Steris AMSCO 5000 Series Manuel utilisateur

10057344

Revision H

AMSCO®5000 Series

Washer/Disinfector Model #5052

Operator Manual

— A Word from STERIS

10057344_H AMSCO®5000 Series Operator Manual

A Word from STERIS

Introduction

This manual contains important information on the proper use and routine maintenance of this equipment. 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. These instructions are important to protect the health and

safety of personnel operating this equipment and should be retained in a conveniently accessible area for quick

reference. This equipment is specifically designed only for the uses outlined in this manual.

Complete instructions for uncrating and connecting utilities, as well as the equipment drawing, have been provided. If

they are missing, contact STERIS for replacement copies, providing the serial number and model of the equipment.

Advisory

IMPORTANT: A listing of the Safety Precautions to be observed when operating and servicing this washer/disinfector can be

found in Safety Precautions section. Do not operate the equipment until you have become familiar with this information.

STERIS does not intend, recommend or represent in any way that this AMSCO 5052 Single-Chamber

Washer/Disinfector be used for the terminal disinfection or sterilization of any regulated medical device. The AMSCO

5052 Single-Chamber Washer/Disinfector is intended only to perform an initial step in the processing of soiled,

reusable medical devices. If medical devices will be contacting blood or compromised tissues, such devices must be

terminally processed in accordance with device manufacturer's instructions and/or Good Hospital Practices before each

use in human patients.

STERIS does not recommend the use of the Suction Tip and Instrument Rack for processing endoscopes, laparoscopes

or other instruments used for minimally invasive surgery. Processing these types of instruments may result in

equipment damage as well as improperly cleaned items. If there is any doubt about a specific material or product,

contact the instrument manufacturer for recommended washing techniques.

Any alteration of this equipment not authorized or performed by STERIS will void the warranty. Alteration of equipment

which could adversely affect its operation and efficacy may violate national, state and local regulations.

The protection provided by the equipment may be impaired if the equipment is used in a manner not specified by

STERIS.

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;

• personnel working with toxic chemicals and vapors (if applicable) have comprehensive instructions in the washer

disinfector process, relevant health hazards and methods to detect the escape of toxic materials;

• 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;

• current Safety Data Sheets (SDS) should be available to all users in the department. For current SDS, contact

STERIS.

Waste Products Disposal

The following are waste materials associated with the equipment. When disposing of waste materials, ensure disposal

is in compliance with federal, state and local regulations.

• Printer paper – Recyclable.

• HEPA filter – Place HEPA filter in a large, sealable bag. Discard the bagged HEPA filter in an outdoor waste

container.

— A Word from STERIS

Operator Manual AMSCO®5000 Series 10057344_H

• Chemicals – Dispose in a safe manner in accordance with local/national regulations and current Safety Data

Sheets (SDS).

• Chemical containers – Dispose of empty containers in a safe manner in accordance with local/national

regulations.

• Entire washer/disinfector (end-of-life) – Contact STERIS Corporation for disposal or recycling recommendations.

Indications For Use

The AMSCO 5052 Single-Chamber Washer/Disinfector is intended for use in the cleaning and intermediate-level

disinfection of soiled reusable utensils, trays, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid

surgical instruments (such as forceps and clamps) and other similar and related articles found in healthcare facilities.

Service Information

A thorough preventive maintenance program is essential to help ensure safe and proper equipment operation. This

manual contains maintenance schedules and procedures which should be followed for satisfactory equipment

performance.

Customers are encouraged to contact STERIS concerning our comprehensive annual maintenance program. Under the

terms of the program, preventive maintenance, adjustments and replacement of worn parts are performed on a

scheduled basis to help ensure equipment performance at peak capability and to help avoid untimely and costly

interruptions. STERIS maintains a global staff of well-equipped, qualified service technicians to provide this service, as

well as expert repair services. Please contact STERIS for details.

STERIS provides a line of accessories for use with this washer/disinfector. A STERIS representative will gladly review

these with you.

Certification

This AMSCO 5052 Single-Chamber Washer/Disinfector meets the applicable Safety Requirements for Electrical

Equipment for Measurement, Control, and Laboratory Use:

• General Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use:

◻Underwriters Laboratories (UL) Standard UL: UL 61010–1:2012 Ed. 3.

◻EN/IEC: 61010–1: 2010 Ed. 3.

◻Canadian Standards Association (CSA): CAN/CSA-C22.2 No. 61010–1–12:2012 Ed. 3.

• Particular Requirements for Sterilizers and Washer/Disinfectors used to Treat Medical Materials:

◻Underwriters Laboratories (UL) Standard UL: UL 61010–2–040:2016 Ed.2.

◻EN/IEC: 61010-2-040, First Edition (2005).

◻Canadian Standards Association (CSA): CAN/CSA-C22.2 No. 61010-2-040:2016 Ed. 2..

This AMSCO 5052 Single-Chamber Washer/Disinfector meets the following performance requirements:

• General requirements, terms, definitions and tests:

◻EN ISO 15883-1:2009/A1:2014

◻ANSI/AAMI ST15883-1:2009 (R2014)

◻CAN/CSA Z15883-1–09 (R2019)

• Requirements and tests for washer/disinfectors employing thermal disinfection for surgical instruments,

anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc:

◻EN ISO 15883-2:2009

◻ANSI/AAMI ST15883-2:2013 (R2015)

◻CAN/CSA Z15883-2–09 (R2019)

— A Word from STERIS

10057344_H AMSCO®5000 Series Operator Manual

• Decontamination of reusable medical devices:

◻CAN/CSA Z314.8-2008.

This AMSCO 5052 Single-Chamber Washer/Disinfector meets the following EMC/EMI regulations:

• Code of Federal Regulation, CFR 47 (2012) – FCC PART 15, SUBPART B Class A – Unintentional Radiators for Use

in Commercial and Industrial Areas.

• Industry Canada, ICES-001 – Industrial, Scientific and Medical (ISM) Radio Frequency Generators, Issue 4, June

2006.

• European Community, EMC directive 2004/108/EC – Class A, Group 1 ISM Equipment.

This AMSCO 5052 Single-Chamber

Washer/Disinfector meets the following

Governing Directives for affixing of the CE mark:

• Medical Device Directive 93/42/EEC as

amended by 2007/47/EC.

• Machinery Directive 2006/42/EC.

• Low Voltage Directive 2006/95/EC.

• EMC Directive 2004/108/EC - Class A, Group

1 ISM Equipment.

Permissible Environmental Conditions

This washer/disinfector is designed to give optimal results under the following conditions:

• Indoor use only;

• Altitude of operation up to 6561 ft (2000 m);

NOTE: Maximum temperature limitation at 2000 m (6561 ft) is 185.9°F (85.5°C).

• Temperature of 41 to 104°F (5 to 40°C);

• Relative humidity of 30% to 80% non-condensing;

• Pollution Degree 2.

Pollution Degree 2: Equipment must be installed in an environment where normally only non-conductive pollution

occurs but where occasional, temporary conductivity caused by condensation can be expected (as determined according

to International Standard EN/IEC 61010-1, Second Edition).

Seismic Anchorage System (Accessory)

A seismic anchorage system (based on California requirements) is available for high-risk seismic zones.

Noise Level

Equivalent Sound Pressure Level: 57.1 dB (A) with a peak of 64.0 dB (A) during drying stage. (Results determined

according to ISO-3746: 2010(E) Third Edition Standard: Determination of Sound Power Levels and Sound Energy Levels

of Noise Sources Using Sound Pressure).

— A Word from STERIS

Operator Manual AMSCO®5000 Series 10057344_H

Addresses

The base language of this document

is ENGLISH. Any translation must be

made from the base language

document.

Manufactured by:

STERIS Canada ULC

490 boulevard Armand-Paris

Québec (Québec)

CANADA G1C 8A3

Sales and Service –America, 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

European Community Representative:

STERIS Ireland Limited

IDA Business and Technology Park

Tullamore

County Offaly

R35 X865

Ireland

Website: www.steris.com

10057344_H AMSCO®5000 Series Operator Manual

TABLE OF CONTENTS

Section Number Description Page

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

1.1 Safety Precautions — Introduction .......................................................................................... 1

1.2 Safety Precautions ..................................................................................................................... 1

2 Symbols and Labels....................................................................................................................................... 5

2.1 Equipment Symbols.................................................................................................................... 5

2.2 Nameplate Symbols ................................................................................................................... 6

2.3 Transportation and Storage....................................................................................................... 6

3 Component Identification ............................................................................................................................. 8

3.1 Component Identification — Introduction................................................................................ 8

3.2 Washer/Disinfector — General................................................................................................. 8

3.3 Control System ......................................................................................................................... 13

3.4 Emergency Safety Features..................................................................................................... 17

3.5 SCS Conveyor System .............................................................................................................. 18

3.6 ATLAS Workflow Automation Vehicle System ....................................................................... 19

3.7 Chemicals and Cycles ............................................................................................................... 19

4 Operating Instructions ................................................................................................................................ 24

4.1 Operating Instructions — Introduction................................................................................... 24

4.2 Before Operating Washer/Disinfector .................................................................................... 24

4.3 Accessories ............................................................................................................................... 26

4.4 Flexible Hoses for Cannulated Instruments (Accessory) ....................................................... 35

4.5 Loading Washer/Disinfector Manually.................................................................................... 40

4.6 Loading Washer/Disinfector With a Washer Automation System........................................ 42

4.7 Typical Cycle Operation ............................................................................................................ 48

4.8 Unloading Washer/Disinfector ................................................................................................ 51

4.9 Visual Inspection....................................................................................................................... 52

4.10 Responding to an Alarm........................................................................................................... 52

4.11 Aborting Cycle Operation ......................................................................................................... 54

4.12 Shutdown .................................................................................................................................. 54

4.13 Power Door Operation ............................................................................................................. 55

5 Cycle And Control Value Programming ..................................................................................................... 57

5.1 Cycle and Control Value Programming — Introduction ........................................................ 57

5.2 General ...................................................................................................................................... 57

5.3 Supervisor Mode Menus .......................................................................................................... 67

5.4 Cycles Menu .............................................................................................................................. 68

5.5 Transfer Cycle Reports Menu .................................................................................................. 72

5.6 Miscellaneous Menu................................................................................................................. 73

5.7 Password Menu ........................................................................................................................ 75

5.8 Chemical Pumps Name Menu.................................................................................................. 76

5.9 Prime Chemical Pumps Menu.................................................................................................. 77

5.10 Units Menu................................................................................................................................ 79

5.11 Print Menu (Accessory) ............................................................................................................ 80

5.12 Date and Time Menus .............................................................................................................. 81

5.13 Language Menu ........................................................................................................................ 82

5.14 Software Version Menu ........................................................................................................... 83

Operator Manual AMSCO®5000 Series 10057344_H

5.15 Test Menu ................................................................................................................................. 84

5.16 Cycle History Menu................................................................................................................... 86

5.17 Formatting USB Key ................................................................................................................. 88

6 Routine Maintenance .................................................................................................................................. 95

6.1 Routine Maintenance — Introduction .................................................................................... 95

6.2 Preventive Maintenance .......................................................................................................... 95

6.3 Routine Maintenance ............................................................................................................... 96

6.4 Cleaning Debris Screen............................................................................................................. 98

6.5 Cleaning Water Outlet Connection .......................................................................................... 99

6.6 Cleaning Door Gasket .............................................................................................................100

6.7 Cleaning Washer/Disinfector Exterior...................................................................................100

6.8 Inspecting and Cleaning Rotary Spray Arm Assemblies ......................................................102

6.9 Processing Decontamination Cycle .......................................................................................105

6.10 Replacing Chemical Container ...............................................................................................107

6.11 Changing Printer Paper Roll and Ink Cartridge (Accessory).................................................109

6.12 Door Safety Test.....................................................................................................................112

6.13 Sump Safety Level Test..........................................................................................................114

6.14 Verifying Emergency Stop Pushbuttons ..............................................................................115

7 Troubleshooting.........................................................................................................................................117

7.1 Troubleshooting — Introduction...........................................................................................117

7.2 Troubleshooting — General ..................................................................................................117

7.3 Alarm# 1 Load Door Open......................................................................................................118

7.4 Alarm# 2 Unload Door Open..................................................................................................118

7.5 Alarm# 3 Cycles Returned to Default Values .......................................................................119

7.6 Alarm# 4 Sump Too Long to Fill ............................................................................................119

7.7 Alarm# 5 Sump Not Drained..................................................................................................120

7.8 Alarm# 6 Water Remained in Chamber ................................................................................120

7.9 Alarm# 7 Sump Too Long to Heat.........................................................................................121

7.10 Alarm# 8 Sump Safety Water Level Reached.......................................................................122

7.11 Alarm# 9 Recirculation Temperature Probe #1 Defective...................................................122

7.12 Alarm# 10 Sump Temperature Too High..............................................................................122

7.13 Alarm# 11 Drying Temperature Too High.............................................................................123

7.14 Alarm# 12 Sump Over Temperature Switch Tripped...........................................................123

7.15 Alarm# 13 Pump Did Not Start .............................................................................................123

7.16 Alarm# 14 Drying Over Temperature Switch Tripped..........................................................124

7.17 Alarm# 15 Recirculation Temperature Probe #2 Defective ................................................124

7.18 Alarm# 16 Chemical Injected Volume Too Low....................................................................125

7.19 Alarm# 17 Recirculation Temperature Variance Exceeds Range........................................125

7.20 Alarm# 18 Motor Overload Detected....................................................................................125

7.21 Alarm# 19 Power Failure During Cycle .................................................................................126

7.22 Alarm# 20 I/O Boards Comm. Failure ...................................................................................126

7.23 Alarm# 21 Error 21.................................................................................................................126

7.24 Alarm# 22 Emergency Stop Pressed ....................................................................................127

7.25 Alarm# 23 Pressure Transmitter Defective..........................................................................127

7.26 Alarm# 24 Load Door Did Not Open......................................................................................128

7.27 Alarm# 25 Load Door Did Not Close .....................................................................................128

7.28 Alarm# 26 Load Door Obstruction ........................................................................................129

7.29 Alarm# 27 Unload Door Did Not Open..................................................................................129

7.30 Alarm# 28 Unload Door Did Not Close..................................................................................130

10057344_H AMSCO®5000 Series Operator Manual

7.31 Alarm# 29 Unload Door Obstruction.....................................................................................130

7.32 Alarm# 30 Water Level Defective .........................................................................................131

7.33 Alarm# 31 Low Pressure Detected .......................................................................................132

7.34 Alarm# 32 Drying System Not Heating ................................................................................133

7.35 Alarm# 33 Unload Conveyor Full...........................................................................................134

7.36 Alarm# 41 to 45 Chemical Container [X] Empty ..................................................................134

7.37 Abnormal noise generated by washer/disinfector...............................................................135

7.38 Auto-Docking Transfer Cart does not remain docked to FD214 Transfer Cart

Adaptor....................................................................................................................................135

7.39 Bar code reader does not operate properly..........................................................................136

7.40 Chamber does not drain properly..........................................................................................136

7.41 Chamber rotary spray arm assembly does not rotate during cycle....................................136

7.42 Close Door(s) ...........................................................................................................................137

7.43 Decontamination Cycle Due...................................................................................................137

7.44 Display blank; no acknowledgment when touch pads pressed ..........................................137

7.45 Display shows red screen with an error message ...............................................................138

7.46 Door Safety Test Required.....................................................................................................138

7.47 Excessive foam in chamber ...................................................................................................138

7.48 Generated printout is light or blank or parts of characters are missing.............................139

7.49 Interior light does not turn on ...............................................................................................139

7.50 Load comes out dirty at the end of a cycle...........................................................................140

7.51 Load comes out wet at the end of a cycle............................................................................141

7.52 Maintenance Due....................................................................................................................141

7.53 No audible signal when alarm occurs or cycle is completed ...............................................142

7.54 No Barcode Detected .............................................................................................................142

7.55 Paper is not taken up into power take-up............................................................................142

7.56 Phase stops for no apparent reason.....................................................................................142

7.57 Printer does not work ............................................................................................................143

7.58 Printer printout is erratic........................................................................................................143

7.59 Pump starts before appropriate chamber water level is reached ......................................143

7.60 Sump Safety Level Test Required .........................................................................................144

7.61 Touch screen does not work properly...................................................................................144

7.62 Transfer does not occur between conveyors and chamber ................................................144

7.63 Unload Conveyor Full..............................................................................................................145

7.64 Unload door does not open....................................................................................................145

7.65 Washer Not Calibrated ...........................................................................................................145

7.66 Water leaks from washer/disinfector ...................................................................................145

8 Replacement Parts And Products............................................................................................................146

1 — Safety Precautions

Operator Manual AMSCO®5000 Series 10057344_H

Safety Precautions

1.1 Safety Precautions — Introduction

The following Safety Precautions must be observed when uncrating/installing, operating or servicing this equipment.

WARNING indicates the potential for personal injury and CAUTION indicates the potential for damage to equipment. It

is important to review ALL Safety Precautions before operating or servicing the equipment.

Strictly following these Safety Precautions enhances the Customer’s ability to safely and effectively utilize the unit 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.

1.2 Safety Precautions

WARNING

PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD

Always load empty baskets on appropriate loading cart or surface.

Always use a hold-down screen to secure small or light items. While loading instrument

racks, do not place miscellaneous articles on the sides of instrument trays. Incorrect

rack loading/overloading could lead to injury and/or damage to the equipment or

instruments.

Always wear Personal Protective Equipment (PPE) appropriate to the task to perform.

Do not place empty baskets on the conveyor modules to load soiled articles. If you do,

proximity sensor will detect basket and indexing will automatically start.

If an obstruction is present in the wash chamber door, door safety bar will detect

obstruction and door will automatically stop from closing. Wait until door is fully open

before removing obstruction.

If an obstruction occurs and that the chamber door is not fully open, press Emergency

Stop pushbutton prior to removing obstruction.

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