Steris VHP X10 Bedienungsanleitung

OPERATOR MANUAL

X10™Biodecontamination Unit

(TEAM) 10087252

Introduction Operator Manual 10087252

A WORD FROM STERIS CORPORATION

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

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.

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

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

resentative

STERIS Ltd.

Chancery House

190 Waterside Road

Hamilton Industrial Park

Leicester LE5 1QZ UK

STERIS Cor

oratio

960 Heisle

Roa

Mentor,

H 44060-1834 U

54-

2600

•

800

-444-

9009

www.

com

STERIS CORPORATION

6515 Hopkins Road

Mentor, OH 44060 • USA

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

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

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