothing, shoes or other combustible materials that have come in contact with hydrogen peroxide must
be immediately and thoroughly washed with water. Discard shoes contaminated with Vaprox 59 Hydrogen
Peroxide Sterilant in a fireproof container. If Vaprox Sterilant is allowed to dry in the materials, a fire may
result. IN CASE OF FIRE, use water only. CONTAIN SPILLS and dilute with water (at least 20 parts
water to one part H2O2). After diluting the spill, sodium metabisulfide or sodium sulfite (1.9 lb of SO2
equivalent per 500 mL of H2O2) may be used to destroy the peroxide. SEE SDS FOR ADDITIONAL
INFORMATION. EFFECTS MAY BE DELAYED.
Verify all materials coming in contact with hydrogen peroxide, especially the concentrated liquid, are
compatible with oxidizers. Contact STERIS Life Sciences or the material manufacturer for information
on material compatibility.
This Biodecontamination Unit is not designed to process flammable liquids. Do not process liquids,
linens, powders or any cellulose materials. Process only those materials compatible with hydrogen
peroxide.
SAFETY PRECAUTIONS 1

1-2
10087252 Operating Manual Safety Precautions
DANGER – PERSONAL INJURY, CONTAMINATED ENCLOSURE AND/OR EQUIPMENT
DAMAGE HAZARD:
DANGER – CHEMICAL INJURY HAZARD:
Use only Vaprox 59 Hydrogen Peroxide Sterilant Containers, 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 H2O2other than Vaprox 59 Hydrogen Peroxide Sterilant could impair equipment
operation, result in costly repairs, result in an ineffective Biodecontamination Cycle, violate federal law
and void the equipment warranty.
Before using Vaprox 59 Hydrogen Peroxide Sterilant, check the expiration date. Do not use a Sterilant
if it is beyond its expiration date, or if it will not be fully used before its expiration date.
When using a Vaprox 59 Hydrogen Peroxide Sterilant Cup, always wear appropriate Personal Protective
Equipment (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE), keep the Cup upright and
do not squeeze.
Before disposing of a Vaprox 59 Hydrogen Peroxide Sterilant Cup, empty all remaining Cup contents
into a sink with running water (at least 20 parts water to one part Vaprox H2O2), then carefully triple rinse
the Cup with tap water.
Before starting a cycle, check Sterilant to ensure it is not expired.
No one may open a sealed Enclosure during or after an aborted cycle without PPE (refer to Sterilant SDS
for PPE) if Sterilant levels within the treated Enclosure are above one PPM. Refer to Sterilant label and
package insert for instructions.
When handling hydrogen peroxide, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide
Sterilant SDS for PPE) and observe all Safety Precautions. See Vaprox 59 Hydrogen Peroxide Sterilant
SDS, product label and package insert for additional handling information.
CORROSIVE. Causes irreversible eye damage or skin burns. May be fatal if inhaled. Harmful if swallowed
or absorbed through the skin. Do not get in eyes, on skin or on clothing. Do not breathe spray mist. Prolonged
or frequently repeated skin contact may cause allergic reaction in some individuals. User should wash
hands before eating, drinking, chewing gum, using tobacco or using the toilet. User should remove
contaminated clothing and wash before reuse. Applicators and all other handlers must wear PPE (refer to
Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE). See Vaprox 59 Hydrogen Peroxide Sterilant product
label and package insert for additional handling information.
When handling the Biodecontamination System hoses, wear appropriate PPE (refer to Vaprox 59
Hydrogen Peroxide Sterilant SDS for PPE). Any visible liquid in the hoses must be treated as concentrated
hydrogen peroxide and all hydrogen peroxide handling precautions must be observed.
If power has been interrupted, do not attempt to access the Enclosure (refer to SECTION 2.1, TERMS AND
DEFINITIONS). Hydrogen peroxide may be present in the Enclosure.
Read the manufacturer operating instructions before attempting to use the low level hydrogen peroxide
monitor.

1-3
Safety Precautions Operating Manual 10087252
DANGER – CHEMICAL INJURY HAZARD (Cont’d):
When handling Vaprox 59 Hydrogen Peroxide Sterilant Cups, note the following:
• Use extreme caution when handling a damaged, leaking or expired hydrogen peroxide Cup. Always
wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE) when
handling damaged, leaking or expired Cups, or when wiping up hydrogen peroxide spills.
• When handling a Cup under water, do not allow your glove openings to go below the surface of the
water permitting liquid to enter the gloves.
• A Vaprox 59 Hydrogen Peroxide Sterilant Cup must be in the Cup holder at all times. When no Cup
is in place, concentrated liquid hydrogen peroxide may drip from the Cup connector.
Before running a Biodecontamination Cycle, always verify that the Biodecontamination Unit is properly
connected to the sealed Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) to ensure complete
containment of the hydrogen peroxide vapors (check hose connections and ensure all Enclosure vents/
ports are sealed). Post warning signs on and around the treated Enclosure to prevent accidental entry
during the Biodecontamination Cycle. Refer to the Vaprox 59 Hydrogen Peroxide Sterilant label and
package insert for specific detailed instructions.
When the control panel warning light is ON, harmful Sterilant vapors are present within the Enclosure
(refer to SECTION 2.1, TERMS AND DEFINITIONS). Do not access the Enclosure. If it is necessary to access
the Enclosure being processed under these conditions before the end of the Aeration phase or after an
aborted Cycle, wear appropriate PPE (refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for PPE).
Ensure no skin is exposed. Follow all re-entry protocols listed on the Vaprox 59 Hydrogen Peroxide
Sterilant label and package insert.
At the end of the Aeration phase, use a low level hydrogen peroxide monitor to check and periodically
monitor the hydrogen peroxide vapor concentration within the Enclosure (refer to SECTION 2.1, TERMS
AND DEFINITIONS). The hydrogen peroxide vapor concentration should be at or below established levels
before the Enclosure is accessed by Trained and Certified Applicators. The Vaprox 59 Hydrogen Peroxide
Sterilant label and package insert contain required hydrogen peroxide limits for re-entry and releasing
of the Enclosure after Biodecontamination.
Any visible liquids in the Enclosure (refer to SECTION 2.1, TERMS AND DEFINITIONS) must be treated as
concentrated hydrogen peroxide. Always test residual liquids, using a Liquid Hydrogen Peroxide test
strip (follow manufacturer's instructions), before diluting and wiping up. Observe all hydrogen peroxide
handling precautions presented in the Vaprox 59 Hydrogen Peroxide Sterilant SDS, product label and
package insert.
The Biodecontamination Unit generates harmful hydrogen peroxide vapor and discharges it from the
Outlet port. Always ensure all connections are vapor tight and that the Enclosure (refer to SECTION 2.1,
TERMS AND DEFINITIONS) is properly sealed, secured and placarded as described on the Vaprox 59
Hydrogen Peroxide Sterilant label and package insert. Heed this Safety Precaution to ensure, under
normal conditions, the Biodecontamination Unit and Enclosure do not leak H2O2vapor.

1-4
10087252 Operating Manual Safety Precautions
WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:
WARNING – ELECTRIC SHOCK HAZARD:
CAUTION – POSSIBLE EQUIPMENT DAMAGE:
REMEMBER – POSSIBLE TIME DELAY:
Repairs and adjustments to this equipment must be made only by STERIS Life Sciences or STERIS-
trained service personnel. Maintenance performed by unqualified personnel or installation of
unauthorized parts could cause personal injury, impair equipment protection design, result in improper
equipment performance, invalidate the warranty or result in costly damage. Contact STERIS Life
Sciences regarding service options.
Regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment.
Contact STERIS Life Sciences to schedule preventive maintenance.
Lifting the Biodecontamination Unit requires more than one person. The unit weighs approximately 68 lb
(31 kg).
Place the Biodecontamination Unit only on flat surfaces. Various internal components are designed for
operation when Unit is placed on a level, flat surface.
Ensure the Biodecontamination Unit is positioned so access to power switch and facility outlet are not
restricted. To disconnect Biodecontamination Unit, pull cord from facility outlet. The power switch is NOT
intended to be used as a means of disconnect.
Integrated (temperature and humidity) sensors are fragile. Do not bang, twist or crush. Biodecontamination
Unit does not operate properly with a damaged sensor.
Disconnect electrical power source to equipment (pull plug from facility outlet) before attempting to
access the
Biodecontamination Unit . The power switch is NOT intended to be used as a means of
disconnect.
Use nonabrasive cleaners when cleaning unit. If you need technical assistance or additional instructions,
call STERIS Life Sciences.
• Follow all directions on container.
• Do not use abrasive cleaners on plastic surfaces.
• Avoid detergents with bases, aromatics, ketones, esters and chlorinated hydrocarbons.
• Avoid contacting plastic surfaces with greases and oils.
Keep connecting hoses off the floor. If supply connecting hoses rest on cool floors or other cool surfaces,
hydrogen peroxide may condense in the hoses. Place a support under the hoses (e.g., lash hoses to
plastic easel or plastic tripod) to prevent kinks and undue strain on the hose connections.
Use only Distilled Water for the hydrogen peroxide piping purge. Use of tap water will damage the
vaporizer.
Insufficient clearance space will make repairs more difficult and time-consuming. Refer to the equipment
drawing for minimum clearance for service/maintenance access requirements.

2-1
Terms, Definitions and Symbols Operator Manual 10087252
2.1 Terms and
Definitions
Aeration – Final phase of a Biodecontamination Cycle. Allows for re-
entry into treated, sealed Enclosures once the Sterilant concentration
levels are at or below permissible levels. Typical H2O2concentration
≤1 PPM.
BI – Biological Indicator used for Biodecontamination Cycle
evaluation. Typically E6 Geobacillus stearothermophilus is used.
Biodecontamination1– Third phase of the Biodecontamination Cycle
or the obtaining of bioburden reduction targets in a sealed Enclosure.
Biodecontamination Cycle1– Represents the complete process
(Biodecontamination) from start to finish which may include
Dehumidify, Condition, Biodecontamination and Aeration phases.
Biodecontamination Unit – STERIS X10™Biodecontamination Unit.
Catalytic Converter – A component of the Biodecontamination Unit
utilizing a catalyst to degrade H2O2into water vapor and oxygen.
CI – Chemical Indicator used for Biodecontamination Cycle validation
and Sterilant mapping.
Condition – Second phase of the Biodecontamination Cycle. Sterilant
is added to the sealed Enclosure to reach the target concentration
needed for the Biodecontamination phase.
Cup – Vaprox®59 Hydrogen Peroxide Sterilant container, 70 mL.
Dehumidify –First phase of the Biodecontamination Cycle. Achieves
temperature and humidity conditions necessary for subsequent
Biodecontamination phases.
Enclosure – Contained area to be Biodecontaminated (e.g., Class II
Type A2 Biosafety Cabinet).
FMP – Fumigation Management Plan.2
HMI – Human Machine Interface (such as the control display).
H2O2 or H2O2– Hydrogen peroxide.
I/O – Input/Output.
PLC – Programmable Logic Controller.
1When using STERIS X10 Biodecontamination Units with Vaprox 59 Hydrogen Peroxide Sterilant in the United States, the term
Biodecontamination referred to in this Operator Manual is defined as Sterilization of exposed porous and non-porous surfaces in a precleaned,
dry, sealed Enclosure. Any reference to Biodecontamination as it relates to the use of this equipment in the United States does not impart
additional claims of effectiveness beyond that approved in the EPA registered labeling of Vaprox 59 Hydrogen Peroxide Sterilant for use on
precleaned, dry, exposed porous and non-porous surfaces in a sealed Enclosure.
2Guidance for developing a suitable Fumigation Management Plan can be found in STERIS publication (P129383-938) or searching EPA
website (epa.gov) for the key words ’Vaprox Package Insert.’
Continued ...
TERMS, DEFINITIONS AND SYMBOLS 2

2-2
10087252 Operator Manual Terms, Definitions and Symbols
Terms and Definitions
(Cont’d)
PPE – Personal Protective Equipment including goggles or face
shield, chemical-resistant gloves (barrier laminate, butyl rubber, nitrile
rubber, neoprene rubber, polyvinyl chloride, or Viton®3) and SCBA
(Self-Contained Breathing Apparatus) if hydrogen peroxide
concentrations exceed one ppm during handling/or application of
Sterilant. Refer to Vaprox 59 Hydrogen Peroxide Sterilant SDS for
appropriate PPE.
RH – Relative Humidity.
SCBA – Self-Contained Breathing Apparatus.
scfm – Standard Cubic Feet per Minute.
scmh – Standard Cubic Meters per Hour.
SDS – Material Data Sheet.
Sporicidal – Antimicrobial activity which destroys or eliminates all
forms of microbial life including hard-to-kill microbial spores.
SSR – Solid State Relay.
Sterilant – Vaprox 59 Hydrogen Peroxide Sterilant (STERIS EPA-
registered, 1043-123, 59%). Sterilant contains stabilizers and other
additives making it suitable for STERIS VHP Biodecontamination
Units.
Sterilization – Complete killing of all microbial life including spores.
Unit – Biodecontamination Unit.
USB – Universal Serial Bus. Industry standard defining cables,
connectors and communication protocols used in a bus for
connection, communication and power supply between computers
and electronic devices.
Vac – Volts Alternating Current.
Vdc – Volts Direct Current.
VHP – STERIS proprietary process technology utilizing H2O2vapor as
a broad spectrum anti-microbial without condensation of the active
ingredient on the surfaces.
3 Viton is a registered trademark of DuPont Performance Elastomers.

2-
3
2.2 Symbols Table 2-1 contains symbols which may appear on your STERIS X10
Biodecontamination Unit components.
Table 2-1. Definition of Symbols
Symbol Definition
Protective Earth (Ground)
Electrostatic Sensitive Device
Electric Shock Hazard
Attention, Consult Manual for Further Instructions
This Product Has Been Tested To The Requirements Of CAN/CSA-C22.2
No. 61010-1, Second Edition, Including Amendment 1, Or A Later Version
Of The Same Standard Incorporating The Same Level Of Testing
Requirements
Inlet Sterilant Hose Connection (From Enclosure Exhaust Into
Biodecontamination Unit)
Outlet Sterilant Hose Connection (From Biodecontamination Unit Into
Enclosure Work Area)
SN Serial Number of Unit
V~ Voltage Rating of Unit, Alternating Current
AAmperage Rating of Unit
Hz Frequency Rating of Unit
φPhase of Unit


2-4
10087252 Operator Manual Terms, Definitions and Symbols
Life
Sciences