Steris Amsco 300 Series Steam Sterilizer Operating instructions

11451089

Revision F

AMSCO®300 Series

Steam Sterilizer

Operator Manual

ii

11451089_F AMSCO®300 Series Operator Manual

Published: 2023-4-21

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Operator Manual AMSCO®300 Series 11451089_F

A Word from STERIS

Introduction

This manual contains important information on proper use of this equipment. All operators and department heads

must carefully review and become familiar with the warnings, cautions and instructions contained in this manual.

These instructions are important to the health and safety of personnel operating the sterilizer and should be retained in

a conveniently accessible area for quick reference.

This equipment is specifically designed to process goods using only the cycles as specified in this manual. If there is any

doubt about a specific material or product, contact the manufacturer of the product for the recommended sterilization

technique. STERIS Corporation carries a complete line of accessories for this unit to simplify, organize and assure the

conditions for sterilization have been achieved. Instrument trays, pouches and biological/chemical monitoring systems

are all available to fulfill your facility's processing needs. STERIS will gladly review these with you.

Revision F writing completed 02/27/23.

Advisory

This equipment is specifically designed to only process goods using the cycles as specified in this manual. If there is any

doubt about a specific material or product, contact the manufacturer of that product for the recommended sterilization

technique.

A summary of the safety precautions to be observed when operating and servicing this equipment can be found in

Safety Precautions section of this manual. Do not operate or service equipment until becoming familiar with this

information.

Any alteration of the sterilizer not authorized or performed by STERIS Service Engineering which could affect its

operation will void the warranty, could adversely affect sterilization efficacy, could violate national, state and local

regulations and jeopardize your insurance coverage.

To help ensure operators are adequately trained in the safe use of the equipment, STERIS recommends:

• all personnel who operate or maintain the equipment are trained in its operation and in its safe use

• there is regular training of all personnel concerned with the operation and maintenance of the equipment;

attendance records are maintained; and that evidence of understanding is demonstrated

Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and

competent authority in the country where the incident occurred.

Intended Use

The AMSCO® 300 Series Steam Sterilizer is offered in a prevacuum configuration and is designed for fast, efficient

sterilization of heat and moisture stable materials in healthcare applications. The sterilizer is equipped with prevacuum,

leak test, and daily steam penetration (Bowie-Dick) test cycles as standard.

Intended Users

The sterilizers are generally operated by technicians in a central service or sterile processing department of healthcare

facilities.

Waste Products Disposal

The following are waste materials associated with the sterilizer. When disposing of waste materials, verify disposal is in

compliance with federal, state, and local regulations.

• Printer paper – recyclable

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11451089_F AMSCO®300 Series Operator Manual

• Printer ribbon – not recyclable

• Water filters – not recyclable

• Waste water – see equipment drawing for flow rate. WRAS category 4.

• Entire sterilizer (end-of-life) – Contact STERIS for disposal or recycling recommendations.

CAUTION: Decommissioned devices must be decontaminated before disposal.

CAUTION: Improper disposal of sterilizer parts could be in violation of PED and WEEE regulations.

Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste.

It must be collected separately and must be disposed as per local regulations. Contact your

authorized representative for information concerning the decommissioning of your equipment.

Addresses

The base language of this document is

ENGLISH. Any translations must be made

from the base language document.

Manufactured by:

STERIS Corporation

5960 Heisley Road

Mentor, Ohio 44060

Made in Mexico

Sales and Service:

STERIS Corporation

5960 Heisley Road

Mentor, Ohio 44060

440-354-2600 • 800-444-9009

www.STERIS.com

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Operator Manual AMSCO®300 Series 11451089_F

STERIS Ireland Limited

IDA Business and Technology Park Tullamore

County Offaly

R35 X865 Ireland

Sales and Service – Americas, Oceania and

Asia:

STERIS Corporation

5960 Heisley Road

Mentor, Ohio 44060

800-548-4873

Sales and Service – Europe, Middle-East

and Africa:

STERIS

116 Avenue de Magudas, 33185

Le Haillan

FRANCE

Support Service, by email:

[email protected]

All other requests, by phone:

+33 5 56 93 94 94

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11451089_F AMSCO®300 Series Operator Manual

TABLE OF CONTENTS

Section Number Description Page

1 Safety Precautions ............................................................................................................................ 9

2 Symbols and Labels.........................................................................................................................14

3 Symbol Stickers Placement............................................................................................................18

4 Component Identification ...............................................................................................................20

4.1 Technical Specifications ............................................................................................... 20

4.2 Product Features .......................................................................................................... 20

4.3 Product Information ..................................................................................................... 24

4.4 Printing Report.............................................................................................................. 25

4.5 Touch Screen................................................................................................................. 25

4.6 Control Panel for Double Doors................................................................................... 27

4.7 Pre-Programmed Cycle Table – Manufacturer’s Configuration and Service

Cycle/Maintenance ....................................................................................................... 27

4.8 Recommended Cycles .................................................................................................. 29

4.9 Security Systems .......................................................................................................... 29

4.10 Peripherals .................................................................................................................... 33

5 Operating Instructions .................................................................................................................... 34

5.1 Preparing Packages ...................................................................................................... 34

5.2 Sterilization Units (STU) ............................................................................................... 35

5.3 Operation Checklist....................................................................................................... 35

5.4 Turn On Equipment ...................................................................................................... 35

5.5 Opening Loading Door.................................................................................................. 36

5.6 Loading Chamber Using External Cart ........................................................................ 37

5.7 Locking Sequence for Sterilizer Loading ..................................................................... 37

5.8 Placing Material Inside Chamber ................................................................................. 39

5.9 Closing Loading Door.................................................................................................... 39

5.10 Programming Sterilization Cycles................................................................................ 40

5.11 Logout Time .................................................................................................................. 40

5.12 Starting Desired Cycle .................................................................................................. 40

5.13 End of Cycle................................................................................................................... 40

5.14 Unloading Chamber Using External Cart..................................................................... 40

5.15 Navigating the System................................................................................................. 43

5.16 Starting a Cycle ............................................................................................................. 45

5.17 Cycle Color Legend ....................................................................................................... 46

5.18 Equipment Doors.......................................................................................................... 51

5.19 Quick Reference Instructions....................................................................................... 53

6 Supervisor Level ..............................................................................................................................55

6.1 Performing Cycles......................................................................................................... 55

6.2 Editing a Cycle............................................................................................................... 58

6.3 System Settings............................................................................................................ 72

6.4 Setting Language.......................................................................................................... 73

6.5 Downloading Cycles (USB) ........................................................................................... 75

6.6 Processing Graphs and Variables ................................................................................ 76

6.7 Cycle Screen .................................................................................................................. 78

6.8 Aborting/Cancelling Cycle ............................................................................................ 79

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Operator Manual AMSCO®300 Series 11451089_F

6.9 Absolute Pressure Control ........................................................................................... 80

7 Cycles and Programming................................................................................................................81

7.1 System Startup ............................................................................................................. 81

7.2 Changing Password ...................................................................................................... 83

7.3 Adding New User .......................................................................................................... 84

7.4 Delete User ................................................................................................................... 88

7.5 Exiting User Management or Switch User.................................................................. 89

8 Routine Maintenance ...................................................................................................................... 91

8.1 Preventive Maintenance .............................................................................................. 91

8.2 Clean Stainless-Steel Surfaces of Sterilizer................................................................ 92

8.3 Clean Touch Screen ...................................................................................................... 92

8.4 Loading Equipment Cleaning ....................................................................................... 93

9 Troubleshooting...............................................................................................................................94

9.1 Introduction................................................................................................................... 94

9.2 Chamber Over-Pressure .............................................................................................. 94

9.3 Chamber Pressure Sensor Failure............................................................................... 95

9.4 Chamber Pressurization Failure .................................................................................. 95

9.5 Chamber Temp. Sensor Failure.................................................................................... 95

9.6 Compressed Air Failure ................................................................................................ 95

9.7 Cycle Aborted................................................................................................................ 96

9.8 Door Opened In Cycle ................................................................................................... 96

9.9 Emergency Button Pressed ......................................................................................... 96

9.10 Feedwater Pump Overload .......................................................................................... 96

9.11 Generator Temp Limit Failure ...................................................................................... 97

9.12 Heater Failure – Time Exceeded ................................................................................. 97

9.13 High Level Sensor Failure............................................................................................. 97

9.14 High-Pressure – Sterilization ...................................................................................... 97

9.15 High-Temperature – Sterilization ............................................................................... 98

9.16 House Steam Failure .................................................................................................... 98

9.17 Jacket Heating Failure .................................................................................................. 98

9.18 Jacket Over Pressure .................................................................................................... 98

9.19 Jacket Pressure Sensor Failure .................................................................................... 99

9.20 Lack of Water Flow in Vacuum Pump ......................................................................... 99

9.21 Load Door Pressure Failure ......................................................................................... 99

9.22 Load Safety Sensor Activated...................................................................................... 99

9.23 Low Level Sensor Failure ............................................................................................. 99

9.24 Low-Pressure – Sterilization.....................................................................................100

9.25 Low-Temperature - Sterilization...............................................................................100

9.26 Osmosis Water Supply Failure...................................................................................100

9.27 Phase Fault Failure.....................................................................................................100

9.28 Power Failure..............................................................................................................101

9.29 Recorder Pressure Deviation .....................................................................................101

9.30 Recorder Pressure Sensor Failure.............................................................................101

9.31 Recorder Temperature Deviation ..............................................................................101

9.32 Recorder Temp. Sensor Failure .................................................................................102

9.33 Temp/Press Deviation................................................................................................102

9.34 Unload Door Pressure Failure....................................................................................102

9.35 Unload Safety Sensor Activated ................................................................................102

9.36 Vacuum Failure ...........................................................................................................103

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11451089_F AMSCO®300 Series Operator Manual

9.37 Vacuum Pump Overload.............................................................................................103

9.38 Waste Temp. Sensor Failure......................................................................................103

1 — Safety Precautions

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Operator Manual AMSCO®300 Series 11451089_F

Safety Precautions

The following Safety Precautions must be observed when operating or servicing this equipment.

•WARNING indicates the potential for personal injury.

•CAUTION indicates the potential for damage to equipment.

It is important to review all Safety Precautions before operating or servicing the unit.

Strictly following these Safety Precautions enhances the ability to safely and effectively use the equipment and helps

avoid improper maintenance methods which may damage the unit or render it unsafe. It is important to understand

that these Safety Precautions are not exhaustive; Customers are encouraged to develop their own safety policies and

procedures to enhance and complement these Safety Precautions.

IMPORTANT: Please read this Operator Manual to get the best understanding and to help ensure best performance of

this equipment, which has been thoroughly inspected, tested and adjusted by trained personnel.

Equipment maintenance other than described in the manual (unless by authorized representatives of the STERIS

Corporation), shall be at the risk of invalidating the equipment warranty.

To obtain authorized service call STERIS Corporation: 1-800-548-4873

WARNING

ELECTRIC SHOCK HAZARD

Disconnect all utilities to sterilizer before servicing. Do not service the sterilizer unless

all utilities have been properly locked out. Always follow OSHA Lockout-Tagout and

electrical safety-related work practice standards.

Use appropriate tools with insulation.

Do not handle the sterilizer if it has been exposed to electric shock. Use the appropriate

Personal Protective Equipment (PPE) that contain insulators.

Do not operate the equipment if it has been dropped or exposed to strong electric

shock.

1 — Safety Precautions

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11451089_F AMSCO®300 Series Operator Manual

WARNING

BURN HAZARD

Sterilizer, rack/shelves, and loading car will be hot after cycle is run. Always wear

Personal Protective Equipment (PPE) when removing a processed load. PPE must also

be worn when reloading sterilizer following the previous operation.

Always wear gloves and a suitable apron when removing sterilized items and reloading

new items for a new sterilization cycle after the previous cycle as the equipment may

be elevated.

Containers, containers, trays and containers in general, as well as internal carts should

be handled by persons using personal protective equipment (glasses, mask and suitable

gloves) to prevent burns at the end of the cycle or whenever sterilization.

Do not open door until the cycle has finished.

Avoid burns from hot fluids. Use caution when opening sterilizer door.

Prior to any cleaning or maintenance, the equipment and its utensils must be at room

temperature.

A malfunction of the steam supply can fill the sterilizer chamber with boiling water,

which will be identified by a noise or alarm signaling: Do not open the door; call for

service immediately.

Verify the equipment is under no pressure before performing any maintenance

procedure.

Failure to turn off steam lines or equipment before cleaning or changing sterilizer filters

can cause burns and injuries.

At the end of the cycle, the equipment and its accessories are covered with their hot

surfaces so it is recommended to wear gloves that can withstand temperatures up to

100°C and apron (also face shield if you are processing liquids) to avoid possible injury

to the operator.

1 — Safety Precautions

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Operator Manual AMSCO®300 Series 11451089_F

WARNING

EXPLOSION HAZARD

This sterilizer is not designed to sterilize liquids out of suitable containers and abrasive

liquids.

Do not use the sterilizer to sterilize flammable components.

In the case of the sterilizer with cycle with liquids, follow instructions for the correct

execution of the same, avoiding risks of explosion of bottles that contain hot liquids.

●Do not sterilize liquids in hermetically sealed containers in this type of sterilizer.

●To sterilize liquids in open containers, use only the specific cycle.

●Use containers suitable for liquids and temperatures.

●Wait until the cycle has finished to open the door.

●Handle containers with care using suitable protective gloves.

●Never try to cool glasses or liquids by throwing water or other product into the

sterilizer.

WARNING

PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD

Repairs and adjustments to this equipment must be made only by fully qualified service

personnel. Maintenance performed by inexperienced, unqualified persons or installation

of unauthorized parts could cause personal injury or result in costly equipment damage.

Regularly scheduled preventive maintenance is required for safe and reliable operation

of this equipment. Contact your STERIS service representative to schedule preventive

maintenance.

Do not operate the equipment unless you have been properly trained and qualified on

the use and operation of the equipment.

Employees and maintenance personnel must be properly equipped with PPE (Personal

Protective Equipment) corresponding to their activity.

Avoid slippery ground, contact with chemicals. Keep material loading area in the

sterilizer clean and organized.

1 — Safety Precautions

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11451089_F AMSCO®300 Series Operator Manual

Avoid fire or smoke hazard. Do not place processed and hot materials on surfaces which

may cause fire or smoke hazard.

When closing chamber door, keep hands and fingers out of door aperture. Verify

aperture is clear of obstructions.

Follow all guidelines in the installation, operation, and maintenance instructions.

Operators cannot move away from the control areas of the machines under their

responsibility when in operation.

Only the operator and authorized persons should remain in the work area of the

equipment.

Handling of the accessories outside the manufacturer's directions may cause injury to

the operator.

Avoid physical Injury: Get help if you are stuck or difficult to move in order to carry the

cart. Do not attempt to lift a freight cart without assistance.

Install the equipment out of the reach of children.

WARNING

FALLING RISK

Avoid falling risk. Keep the floor dry by cleaning any liquid or condensation that may be

spilled by the equipment.

1 — Safety Precautions

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Operator Manual AMSCO®300 Series 11451089_F

CAUTION

POSSIBLE EQUIPMENT DAMAGE

Use only original components, supplied by the manufacturer or authorized

representative.

No part of the sterilizer may be modified or altered for any reason without the

manufacturer's approval.

Cleaning the front panels of the sterilizer should be done using a soft cloth and

solutions that do not damage the stainless-steel finish.

Chamber cleaning should be done using a soft cloth and solutions that do not damage

stainless steel.

Pointed tools should not be used to insert or remove the gasket from the chamber.

●Do not remove the gasket if it is not really needed.

●Do not use sharp tools to install gasket.

Removing manometer incorrectly may interfere with calibration.

2 — Symbols and Labels

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11451089_F AMSCO®300 Series Operator Manual

Symbols and Labels

The following symbols may appear on the equipment.

Symbol Definition

Alternating Current

3–Phase Alternating Current

Earth Terminal Ground

Earth Protection Terminal

On (Power)

Off (Power)

Equipment Protected Entirely by Double or Reinforced

Insulation

Warning! Electric Shock

Hot Surface

Crushing Hazard

2 — Symbols and Labels

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Operator Manual AMSCO®300 Series 11451089_F

Symbol Definition

See Instructions for Use

Caution, consult accompanying documents

Fragile, handle with care

Keep Away from Rain (Keep Dry)

Shelf Life

Date of Manufacture

Reference (Model)

Serial Number

Medical Device

Unique Device Identifier

Invoice

No Use of Hooks/No Hoisting

2 — Symbols and Labels

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11451089_F AMSCO®300 Series Operator Manual

Symbol Definition

Use Forklift

Do Not Use This Location for Transportation with Forklift

CE Marking

This Side Up

Moisture Limit

Maximum Temperature Limit Symbol

Stacked Forbidden

Jacket Pressure

Internal Chamber Pressure

Closed Gate Flag

Cycle Flag in Progress

End Cycle Flag

Cycle Fault Flag

2 — Symbols and Labels

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Operator Manual AMSCO®300 Series 11451089_F

Symbol Definition

Button Open Door Side Download

Close Button Door Side Download

DANGER: Indicates an imminently hazardous situation

which, if not avoided, could result in death or serious

injury and property damage.

WARNING: Indicates a potentially hazardous situation

which, if not avoided, could result in death or serious

injury and property damage.

CAUTION: Indicates a potentially hazardous situation

which, if not avoided, could result in minor or moderate

injury and property damage.

3 — Symbol Stickers Placement

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11451089_F AMSCO®300 Series Operator Manual

Symbol Stickers Placement

Stickers:

1. Crushing Hazard

2. Hot Surface

3. Warning! Electric Shock

NOTE: When the unit has a double door, the adhesive 1 and 2 must be fixed on both sides of the

sterilizer.

Figure 3-1. Position of Adhesives/Labels

3 — Symbol Stickers Placement

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Operator Manual AMSCO®300 Series 11451089_F

WARNING

PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD

It is strictly forbidden to remove and/or damage hazard warning labels placed on the

machine. These labels have been tested to ensure they are not easily removed or

damaged by the use of common cleaning agents.

4 — Component Identification

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11451089_F AMSCO®300 Series Operator Manual

Component Identification

4.1 Technical Specifications

Configurations Single Door, Double Door

Chamber Size (W x L x H) 304 Litres: 460 x 660 x 1000 mm

364 Litres: 460 x 660 x 1250 mm

436 Litres: 660 x 660 x 1000 mm

523 Litres: 660 x 660 x 1250 mm

741 Litres: 660 x 660 x 1700 mm

Weight [304 Litres] — Automatic Sliding Door — 1030 kg

(2271 lb)

[364 Litres] — Automatic Sliding Door — 1120 kg

(2469 lb)

[436 Litres] – Automatic Sliding Door – 1225 kg

(2700 lb)

[523 Litres] – Automatic Sliding Door – 1375 kg

(3031 lb)

[741 Litres] – Automatic Sliding Door – 1500 kg

(3306 lb)

Utility Requirements Refer to the sterilizer equipment drawings for

detailed information including, but not limited to:

• Electrical Requirements

• Plumbing Utility Requirements

• Cold Feedwater

• DI Water

• Air Supply

• Facility Steam Supply

4.2 Product Features

Access for Validation (Sensors for Temperature and Pressure)

One sanitary port for validation temperature and pressure sensors located on the side of the sterilizer chamber.

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Steris Amsco 300 Series Steam Sterilizer Operating instructions

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