Steris Pathogon Uv Disinfection System Operating instructions

OPERATOR MANUAL

PATHOGON™ UV Disinfection System

(Rev. C) 10073180

i

Introduction Operator Manual 10073180

A WORD FROM STERIS CORPORATION

This manual contains important information on proper use and

maintenance of the PATHOGON™ UV Disinfection System. All

personnel involved in the use and maintenance of this

equipment must carefully review and become familiar with the

Precautionary Statements and instructions contained in this

manual. These instructions are important to protect the health and

safety of personnel operating the equipment and should be retained

in a conveniently accessible area for quick reference.

Complete instructions for uncrating this unit have been furnished. If

missing, contact STERIS for replacement copies, giving the serial,

equipment and model numbers of the unit.

Indications for Use The PATHOGON UV Disinfection System is designed for use as part

of a cleaning and disinfection program to kill pathogens on hard non-

porous environmental surfaces. After completion of a manual

cleaning process, the PATHOGON UV system can be employed to

automatically deliver germicidal Ultraviolet-C (UVC) energy to

exposed, line-of-sight, environmental surfaces.

Uses other than as specified in this manual are not recommended

and may not be effective or safe in operating the system. Consult the

manual or STERIS for further information.

Advisory A summary of the PRECAUTIONARY STATEMENTS to be observed when

operating and servicing this equipment can be found in SECTION 1 of

this manual. Do not operate or service the equipment until you have

been trained to operate this equipment.

Any alteration of this equipment not authorized or performed by

STERIS Service Engineering will void the warranty and could

adversely affect equipment operation.

Service Information A thorough preventive maintenance program is essential for safe

and proper equipment operation. Customers are encouraged to

contact STERIS concerning our annual maintenance program. Under

terms of the program, preventive maintenance, adjustments and

replacement of worn parts are provided on a scheduled basis to

help assure equipment performance and to minimize untimely or

costly schedule interruptions. STERIS 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 for details.

ii

10073180 Operator Manual Introduction

The base language of this document is

ENGLISH. Any translations must be made

from the base language document.

Distributed by:

STERIS Corporation

5960 Heisley Road

Mentor, OH 44060 • USA

iii

Table of Contents Operator Manual 10073180

TABLE OF CONTENTS

Section

Number Title Page

1 Precautionary Statements....................................................................................................1-1

2 Symbols and Definitions......................................................................................................2-1

3 Technical Specifications......................................................................................................3-1

3.1 Dimensions ..................................................................................................................................3-1

3.2 Technical Information...................................................................................................................3-2

3.3 Lamp Numbering..........................................................................................................................3-3

4 Directions For Use................................................................................................................4-1

4.1 General ........................................................................................................................................4-1

4.2 Preparing Room for PATHOGON UV Disinfection System..........................................................4-1

4.3 Prepare Unit for Operation...........................................................................................................4-3

4.4 Prepare Wireless Remote Controller for Operation .....................................................................4-6

4.5 Operation Guidelines for Efficient Disinfection of Multiple Rooms...............................................4-8

4.6 Operation .....................................................................................................................................4-8

4.6.1 Battery................................................................................................................................4-9

4.6.2 Connection Status..............................................................................................................4-9

4.6.3 Log In Procedure..............................................................................................................4-10

4.6.4 Application Settings..........................................................................................................4-11

4.7 Data Logging..............................................................................................................................4-19

4.8 About Screen .............................................................................................................................4-22

5 Cleaning the Equipment.......................................................................................................5-1

5.1 Cleaning Equipment.....................................................................................................................5-1

5.2 Cleaning the Lamps.....................................................................................................................5-1

5.3 General Cleaning/Disinfecting Procedure....................................................................................5-2

5.4 Areas to Be Cleaned....................................................................................................................5-3

6 Troubleshooting....................................................................................................................6-1

7 Routine Maintenance............................................................................................................7-1

7.1 General ........................................................................................................................................7-1

7.2 Maintenance Intervals..................................................................................................................7-2

7.3 General Maintenance...................................................................................................................7-3

7.4 Preventive Maintenance...............................................................................................................7-3

7.5 Lamp Installation..........................................................................................................................7-4

7.6 Storage and Disposal...................................................................................................................7-5

iv

10073180 Operator Manual Table of Contents

8 Efficacy Data Summary........................................................................................................8-1

8.1 Overview......................................................................................................................................8-1

8.2 Evaluation of Antimicrobial Effectiveness of a UVC Generating Device on Hard Nonporous

Surfaces.......................................................................................................................................8-2

v

Table of Contents Operator Manual 10073180

LIST OF FIGURES

Figure Title Page

Figure 3-1. Dimensions..........................................................................................................................................3-1

Figure 3-2. Lamp Numbering.................................................................................................................................3-3

Figure 4-1. Example of Using One PATHOGON UV Disinfection System.............................................................4-4

Figure 4-2. Example of Using Two PATHOGON UV Disinfection Systems...........................................................4-5

Figure 4-3. Example of Running Two Cycles with One PATHOGON UV Disinfection System .............................4-5

Figure 4-4. Example of Using Two PATHOGON UV Disinfection Systems in Patient Room................................4-6

Figure 4-5. UV Light Warning Located on Covers .................................................................................................4-7

Figure 5-1. Clean PATHOGON UV Disinfection System Lamps ...........................................................................5-1

Figure 5-2. PATHOGON UV Disinfection System..................................................................................................5-3

vi

10073180 Operator Manual Table of Contents

Healthcare

Capital Equipment

vii

Table of Contents Operator Manual 10073180

LIST OF TABLES

Table Title Page

Table 2-1. Symbol Definitions...........................................................................................................................2-1

Table 3-1. Technical Information ......................................................................................................................3-2

Table 4-1. Application Diameter and Cycle Times* ..........................................................................................4-1

Table 6-1. Troubleshooting Guide ....................................................................................................................6-2

Table 8-1. Bacterial Efficacy.............................................................................................................................8-2

Table 8-2. Virucidal Efficacy .............................................................................................................................8-2

Table 8-3. Bacterial Spore Efficacy ..................................................................................................................8-2

viii

10073180 Operator Manual Table of Contents

Healthcare

Capital Equipment

1-1

Safety Precautions Operator Manual 10073180

1

The following Precautionary Statements must be observed when operating or servicing the PATHOGON™ UV

Disinfection System. WARNING indicates the potential for personal injury and CAUTION indicates the potential for

damage to equipment. For emphasis, certain Precautionary Statements are repeated throughout the manual. It is

important to review all Precautionary Statements before operating or servicing the unit.

Strictly following these Precautionary Statements enhances the Customer’s ability to use the unit safely and

effectively and helps avoid improper maintenance methods which may damage the unit or render it unsafe.

WARNING – PERSONAL INJURY HAZARD:

WARNING – HIGH VOLTAGE HAZARD:

WARNING – FIRE HAZARD:

Ultraviolet lamps emit radiation that is harmful to the eyes and skin. No personnel are to be exposed to

direct or reflected radiation. DO NOT enter room while cycle is in progress!

Ultraviolet-C (UVC) exposure causes moderate eye irritation. Avoid exposure to skin. Light in the short-

wave UVC band can cause erythema (reddening of the skin) and conjunctivitis (inflammation of the

mucous membranes of the eye). Avoid direct exposure to UVC light.

In case of accidental Ultraviolet-C (UVC) exposure – seek medical attention.

Exit the room that will receive the Ultraviolet-C (UVC) treatment. Ensure all personnel have exited the

treatment area and all other sensitive material has been removed. Properly label the room for treatment

with warning signs in accordance with the facility’s safety regulations.

Lamps contain mercury. If a lamp breaks, use approved hospital procedure for cleaning up and disposing

of broken fluorescent lamps.

The 20/10 Amp outlet for the PATHOGON unit must be accessible in order to remove the power cord in

case of an emergency.

Safety features, such as Motion Safety Sensor and Signage/Physical Barricades in NO WAY reduce or

eliminate the responsibility of the operator to verify that the room is empty and that all access points are

secure.

This unit uses high voltage. Proper electrical connections are required. Use only in dry areas.

DO NOT operate this unit in an area containing combustible materials.

!

PRECAUTIONARY STATEMENTS 1

1-2

10073180 Operator Manual Safety Precautions

WARNING – ELECTRIC SHOCK HAZARD:

WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

To avoid electric shock, turn OFF the power to the system and ensure there is no voltage being supplied

to the unit before attempting to install the lamp(s).

Repairs and adjustments to this equipment must be made only by STERIS or STERIS-trained service

personnel. Maintenance performed by inexperienced, unqualified personnel or installation of

unauthorized parts could cause personal injury, invalidate the warranty or result in costly equipment

damage. Contact STERIS regarding service options.

Regularly scheduled preventive maintenance is required for safe and reliable operation of this

equipment. Contact STERIS to schedule preventive maintenance.

Clean, cotton gloves must be worn when lamps are installed to prevent fingerprints on lamps. If lamp is

accidentally touched, clean with isopropyl alcohol.

To avoid damage to the PATHOGON UV Disinfection System, do not use scouring agents or cleaning/

disinfecting agents containing alkaline or acidic components.

Allow bulbs to cool to room temperature prior to cleaning.

Do not run the Windows hard drive defragmentation utility on the remote controller hard drive.

Defragmentation will destroy the PATHOGON unit’s software license file, preventing the program for the

PATHOGON unit from operating properly.

!

2-1

Symbols and Definitions Operator Manual 10073180

Table 2-1 contains symbols (with corresponding definitions) that may appear on the PATHOGON™ UV

Disinfection System.

Table 2-1. Symbol Definitions

Symbol Definition

Equipment or Reorder Number

Attention, Consult Manual for Further Instructions

Serial Number of Unit

PN Part Number

Ultraviolet

High Voltage

Fire

Consult instructions before use

SYMBOLS AND DEFINITIONS 2

2-2

10073180 Operator Manual Symbols and Definitions

Healthcare

Capital Equipment

3-1

Technical Specifications Operator Manual 10073180

3.1 Dimensions See Figure 3-1.

Figure 3-1. Dimensions

31" (787 mm)

67"

(1702 mm)

28" (711 mm)

TECHNICAL SPECIFICATIONS 3

3-2

10073180 Operator Manual Technical Specifications

3.2 Technical

Information

See Table 3-1 and refer to SECTION 8, EFFICACY DATA SUMMARY .

NOTE: Professional equipment that does not comply with the

requirements of this standard (IEC 61000-2) may be permitted to be

connected to certain types of low voltage supplies, if the instruction

manual contains a requirement to ask the supply utility for permission

to connect. Recommendations concerning this aspect are contained in

IEC/TS 61000-3-4 or IEC 61000-3-12.

Table 3-1. Technical Information

Input Voltage 120/230 V, 50/60 Hz, 15/8 Amp

Internal Fuse Rating 120 V, 15 Amp/ 230 V, 8 Amp

Power Cable Length 15’ (2.6 m)

Weight (with covers) 145 lb (66 kg)

Lamp Type GML 515

Lamp Quantity 24

Controller Battery Life ~ 8 hours

UVC Wavelength 100-280 nm (peak germicidal effectiveness 253.7)

NOTE: Consult the manufacturer’s manual for proper charging procedures for the tablet controller.

3-3

Technical Specifications Operator Manual 10073180

3.3 Lamp Numbering The lamps are numbered in ascending order, in a counterclockwise

direction, with lamp 1 being furthest from the two red pilot lights. .

The red, "Cycle Complete", pilot light is located nearest lamp number

16. The red, "System Fault," pilot light is located nearest lamp number

10.

Figure 3-2. Lamp Numbering

Cycle Complete

System Fault

3-4

10073180 Operator Manual Technical Specifications

Healthcare

Capital Equipment

4-1

Directions for Use Operator Manual 10073180

4.1 General See Table 4-1.

4.2 Preparing Room for

PATHOGON UV

Disinfection System

1. Remove sheets, blankets, pillow cases and similar items to

expose hard non-porous environmental surfaces to application

of UVC.

2. Remove or shield any medications or medication dispensing

systems or containers, such as IV fluid containers, water bottles,

saline bullets, etc.

3. Cover or remove all live plants prior to commencement of

disinfection cycle. Germicidal energy damages live plants.

4. Remove all visible soil loads from surfaces that are to be treated.

5. Identify high-touch objects, such as keyboards, TV remote

controls, phone keypads, etc. If possible, turn or “face” all high-

touch objects toward the PATHOGON system so surface to be

exposed to UVC is in direct line-of-sight with the unit.

Special Cleaning Instructions for Cleaning Prior to

Applications against Clostridium difficile spores

Personal Protection: Wear appropriate barrier protection such

as gloves, gowns, masks or eye covering.

Cleaning Procedure: Fecal matter/waste must be thoroughly

cleaned from surfaces/objects before UVC application with a

clean cloth, mop, and/or sponge saturated with a cleaning or

disinfectant product. Cleaning is to include vigorous wiping

and/or scrubbing, until all visible soil is removed. Special

attention is needed for high-touch surfaces. Surfaces in patient

rooms are to be cleaned in an appropriate manner, such as from

right to left or left to right, on horizontal surfaces, and top to

bottom, on vertical surfaces, to minimize spreading of the

spores. Restrooms are to be cleaned last. Do not reuse soiled

cloths.

Infectious Materials Disposal: Materials used in the cleaning

process that may contain feces/wastes are to be disposed of

immediately in accordance with local regulations for infectious

materials disposal.

6. When possible, move objects away from walls and all other

objects by up to 3’ (1 m).

Table 4-1. Application Diameter and Cycle Times*

Application Diameter Bacteria and Viruses C. difficile Spores

10 ft. (3 m) 4 minutes 11 minutes

18 ft. (5.4 m) 9 minutes 25 minutes

* See SECTION 8, EFFICACY DATA SUMMARY for performance data

supporting application conditions.

DIRECTIONS FOR USE 4

4-2

10073180 Operator Manual Directions for Use

7. Open all drawers and/or cabinet doors to expose interior

surfaces to UVC germicidal energy.

8. Identify primary entrance to the room and lock/secure all other

entrances to prevent accidental entry during application with

UVC.

9. VERIFY that rooms with glass windows to interior occupied

spaces are compliant with national building codes regarding

Safety rated glass prior to application.

10. Locate an available grounded electrical outlet that is rated for

20/10 Amp load.

WARNING – PERSONAL

INJURY HAZARD:

• Ultraviolet lamps emit

radiation that is harmful to

the eyes and skin. No

personnel are to be

exposed to direct or

reflected radiation. DO

NOT enter room while

cycle is in process!

• Ultraviolet-C (UVC)

exposure causes

moderate eye irritation.

Avoid exposure to skin.

Light in the short-wave

UVC band can cause

erythema (reddening of

the skin) and

conjunctivitis

(inflammation of the

mucous membranes of

the eye). Avoid direct

exposure to UVC light.

• In case of accidental

Ultraviolet-C (UVC)

exposure – seek medical

attention.

• Lamps contain mercury. If

a lamp breaks, use

approved hospital

procedure for cleaning up

and disposing of broken

fluorescent lamps.

• Safety features, such as

Motion Safety Sensor and

Signage/Physical

Barricades in NO WAY

reduce or eliminate the

responsibility of the

operator to verify that the

room is empty and that all

access points are secure.

!

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Steris Pathogon Uv Disinfection System Operating instructions

Steris Pathogon Uv Disinfection System Operating instructions

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