FOR STERIS AMSCO 600 STEAM STERILIZER AMSCO 600.pdfAMSCO® 600 Steam Sterilizer OPERATOR MANUAL File Name: D025304,0 Model: FAHC7710-D Al Jeel Medical & Trading Date: 02.05.2019 Serial

EQUIPMENT DOCUMENTATION

OPERATOR MANUAL

FOR

STERIS AMSCO® 600

STEAM STERILIZER

AMSCO® 600 Steam Sterilizer OPERATOR MANUAL File Name: D025304,0

Model: FAHC7710-D Al Jeel Medical & Trading Date: 02.05.2019

Serial No.: 11334863 King Fahad Rd., Olaya St Revision: 0

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TABLE OF CONTENTS

1. GENERAL ....................................................................................................................... 1

1.1 Introduction ............................................................................................................... 1

1.2 Scope ........................................................................................................................ 1

2. COMPLIANCE TO STANDARDS ................................................................................... 3

3. SAFETY CONSIDERATIONS ......................................................................................... 4

3.1 Harmonized Safety Labeling and Residual Risks ...................................................... 4

3.2 User Training ............................................................................................................. 4

4. STEAM STERILIZER SYSTEM AND CYCLE OVERVIEW ............................................ 5

4.1 System Overview ...................................................................................................... 5

4.2 Cycle Overview ......................................................................................................... 6

4.2.1 Operating Cycle Descriptions ........................................................................... 7 4.2.2 Cycle 01 ............................................................................................................ 7

4.2.3 Cycle 02 ............................................................................................................ 8 4.2.4 Cycle 03 ............................................................................................................ 8

4.2.5 Cycle 04 .......................................................................................................... 10 4.2.6 Leak Test (Cycle 16) ....................................................................................... 10

4.2.7 Warm Up (Cycle 17) ....................................................................................... 10 4.2.8 Bowie Dick (Cycle 18) ..................................................................................... 10

4.2.9 Air Detector Test Cycle ( Cycle 19 – Separate Option ) .................................. 12 4.2.10 Pass Through (Cycle 20) .............................................................................. 13

4.3 Chamber Reference Locations for Validation activities ........................................... 13

4.4 Cycle Tape Description ........................................................................................... 13

5. OPERATING THE STEAM STERILIZER ...................................................................... 14

5.1 Preparing for use ..................................................................................................... 15

5.1.1 Prepare Loads for Sterilisation Cycles ............................................................ 15

5.1.2 Guidelines for Placement of Various Loads .................................................... 16 5.1.3 Test Cycles ..................................................................................................... 17

5.1.4 Operating doors .............................................................................................. 17

5.2 Sterile Side User Interface - Double Door Unit (Option) .......................................... 18

5.3 Loading and Unloading the Sterilizer....................................................................... 19

5.3.1 Emergency Door Open Procedure .................................................................. 21

5.4 Selecting Cycle ....................................................................................................... 22

5.5 Alarms ..................................................................................................................... 23

5.6 Shutting Down the Sterilizer .................................................................................... 23

5.7 Entering Data via the User Interface ....................................................................... 25

5.7.1 Alphanumerical Keyboard ............................................................................... 25




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5.7.2 Entering Numerical Values ............................................................................. 26

5.8 Security/Login ......................................................................................................... 27

Summary of Access Levels on the User Interface ................................................... 28

5.8.1 Initial Login and User Accounts ...................................................................... 30

5.9 Logout ..................................................................................................................... 30

5.10 Operator Mode ...................................................................................................... 31

5.10.1 Home 1/4 (Status) ......................................................................................... 32 5.10.2 Menu ............................................................................................................. 33

5.10.2.1 Cycle Select ..................................................................................... 34 5.10.2.2 Cycle Start........................................................................................ 35

5.10.2.3 Cycle Running .................................................................................. 36 5.10.2.4 Abort Cycle....................................................................................... 37

5.10.2.5 Step .................................................................................................. 38

5.10.3 Home 2/4 (Measurements) ........................................................................... 39

5.10.4 Home 3/4 (Active Alarms) ............................................................................. 40 5.10.5 Home 4/4 (Cycle Parameters) ...................................................................... 41

5.10.6 Copy Cycle Data ........................................................................................... 42 5.10.7 Alarm List ...................................................................................................... 43

5.10.7.1 Interlocks .......................................................................................... 44 5.10.7.2 Power Failure ................................................................................... 44

5.10.7.2.1 Emergency Stop ................................................................ 45 5.10.7.3 Door Pressure Error ......................................................................... 45

5.10.7.4 Unloading Door Selection ................................................................ 46

5.11 Administrator Mode - Configure Cycle .................................................................. 47

5.11.1 Config 1/9 (Cycle Info) .................................................................................. 51 5.11.2 Config 2/9 (Pre-Cycle) .................................................................................. 52

5.11.2.1 Leak Rate Test ................................................................................. 53 5.11.2.2 None ................................................................................................ 53

5.11.3 Config 3/9 (Pre-conditioning) ........................................................................ 54 5.11.3.1 Forced Air Removal ......................................................................... 55

5.11.4 Config 4-5/9 (Pulsed Air Removal) ............................................................... 56 5.11.4.1 None ................................................................................................ 58

5.11.5 Config 6/9 (Exposure) ................................................................................... 59 5.11.5.1 Overshoot Functionality ................................................................... 60

5.11.5.2 Time Based Exposure ...................................................................... 61 5.11.5.3 Air detection (Option) ....................................................................... 61

5.11.5.4 None ................................................................................................ 61

5.11.6 Config 7-8/9 (Postconditioning) ..................................................................... 62

5.11.6.1 Vacuum Drying................................................................................. 64 5.11.6.2 Pulse Drying ..................................................................................... 65

5.11.6.3 None ................................................................................................ 65

5.11.7 Config 9/9 (Other Parameters) ...................................................................... 66




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5.11.7.1 Alarm Delays .................................................................................... 67

5.11.7.2 Jacket Heating ................................................................................. 67 5.11.7.3 Door Interlock Type (Double Door Option) ....................................... 67

5.11.7.4 Print Settings .................................................................................... 68

5.12 Common Settings Configure Parameters .............................................................. 69

5.12.1 Common Settings 1/6 (Jacket Control) ......................................................... 69

5.12.2 Common Settings 2/6 (Process Control) ...................................................... 71 5.12.3 Common Settings 3/6 (Alarm Settings) ......................................................... 72

5.12.4 Common Settings 4/6 (PID Settings) ............................................................ 74 5.12.5 Common Settings 5/6 (Door Pressure Limits)............................................... 75

5.12.6 Common Settings 6/6 (ST Door Pressure Limits) (Option) ........................... 76

5.13 Service Mode ........................................................................................................ 77

5.13.1 Service 1/10 (Digital Inputs) .......................................................................... 77 5.13.2 Service 2-3/10 (Digital Outputs) .................................................................... 78

5.13.3 Service 4-5/10 (Analog Inputs) ..................................................................... 80 5.13.4 Service 6/10 (Pressure Calibration) .............................................................. 82

5.13.5 Service 7/10 (Temperature Calibration) ........................................................ 84 5.13.6 Service 8/10 (Alarm History) ......................................................................... 86

5.13.7 Service 9/10 (User Accounts) ....................................................................... 87 5.13.7.1 Add/Edit User ................................................................................... 88

5.13.7.2 Delete User ...................................................................................... 89

5.13.8 Service 10/10 (System Settings Screen – Time and Date) ........................... 90

5.13.8.1 Advanced Functions ......................................................................... 91

6. WASTE PRODUCTS DISPOSAL ................................................................................. 92

7. INDEX............................................................................................................................ 93

8. REVISION HISTORY..................................................................................................... 94




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TABLE OF FIGURES

Figure 1 - Principal Front View of the Sterilizer .................................................................... 5

Figure 2 - Cycle 01 Graph Chart .......................................................................................... 7 Figure 3 - Cycle 02 Graph Chart .......................................................................................... 8

Figure 4 - Cycle 03 Graph Chart .......................................................................................... 9 Figure 5 - Cycle 04 Graph Chart ........................................................................................ 10

Figure 6 - Typical Printout .................................................................................................. 13 Figure 7 - Cycle View Screen ............................................................................................ 18

Figure 8 - Principal view of the Sterilizer Loading / Unloading Area(s) .............................. 19 Figure 9 - Select Cycle screen ........................................................................................... 22

Figure 10 - Alphanumerical Keyboard................................................................................ 25 Figure 11 - Key Pad ........................................................................................................... 26

Figure 12 - Login Screen ................................................................................................... 27 Figure 13 - Steris Screen ................................................................................................... 27

Figure 14 - Operator Mode Screen .................................................................................... 31 Figure 15 - Status Screen .................................................................................................. 32

Figure 16 - Menu screen .................................................................................................... 33 Figure 17 - Cycle Select Screen ........................................................................................ 34

Figure 18 - Cycle Start Screen ........................................................................................... 35 Figure 19 - Cycle Running Window.................................................................................... 36

Figure 20 - Abort Cycle Window ........................................................................................ 37 Figure 21 - Measurements Screen .................................................................................... 39

Figure 22 - Active Alarms Screen ...................................................................................... 40 Figure 23 - Cycle Parameters Screen ................................................................................ 41

Figure 24 - Copy Cycle Data Screen ................................................................................. 42 Figure 25 - Power Failure screen ....................................................................................... 44

Figure 26 - Door Pressure Error screen ............................................................................. 45 Figure 27 - Unloading Side Selection (Abort Condition) Screen ........................................ 46

Figure 28 - Configure Cycle Screen ................................................................................... 47 Figure 29 - Cycle Info Screen ............................................................................................ 51

Figure 30 - Pre-Cycle Screen ............................................................................................ 52 Figure 31 - Precondition Screen ........................................................................................ 54

Figure 32 - Pulsed Air Removal Screen ............................................................................. 56 Figure 33 - Pulsed Air Removal 2 Screen .......................................................................... 58

Figure 34 - Exposure Screen ............................................................................................. 59 Figure 35 - Postconditioning Screen .................................................................................. 62

Figure 36 - Postconditioning 2 Screen ............................................................................... 63 Figure 37 - Other Cycle Parameters Screen ...................................................................... 66 Figure 38 - Jacket Control Screen ..................................................................................... 69

Figure 39 - Process Control Screen ................................................................................... 71 Figure 40 - Alarm Settings Screen ..................................................................................... 72

Figure 41 - PID Settings Screen ........................................................................................ 74 Figure 42 - NS Door Pressure Limits Screen ..................................................................... 75

Figure 43 - ST Door Pressure Limits Screen ..................................................................... 76 Figure 44 - Digital Inputs Screen ....................................................................................... 77

Figure 45 - Digital Outputs and Valve Outputs screens ..................................................... 78 Figure 46 - Analog Inputs Screens .................................................................................... 80




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Figure 47 - Calibrate Pressure Screen............................................................................... 82

Figure 48 - Calibrate Temperatures Screen ....................................................................... 84 Figure 49 - Alarm History Screen ....................................................................................... 86

Figure 50 - User Accounts Screen ..................................................................................... 87 Figure 51 - Add/Edit User Screen ...................................................................................... 88 Figure 52 - Delete User Screen ......................................................................................... 89

Figure 53 - System Settings Screen .................................................................................. 90 Figure 54 - Admin Functions Screen.................................................................................. 91




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1. GENERAL

1.1 Introduction

This document has been produced by STERIS and forms the Operator Manual for the:

Equipment Name: STERIS AMSCO 600

Steam Sterilizer

Manufacturer:

STERIS Corporation

5960 Heisley Road

Mentor, Ohio 44060 U.S.A.

EU Authorized Representative:

STERIS Ireland Limited

IDA Business and Technology Park

Tullamore

County Offaly

R35 X865

Ireland

1.2 Scope

The aim of this manual is to describe the function and design of the system and to provide the user

with complete information relative to operation of the unit.




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SYNOPSIS OF STERIS

For more than eighty years STERIS has pioneered new products for pharmaceutical companies,

research laboratories and hospitals. STERIS’s expertise in sterilization, disinfection, washing,

Water for Injection and Pure Steam production equipment is unparalleled in the industry. With a

reputation for advancing standards, STERIS’s products are widely known for their reliability,

performance and quality. Our goal is to provide value to every Customer with each product and

service we offer.

STERIS systems have proven to be a profitable long term investment. In designing each system

we focus on giving our Customers increased flexibility and unsurpassed reliability, thus

minimizing downtime.

The professional team behind every STERIS system is also committed to giving our Customers

the best service during the lifetime of your sterilizer.




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2. COMPLIANCE TO STANDARDS

AMSCO 600 Steam Sterilizer is designed and constructed to fulfill the requirements of

EN 285:2015: Steam Sterilizers, Large Sterilizers for performance, instrumentation accuracy, and

capability to perform the tests required.

Governing Directives for the affixing of the CE mark:

European Union Medical Device Directive (MDD) 93/42/EC as amended by 2007/47/EC.

European Pressure Equipment Directive (PED) 2014/68/EU

European Union Machinery Directive 2006/42/EC

European Union Directive 2012/19/EU "Waste Electrical and Electronic Equipment

European Union Directive 2011/65/EU "Restriction on Hazardous Substances”

European Union Electromagnetic Compatibility Directive 2014/30/EU

European Union Low-Voltage Directive 2014/35/EU

Applicable EU Standards

IEC EN 61326-1:2013 EMC requirements of CISPR 11:2015 "Industrial, scientific and medical

equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement"

IEC EN 61010-1:2010, Third Edition, "Safety requirements for electrical equipment for measurement,

control, and laboratory use. General requirements”

IEC 61010-2-040:2015 "Safety requirements for electrical equipment for measurement, control, and

laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat

medical materials"

HTM 01-01 "Management and decontamination of surgical instruments (medical devices) used in acute

care"

IEC 62304:2006 "Medical device software. Software life-cycle processes"

IEC 62366:2015 Application of Usability Engineering

ISO 13485: 2016 Medical Devices – Quality Management Systems – Requirements for Regulatory

Purposes




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3. SAFETY CONSIDERATIONS

3.1 Harmonized Safety Labeling and Residual Risks

STERIS Corporation uses internationally recognized safety labels. You may see these symbols

used throughout this document and on the Sterilizer. In order to ensure full understanding of the

risks they highlight, please review the General Safety Instructions, document D026398.

3.2 User Training

This sterilizer is a sophisticated piece of equipment. Operators must be trained on how to properly

and safely load and unload the sterilizer to reduce the risk of injury. Proper protective equipment

is also required as the sterilized load will be hot upon removal from the sterilizer.

Maintenance operations for this machine are described in the Maintenance Manual (document

D025305). To request a copy of this, contact STERIS for information on a replacement.




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4. STEAM STERILIZER SYSTEM AND CYCLE OVERVIEW

4.1 System Overview

The sterilizer is designed for moist heat sterilization of medical devices. Various products need

different sterilizing processes. Sterilizing process included in the unit is described in the paragraph

Cycle Overview, see paragraph 4.2 on page 6.

Main parts are covered with stainless steel fascia panels. Following figure shows principle view of

the sterilizer:

Figure 1 - Principal Front View of the Sterilizer




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4.2 Cycle Overview

The sterilizer is designed for moist heat sterilization of various types of products. Recommended

loads are defined in Table 1.

Table 1: Factory Default Prevacuum Cycles:

Cycles: Sterilize

Temp.

Sterilize

Time

Dry

Time Recommended Load*

Verified

Standard

1. Prevac Cycle 134°C 3.5 Minutes 25 Minutes

STU Container or Double wrapped

instrument tray containing multiple instruments, porous and non-porous

loads.

Maximum weight per STU: 10 kg

EN285

2. Prevac Cycle 121°C 16 Minutes 35 Minutes

STU Container or Double

wrapped instrument tray containing multiple instruments,

porous and non-porous loads.

Maximum weight per STU: 10 kg

EN285

3. Prevac Cycle 134°C 3.5 Minutes 10 Minutes Fabric Packs

Maximum weight per STU:7.5 kg EN285

4. Prevac Cycle 121°C 16 Minutes 10 Minutes Fabric Packs

Maximum weight per STU:7.5 kg EN285

There are 4 stages of the AMSCO 600 sterilization cycle:

Pre-cycle: Preconditioning: None* Pulsed Air

Removal*

Exposure: Post-conditioning:

Time Based Exposure* Vacuum Drying*

* - default parameters




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4.2.1 Operating Cycle Descriptions

The sterilizer comes provided with four default cycles and four test cycles. A possible 20 cycles,

including the four default cycles, are programmable to meet user needs. Editing these cycle

parameters is permitted for service and administrator access levels and is explained more

completely in section 5.11: Administrator Mode - Configure Cycle.

Each cycle button contains descriptions of how the cycle will function.

4.2.2 Cycle 01

This cycle is designed to process metal loads for 3.5 minutes in sterilize phase at 134°C with a dry

time of 25 minutes.

Figure 2 - Cycle 01 Graph Chart

0

20

40

60

80

100

120

140

0

50

100

150

200

250

300

350

0:00 0:14 0:28 0:43 0:57 1:12 1:26

Tem

per

atu

re (°

C)

Pre

ssu

re (

kPa)

Time (h:mm)

134°C Prevac Cycle - Sterilize Time 3.5 Dry Time 25m

Pressure (kPa) Temp (°C)




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4.2.3 Cycle 02

This cycle is designed to process metal loads for 16 minutes in sterilize phase at 121°C with a dry

time of 35 minutes.


4.2.4 Cycle 03

This cycle is designed to process fabric loads for 3.5 minutes in sterilize phase at 134°C with a

dry time of 10 minutes.

0

20

40

60

80

100

120

140

0

50

100

150

200

250

0:00 0:14 0:28 0:43 0:57 1:12 1:26 1:40 1:55

Tem

per

atu

re (°

C)

Pre

ssu

re (

kPa)

Time (h:mm)

121°C Prevac Cycle - Sterilize Time 16m Dry Time 35m





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0

20

40

60

80

100

120

140

160

0

50

100

150

200

250

300

350

0:00 0:07 0:14 0:21 0:28 0:36 0:43

Tem

per

atu

re (°

C)

Pre

ssu

re (

kPa)

Time (h:mm)

134°C Prevac Cycle - Sterilize Time 3.5m Dry Time 10m

Pressure (kPa)




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4.2.5 Cycle 04

This cycle is designed to process fabric loads for 16 minutes in sterilize phase at 121°C with a dry

time of 10 minutes.


4.2.6 Leak Test (Cycle 16)

This cycle is designed to pass EN285 section 8.2.3 for an empty chamber leak test. It will

condition the chamber and then draw a vacuum to minimal pressure. The sterilizer will lock the

chamber, evacuate and check the pressure again after ten minutes to determine the flow rate of

any leaks in the system. A leak rate greater than 0.13kPa/min (1.3mbar/min) will cause an alarm

to occur and the cycle will not pass.

4.2.7 Warm Up (Cycle 17)

This cycle will perform a forced air removal and short exposure phase to prepare the chamber for

a Bowie Dick test, for Leak Test, or for any other cycle.

4.2.8 Bowie Dick (Cycle 18)

0

20

40

60

80

100

120

140

0

50

100

150

200

250

0:00 0:07 0:14 0:21 0:28 0:36 0:43 0:50 0:57

Tem

per

atu

re (°

C)

Pre

ssu

re (

kPa)

Time (h:mm)

121°C Prevac Cycle - Sterilize Time 16m Dry Time 10m





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This test cycle is designed for processing Bowie-Dick packs. Bowie-Dick indicators must be

designed to EN ISO 11140-3. The sterilize temperature is 134°C, Sterilize Time is 3.5 minutes,

and Dry time is minimized to 1 minute.




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4.2.9 Air Detector Test Cycle ( Cycle 19 – Separate Option )

This cycle only appears when unit configuration is set to Air Detector: Enabled

This cycle is developed to verify the operation of the air detector test. The system will

automatically induce an air leak into the chamber during this cycle to ensure the air detector

senses air in chamber and cycle aborts.

NOTE: When the air detector successfully detects air inside the chamber, your cycle tape will

show that “Cycle Aborted” – this is indication of a successful detection. The tape record will

appear as follows:

...

13:13:11 21.73 108.0 127.0 53.3

13:13:22 AIR DETECTED IN DRAIN

13:13:22 POSTCONDITION

13:13:22 CYCLE ABORTED

13:13:44 *7.943 85.79 125.9 58.2

13:14:11 2.376 60.13 125.3 49.6

13:14:14 *2.173 58.83 125.3 49.3

13:15:11 10.77 62.33 125.0 51.6

13:16:11 13.56 62.84 124.9 49.2

13:16:26 CYCLE COMPLETED

13:16:26 *13.82 62.44 124.8 48.3

13:16:46 *14.42 62.33 124.9 48.5

13:17:11 14.42 61.03 127.6 48.2

13:17:15 STANDBY

--------- CYCLE FAILED




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4.2.10 Pass Through (Cycle 20)

This cycle only appears when the unit configuration is set to Double Door: Enabled.

A short cycle, the Pass Through Cycle will process control of the sterilizer from one side to the

other. It does not inject steam into the chamber, does not have a sterilize exposure time, and has

no dry period. The load may still become warm if left in the chamber; proper PPE is still required

when handling any load from the sterilizer.

4.3 Chamber Reference Locations for Validation activities

Hospitals are required to develop procedures to validate their equipment. In order to do this, they

require a reference point to the coldest part of the chamber. The reference point for this sterilizer

is located in the chamber drain piping next to the Drain RTD (TE517).

4.4 Cycle Tape Description

The printout reports useful information about each cycle

the sterilizer runs including cycle number, cycle name,

time and date, cycle parameters, and the person currently

signed in who is operating the sterilizer.

During the cycle, data points are printed according to

cycle parameter settings. Transition points are noted by

use of an *.

When “CYCLE PASSED” appears on the Sterilization

Cycle printout it indicates critical cycle parameters were

met.

Figure 6 - Typical Printout

Cycle Number

Cycle Name

Total Cycle Counter

Column Headers

Cycle Parameters




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3.

8.

6.

5.

1.

4.

7.

2.

5. OPERATING THE STEAM STERILIZER

The Sterilizer is operated mainly from the touch screen which is

mounted on the Sterilizer integrated cabinet.

Other control and indication functions of the Sterilizer are:

Main Switch (Power Disconnect) - enables the user to

turn ‘ON’ (1) or ‘OFF’ (0) all power to the system.

Key Switch [1.] - enables the user to turn ‘ON’ or ‘OFF’

the control system power.

Emergency Stop Push Button [2.] - enables the user to

manually stop the unit

Audible Alarm (Buzzer) [3.] - is activated if there is an

alarm condition

Non-Sterile Door OPEN & CLOSE Buttons [4.]

Chamber Pressure [5.] - independent chamber reference

pressure display

Jacket Pressure [6.] - independent jacket reference

pressure display

USB Port [7.]

Printer [8.]

Sterile side control and indication functions are:

Emergency Stop Push Button - enables the user to

manually stop the unit

Sterile Door OPEN & CLOSE Buttons

Chamber Pressure - independent chamber reference

pressure display




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5.1 Preparing for use

STERIS recommends that the following procedures be completed upon starting-up the unit:

1. See the General Safety Precautions described in User’s Manual section 3, and door opening

instructions below before operating the equipment.

2. Verify that all of the required utilities are available.

3. Open all utility isolation valves to the unit.

4. Turn the dedicated main 3PH and 1PH, if applicable, electrical fused or breaker disconnect

switch(es) to the ‘ON’ position.

5. Turn the main power disconnect switch (‘Main Switch’) to the ‘ON’ position.

6. Turn the control power ‘Key Switch’ 90 degrees clockwise to the ‘ON’ position.

The control system will initialize the system memories, upon which the unit will be placed in the

‘Standby’ mode.

NOTE: In normal use, only the ‘Key Switch’ must be turned to the ‘ON’ position before

operating the unit.

5.1.1 Prepare Loads for Sterilisation Cycles

Before sterilisation, all materials must be thoroughly cleaned.

The Amsco® 600 sterilisation chamber holds commonly used sterilisation modules, wrapped or

unwrapped instruments and equipment. Reference EN285 for limitations of the size and density

for prepared loads.

1. Wrappers may be made of 100% cotton, two- ply fabric, and must be laundered;

alternatively, use commercially available, non-woven disposable wrappers. Recommended

maximum size: 300 x 270 x 600 mm; Maximum weight: 7.5 kg.

2. Limit the weight of wrapped instrument sets or containers to 10 kg to minimize moisture

retention.

3. Recommends STERIS order # AX0710000000000027 wire baskets for individually

wrapped items.




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5.1.2 Guidelines for Placement of Various Loads

Refer to EN ISO 17665-1:2006, and instructions below, for load

placement guidelines.

1. Open the steriliser chamber door.

2. Place all packs on edge, and arrange load to allow for maximum

steam exposure so that there is minimal resistance for steam

passage through the load.

3. Place utensils and treatment trays on their edges so that they will

be sterilised and properly dried.

4. Place instrument sets in trays that have a perforated or mesh

bottom. Place flat for sterilisation.

5. In mixed loads of fabrics and hard goods, place the hard goods

on lower shelf. This reduces wetting of fabric packs from

condensate dripping from a hard goods load.

6. DO NOT OVERLOAD steriliser (refer to Paragraph 5.3 for

recommended loading guidelines). Allow for steam penetration

between packs. Avoid contact of load components with the wall

of the chamber.

7. After placing load in chamber, close the chamber door. The

steriliser is now ready to run a cycle. Proceed to appropriate

cycle description in this section.

8. Materials capable of holding water, such as solid-bottomed

pans, basins and trays, should be positioned so that they are

oriented in the same direction and so that condensate can be

eliminated.

NOTE: If a cycle has been run, steriliser and shelves or loading

carrier may be hot.

NOTE: Wear clean gloves and use clean towels as “pot holders”

when carefully placing the load/tray(s) on the chamber shelves or

loading carrier.




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WARNING:

BURN HAZARD: Steriliser, shelves and loading carrier will be hot after

cycle is run. Always wear protective gloves and apron when removing a

processed load. Protective gloves and apron must be worn when reloading

sterilizer following the previous operation.

WARNING:

PERSONAL HAZARD: When closing the chamber door, keep hands and

arms out of the door opening and make sure opening is clear of any

obstructions.

5.1.3 Test Cycles

Run required test cycles:

Run a Bowie-Dick test with an otherwise empty chamber at least once a day to document

removal of residual air from sample challenge loads.

NOTE: Always run a warm-up cycle before running the daily Bowie-Dick test.

CAUTION: Use only a Bowie-Dick indicator that has met EN ISO 11140-3:2009 and is the

correct indicator for the cycle type selected. Verify indicator is successful based on that products’

IFU.

Run a vacuum leak test at least once each week to measure the integrity of chamber and

associated piping.

CAUTION: If a biological indicator is used, ensure that it is the correct indicator for the cycle

type selected.

5.1.4 Operating doors

Door open and close buttons must be continually pressed until the door is in the open or closed

position.




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5.2 Sterile Side User Interface - Double Door Unit (Option)

When user logs in from one side, the other side screen will display the Cycle View screen. An

example of the screen is shown in the following figure.

Figure 7 - Cycle View Screen

Press OPERATE NS (OPERATE ST) button to operate sterilizer at the appropriate side. Sterile

side is similar to non-sterile side with the exception of Configuration menu.




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5.3 Loading and Unloading the Sterilizer

WARNING:

BURN HAZARD: The loading cart, sterilizer doors and other sterilizer

surfaces will be extremely hot after a cycle is completed. Always wear

protective gloves and apron when loading or unloading the Sterilizer.

NOTE: It is recommended to generate instructions for the use of protective clothing and other

safety guidelines.

Various types of loading accessories are used to support and convey assorted products in the

loading, sterilizing and unloading process. Loading accessories, transfer trolleys and loading cars

for all size chambers. For 6STU chamber sizes, a rack and shelf system inside the chamber is also

offered.

NOTE: For Loading Equipment operating instructions refer to the operating manuals sent with

the loading equipment.

STERIS recommends generating instructions for loading and unloading the sterilizer. Loading and

unloading area(s) should be marked on the floor to the front of the sterilizer. In the following

figure is shown the principle view of the sterilizer loading and unloading areas.

Figure 8 - Principal view of the Sterilizer Loading / Unloading Area(s)




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The following instructions are to be observed when loading the sterilizer.

Fully open the door.

Always wear protective gloves and apron when loading or unloading the sterilizer.

Do not try to open the door unless the cycle is complete.

Do not try to open the door if the chamber pressure gauge or user interface indicates any other

pressure than atmospheric pressure.

If the chamber pressure is other than atmospheric pressure, then:

Immediately contact your service department.

Do not operate the sterilizer until an authorized service technician has resolved the situation.

NOTE: The door open and close buttons must be continually pressed until the door is in the open

or closed position.

CAUTION: EQUIPMENT HAZARD: Ensure item(s) being loaded in the chamber are suitable

for the selected cycles sterilize temperature. Failure to ensure device heat ratings

may cause premature failure of the items to be sterilized.

CAUTION: At the end of a cycle, remaining steam and heat in chamber will exhaust to room

when door is opened. This may affect heat or moisture sensitive equipment placed nearby.

NOTE: Verify that the cycle has finished and the screen shows Cycle Complete. Verify that there

are no alarms shown on the screen. Check that the AMSCO 600 printout states that the

load has been properly processed with a recorded {i} sterilization time {ii} sterilization

temperature {iii} sterilization pressure, and {iv} cycle complete. Release the load and

follow the unloading procedures.




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It is important to not load the chamber using non-standard loading equipment. Use of non-

standard loading configuration is not supported.

EN-285 compliant

AMSCO 600 Sterilizer Size Number of

1 STU

Wrapped

Trays or

Instrument

Sets

(@ 10kg each)

Maximum

weight (kg)

for Wrapped

Trays or

Instrument

Sets

(@ 10kg each)

Maximum

weight (kg)

for Fabric

Packs

(@ 7.5kg

each)

675 x 675 x 990 mm (6 STU) 6 60 45

675 x 675 x 1290 mm (8 STU) 8 80 60

675 x 675 x 1590 mm (10 STU) 10 100 75

675 x 675 x 1890 mm (12 STU) 12 120 90

Standard loading equipment is as follows:

For 6STU chamber, use a single 6STU loading cart or Rack and Shelves option.

For 8STU chamber, use a single 8STU loading cart or two 4STU loading carts.

For 10STU chamber, use a single 10STU loading cart.

For 12STU chamber, use two 6STU loading carts.

CAUTION: Use of an improper load may result in the items not being properly sterilized. Ensure

that the cycle type is suitable and properly validated for the load being sterilized.

5.3.1 Emergency Door Open Procedure

In the event of power failure, the emergency door open procedure can be performed to bypass safety

features by authorized personnel only. The instructions can be accessed in the maintenance manual in

section 3.6.2.




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5.4 Selecting Cycle

Figure 9 - Select Cycle screen

Description of Cycle Select Buttons:

Cycle Name and Number

Sterilize Temperature (can be set to °C or °F) – this is the sterilize time – The amount of time the load is

exposed to the sterilization temperature

Dry Time – The amount of time which the load is given to dry at the end of the cycle

For more information on each cycle, please see section 4.2.1:

CAUTION: If the incorrect cycle type is selected the cycle can be aborted within the Door Seal

phase (duration 1 minute) and a new cycle can be selected. Once the cycle reaches Conditioning

phase, steam has entered the chamber and reprocessing the load may be necessary.

For more information about on selecting, starting and aborting the cycle in following paragraphs:

Select Cycle, see paragraph 5.10.2.1, page 34

Start, see paragraph 5.10.2.2, page 35

Abort, see paragraph 5.10.2.4, page 37




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5.5 Alarms

Alarms are designed to identify anomalies and deviations within the system. All active alarms will

remain active until the situation has been resolved, acknowledged, and reset.

When an alarm condition becomes active it is displayed to the operator with:

audible alarm (buzzer)

Active Alarms screen, see section 5.10.7 Alarm List, page 43.

Common alarm relay output for Customer monitoring purposes

The alarm is acknowledged and reset by selecting the alarm, then pressing the ACK button on the

user interface.

Should the ACK button be pressed when the alarm condition is active, then the audible alarm is

cancelled.

Please reference the Maintenance Manual Alarm List paragraph for a complete list of alarms and

the Alarm Formats and Troubleshooting section in the Maintenance Manual for additional alarm

information.

CAUTION: Failure to follow troubleshooting recommendations of an alarm may result in damage

to the machine or load.

Alarms fall into two categories:

Critical (aborting)

Non-critical (non-aborting)

A critical (aborting) alarm - interrupts the cycle by automatically bringing the chamber to

atmospheric pressure and shutting down the Sterilizer in a safe, controlled manner. The situation

must be resolved before any other cycles may be processed.

A non-critical (non-aborting) alarm causes only audible alarm (buzzer) and ALARMS button

starts blinking. The cycle is continued unless the user wants to abort the cycle by selecting

ABORT from the Cycle Status screen.

5.6 Shutting Down the Sterilizer

Shutting down the sterilizer when it is in the ‘Standby’ mode is accomplished as follows:

1. The control system of the unit may be shutdown by turning the control power ‘Key Switch’

90 degrees counter clockwise to the ‘OFF’ position. Upon switching the control power off,

the unit will automatically logout the user.

NOTE: In normal use, turning the ‘Key Switch’ to the ‘OFF’ position is sufficient action to

shutdown the sterilizer. If you need to shut off all power, follow points 2. and 3.




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2. Turning the main power disconnect switch (‘Main Switch’) to the ‘OFF’ position turns off all

power at the unit.

3. Turning the dedicated main 3PH and 1PH, if applicable, electrical fused or breaker disconnect

switch(es) to the ‘OFF’ position remotely isolates all power from the unit.

NOTE: Please observe the following before shutting down the sterilizer:

Return control of the unit to the non-sterile side, if using passthrough function.

Do not turn the compressed air off.

It is important to follow these observations to prevent the door interlocking system

from losing containment between the non-sterile and sterile sides.




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5.7 Entering Data via the User Interface

The user is able to enter data such as user name, password, cycle name, batch number and cycle

parameters to the system. Data entering is made either with key pad or alphanumerical keyboard

depending on which kind of data should be entered.

5.7.1 Alphanumerical Keyboard

The user can enter alphabetical and numerical values with alphanumerical keyboard.

Alphanumerical keyboard is displayed in the following figure.

Figure 10 - Alphanumerical Keyboard

When the input data is completely keyed accept this by pressing ‘Enter’ key (↵). After this the

alphanumerical keyboard will close.

If a keystroke error happened during entering press the ‘Backspace’ key (←) to erase the

appropriate character and then enter the new one. Pressing the ESC key will leave the screen

without changing the data.




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5.7.2 Entering Numerical Values

A parameter value including only numerical characters is able to enter with numerical key pad to

the system. Press first the appropriate field or button, which will display a key pad. Enter the

desired value for the selected parameter. When the entered value is correct accept it by pressing

‘Enter’. Numerical key pad is shown in the following figure.

Figure 11 - Key Pad

The minimum and maximum values of the parameter will also be shown on the screen. If the

entered value is outside the range of the parameter, the display does not allow the user to proceed

even if the ‘Enter’ key would be pressed. Enter the value again and confirm it by pressing ‘Enter’.

If a keystroke error happened during entering press the ‘Del’ key to erase the appropriate figure

and then enter the new one. Pressing the ESC key will leave the screen without changing and

saving the value. The value does not store in the memory without confirmation of ‘Enter’.




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5.8 Security/Login

Login screen is displayed after the power is turned on. This screen is also displayed by pressing

the LOGOUT button on the STERIS screen.

Figure 12 - Login Screen

After entering the correct user name and password, the STERIS screen is displayed. The easy

mode is designed for basic operation of the unit while advanced mode includes all available

features.

Figure 13 - Steris Screen




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Password protection provides restricted access of unauthorized users to critical operator modes.

Access levels are available for ‘Operator’, ‘Supervisor’, ‘Service’ and ‘Administrator’ level user

groups as follows:

With the ‘Operator’ level password, it is permissible to select a cycle, start a cycle, acknowledge

alarms, view measurements information and copy cycle data to USB.

With the ‘Supervisor’ level password, in addition to the ‘Operator’ level also permits editing time

and date. This extra feature is accessed on the supervisor menu screen.

With the ‘Service’ level password, in addition to the ‘Supervisor’ level, it is permitted to view

inputs, activate/deactivate outputs, edit common settings, edit user accounts, calibrate instruments

and change date/time, and skip the current step of the running cycle.

With the ‘Administrator’ level password, in addition to the ‘Service’ level, it is permitted to

configure user names and edit passwords for all access levels.

Summary of Access Levels on the User Interface

The following table is a summary of the access levels and it can be used to facilitate the users and

service technicians to find out their access levels for the appropriate functions on the user

interface.

Notice also the following functions:

after the initialization process is completed, Login screen is always the first screen on the

user interface.

login to the system will be required to operate the unit.

if the user has no access to a function then the appropriate dialog box or parameter field has

been hidden on the screen.

some functions require that the equipment must be in Standby process status prior to the

appropriate function being executed.

The following abbreviations are used in the table below:




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X = Access to modify is possible with this password level

--- = No access with this password level

OP = ‘Operator’

SU = ‘Supervisor’

SE = ‘Service’

AD = ‘Administrator’

MENU or FUNCTION OP SU SE AD

Login /Main Menu (STERIS Screen) X X X X

Home (4 screens) X X X X

1. Status Screen - Select Cycle, Start Cycle, Abort, Main Menu X X X X

2. Measurements X X X X

3. View Parameters, Copy Cycle Data to USB, Jacket heating in standby X X X X

4. Active Alarms (acknowledge and clear) X X X X

Configure Cycle (9 screens) - - X X

1. Cycle Info (name and comment) - - X X

2 to 8. Pre-Cycle, Forced and Pulsed Air Removal, Exposure, Post-Conditioning - - X X

9. Other Parameters (alarm delays, jacket heating, interlocks, print settings) - - X X

Common Settings (6 screens) (See Maintenance Manual) - - X X

1 and 2. Jacket Temp Control (AUS), Process Control - - X X

3. Alarm Settings - - X X

4. PID Settings - - X X

5 and 6. Door Pressure Limits – NS and ST - - X X

Service (10 screens) - - X X

1 to 4. Digital Inputs/Outputs - - X X

5. Analog Inputs - - X X

6 and 7. Pressure/Temperature Calibration - - X X

8. Alarm History - - X X

9. User Accounts - - X X

10. Time/Date Setting - X X X




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5.8.1 Initial Login and User Accounts

The unit is shipped from the factory with the ‘Administrator’ user name and password set to

default values ‘admin’ and ‘admin’. Upon start-up of the equipment it is HIGHLY

RECOMMENDED that the ‘Administrator’ level password is changed by the Customer and

stored in a safe location.

1. Log in to the unit as described in paragraph 5.8, page 27.

2. Press the ‘User Name’ field, this will display an alphanumerical keyboard; enter then the

user name ‘admin’. Then press the ‘Password’ field, enter also the password ‘admin’. If an

error is made keying in the user name or password, prior to pressing ‘Enter’ key on the

alphanumerical keyboard, the ‘Del’ key may be used to erase a value. If an incorrect user

name and/or password value was entered, then the login will fail.

3. Following a successful login with ‘Administrator’ and ‘Service’ access levels, STERIS

screen will be displayed.

4. Press the ADVANCED MODE button on the screen and the Status screen is displayed.

5. Press the MENU button on the Status screen and the Menu window is displayed.

6. Press the SERVICE button from the Menu window and search for User Accounts screen

(9/10) with arrow buttons.

7. Press the ADD USER button from the User Accounts screen, Add User screen is displayed,

see paragraph 5.13.7.1, page 88.

8. The user name and passwords of any level may now be set. For more information about

password setting is described in paragraph 5.13.6, page 86.

9. It is RECOMMENDED that all ‘Operator’, ‘Supervisor’, ‘Service’ and ‘Administrator’

users names and passwords are agreed upon and DOCUMENTED prior to login to the

system. It is suggested to set the ‘Administrator’ level password first and retain the default

user name admin, only change the password.

10. Upon completion of adding new users to the system, return to the Login screen, by pressing

MENU button, then HOME button and then pressing LOGOUT.

Other default users are oper1 (password: oper1), super1 (password: super1) and serv1 (password:

serv1).

Additional information and settings are present in 5.13.7) Service 9/10 (User Accounts)

.

5.9 Logout

The user may logout from the system by pressing MAIN MENU on the Status screen and then

LOGOUT button on the Status screen. After a power failure the user is automatically logged out.




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5.10 Operator Mode

The Operator Mode screen is displayed by pressing the Operator Mode button on the STERIS

screen.

Figure 14 - Operator Mode Screen

The Operator Mode screen is used to access additional sub-menus.

When the unit is in standby mode, status of the start conditions is shown on the screen. When a

cycle is running, it is shown on the screen.

The following sub-menus and operations are accessible from this screen:




Selection of the MAIN MENU button will return you to the STERIS screen.




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5.10.1 Home 1/4 (Status)

The Status screen is displayed by pressing the ADVANCED MODE button on the STERIS

screen or HOME button on the Menu screen.

Figure 15 - Status Screen

The Status screen is used to access additional sub-menus and display the current status.

When the unit is in standby mode, status of the start conditions is shown on the screen. When a

cycle is running, measurements are shown on the screen.

The following sub-menus and operations are accessible from this screen:




Step, see paragraph 5.10.2.5, page 38

Measurements, see paragraph 5.10.3, page 39

Alarms, see paragraph 5.10.4, page 40

Copy Cycle Data, see paragraph 5.10.6, page 42

Selection of the MAIN MENU button will return you to the STERIS screen.




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5.10.2 Menu

NOTE: This button is only available in Supervisor, Service, and Administrator access modes.

By pressing MENU button from the top bar, the Menu screen will be displayed. An example of

the screen is shown in the following figure.

Figure 16 - Menu screen

The following sub-menus are accessible from this screen:

Home, see paragraph 5.10.1, page 32

Configuration, see paragraph 5.11, page 47

Common Settings, see paragraph 5.12, page 69

Service, see paragraph 5.13, page 77

Selection of will close the Menu screen.




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5.10.2.1 Cycle Select

Selection of SELECT CYCLE from the Status screen will display the Cycle Select screen.

Figure 17 - Cycle Select Screen

The total number of cycles available is 20. Selection of an individual cycle is made from the list.

Confirm the selected cycle by pressing the cycle button.

The Cycle Select screen will be cleared and the Status screen will be displayed.




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5.10.2.2 Cycle Start

Selection of selected cycle from the Cycle Select screen will display the Cycle Start screen. An

example of the screen is shown in the following figure.

Figure 18 - Cycle Start Screen

Enter the batch number by pressing the ‘Batch Number’ field.

To start the selected cycle, press the START button on the screen, and the Cycle Start screen will

be cleared and the Status screen will be displayed.

NOTE: Cycle starting is possible only when the interlock type and start conditions are OK. If

program step is not correct, selection of START will return you to the Status screen

without starting a cycle.

The batch number will remain when the cycle is completed. It is possible to enter a new batch

number for the current cycle.

NOTE: The condition of the chamber drain debris filter must be checked prior to each sterilizing

cycle. Filter must be cleaned if required.

‘Started Cycles’ shows cycles after last reset. Reset cycle counter by pressing RESET button.

NOTE: Cycle counter is not visible on the Cycle Start screen in Easy Mode.

Selection of CANCEL will return you to the Status screen without starting the cycle.




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5.10.2.3 Cycle Running

When the Cycle is running, screen will display the Cycle Running window.

Figure 19 - Cycle Running Window

Selection of ALARMS or pressing ALARM button will display the Active Alarms screen.

Selection of ABORT will abort the cycle in a safe manner.

Selection of MAIN MENU button will return you to the MAIN MENU




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5.10.2.4 Abort Cycle

When the Cycle is running, selection of ABORT from the Status screen will display the Abort

Cycle window.

Figure 20 - Abort Cycle Window

Selection of ABORT will abort the cycle in a safe manner. Upon selecting ABORT the Abort

Cycle window will be cleared.

Selection of CANCEL will continue the cycle providing there are no other active aborting alarms,

and display the Status screen.

NOTE: If a cycle is aborted:

Do not try to open the door.

Immediately contact your service department.

Do not operate the sterilizer until an authorized service technician has resolved the

situation.




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5.10.2.5 Step

The STEP button is displayed on the Status screen if the user is logged on higher than ‘Operator’

access level while running a cycle. Step button can be used to move forward in sterilization cycle

when chamber pressure sensor PT549 is faulted.

NOTE: ALWAYS check chamber pressure from the external pressure gauge before pressing

Step-button!




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5.10.3 Home 2/4 (Measurements)

Selection of MEASUREMENTS from the Home menu (2/4) will display the Measurements

screen.

Figure 21 - Measurements Screen

The Measurements screen is used to display the current process data in real time. Information

such as chamber pressure, chamber temperature, air detector temperature (option), load probe

temperature, and jacket temperature are displayed.




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5.10.4 Home 3/4 (Active Alarms)

Selection of ALARMS from the Home menu (3/4) or pressing ALARM button from the Top Bar

will display the Active Alarms screen.

Figure 22 - Active Alarms Screen

Alarms are designed to identify anomalies and deviations within the system. All active alarms will

remain active until the situation has been resolved and acknowledged.

A critical alarm, automatically aborts the current cycle to a safe state, whereas a non-critical alarm

do not abort the cycle. When an alarm is active then the ‘Active alarm’ text flashes and an audible

alarm sounds. Text, briefly describing the alarm condition will be visually displayed.

Access to the Active Alarms screen from the Cycle Status screen is typically used to check the

status of any active alarms that have been acknowledged. The alarm text will remain on the screen

until the alarm condition is cleared, acknowledged and reset with RESET button.




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5.10.5 Home 4/4 (Cycle Parameters)

Selection of CYCLE PARAMETERS from the Home menu (4/4) will display the Cycle

Parameters screen.

Figure 23 - Cycle Parameters Screen

Press the VIEW PARAMETERS button to see parameters of the selected cycle.

The COPY button is designed for copying the last cycle data to USB, see paragraph 5.10.6 on the

next page.

Jacket heating during Standby phase can be chosen from this screen. Jacket control settings can be

configured from the Jacket Control screen, see paragraph 5.12, page 69.

Cycle Data can be automatically downloaded to a STERIS ConnectAssure Software Archive if

the ConnectAssure Package option is purchased. Instructions on how this is to be done will be

found in the STERIS ConnectAssure installation and operating instructions.




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5.10.6 Copy Cycle Data

When a cycle is completed, the Copy Cycle Data screen is displayed.

Figure 24 - Copy Cycle Data Screen

The screen asks from the user that ‘Copy Cycle Data to USB?’.

USB memory has to be plugged to the USB port before copying cycle data. ‘USB storage for

cycle data’ shows green when USB memory is plugged in.

Press COPY button to copy cycle data to USB memory and the Status screen is displayed.

Press CANCEL button to cancel cycle data copy and the Status screen is displayed. Data of the

last cycle can be copied on the Cycle Parameters screen, see paragraph 5.10.5, page 41. Starting a

new cycle will remove the last cycle data.




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5.10.7 Alarm List

The following alarms are provided on the Sterilizer:

Aborting Alarms:

NS Door Open

ST Door Open (Option)

NS Door Failed To Seal

ST Door Failed To Seal (Option)

NS Door Seal Failure

ST Door Seal Failure (Option)

Pressure Channel Fault

Control Temperature Channel Fault

Too Long In Heating-Up

Temperature Deviation

Power Failure

Too Long In Evacuation Phase

Too Long In Pressurization Phase

Door Safety Edge

Emergency Stop Pressed

Leak Test Failure

Cycle Aborted

Chamber Pressure High

Water in Chamber

Rack Failure

PT685/PT686/PT876/PT877 Fault

Air Detected in Drain (Option)

TE520 Temp channel Fault (Option)

PT870 Pressure Channel Fault (Option)

PSG Overtemperature (Option)

PSG Water Level high (Option)

PSG Water Level low (Option)

PSG Steam Pressure High (Option)

PSG Heating Fault (Option)

Non-Aborting Alarms:

Vacuum Pump Tripped

Air In Chamber (Option)

Chamber Support Air Pressure Low (Option)

Pressure Transmitter Conflict

Circulation Water Tank Level Low (Option)

TE525 temperature channel fault (Option)

CAUTION: In order to prevent alarms, it is important that all utilities are connected properly and

supply the correct range to the sterilizer.




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5.10.7.1 Interlocks

The following door and starting interlocks are provided:

The cycle cannot be initiated until the door(s) is closed and locked.

The cycle can be initiated only if there are no active alarms, jacket temperature is OK and cycle

is selected.

The door cannot be opened until the sterilization cycle is completed, the chamber pressure has

equalized to atmospheric pressure and the door gasket has been retracted.

In double door units, the only door that can be opened, after the cycle has been completed, is

the one based on the door interlock configuration.

In double door units, in case of an aborted cycle, only the original loading door can be opened

if the cycle was aborted before a post-conditioning phase. If the cycle was aborted during or

after the post-conditioning phase, the cycle interlock setting selects the unloading side.

In double door units, only one (1) door can be opened at a time.

The steam chamber valve cannot be opened by the PLC if a door is open.

The gasket cannot be pressurized if the door is open.

NOTE: See paragraph 5.11.7.3 for table of interlock types.

5.10.7.2 Power Failure

In the event that there is an electrical power failure of the facility delivery system while a cycle is

being run, then upon restoration of power the Power Failure screen will be displayed.

Figure 25 - Power Failure screen

Press CONTINUE/ABORT button to continue the cycle and it is automatically aborted to a safe

state.




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5.10.7.2.1 Emergency Stop

In the event that the Emergency Stop switch is activated, the ‘Emergency Stop’ text is displayed

on the left top corner of the screen.

Upon pressing the Emergency Stop switch all outputs are immediately disabled. The switch must

be released to continue the operation. Upon releasing the switch, the Power Failure screen will be

displayed, and the user have to press CONTINUE/ABORT button to continue the cycle and it is

automatically aborted to a safe state.

5.10.7.3 Door Pressure Error

When the door pressure is not in door pressure limits and door open or close button is pressed, the

Door Pressure Error screen will be displayed.

Figure 26 - Door Pressure Error screen

Press ACKNOWLEDGE button and wait for door pressure limits will be achieved. Door pressure

limits can be configured on the Door Pressure Limits screen, see paragraph 5.12.5, page 75.




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5.10.7.4 Unloading Door Selection

In case of an aborted cycle, only the original loading door can be opened if the cycle was aborted

before a post-conditioning phase. If the cycle was aborted during or after the post-conditioning

phase, the user has the ability to choose which door can be opened (unloading side). When the

Equalization phase is completed after an aborted cycle the following screen is displayed:

Figure 27 - Unloading Side Selection (Abort Condition) Screen

Upon selecting the unloading side the program will continue to unseal selected door.




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5.11 Administrator Mode - Configure Cycle

Selection of CONFIGURATION from the Menu window will display the Configure Cycle

screen.

Figure 28 - Configure Cycle Screen

Select the cycle you want to configure from the dropdown list.

CONFIGURE button will display the Cycle Info screen and you can edit parameters of the

selected cycle on the Config screens.

NOTE: Before running the Bowie Dick cycle, make sure that cycle 06 parameters match the

Bowie-Dick test pack manufacturer's cycle parameters. Preconfigured Bowie-Dick cycle

is also user configurable.

NOTE: After configuring a cycle, you have to re-select the cycle on the Cycle Select screen (see

paragraph 5.10.2.1, page 34) to have the latest changes.

WARNING: Service and Administrator modes are for authorized users only. Normal

operators should not have access to the service menu and the ability to change cycle

parameters.

CAUTION: Modifying cycle parameters without re-validating the cycle, can cause inefficatious loads.




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Cycle Parameter Chart

Parameters Units Low Limit High Limit

Cycle Info (Config screen 1/9)

Number text N/A N/A

Cycle Name: text N/A N/A

Cycle Comment: text N/A N/A

Pre-Cycle (Config screen 2/9)

Pre-Cycle type: F-A LRT/None N/A N/A

Init vacuum level kPa 0 100

Init vacuum time min 0 20

Stabilization time min 0 60

Vacuum test time min 0 60

Acceptable leak kPa 0 24

Vacuum pump during stabilization ON/OFF N/A N/A

Air Detector Leak Test ON/OFF N/A N/A

Preconditioning (Config screen 3/9)

PreCondition 1 Type: None/Pulsed/Forced N/A N/A

PreCondition 2 Type: None/Pulsed/Forced N/A N/A

Forced Air Removal:

Forced air removal time min 1 600

Forced air removal temperature °C 80.0 110.0

Preconditioning 1 (Config screen 4/9)

Pulsed Air Removal 1:

Number of pulses integer 1 99

First pulse type Vacuum/Pressure N/A N/A

Vacuum Level (1st) kPa 0 200

Vacuum Level (2nd) kPa 0 200

Vacuum Level (3rd ->) kPa 0 200

Vacuum hold time (1st) sec 0 600

Vacuum hold time (2nd) sec 0 600

Vacuum hold time (3rd ->) sec 0 600

Pressure Level (1st) kPa 0 300

Pressure Level (2nd) kPa 0 300

Pressure Level (3rd ->) kPa 0 300

Pressure hold time (1st) sec 0 600

Pressure hold time (2nd) sec 0 600

Pressure hold time (3rd ->) sec 0 600

Preconditioning 2 (Config screen 5/9)

Pulsed Air Removal 2:

Number of pulses integer 1 99

First pulse type Vacuum/Pressure N/A N/A

Vacuum Level (1st) kPa 0 200

Vacuum Level (2nd) kPa 0 200

Vacuum Level (3rd ->) kPa 0 200




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Vacuum hold time (1st) sec 0 600

Vacuum hold time (2nd) sec 0 600

Vacuum hold time (3rd ->) sec 0 600

Pressure Level (1st) kPa 0 300

Pressure Level (2nd) kPa 0 300

Pressure Level (3rd ->) kPa 0 300

Pressure hold time (1st) sec 0 600

Pressure hold time (2nd) sec 0 600

Pressure hold time (3rd ->) sec 0 600

Exposure (Config screen 6/9)

Exposure Type: None/Time N/A N/A

Exposure temperature °C 110.0 135.0

Exposure time min 0.0 600.0

Deviation high limit °C 0.5 9.9

Deviation low limit °C 0.0 9.9

Jacket temperature °C 90.0 130.0

Exposure Pressure Control:

Pressure control enabled ON/OFF N/A N/A

Exposure pressure kPa 170 340

Overshoot:

Overshoot enabled ON/OFF N/A N/A

Overshoot offset °C 0.0 3.0

Air Detector:

Airdetect. enabled ON/OFF N/A N/A

Airdetect. temperature °C 60.0 120.0

Airdetect. pressure kPa 30 200

Postconditioning (Config screen 7/9)

Postcondition 1: None/Vacuum/Pulsed N/A N/A

Postcondition 2: None/Vacuum/Pulsed N/A N/A

Postconditioning (Config screen 8/9)

Vacuum Drying:

Vacuum level kPa 0 100

Vacuum hold time min 0 600

Pulse Drying:

Drying pulses integer 1 99

Vacuum level kPa 0 100

Vacuum hold time min 0 600

Pressure level kPa 0 100

Pressure hold time min 0 600

Other Cycle Parameters (Config screen 9/9)

Interlock Type text N/A N/A

Alarm Delays:

Too long in evacuation sec 60 9999




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Too long in pressurization sec 60 9999

Too long in heating up sec 60 9999

Cycle print interval: sec 60 60

Jacket Heating:

Precycle ON/OFF N/A N/A

Preconditioning 1 ON/OFF N/A N/A

Preconditioning 2 ON/OFF N/A N/A

Postconditioning 1 ON/OFF N/A N/A

Postconditioning 2 ON/OFF N/A N/A

Descriptions of these parameters are found throughout section 5.11) Administrator Mode -

Configure Cycle.




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5.11.1 Config 1/9 (Cycle Info)

Pressing EDIT CYCLE button from the Configure Cycle screen or selection of CYCLE INFO

from the Config menu (1/9) will display the Cycle Info screen.

Figure 29 - Cycle Info Screen

To rename the selected cycle, press the CYCLE NAME field, this will display an alphanumeric

keyboard. Enter the new cycle name on the keyboard and press enter.

Comments of the cycle can be entered to the CYCLE COMMENT field.




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5.11.2 Config 2/9 (Pre-Cycle)

Selection of PRE-CYCLE from the Config menu (2/9) will display the Pre-Cycle screen.

Figure 30 - Pre-Cycle Screen

The pre-cycle phase is designed to perform a leak rate test to test the integrity of the chamber and

door gasket under vacuum. The pre-cycle can only be performed as an individual cycle.

Select PRE-CYCLE TYPE from the dropdown list:

Leak Rate Test, see paragraph 5.11.2.1, page 53

None, see paragraph 5.11.2.2, page 53




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5.11.2.1 Leak Rate Test

The leak rate test is divided into three steps. During the first step the unit must reach the pre-

configured ‘Initial Vacuum Level’ value within the pre-configured ‘Initial Vacuum Time’

timeframe. If the initial vacuum level is not reached, ‘Leak Test Failure’ alarm will be displayed

and test is aborted.

During the second step (stabilization phase) the pump is running or stopped according to the

‘Vacuum Pump during Stabilization’ parameter. The length of this step is equal to the

‘Stabilization Time’. This phase will stabilize the pressure and temperature within the chamber.

During the third step the ‘Vacuum Test Time’ pressure will be maintained, the pump is stopped,

all the valves are closed and the leak rate will be measured. If the measured leak rate exceeds

configured ‘Acceptable Leak Rate’, ‘Leak Test Failure’ alarm will be displayed and test is

aborted.

The Leak Test consists of the following process steps in this order:

LRT VACUUM LEVEL

LRT STABILIZATION

LRT VACUUM HOLD

The following parameters are configurable for the leak rate test:

PARAMETER RANGE DEFAULT

Initial Vacuum Level 0-100 kPa 7 kPa

Initial Vacuum Time 0-20 min 10 min

Stabilization Time 0-60 min 5 min

Vacuum Test Time 0-60 min 10 min

Acceptable Leak Rate 0.0-24.0 kPa 1.24 kPa

Vacuum Pump During Stabilization ON / OFF OFF

Air Detector Leak Test ON / OFF OFF

Default values for the leak rate test are designed to meet the leak rate requirements defined by

EN285. Alternatively, specific leak rate test parameters may be configured in accordance with

your SOP.

It is recommended to perform a leak rate test at weekly intervals.

5.11.2.2 None

By selecting NONE, the system will bypass the pre-cycle and sterilization cycles can be run.




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5.11.3 Config 3/9 (Pre-conditioning)

Selection of PRECONDITIONING from the Config menu (3/9) will display the Precondition

screen.

Figure 31 - Precondition Screen

This phase is designed to remove air from the chamber prior to the heating-up step.

User may configure either one pre-conditioning phase or select two consecutive pre-conditioning

phases. Usually, only one pre-conditioning phase is configured and NONE is selected for the

PRECONDITION 2 field.

Following table shows possible combinations for the pre-conditioning phases:

PRECONDITION 1 PRECONDITION 2

None Forced Air Removal Pulsed Air Removal

None X – –

Forced Air Removal X – X

Pulsed Air Removal X X X




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Selection of one of the following pre-conditioning button from this screen will highlight the

button:

Forced Air Removal, see paragraph 5.11.3.1, page 55

Pulsed Air Removal, see paragraph 5.11.4, page 56


5.11.3.1 Forced Air Removal

Forced air removal removes air from the chamber by introducing steam to force the air out

through the drain line system. The vacuum pump is simultaneously operated to assist in

evacuating the air. Both the chamber pressure and temperature are controlled during the phase.

The Forced Air Removal consists of the following process step:

FORCED AIR REMOVAL

The following parameters are configurable for Forced Air Removal:


Forced Air Removal Time 1-600 min 2 min

Forced Air Removal Temperature 80.0-110.0 °C 100.0 °C




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5.11.4 Config 4-5/9 (Pulsed Air Removal)

Selection of PRECONDITIONING 1 (PULSED AIR REMOVAL) from the Config menu (4/9)

will display the Pulsed Air Removal screen.

Figure 32 - Pulsed Air Removal Screen

Pulsed air removal will remove the air from the chamber by using vacuum and steam pulses. It is

designed for dry goods.

The Pulsed Air Removal consists of the following process steps (order depends on selected first

pulse type):

VACUUM LEVEL

VACUUM HOLD

PRESSURE LEVEL

PRESSURE HOLD




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The following parameters are configurable for pulsed air removal:


Number Of Pulses 1-99 4

First Pulse Vacuum /

Pressure Vacuum

1st Vacuum Level 0-200 kPa 8.6 kPa

1st Vacuum Hold Time 0-600 s 0 s

1st Pressure Level 0-300 kPa 48.3 kPa

1st Pressure Hold Time 0-600 s 0 s

2nd Vacuum Level 0-200 kPa 10.3 kPa

2nd Vacuum Hold Time 0-600 s 0 s

2nd Pressure Level 0-300 kPa 96.5 kPa

2nd Pressure Hold Time 0-600 s 0 s

3rd Vacuum Level 0-200 kPa 13.8 kPa

3rd Vacuum Hold Time 0-600 s 0 s

3rd Pressure Level 0-300 kPa 96.5 kPa

3rd Pressure Hold Time 0-600 s 0 s

Fourth and additional pulses to ninety-nine use the same parameter values as the third pulse.




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Selection of PRECONDITIONING 2 (PULSED AIR REMOVAL) from the Config menu (5/9)

will display the Pulsed Air Removal 2 screen.

Figure 33 - Pulsed Air Removal 2 Screen

5.11.4.1 None

By selecting NONE, the system will bypass the pre-conditioning phase (1 or 2) and proceed to the

next phase.




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5.11.5 Config 6/9 (Exposure)

Selection of EXPOSURE from the Config menu (6/9) will display the Exposure screen.

Figure 34 - Exposure Screen

The Exposure consists of the following process step:

HEATING UP

EXPOSURE

The following paragraphs describe functionality of the Overshoot and the Air Detection.

Selection of one of the following exposure buttons from this screen will highlight the button:

Time, see paragraph Error! Reference source not found., page Error! Bookmark

not defined.





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5.11.5.1 Overshoot Functionality

Overshoot is designed to shorten the heating-up time required for products which absorb large

quantities of heat, i.e. large metal loads. The heating-up step is accelerated by initially setting the

setpoint temperature higher than the user configured exposure temperature.

The following formula symbols are used within the overshoot calculation:

T(set) = Calculated Setpoint Temperature

T(exp) = User Configured Exposure Setpoint

Overshoot may be selected by pressing the ‘Overshoot ON/OFF’ button from the screen.

The overshoot offset determines a specific constant which is added to the user configured

exposure setpoint:

T(set) = T(exp) + OFFSET

See the following sample calculation:

T(exp) = 121.1 C

OFFSET 0.2 C

T(set) = 121.1 C + 0.2 C = 121.3 C

The overshoot feature will be automatically deactivated when the temperature of the coldest load

probe and controlling probe is above the user-defined exposure setpoint (Exposure Temperature)

minus the user-defined exposure temperature low limit (Deviation Low Limit) plus 0.2 °C

hysteresis. The hysteresis is to allow the temperatures to stabilize within the deviation window,

and to avoid premature temperature deviation alarms. The ‘Deviation Low Limit’ is typically set

at 0.5 C.

The following parameters are configurable for overshoot:


Overshoot ON / OFF OFF

Overshoot Offset 0.0-3.0 C 0.0 C




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5.11.5.2 Time Based Exposure

Time based exposure is based on the time the load is at the exposure temperature.

The following parameters are configurable for time based exposure.


121C PREVAC

DEFAULT

134C PREVAC

Exposure Temperature 110.0-135.0 °C 121.0 °C 134.0 °C

Exposure Time 0-600 min 16 min 3.5 min

Deviation High Limit 0.5-9.9 °C 3 °C 3 °C

Deviation Low Limit 0.0-9.9 °C 0 °C 0 °C

Jacket Temperature 90.0-130.0 °C 117.0 °C 130.0 °C

Overshoot ON / OFF OFF OFF

Overshoot Offset 0.0-3.0 C 0.0 C 0.0 C

5.11.5.3 Air detection (Option)

The purpose of the Air Detector device is to simulate the task of removing the air and replacing it

by steam. Just like for certain packed loads it is difficult to get the air replaced by steam, it is

difficult to get the air replaced in a narrow, long dead-end tube. In the Air Detection option, a tube

like this is mounted into the drain pipework of the sterilizer. Temperature is measured from the

end of the pipe. If some air remains in the tube after the air removal phase, the temperature in the

end of the tube will remain lower than that of the main drain probe. On the other hand, if the air

removal worked properly, the temperature of the Air Detector probe will follow that of the main

drain probe (TE517) after the air removal.

For further information see paragraph ‘Air Detector Installation and Tuning Instructions’ in

Maintenance Manual.

The following parameters are configurable for air detection:


Air Detection ON / OFF ON

Air Detection Pressure 30-200 kPa 172.4 kPa

Air Detection Temperature 60.0-120.0 °C 108.0 °C

5.11.5.4 None

By selecting the button NONE from the Exposure screen will highlight the button, and the system

will bypass the exposure phase and proceed to the post-conditioning phase.




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5.11.6 Config 7-8/9 (Postconditioning)

Selection of POSTCONDITIONING from the Config menu (7/9) will display the

Postconditioning screen.

Figure 35 - Postconditioning Screen




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Selection of POSTCONDITIONING 2 from the Config menu (8/9) will display the

Postconditioning 2 screen.

Figure 36 - Postconditioning 2 Screen

The purpose of the postconditioning phase is to dry and/or cool the product after the exposure

phase to allow safe unloading of the sterilizer.

User may configure either one post-conditioning phase or select two consecutive postconditioning

phases.

Selection of one of the following postconditioning buttons from this screen will highlight the

button:

Vacuum Drying, see paragraph 5.11.6.1, page 64

Pulse Drying, see paragraph 5.11.6.2, page 64





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5.11.6.1 Vacuum Drying

Vacuum drying is designed and typically used to dry and also slightly cool dry goods. The

internal heat energy of the product(s) is used to dry its exterior surfaces. The depth of the vacuum

will affect the final load temperature. Jacket heating may be used to introduce additional heat

energy into the system to decrease the overall drying time. The vacuum hold time starts when the

system has reached the configured vacuum level.

The Vacuum Drying consists of the following process steps in this order:

VACUUM LEVEL

VACUUM HOLD

The following parameters are configurable for vacuum drying:


FABRIC

DEFAULT

METAL

Vacuum Level 0-100 kPa 8.6 kPa 8.6 kPa

Vacuum Hold Time 0-600 min 10 min 25/35 min*

* 35 minutes should be used with the steam to steam generator option




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5.11.6.2 Pulse Drying

Pulse drying is designed and typically used to dry and cool porous product(s) or product(s)

packaged in pouches. The internal heat energy of the product(s) is used to dry its exterior surfaces.

Vacuum pulses are followed by unheated dry air pulses which carry out evaporated moisture from

the chamber. Jacket heat may also be used to introduce additional heat energy into the load to

decrease the overall drying time.

The Pulse Drying consists of the following process steps in this order:

VACUUM LEVEL

VACUUM HOLD

PRESSURE LEVEL

PRESSURE HOLD

The following parameters are configurable for pulse drying:


Drying Pulses 1-99 1

Vacuum Level* 0-100 kPa 0 kPa

Vacuum Hold Time 0-600 min 10 min

Pressure Level 0-100 kPa 0 kPa

Pressure Hold Time 0-600 min 0 min

* if required, use vacuum drying parameters as starting point

5.11.6.3 None

By selecting NONE from the Postconditioning screen, the system will bypass the post-

conditioning phase and appropriately equalize the chamber pressure to atmospheric pressure by

opening the drain line and simultaneously running the vacuum pump.

CAUTION: The temperature of the product(s) may exceed 100 °C and residual steam will remain

in the chamber at atmospheric pressure.




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5.11.7 Config 9/9 (Other Parameters)

Selection of OTHER CYCLE PARAMETERS from the Config menu (9/9) will display the Other

Cycle Parameters screen.

Figure 37 - Other Cycle Parameters Screen

Other Cycle Parameters are designed to include all other cycle specific variables.

The following parameters are available for selection from the Other Cycle Parameters screen:

Alarm Delays, see paragraph 5.11.7.1, page 67

Jacket Heating, see paragraph 5.11.7.2, page 67

Interlock Type, see paragraph 5.11.7.3, page 67

Print Settings, see paragraph 5.11.7.4, page 68




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5.11.7.1 Alarm Delays

Alarm delays settings may be configured from this screen. Configurable alarm settings are: ‘Too

Long in Evacuation’, ‘Too Long in Pressurization’ and ‘Too Long in Heating Up’.

The following parameters are configurable for alarms:


Too Long in Evacuation 60-9999 s 3600 s

Too Long in Pressurization 60-9999 s 2400 s

Too Long in Heating Up 60-9999 s 3600 s

5.11.7.2 Jacket Heating

The Jacket Heating screen is used to allow heating of the jacket when performing pre-cycle, pre-

conditioning or post-conditioning. Jacket heating for appropriate phase is selected when its mode

is ON. Jacket temperature setpoint for the above-mentioned cycle phases is Common Settings

parameter and its configured on Jacket Control screen, see paragraph 5.12 on page 69.

The following parameters are configurable for Jacket Heating:


Precycle ON / OFF OFF

Preconditioning 1 ON / OFF ON

Preconditioning 2 ON / OFF ON

Postconditioning 1 ON / OFF ON

Postconditioning 2 ON / OFF OFF

5.11.7.3 Door Interlock Type (Double Door Option)

The Sterilizer loading and unloading door interlock process flow is configured from this screen.

Press the appropriate process flow button to select the desired cycle process flow configuration -

only one process flow may be selected for each cycle.

Option Loading Door Unloading Door Next Cycle Loading

NSNS Non-Sterile Non-Sterile Non-Sterile

NSST Non-Sterile Sterile Sterile

NSSTNS Non-Sterile Sterile Non-Sterile

STST Sterile Sterile Sterile

STNSST Sterile Non-Sterile Sterile

STNS Sterile Non-Sterile Non-Sterile




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5.11.7.4 Print Settings

Cycle print interval is configurable for printing data to the batch report:


Cycle Print Interval 60-600 s 60 s

Printing contents:

Cycle Header with:

- Serial number

- Cycle number and name

- Batch number

- Cycle start date/time

Cycle Phase types (precycle, preconditioning, exposure, postconditioning)

Measured process values (at given print interval):

- Chamber pressure

- Chamber (drain) temperature

- Jacket temperature

- Load probe temperature

Alarms:

- Alarm name

- Alarm ON time

Phase name and process values at step or phase transition.




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5.12 Common Settings Configure Parameters

5.12.1 Common Settings 1/6 (Jacket Control)

Selection of COMMON SETTINGS from the Menu window will display the Jacket Control

screen.

Figure 38 - Jacket Control Screen

Jacket heating during Standby phase is configured from this screen. Jacket heating during cycle is

cycle specific setting for each cycle phase and is configured from Other Cycle Parameters screen,

see paragraph 5.11.7.2 on page 67.

If heating during standby is turned off, jacket heating begins when the door is closed. When jacket

heating is turned on, temperature setpoint is configured with parameter ‘Jacket Temperature

Setpoint’. This setpoint is used during all phases with exception for Heating Up and Exposure.

Parameter ‘Minimum Temperature for Cycle Start’ defines the temperature which jacket shall be

reached before the cycle starting is enabled.

NOTE: ‘Jacket Temperature Setpoint’ must be higher than ‘Minimum Temperature for Cycle

Start’. Otherwise, the cycle starting is impossible.

Automatic utility shutdown is designed to minimize the consumption of the steam for jacket

heating. ‘Jacket heating off delay in standby’ can be configured when ‘Heating during Standby’ is

ON.




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NOTE: The recommended setting for the “Jacket heating off delay in standby” time is a minimum

of one hour longer the planned daily operating time. (i.e. – If the sterilizer is to operate 9 hours a

day, the “Jacket heating off delay in standby” setting would be 600 minutes (10hrs)).

The following parameters are configurable for jacket control:


Heating During Standby ON / OFF ON

Minimum Temperature for Cycle Start 0.0-120.0 °C 114.0 °C

Jacket Temperature Setpoint 90.0-130.0 °C 117.0 °C

Jacket heating off delay in standby 15-1440 min 120 min




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5.12.2 Common Settings 2/6 (Process Control)

Selection of PROCESS CONTROL from the Common settings menu (2/6) will display the

Process Control screen.

Figure 39 - Process Control Screen

Parameter ‘Door Unsealing Time’ defines vacuum pump running time when unsealing the door

gasket.

Equalization abort vacuum is used in B-process to remove remaining steam from the chamber in

abort condition. Unit will decrease the pressure in the chamber to the user-defined ‘Equalization

Abort Vacuum Level’ and hold that level for the ‘Equalization Abort Vacuum Hold Time’.

Parameters are intended to be adjusted according to the loads, e.g. low vacuum and long hold time

for vacuum sensitive loads and deeper vacuum and shorter time if the load can withstand such

conditions. If Slow Exhaust is configured in the cycle, process destination is always Slow Exhaust

in abort condition.

The following parameters are configurable for process control:


Door Unsealing Time 10-120 s 30 s

Equalization Abort Vacuum Level 0-100 kPa 55 kPa

Equalization Vacuum Hold Time 0-999 s 30 s

Seal Purge Time 0-300 s 60 s




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5.12.3 Common Settings 3/6 (Alarm Settings)

Selection of ALARM SETTINGS from the Common settings menu (3/6) will display the Alarm

Settings screen.

Figure 40 - Alarm Settings Screen

Alarm settings may be configured from this screen. The configurable alarm settings are related on

following alarms: ‘Air in Chamber’ and ‘Temperature Deviation’. For more information about

alarms see Maintenance Manual.

The Steam Generator (Option) is designed to produce steam of a quality equal to the feed water

that is introduced into the system; therefore, the feed water should meet the requirements of US

Pharmacopoeia relating to USP quality water. The integral steam generator does not include any

entrainment device to remove pyrogens.

The feed water for the integral steam generator system should be either deionized, RO or WFI

quality water. GMP requirements dictate that steam must not contain any boiler additives.

The system includes the feed water system, steam generation system and the controls. Operation

of the clean steam generator is entirely automatic, when power is on to the unit.




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The following parameters are configurable for alarms:


Air in Chamber Alarm Delay 0-9999 s 30 s

Air in Chamber Alarm Limit 0-100 kPa 35 kPa

Air in Chamber Alarm Type

Not Active/

Aborting/

Non-Aborting

Aborting

Temperature Deviation Alarm Delay 0-999 s 1 s

Temperature Deviation Aborting Delay 0-9999 s 1 s

PSG Enabled ON / OFF OFF

PT549-PT550 Deviation Alarm Limit 1-50 kPa 6.9 kPa

TE517A-TE517B Deviation Alarm Limit 0-10 °C 1.0 °C




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5.12.4 Common Settings 4/6 (PID Settings)

Selection of PID SETTINGS from the Common settings menu (4/6) will display the PID Settings

screen.

Figure 41 - PID Settings Screen

Proportional Gain (P), Integral (I) and Derivative (D) terms of the control loop equation are pre-

configured at the factory qualification. However, the parameters may be configured for a cycle by

the user with a ‘Supervisor’ or higher access level. The PID control loop terms and set point may

also be changed in the run mode for testing purposes. The set point value will default to the

exposure setting value of a specific cycle upon selection of a cycle.

The following parameters are configurable for the PID control valve:

PARAMETER RANGE

Chamber

Temperature

DEFAULT

Chamber

Pressure

DEFAULT

Proportional Gain (P) 1-10000 20 10

Integral (I) 1-10000 55 15

Derivative (D) 1-10000 0.0 0.0




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5.12.5 Common Settings 5/6 (Door Pressure Limits)

Selection of NS DOOR PRESSURE LIMITS from the Common settings menu (5/6) will display

the NS Door Pressure Limits screen.

Figure 42 - NS Door Pressure Limits Screen

The following parameters are configurable for the door pressure limits:


Door Close Max Pressure 300 – 500 kPa 500 kPa

Door Close Min Pressure 250 – 450 kPa 360 kPa

Door Open Max Pressure 200 – 400 kPa 400 kPa

Door Open Min Pressure 50 – 350 kPa 100 kPa




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5.12.6 Common Settings 6/6 (ST Door Pressure Limits) (Option)

Selection of ST DOOR PRESSURE LIMITS from the Common settings menu (6/6) will display

the ST Door Pressure Limits screen.

Figure 43 - ST Door Pressure Limits Screen

The following parameters are configurable for the door pressure limits:


Door Close Max Pressure 300 – 500 kPa 500 kPa

Door Close Min Pressure 250 – 450 kPa 360 kPa

Door Open Max Pressure 200 – 400 kPa 400 kPa

Door Open Min Pressure 50 – 350 kPa 100 kPa




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5.13 Service Mode

5.13.1 Service 1/10 (Digital Inputs)

Selection of SERVICE from the Menu window will display the Digital Inputs screen (1/10).

CAUTION: Refer to the machine schematic for diagram of each input or output in this section.

Figure 44 - Digital Inputs Screen

The Digital Inputs screen is used for input verification purposes only; it is not possible to force

the PLC inputs directly from this screen.

Each input is identified by a slot and individual input number and a visual status indicator, which

is green when the input is ‘high’ and red when the input is ‘low’.

Manually change the status of the field mounted equipment (FME) via switches, pressure

switches, buttons, etc. When the FME status has changed, i.e. a button is depressed, the PLC input

status will be displayed on the screen in either a ‘high’ or ‘low’ state.

The Digital Inputs screen may be viewed during cycle operation to verify that the FME are

functioning.




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5.13.2 Service 2-3/10 (Digital Outputs)

Selection of DIGITAL OUTPUTS and VALVE OUTPUTS from the Service menu (2/10 and

3/10) will display Digital Outputs and Valve Outputs screens.

Figure 45 - Digital Outputs and Valve Outputs screens

The Digital Outputs and the Valve Outputs screens are used for forcing individual digital outputs

to test FME.

Each output is identified by a slot and individual output number and a visual status indicator,

which is green when the output is ‘high’ and red when the input is ‘low’.




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To activate an output, shown above, press the desired output switch on the screen, which will

activate the output. Selecting the same output switch again will deactivate the output.

NOTE: The steam supply should be closed while testing the digital output of the PID valve.

NOTE: The status of an individual output, ‘high’ or ‘low’ does not necessarily imply that the

FME has responded correctly. Forcing of outputs should always be followed with visual

verification of the FME status.

Output forcing mode is changed by pressing the button FORCE MODE ON (blue enabled/ red

disabled).

When output forcing mode is enabled, the outputs are fixed until user deselects the forcing mode

by pressing the button again. NOTE: The output forcing mode MUST BE SWITCHED OFF when service operations has be

done. The forcing mode is automatically switched off only in event of the power break.




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5.13.3 Service 4-5/10 (Analog Inputs)

Selection of ANALOG INPUTS from the Service menu (4/10 and 5/10) will display Analog

Inputs screens.

Figure 46 - Analog Inputs Screens

The Analog Inputs screen displays the systems temperatures and pressures with their

corresponding input values.




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This screen is for visual information only. It is not possible to make any changes or other inputs to

this screen.

The analog inputs are scaled linearly according to calibration values.

The total number of product probes displayed depends on the quantity delivered with the unit.




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5.13.4 Service 6/10 (Pressure Calibration)

Selection of CALIBRATE PRESSURE CHANNELS from the Service menu (6/10) will display

the Calibrate Pressure screen.

Figure 47 - Calibrate Pressure Screen

One point calibration is done without a pressure calibration instrument. One point calibration only

requires a, certified, calibrated pressure gauge capable of measuring ambient atmospheric

pressure.

The calibration is to be performed with pressure vessel at ambient temperature and the door open.

DO NOT close the chamber door. Read the atmospheric pressure value on the calibrated pressure

gauge and document the pressure reading.

1. Select the pressure sensor by pressing it on the screen. The selected probe will highlight.

2. Select the ‘Calibration pressure reference’ button on the screen. This will display a numeric

keypad. Enter the measured atmospheric pressure value and then press ‘Enter’.

Wait until the pressure value displayed on the screen stabilizes. Then press the CALIBRATE

button to set the calibration pressure value.

Three point calibration is done with a pressure calibration instrument. Three point calibration

requires a, certified, calibrated pressure gauge capable of measuring 0-414 kPa (0-60 psia).




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This calibration is to be performed with pressure vessel at ambient temperature, the door open and

the pressure transducers removed from the piping. DO NOT close the chamber door.

For the High Point:


2. Select the High Pressure point by pressing it on the screen. The selected point will highlight.


keypad. Enter the measured High pressure value around 350 kPa (50 psia) and then press

‘Enter’.

4. Wait until the pressure value displayed on the screen stabilizes. Then press the ‘Calibrate

Point’ button to set the calibration pressure value.

For the Middle Point:


2. Select the Middle Pressure point by pressing it on the screen. The selected point will highlight.


keypad. Enter the measured atmospheric pressure value 101kPa (14.7 psia) and then press

‘Enter’.



For the Low Point:


2. Select the Low Pressure point by pressing it on the screen. The selected point will highlight.


keypad. Enter the measured Low pressure value around 7kPa (1 psia) and then press ‘Enter’.



Saving Calibraion Values:

1. Once the High, Middle and Low values have been entered press the ‘Save All’ button to store

the complete calibration




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5.13.5 Service 7/10 (Temperature Calibration)

Selection of CALIBRATE TEMPERATURE CHANNELS from the Service menu (7/10) will

display the Calibrate Temperatures screen.

Figure 48 - Calibrate Temperatures Screen

Two-point temperature probe calibration requires an adjustable temperature bath with a

temperature stability of ±0.1 °C. The temperatures used during the FAT are 90.0 °C for the low

point calibration and 136.0 °C for the high point calibration. Other values may be used depending

on the calibration SOP´s and available calibration equipment.

A certified, calibrated, reference temperature measuring instrument with a measuring resolution of

±0.1 °C is required. ‘Low Point Value’ and ‘High Point Value’ should be read from this

instrument and sufficient time allowed for the stabilization.

NOTE: The total number of probes available for selection depends on the quantity delivered with

the unit.




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Calibration Procedure:

1. Select the probe(s) to be calibrated by selecting the appropriate probe(s) on the screen. The

selected probe(s) will be highlighted.

2. Select the ‘Calibration temperature reference’ button on the screen. This will display a

numeric keypad. Enter the appropriate low point value and then press ‘Enter’.

3. Submerge the selected probe(s) into the low temperature bath. Wait until the temperature

values(s) displayed on the screen stabilize. Then press the CAL. LOW button to set the low

point calibration temperature value(s)..

4. Select the ‘Calibration temperature reference’ button on the screen. This will display the

numeric keypad. Enter the appropriate high point value and then press ‘Enter’.

5. Submerge the selected probe(s) with reference probe into the high temperature bath. Wait

until the temperature values(s) displayed on the screen stabilize. Then press the CAL. HIGH

button to set the high point calibration temperature value(s).




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5.13.6 Service 8/10 (Alarm History)

Selection of ALARMS from the Service menu (8/10) will display the Alarm History screen.

Figure 49 - Alarm History Screen

Alarm history screen displays alarms from the selected time period (dropdown list).

Alarm history screen is useful for maintenance if the same alarm occurs many times. Alarm time

and alarm off time is also displayed on the history list.




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5.13.7 Service 9/10 (User Accounts)

Selection of USER ACCOUNTS from the Service menu (9/10) will display the User Accounts

screen.

Figure 50 - User Accounts Screen

The User Accounts screen is used to add and delete users.

NOTE: Only successful logon with ‘Administrator’ access level (level 5) grants access to the

screen.

The following sub-menus are accessible from this screen:

Add/Edit User, see paragraph 5.13.7.1, page 88

Delete User, see paragraph 5.13.7.2, page 89




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5.13.7.1 Add/Edit User

Selection of ADD USER or EDIT USERS button from the User Accounts screen will display the

Add/Edit User screen.

Figure 51 - Add/Edit User Screen

The following parameters are configurable for each user after appropriate user is selected:

PARAMETER RANGE

Group

Operator

Supervisor

Service

Administrator

Logout Time 0-150 min

NOTE: There are also groups “Guest” and “Unauthorized” in the list but those are not in use in

this unit.

Add the user name by pressing the ‘User name’ field on the screen. Enter the appropriate user

name and press ‘Enter’. On the edit users screen, choose the appropriate user name from the list.

Add the user password, press the ‘Set Password’ field on the screen. user password and press

‘Enter’. Upon entry of your password, characters are not displayed on the screen, they are

replaced by bullets ‘ • ’.

To change user’s group level, press the ‘Group’ field on the screen and select access level from

the list (e.g. ‘Operator’).

You can add comment, change requirements of the password and set the inactivity logoff time if

the ‘Enable logoff time’ is TRUE.

When all items (user name, password and other settings) are properly set, press the ADD (APPLY

on the edit users screen) to accept new user account.




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Selection of CANCEL button will return you to the User Accounts screen.

5.13.7.2 Delete User

Selection of DELETE USER button from the User Accounts screen will display the Delete User

screen.

Figure 52 - Delete User Screen

Select the user (USER NAME and GROUP from the dropdown lists) and press DELETE button

to delete appropriate user account.

Selection of CANCEL button will return you to the User Accounts screen.




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5.13.8 Service 10/10 (System Settings Screen – Time and Date)

Selection of SYSTEM TIME 24H from the Service menu (3/10) will display the System Settings

screen.

Figure 53 - System Settings Screen

The Time / Date Setting screen is used to enter new time and/or date values.

To change the time, press the time values on the screen. This will display a numeric keypad. Enter

the appropriate month/day/year/hour/minute values. The newly entered time will be displayed on

the screen.

Press SET TIME button to save values to the PLC memory.

NOTE: The TIME/DATE SETTING button is not displayed if a cycle is in process.

Change language by pressing the flag of the appropriate language.

HMI settings list can be opened by pressing the HMI button.




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5.13.8.1 Advanced Functions

Selection of FUNCTIONS button from the System Settings screen will display the Advanced

Functions screen.

Figure 54 - Admin Functions Screen

Continue from wait step, see paragraph 5.10.7.2, page 44.

Select unload side, see paragraph 5.10.7.4, page 46.

Go to next step, see paragraph 5.10.2.5, page 38.

Copy cycle data to USB, see paragraph 5.10.6, page 42.




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6. WASTE PRODUCTS DISPOSAL The following are waste materials associated with the steriliser. When disposing of waste materials, be sure to do so in compliance with federal, state, and local regulations. • Printer paper – recyclable. • Printer ribbon – not recyclable. • Water filters – not recyclable. • Waste water – see equipment drawing for flow rate. WRAS category 4. • Entire steriliser (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.




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7. INDEX

A

Abort Cycle, 37 Access level, 28 Active Alarms, 40 Air Detection, 61 Alarm Delays, 68 Alarm History, 41, 87 Alarm List, 43 Alarm Settings, 74

Alarms, 23, 40, 43 Alphanumerical Keyboard, 25 Analog Inputs, 82

B

Batch Number, 35

C

Common Settings, 70

Configure Cycle, 47 Cycle Running, 36 Cycle Select, 34 Cycle Start, 35 Cycle Status, 32

D

Date Setting, 91 Digital Outputs, 80

E

Emergency Stop, 45 Entering Data via the User Interface, 25 Exposure, 59, 61

F

Fast Exhaust, 66 Finn-Aqua Leak Rate Test, 53 Forced Air Removal, 55

H

HTM 2010, 61

I

Initial Password Setting at Start-up, 30 Interlocks, 44

J

Jacket Heating, 68

K

Key Pad, 26

L

Leak Rate Test, 53 Loading and Unloading the Sterilizer, 19 Login, 27 Logout, 30

M

Mode Select, 33

O

Operation Description of the Steam Sterilizer, 5 Other Parameters, 67 Overshoot, 60

P

Password, 30, 88 Post-conditioning, 63 Power Failure, 44 Pre-conditioning, 54 Pre-cycle, 52 Pressure Calibration, 84 Print Settings, 69

Process Control, 73 Process Overview, 6 Pulse Drying, 66 Pulsed Air Removal, 56

R

Run Mode, 32

S

Security, 27 Service Mode, 79 Set Passwords, 88 Shutting Down the Sterilizer, 23 Starting the Sterilizer, 14 Step, 38 System Overview, 5

T

Temperature Calibration, 85 Time Based Exposure, 61 Time Setting, 91

U

Unloading Door Selection, 46 User Interface, 25, 28

V

Vacuum Drying, 65




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8. REVISION HISTORY

Base Document:

File name : OM_E_HC_FE

Revision Date : 9.5.2018

Version : Revision 2

Person Responsible : Juho Lauhakangas

Revision Description : Operator Manual

Customer Specific Document:

File name : D025304,0

Revision Date : 02.05.2019

Version : Revision 0

Person Responsible : Tinja Harjunen

Revision Description : Operator Manual for 11334863

Documents

FOR STERIS AMSCO 600 STEAM STERILIZER AMSCO 600.pdfAMSCO® 600 Steam Sterilizer OPERATOR MANUAL File Name: D025304,0 Model: FAHC7710-D Al Jeel Medical & Trading Date: 02.05.2019 Serial