STERIS VHPX10 Users Manual

OPERATOR MANUAL

X10™ Biodecontamination Unit

(TEAM) 10087252

A WORD FROM STERIS CORPORATION

IMPORTANT: A listing of the equipment and/or handling Vaprox 59 Hydrogen Peroxide Sterilant can be found in

SAFETY PRECAUTIONS

to be observed when operating and servicing this

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 Hydrogen Peroxide Sterilant. The U.S. EPA has registered (EPA Reg. No. 1043-123) and its use. Refer to either the

Vaprox 59 Hydrogen Peroxide Sterilant

Vaprox 59

Hydrogen Peroxide Sterilant

Vaprox 59

label and package insert for detailed Safety Precautions and application instructions.

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 S in this manual and the Safety Data Sheet (SDS), product label and package insert.

AFETY PRECAUTIONS and instructions contained

Vap rox® 59

Hydrogen Peroxide Sterilant

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 S

ECTION 2 of 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 S

ECTION 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 S

ECTION 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.

Introduction Operator Manual 10087252

Intended Use

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.

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

ECTION 2.1, TERMS AND DEFINITIONS) of three, four, five and six foot

widths with corresponding internal volumes from 15.6 - 31.2 ft

.88 m

) using STERIS’s patented VHP® Process Technology and

(.44 -

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 S

ECTION 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 ft (.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.

10087252 Operator Manual Introduction

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 wellequipped, 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 (800) 440-9009 or www.sterislifesciences.com.

Introduction Operator Manual 10087252

iii

The base language of this document is

ENGLISH. Any translations must be

made from the base language document.

EC Authorized Representative

STERIS Ltd. Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ UK

STERIS Corporatio

960 Heisley Roa

Mentor, OH 44060-1834 U

440-354-

2600

•

800

-444-

9009

www.steris.

com

STERIS CORPORATION

6515 Hopkins Road

Mentor, OH 44060 • USA

10087252 Operator Manual Introduction

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

Table of Contents Operator Manual 10087252

TABLE OF CONTENTS (CONT’D)

Section

Number Description Page

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

vi 10087252 Operator Manual Table of Contents

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

Table of Contents Operator Manual 10087252

vii

Life

viii 129396-083 Operator Manual Table of Contents

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

Table of Contents Operator Manual 10087252

Life

xii

10087252 Operator Manual Table of Contents

SAFETY PRECAUTIONS

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: equipment is used in a manner not specified by STERIS, the protection provided by the equipment may be impaired.

Disregarding the presented safety information is considered

ABNORMAL USE

of this product. If the

DANGER – SLIPPING 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 H up. Observe all hydrogen peroxide handling precautions. Refer to the Vaprox 59 Hydrogen Peroxide Sterilant SDS for spill containment and cleanup.

) prior to wiping

2O2

DANGER – FIRE AND EXPLOSION HAZARD:

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 thoroug hly washed with water. Discard shoes contaminated wi th 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 H equivalent per 500 mL of H INFORMATION. EFFECTS MAY BE DELAYED.

). After diluting the spill, sodium metabisulfide or sodium sulfite (1.9 lb of SO2

2O2

) may be used to destroy the peroxide. SEE SDS FOR ADDITIONAL

2O2

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 Operating Manual 10087252

1-1

DANGER – PERSONAL INJURY, CONTAMINATED ENCLOSURE AND/OR EQUIPMENT DAMAGE 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 H 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 H 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.

other than Vaprox 59 Hydrogen Peroxide Sterilant could impair equipment

2O2

), then carefully triple rinse

2O2

DANGER – CHEMICAL INJURY HAZARD:

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 S terilant SDS for PPE). Any visible liqui d in the hoses must be treated as concentrat ed 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 S

EFINITIONS). Hydrogen peroxide may be present in the Enclosure.

Read the manufacturer operating instructions before attempting to use the low level hydrogen peroxide monitor.

ECTION 2.1, TERMS AND

1-2

10087252 Operating Manual Safety Precautions

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 S 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 S

ECTION 2.1, TERMS AND D EFINITIONS). 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.

ECTION 2.1, TERMS AND DEFINITIONS) to ensure complete

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 S

AND DEFINITIONS). The hydrogen peroxide vapor concentration should be at or below established levels

ECTION 2.1, TERMS

before the Enclosure is accessed by Trained and Certified Applic ators. 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 S concentrated hydrogen peroxide. Always test residual liquids, using a Liquid Hydrogen Peroxide

ECTION 2.1, TERMS AND DEFINITIONS) must be treated as

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 S

ERMS AND DEFINITIONS) is properly sealed, secured and placarded as described on the Vaprox 59

ECTION 2.1,

Hydrogen Peroxide Sterilant label and package insert. Heed this Safety Precaution to ensure, under normal conditions, the Biodecontamination Unit and Enclosure do not leak H

2O2

vapor.

Safety Precautions Operating Manual 10087252

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