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Steam sterilizer

MST-V 6-6-X
User Manual
These instructions apply to:

Product Steam Sterilizer MST-V

Product version 09.02

PLC version V1.16.xxx

Country-specific regulations Product subject to Pressure Equipment Directive (PED)

Material 107-9813

Document | Version 1004-2796 | 03

Language EN-US English

Month | Year 10 | 2017

Copyright 2017

Belimed AG
Grienbachstrasse 11
6300 Zug, Switzerland
+41 41 449 78 88
+41 41 449 78 89
info@belimed.com | www.belimed.com
Steam sterilizer MST-V 6-6-X | © Belimed

Content

1 Introduction 7
1.1 Product identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.2 Target group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.3 Change and copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.4 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5 Contact person . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.6 Symbols and notices used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2 Safety 10
2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.3 Personnel requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.4 General safety instructions for operation . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.5 Summary of the safety instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.6 Signs on the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3 Description 16
3.1 Overview of the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2 Operating elements and display elements . . . . . . . . . . . . . . . . . . . . . . . . 19
3.2.1 Location of main switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.2.2 Control panel on loading side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2.2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2.2.2 Status bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2.2.3 Communication bar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.2.4 Activity bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.3 Display when a program is running . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.2.4 Display of the current readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.2.5 Operating panel on unloading side (2-door) . . . . . . . . . . . . . . . . . . . . . . . 24
3.2.5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.2.5.2 Status bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.2.5.3 Activity bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.2.6 Process status indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.3 Loading and unloading equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.3.1 Batch cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.3.2 Transport cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.4 Safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.4.1 Emergency stop button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.5 Mechanism of action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

4 Operation 29
4.1 Switching on the sterilizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.2 Logging on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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4.3 Items to be sterilized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31


4.3.1 Suitable materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.3.1.1 Textiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.3.1.2 Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.3.1.3 Rubber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.1.4 Liquids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.1.5 Other materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.2 Preparing the load. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.2.1 Instructions for sterilizing packaged items . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3.2.2 Packaging items to be sterilized with cloths. . . . . . . . . . . . . . . . . . . . . . . . 33
4.3.2.3 Textile packages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.3.2.4 Instruments in trays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.3.2.5 Packaging in rigid containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.3.2.6 Packaged equipment and utensils . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.3.3 Load capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.3.4 Loading batch carts or extendable shelves (option) . . . . . . . . . . . . . . . . . . . 38
4.4 Loading the sterilizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.5 Sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
4.5.1 Steam sterilizing programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
4.5.2 Abbreviations for procedure designations. . . . . . . . . . . . . . . . . . . . . . . . . 44
4.5.3 Instructions for sterilizing liquids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.5.4 Cycle documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.6 Unloading the sterilizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.6.1 Letting the batch cool down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.6.2 Checking the batch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.6.3 Possible causes of wet goods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.7 Log off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.8 Changing the program parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.9 Further functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.9.1 Inserting and removing the support grid of the batch cart. . . . . . . . . . . . . . . . . 51
4.9.2 Automatic start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.9.3 Automatic switch-off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.9.4 Program intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4.9.4.1 Terminate program manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.9.4.2 Continue program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.9.5 Operating panel settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.9.5.1 Changing the operating language. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.9.5.2 Adjusting the brightness on the operating panel on the
loading side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.9.5.3 Adjusting brightness and contrast on operating panel on
unloading side. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.9.6 Subsequent cycle documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
4.9.7 Machine information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

5 Options 58

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5.1 Steam generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58


5.2 Automation unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.2.1 Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.2.2 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
5.3 Extendable shelves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.3.1 Removing the extendable shelf (option) . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.3.2 Installing the extendable shelf (option) . . . . . . . . . . . . . . . . . . . . . . . . . . 64
5.4 Foot switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
5.5 Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
5.6 ICS8535-BC documentation system . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

6 Errors 68
6.1 Process-relevant errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
6.2 Program intervention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
6.3 Automatic program termination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
6.4 Error display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
6.5 Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
6.6 Other errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

7 Cleaning 79
7.1 Overview of the front surface materials . . . . . . . . . . . . . . . . . . . . . . . . . 79
7.2 Extendable shelves (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
7.3 Chamber and stainless steel surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . 81
7.4 HI-MACS® surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
7.5 Screen and glass surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
7.6 Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

8 Maintenance work 83
8.1 Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
8.2 Daily maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
8.3 Weekly maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
8.4 Maintenance programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.4.1 Leak test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.4.2 Bowie-Dick Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.4.3 Integrated Bowie-Dick Test (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.4.4 Monitoring of the sterilizing process . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
8.5 Replacing the paper roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

9 Technical data 89
9.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
9.2 Dimensions and weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
9.2.1 Steam sterilizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
9.2.2 Batch cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
9.2.3 Extendable shelves (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
9.3 Quality of utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

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9.3.1 Compressed air quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91


9.3.2 Cold water quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
9.3.3 Cooling water quality in systems with cooling circuit
(option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
9.3.4 Feed water quality for steam generator (option) . . . . . . . . . . . . . . . . . . . . . 92
9.3.5 Steam quality, external steam supply (option) . . . . . . . . . . . . . . . . . . . . . . 92
9.4 Electrical connection specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
9.4.1 Steam sterilizer (3N~200–230 V, 50/60 Hz) . . . . . . . . . . . . . . . . . . . . . . . 94
9.4.2 Steam sterilizer (3N~380–420 V, 50/60 Hz) . . . . . . . . . . . . . . . . . . . . . . . 94
9.5 Surrounding conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
9.5.1 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
9.5.2 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
9.6 Cycle documentation printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

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1 Introduction
1.1 Product identification
The MST-V steam sterilizer from Belimed AG is available as 1-door (VS1) or 2-door model (VS2) in
the following sizes:
• 6-6-6
• 6-6-9
• 6-6-12
• 6-6-18
The features which determine the exact designation are listed below:

MST H-W-D VSx

MST Medical Sterilizer

H-W-D H: usable height H = 6 dm


W: usable width B = 6 dm
D: usable depth [dm]

VSx V = vertical door(s)


x = 1: 1-door version
x = 2: 2-door version

1.2 Target group


These instructions are addressed to the following target group:
• Operator
These instructions must be accessible to the target group at all times.

1.3 Change and copyright


The text, graphics and data contained here represent the technical status of the product at the time
of printing of these instructions. Changes due to further development may occur. The original version
of this document is in German (DE).
These instructions, including all parts thereof, are protected by copyright law. Utilization of any kind,
whether for duplication, translation or processing in other media, is not permissible without the con-
sent of Belimed AG. The contents of these instructions must not be used for commercial purposes.

1.4 Warranty
The product must only be installed and commissioned by personnel employed by Belimed AG or per-
sonnel who have been trained by Belimed AG. Belimed AG accepts no responsibility for work per-
formed by personnel neither directly employed by Belimed AG, nor trained by Belimed AG.
No repairs or modifications in or on the product must be carried out by non-authorized personnel. Un-
authorized repairs and modifications exclude any liability of the manufacturer for resulting damages
to the operator and the product. Furthermore, modifications that affect operation may violate local
laws and jeopardize insurance coverage in the event of malfunction.

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Repairs and modifications must only be carried out by personnel either directly employed by
Belimed AG or trained by Belimed AG. Improperly executed repairs and modifications can entail con-
siderable danger to both patient and operator; moreover, such actions will void the warranty claim.
Furthermore, no warranty service is provided for defects caused by non-compliance with these in-
structions, improper use or normal wear and tear of the product.
Defective components must only be replaced by original spare parts from Belimed. Only if these are
used is it ensured that they meet the safety requirements. If spare parts are used that neither originate
from Belimed AG, nor have not been approved by Belimed AG, the warranty is rendered void.

1.5 Contact person


For technical questions, contact the local Belimed service agent.

1.6 Symbols and notices used


The following symbols and notices are used to indicate precautionary measures for handling and for
occupational safety that are important to avoid harm to health and life.

DANGER

Indicates a danger with high risk.


If not avoided, it will cause death or serious injury.
Indicates possible consequences of the danger.

 Indicates work steps to avoid the danger.

WARNING

Indicates a danger with medium risk.


If not avoided, it can cause death or serious injury.
Indicates possible consequences of the danger.

 Indicates work steps to avoid the danger.

CAUTION

Indicates a danger with low risk.


If not avoided, it will cause slight or moderate injury.
Indicates possible consequences of the danger.

 Indicates work steps to avoid the danger.

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NOTICE

Indicates danger of damage to property.


If not avoided, it will cause damage to the product or to objects in its vicinity.
Indicates possible consequences of the danger.

 Indicates work steps to avoid the danger.

TIP

Tips for use and useful information on the best possible utilization.

 Indicates work steps that must be executed successively.


– Describes the reaction to the completed work step.

1 Position numbers that refer to diagrams.


2

• Indicates a list.
a) Indicates a subsection of a list.
b)

‹ › Indicates a software text.

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2 Safety
2.1 Introduction
With this sterilizer, you have acquired a product that is state-of-the-art in terms of safety.
Nevertheless, hazards may arise from the product if it is operated incorrectly or if it is not used as
intended.
By means of the EC Declaration of Conformity and the CE mark, Belimed AG affirms that this product
complies with the basic health and safety requirements.

2.2 Intended use


This Belimed sterilizer is designed to be used for the terminal sterilization of porous and non-porous,
heat and moisture stable materials in the healthcare facilities. Standard sterilization procedures have
been programmed on the sterilizer at the factory. These have been tested in accordance with the con-
ditions defined in the EN 285 standard.
Depending on the program selected, different materials, such as textiles, glass, or packaged or non-
packaged instruments in containers or in paper or fabric packaging, can be sterilized in this sterilizer.
Liquids can only be sterilized if the sterilizer is equipped with the appropriate programs.
If you are uncertain as to whether a material or product can be sterilized, ask the manufacturer of the
product concerned which sterilizing method is recommended.

2.3 Personnel requirements


This product must only be installed, operated and maintained by authorized, trained and briefed per-
sonnel.
If other persons, companies or facilities are entrusted with installation or maintenance (servicing, in-
spection, repair) of the product, the country-specific regulations regarding know-how, requirements
and necessary means must be observed.
Every person who installs, operates or maintains the product by order of the operating company must
first have read and understood these instructions.
Responsibilities with regard to installation, operation and maintenance must be clearly defined and
observed to avoid safety hazards due to unclear responsibilities.
The operating company is responsible for defining the responsibilities.

2.4 General safety instructions for operation


The following safety instructions must generally be observed:
• Before operating the system, the entire User Manual must be read and understood.
• The sterilizer must only be operated in faultless condition and by briefed personnel.
• The sterilizer must only be used if no errors are displayed.
• Safety devices must not be removed, altered or bypassed.
• It must be assumed, as a matter of principle, that the goods to be sterilized are heavy. The appro-
priate loading and unloading equipment must be used for transport, loading and unloading.
• When loading and unloading the goods to be sterilized, the guide values specified by occupational
safety must be observed. Lift packaging units which exceed the guide values with the aid of a sec-
ond person, or divide the content up among two packaging units.
• Take care when transporting the sterilized goods after completion of the sterilizing process. The
sterilized goods and the associated loading and unloading equipment are hot. Wear protective
gloves and apron when loading or unloading.

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• If steam or water should escape from the chamber during operation, immediately close all sliding
doors, activate the Emergency stop button and notify the Belimed service.
• If errors or damages occur, the supervisor must be informed. Errors must be resolved as de-
scribed in the error message list.
• Installation and maintenance work must only be performed by personnel from Belimed AG or by
personnel trained by Belimed AG. Manipulations by persons without adequate training can result
in injuries or damage to the sterilizer.
• Portable and mobile high frequency communication equipment, such as voice radio equipment or
cell phones, must not be used at distances closer than 1 m away from the sterilizer. The function
of the sterilizer could otherwise be impaired.
• Always mop up and dry wet floors immediately.

2.5 Summary of the safety instructions


This is a summary of the safety instructions for safe operation of the product.
Safety instructions are repeated in this manual when the relevant subject is dealt with.
All safety instructions are included in the following list. Read the list through carefully before starting
to operate the product or to perform cleaning and inspection work.

WARNING

Risk of non-sterile goods


If materials are wet, sterility of the load is endangered.

 Check packaged sterilizing goods for visible signs of moisture after unloading.

 If there is moisture outside or inside the packaging, re-package the sterilizing goods and re-ster-
ilize them with a longer drying time.

WARNING

Injury hazard
Liquids on the floor can lead to injuries due to slipping.

 Immediately mop up liquids on the floor.

WARNING

Risk of non-sterility
Textile packages that are too large or pressed together too strongly jeopardize the reliability of steril-
ization.

 The weight of each textile package must not exceed 7.5 kg and the size must not exceed
250 × 550 × 250 mm (density ≤0.45 kg/dm3).

 As far as possible, avoid pressing cloths together.

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WARNING

Burn hazard
The sterilizer and its components are hot after completion of a program cycle.

 Allow the sterilizer and its components to cool down to room temperature.

 Only perform cleaning or maintenance work when the sterilizer and its components have cooled
down.

WARNING

Danger to life
The liquids program must not be used for items with direct patient contact. The liquids program does
not conform to the EN 285 standard. Medical devices (medicines) or toxic substances must not be
sterilized with this program.

 Do not sterilize liquids intended for direct patient contact with this sterilizer.

 Do not sterilize any medical devices (medicines) with this program.

WARNING

Insufficient drying
If the sterilized items are not sufficiently dried and they are stored for a lengthy period, sterility is jeop-
ardized.

 No excessively heavy load.

 If necessary, choose program with longer drying time.

WARNING

Injury hazard
Bursting bottles can cause injury or damage to the machine.

 Observe instructions for sterilizing liquids.

WARNING

Infection hazard
If a program is terminated, sterility of the batch is no longer ensured. In 2-door models, the unloading
side is blocked automatically. The batch must be sterilized afresh.

 Once more sterilize the batch.

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CAUTION

Crushing hazard due to electrically operated sliding door


If hands or arms get stuck, this can lead to injuries.

 Stay clear of door area during opening and closing of sliding door.

 Take heed of adhesive label "Caution! Crushing hazard!".

CAUTION

Injury hazard
Broken glass panes have sharp edges and can cause injuries.

 Have broken glass panes replaced immediately by Belimed service.

CAUTION

Burn hazard
The sterilizer and its content are hot after completion of a program cycle.

 Always wear protective gloves and an apron when loading the sterilizer at operating temperature.

 Always wear protective gloves and apron when unloading.

CAUTION

Injury hazard
Items can fall down in the course of loading.

 Loading batch carts correctly.

 Dock the transport cart before the batch cart is transferred into the chamber.

CAUTION

Injury hazard
Items can fall down during unloading.

 Batch cart must be loaded correctly.

 Dock the transport cart before the batch cart is removed from the chamber.

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CAUTION

Burn hazard
When the sliding doors are opened, hot vapors or liquids can escape.

 There must be no persons in front of the sliding doors while the doors are opening.

 Wear protective gloves.

CAUTION

Injury hazard
The transport cart can roll away due to the floor not being level.

 If the transport cart is not docked onto the sterilizer and is not held firmly by a person, always ac-
tivate the locking brakes on the wheels of the transport cart.

CAUTION

Risk of eye injury


The scanner operates with a laser. Lasers can damage the eyes.

 Never look at the laser of the scanner.

 Never direct the scanner towards a person.

CAUTION

Injury hazard
Batch cart can fall down if the batch cart is not locked.

 Move the docking lever all the way to the left.

 Check that the batch cart cannot fall down.

 Only move the docking lever to the right once the transport cart is docked.

2.6 Signs on the product


The following signs are affixed near the sites of greatest hazard:

Dangerous voltage!

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Warning of a hazard site!

Caution! Crushing hazard!

Caution! Hot!

Read the instructions!

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3 Description
3.1 Overview of the product
The diagrams below show the main elements and operating elements on the loading side and on the
unloading side. The cycle documentation printer is located on the loading or unloading side, depend-
ing on the machine version.

Loading side (LS)

2
3
4

Fig. 3-1 Main loading side components and operating elements

1 Control panel
2 Cycle documentation printer (optionally on unloading side)
3 Chamber door
4 Emergency stop button

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Unloading side (US)

3
4

Fig. 3-2 Main components and operating elements on the unloading side

1 Control panel
2 Cycle documentation printer (optionally on unloading side)
3 Chamber door
4 Emergency stop button

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Loading side, servicing door open

Fig. 3-3 Loading side with servicing door open

1 Main switch
2 Switch cabinet
3 Cycle documentation printer
4 Chamber door
5 Servicing door
6 Door motor

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Unloading side, servicing door open

Fig. 3-4 Unloading side with servicing door open

1 Chamber door
2 Servicing door
3 Door motor

3.2 Operating elements and display elements

3.2.1 Location of main switch


The sterilizer main switch is at the top right behind the screen.

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Fig. 3-5 Loading side with servicing door open

1 Main switch

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3.2.2 Control panel on loading side

3.2.2.1 Overview

1
2
3

5
6

7
8

Fig. 3-6 Overview of operating panel on loading side

1 Status bar
2 button
3 Display with operating panel
4 Selection buttons
5 Activity bar
6 Confirmation button ‹OK›
7 On/Off button (standby)
8 Activity buttons

Green light-emitting diodes indicate, whether or not a button can be activated:

Button cannot be activated

Button can be activated

Info/Home button and Home/Info button


These buttons are shown in simplified form as button in these instruc-
tions.

3.2.2.2 Status bar

Date, time, chamber temperature, chamber pressure as well as certain settings and events are indi-
cated in the status bar 1.

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Message inactive (black) Door on loading side open

Warning active (yellow),


Door on unloading side open
maintenance required

Error active (red) Automatic loading / unloading active (green)

Automatic loading / unloading inactive


Doors locked
(green)

Doors open Automatic loading / unloading error (red)

Doors closed

3.2.2.3 Communication bar

The communication bar 3 comprises a sign and a 2-line text display. The sign indicates whether the
display is in ‹home mode› (basic display) or in ‹information mode›.

Screen in Screen in
‹home mode› ‹information mode›

3.2.2.4 Activity bar

The activity bar 5 displays the available functions as symbols.

Cursor forward Cursor back

Delete Delete all

Reading transponder Writing to transponder

Upper case letters Lower case letters

Numbers New

Page forward Page back

Value minus (smaller) Value plus (larger)

Back Program pause

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Open door Close door

New user No user logged on

Program start Copying programs

Relocating programs

3.2.3 Display when a program is running


When the program is started, the following information is displayed. To switch between the screen
pages, press the button.
First screen page
• Name of the program running
• Remaining program run time
• Current program phase
• Values of chamber pressure (P1) and chamber temperature (T1)
• ‹Cycle information› button active, if cycle information is recorded
• ‹Program intervention› button active

Program P06 running


Leak test

Remaining run 35 min


Step Pre-vacuum
Time Actual 2.2 min
Temp.: Actual 24°C
Pressure: Actual 880 mbar

Cycle information

Program intervention

OK

Table 3-1 Example of first screen page

Second screen page


• Diagram with temperature and pressure curve (sensors T1 and P1)
• Name of the program running
• Remaining program run time

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• Current program phase


• ‹Program intervention› button active

3.2.4 Display of the current readings


All current readings of the temperature and pressure sensors are displayed in the ‹Measurements›
menu. To access this menu, activate the button and the button. Use the and buttons
to switch between the pages.

3.2.5 Operating panel on unloading side (2-door)

3.2.5.1 Overview

1
2
3

Fig. 3-7 Overview of operating panel on unloading side (option, 2-door)

1 Light-emitting diode red


Light flashes - warning active
Continuous light - error active
2 Light-emitting diode green
Continuous light - program active
3 Light-emitting diode green
Continuous light - doors locked
4 Display
Display of status bar and activity bar
5 Activity button inactive
6 Activity button active

3.2.5.2 Status bar

In the status bar, certain settings and events are shown by means of signs and data:

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Automatic loading/unloading active

Automatic loading/unloading inactive

Doors locked

Doors open

Doors closed

Door on loading side open

Door on unloading side open

Light-emitting diode Red flashing light: warning active


‹Warning/error› Continuous red light: error active

Light-emitting diode
Continuous green light: program active
‹Program progress›

Light-emitting diode
Continuous green light: doors locked
‹Door interlock›

3.2.5.3 Activity bar

The activity bar displays the functions of the activity button. What functions are available depends on
the respective program phase.

Open door Adjust contrast

Close door Confirm display settings

Blowing out the door seal Adjust brightness and background illumi-
nation

Retracting the door seal

3.2.6 Process status indicator


The process status indicator is located above the chamber door on the loading side and on the un-
loading side. It indicates the status while a process is under way.

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Fig. 3-8 Process status indicator

* = first bar

One bar corresponds to a time interval of approximately 5 minutes.

Status Light-emitting diode bar display Color of bar

Starting position No display. –

Program started, remaining run 1st bar rotating clockwise. White


time > 60 min

Program started, remaining run An additional bar lights up approximately White


time < 60 min every 5 minutes until the complete status
display is lit up, indicating that the program
is finished.

Program finished, ready for All 12 bars flash. White


unloading

Error pending All 12 bars flash. red

Automatic loading and unloading All 12 bars flash. White


(option)

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3.3 Loading and unloading equipment

3.3.1 Batch cart

Fig. 3-9 Batch cart

3.3.2 Transport cart

Transport cart

Fig. 3-10 Transport cart with locking plates

1 Batch cart locking plate


2 Transport cart locking plate

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3.4 Safety devices

3.4.1 Emergency stop button


An Emergency stop button is located on either side of the sterilizer. The position is shown in Chapter
3.1 «Overview of the product».

Activating the Emergency stop button:


 Press the red cap of the Emergency stop button.
– The Emergency stop button engages.
– All valves are closed.
– Ongoing program is interrupted.
– All motors are stopped.
– Operating panel on loading side indicates error.
Error can only be acknowledged once the Emergency stop button has been reset to its normal posi-
tion.

Bringing the Emergency stop button into normal position:


 Turn the red cap of the Emergency stop button counterclockwise.
– The Emergency stop button is released.
After releasing the Emergency stop button, proceed as follows:
• If there was a brief interruption: The program can be continued. To do this, acknowledge the error
and select the menu item ‹Continue› in the ‹Program intervention› menu.
• If there was a longer interruption: Ensuing errors can arise, for example if the chamber tempera-
ture has dropped below the lower alarm threshold temperature. In such cases, the batch must be
sterilized again

3.5 Mechanism of action


Steam which is produced from demineralized water, and which is therefore non-toxic, is used as the
sterilizing agent. For over 100 years, steam sterilization has been the preferred method employed to
sterilize porous and non-porous, heat-resistant instruments and textiles in hospitals. The commonly
used sterilizing temperatures are 121 °C and 134 °C.
Saturated steam has a high heat capacity. In the chamber of the sterilizer, the steam condenses on
the cooler load (instruments, textiles) and inactivates all microorganisms present. The higher the ster-
ilizing temperature, the less time is required to inactivate the microorganisms.

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4 Operation
4.1 Switching on the sterilizer

NOTICE

Risk of leakage
In order to ensure the success of the sterilizing process, the chamber must be vacuum-proof. This
must be checked on a regular basis.

 Perform leak test at least once a week.

NOTICE

Warm up required on a daily basis


The chamber must be preheated every day if the sterilizer was previously shut down and was able
to cool down to room temperature.

 Start the ‹Warm up program› or the ‹Warm up program with leak test› as first program every day.

NOTICE

Risk of condensate
Before starting a solid-objects program after completion of a liquids program, a Warm up program
must be run in order to prevent the formation of condensate.

 Run a Warm up program before starting a solid-objects program.

NOTICE

Warm up after pause of sterilization


If no sterilization was performed for longer than 4 hours, warm-up of the sterilizer is required.

 Start ‹Bowie Dick test› program or ‹Warm up program›.

The main switch of the sterilizer is switched on when the sterilizer is first taken into operation. For
servicing the sterilizer, or if the sterilizer is not used for longer periods, the main switch must be
switched off and safeguarded against being switched on again.
In systems with external steam supply, the steam shut-off valve in the building must be closed when
the main switch of the sterilizer is switched off.
For daily operation, the sterilizer is switched on by activating the ‹On/Off› button on the operating pan-
el.

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Sterilizer ‹On/Off› button

switching on press briefly.

switching off press for 1 second.

4.2 Logging on
To operate the sterilizer, the user must log on with a password.

 Press the button on the start screen.


– The ‹Menu› screen appears.

Menu

Log on

OK

 Select the menu item ‹Log on›.


– The ‹Log on› screen appears. It displays the registered users.
To display the other users, if there are any, activate the and buttons.

Log on

User

ZSVA Leader

Technical service

Admin

OK

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 Select user name.


– The following screen appears.

A B C D E F G

H I J K L m N

O P Q R S t U

V W X Y Z _ @

OK

 Enter password.
– To switch to lower case or upper case or numeric keyboard, activate the button.
– To delete the last entry to the left of the cursor, activate the button.
 Press selection buttons until the desired letter is highlighted.
 Move the cursor one position forward by activating the button.
 Confirm with ‹OK› button.
– An acknowledgement is displayed, as well as the user level.
– The display then switches to program selection.

TIP

Automatic log-on
If so desired, the Belimed service can configure the controller such that the user ‹System› is auto-
matically logged on when the device is switched on. With this setting, every user can start a process
and the user ‹System› is indicated on the cycle record.

4.3 Items to be sterilized

4.3.1 Suitable materials

4.3.1.1 Textiles

• Only use cloths that are suitable for sterilization at 134 °C or 121 °C.
• The service life of the cloths depends on the number of sterilization cycles. Take heed of the man-
ufacturer's information in this regard.

4.3.1.2 Instruments

• Only use instruments that are cleared by the manufacturer for sterilization at 134 °C or 121 °C.

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• The instruments must not contain any unprotected components made of brass or bronze, since
these materials are not suitable for steam sterilization.
• Instruments made of chromium-nickel-molybdenum steel, for example 1.4485, 1.4571, ASTM316,
are generally suitable for steam sterilization. For other materials, take heed of the manufacturer's
specifications.

4.3.1.3 Rubber

• Items to be sterilized which are made of natural rubber are generally suitable for steam steriliza-
tion up to 257 °F. Observe the manufacturer's specifications regarding number of washing cycles
and sterilizing temperature.

4.3.1.4 Liquids

• Only sterilize liquids by means of the liquid sterilization program.


• Do not sterilize liquids intended for direct patient contact or toxic substances.

WARNING

Danger to life
The liquids program must not be used for items with direct patient contact. The liquids program does
not conform to the EN 285 standard. Medical devices (medicines) or toxic substances must not be
sterilized with this program.

 Do not sterilize liquids intended for direct patient contact with this sterilizer.

 Do not sterilize any medical devices (medicines) with this program.

4.3.1.5 Other materials

• Before sterilizing other materials, take heed of the manufacturer's recommendations and restric-
tions. Particularly the following points must be clarified:
a) steam compatibility
b) maximum temperature of use
c) maximum exposure time
d) sensitivity to pressure
e) vacuum tolerance
f) number of sterilization cycles permitted

4.3.2 Preparing the load

4.3.2.1 Instructions for sterilizing packaged items

DIN 58953-7 is the standard that applies to the packaging of items to be sterilized.

 The items to be sterilized must be cleaned before being sterilized.


• The following packaging means are suitable for sterilization:
– cotton cloths
– sterilizing fleece
– sterile containers
– transparent tubular bags

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 Reusable packaging materials must be washed between sterilization cycles.


 Dry and air the cloths before using them for packaging items to be sterilized.
 1 hour
 Room temperature 15–25 °C
 Relative humidity 30–70 %

4.3.2.2 Packaging items to be sterilized with cloths

NOTICE

FDA conformity
The packaging material must be cleared by the FDA for the sterilizing program to be used.

 Use only packaging material that has been cleared by the FDA for the sterilizing program to be
used.

Cotton cloths must meet the following requirements: the number of threads per centimeter must be
30 ± 6 in warp and 27 ± 5 in weft.

 Place two cloths ready, one over the other. Select cloths of appropriate size to enable the items
to be sterilized to be wrapped completely. Excessively large wrapping cloths can cause problems
with drying.
 Place the items to be sterilized on the cloths and, if this is desired or required, place an indicator
at the center of the items.
 Wrap the items to be sterilized successively in the prepared cloths.
 Secure the cloths with sterilization tape and label them.

TIP

Place cloth crease-free and crosswise


To ensure free circulation of steam, folding must be performed crosswise, avoiding creases as far as
possible.

 Place each layer of cloth crease-free as far as possible.

 Place each layer of cloth crosswise on the preceding layer of cloth.

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A B

C D

E F

G H

Fig. 4-1 Double packaging method I: square folding

A B C

D E F

G H I
Fig. 4-2 Double packaging method II: envelope folding

4.3.2.3 Textile packages

 Wrap the textile package in cloths as described in Chapter 4.3.2.2 «Packaging items to be steril-
ized with cloths» (steps A to I).

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WARNING

Risk of non-sterility
Textile packages that are too large or pressed together too strongly jeopardize the reliability of steril-
ization.

 The weight of each textile package must not exceed 7.5 kg and size must not exceed
250 × 550 × 250 mm (density ≤0.45 kg/dm3).

 As far as possible, avoid pressing cloths together.

4.3.2.4 Instruments in trays

 Use sieve trays made of wire mesh or sieve trays with wire mesh bottom, or equivalent containers.
 Use a sieve tray of appropriate size in order to ensure optimal distribution of the instruments.
 Inspect instruments to make sure they are clean, dry and in good working order.
 Open or disassemble instruments in accordance with the manufacturer's instructions in order to
ensure that all surfaces come into contact with steam.
 Observe the maximum number of sterilization cycles specified by the manufacturer.
 If necessary, insert an absorbent cloth in order to improve drying.
 Place the instruments in the sieve tray, spacing them out as well as possible.
 If this is desired or required, place an indicator in the sieve tray. Make sure that the color indicator
side does not come into contact with metal.
 Wrap the sieve tray in the cloths (steps A to I) as described in Chapter 4.3.2.2 «Packaging items
to be sterilized with cloths».

WARNING

Insufficient drying
If the sterilized items are not sufficiently dried and they are stored for a lengthy period, sterility is jeop-
ardized.

 No excessively heavy load.

 If necessary, choose program with longer drying time.

NOTICE

Risk of non-sterility
Insufficiently sterilized or insufficiently dry loads can be non-sterile. The adequate drying time de-
pends on the load and has to be validated.

 Use only validated programs with appropriate load.

 Do not exceed a total weight of 15 kg (gross weight) per packaging unit.

 Use the ‹Heavy instruments› program to sterilize heavier packaging units. This has a longer drying
time.

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4.3.2.5 Packaging in rigid containers

First and foremost, the instructions of the container manufacturer must be observed. If not otherwise
indicated, follow the instructions below.

 Lay a cloth in the container which overlaps the container as little as possible. If the cloths used are
too large, this can cause problems with drying.
 Place the sieve tray on the cloth in the container.
 Fold the cloth together over the sieve tray. When doing this, care must be taken to ensure that the
cloth ends do not obstruct the sterile-barrier of the container.
 Close the container and label it.
 If this is desired or required, affix an indicator to the outside of the container.

NOTICE

Risk of non-sterility
Insufficiently sterilized or insufficiently dry loads can be non-sterile. The adequate drying time de-
pends on the load and has to be validated.

 Use only validated programs with appropriate load.

 Do not exceed a total weight of 15 kg (gross weight) per packaging unit.

 Use the ‹Heavy instruments› program to sterilize heavier packaging units. This has a longer drying
time.

4.3.2.6 Packaged equipment and utensils

 Clean equipment and utensils and dry them completely.


 Pack basins and bowls individually, each in a cloth, wrapping them up completely.
 Arrange the utensils with bottoms parallel to each other.
 Affix an indicator at a place with poor steam penetration. Make sure that the color indicator side
does not come into contact with metal.
 Wrap the utensils up in cloths as described in Chapter 4.3.2.2 «Packaging items to be sterilized
with cloths».
 Secure the cloths with sterilization tape and label the packages.

WARNING

Insufficient drying
If the sterilized items are not sufficiently dried and they are stored for a lengthy period, sterility is jeop-
ardized.

 No excessively heavy load.

 If necessary, choose program with longer drying time.

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4.3.3 Load capacity

Model Number of StUs Load


[StU] [kg]

Per support grida Per batch cartb Per support grid Per batch cart

6-6-6 2 4 30 68

6-6-9 3 6 45 102

6-6-12 4 8 60 136

6-6-18 2×3 2×6  2 × 45  2 × 102


a. The number of StUs per support grid applies to sterilizing-goods units (StUs) with a max. weight of <15 kg
(gross). If heavier StUs are loaded, the maximum loading capacity per support grid must not be exceeded.
b. The max. number of StUs per batch cart applies to containers 285 mm high on support grids or containers
300 mm high, stacked without support grid.

Table 4-1 Load capacity of the batch carts

Model Number of StUs Load


[StU] [kg]

Per extendable In the sterilizerb Of each extend- Bottom extendable


shelfa able shelf (both shelf (top extend-
installed) able shelf unin-
stalled)

6-6-6 2 4 30 60

6-6-9 3 6 45 90


a. The number of StUs per extendable shelf applies to sterilizing-goods units (StUs) with a max. weight of <15 kg
(gross). If heavier StUs are loaded, the maximum loading capacity per extendable shelf must not be exceeded.
b. The max. number of StUs in the sterilizer applies to containers 275 mm high on extendable shelves or con-
tainers 300 mm high, stacked without upper extendable shelf.

Table 4-2 Load capacity of the extendable shelf (option)

Model Volume per container Number of containers in the sterilizer


[mL] [StU]

6-6-6 44

6-6-9 66
1000
6-6-12 88

6-6-18  2 × 66

Table 4-3 Load capacity for liquids

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4.3.4 Loading batch carts or extendable shelves (option)


The sterilizer can only achieve the specified performance with regard to program duration, dryness
as well as water and steam consumption if the following loading instructions are observed:
• Place the items to be sterilized evenly on a batch cart. Do not place items on the chamber floor.
• Keep a distance of at least 3 cm from the chamber walls of the sterilizer. This distance is ensured
if the load is completely within the batch cart.
• Heavy items cause more condensate to form than light items. Always place the heaviest items at
the bottom so that the condensate cannot drip onto items below.
• Sterilize similar items together. Recommendation:
a) porous items together with textiles
b) various types of instruments
c) various types of rubber
• Make sure that the items are securely in place and cannot slip out of place while the process is
under way.
• Only stack containers if they have been expressly approved by the manufacturer for this mode of
use. Some containers may only be stacked for transport and storage (see manufacturer's instruc-
tions).
• When stacking containers, make sure that the steam inlet openings and the steam outlet openings
are not obstructed. The sterilization of stacked containers must be validated.
• Space the instruments out evenly in the trays.
• If trays are stacked, make sure that the items in the lower trays are not pressed together.
• Stack combined paper/foil packages with the paper side facing down.
• If possible, stand textile packages upright in the batch cart to achieve better steam penetration.
• Position empty, open containers and bottles in such a way that condensate forming can drain off.

Fig. 4-3 Loading batch carts

1 Instruments and utensils in trays


2 Textiles
3 Basins and dishes
4 Instruments in containers
5 Packaged instruments and utensils

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4.4 Loading the sterilizer

CAUTION

Injury hazard
The transport cart can roll away due to the floor not being level.

 If the transport cart is not docked onto the sterilizer and is not held firmly by a person, always ac-
tivate the locking brakes on the wheels of the transport cart.

 Prepare the load.


 If an ICS 8535 (option) documentation system is connected to the sterilizer, first record the cycle
data for the items to be sterilized using the scanner (option). See Chapter 5.6 «ICS8535-BC doc-
umentation system».
 Open the chamber door by activating the button.

CAUTION

Injury hazard
Items can fall down in the course of loading.

 Loading batch carts correctly.

 Dock the transport cart before the batch cart is transferred into the chamber.

 Bring the transport cart into position in front of the sterilizer, aligning it so that it is centered on the
sterilizer. Make sure that the docking facilities on the sterilizer engage in the centering blocks of
the transport cart.

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Fig. 4-4 Turn docking lever 2 clockwise to the right


 Turn the docking lever 2 90° clockwise.
– The locking plate of the transport cart engages in the recess on the docking bar of the sterilizer
and docks the transport cart onto the sterilizer.
– The batch cart locking plate 1 is lowered.

Fig. 4-5 Schematic: Transport cart fixed, batch cart free to move
 Pull the cart back slightly in order to make sure that the transport cart is securely docked.
 Carefully insert the batch cart into the chamber and bring it right up against the rear wall. Then
pull the batch cart back 2 cm.

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Fig. 4-6 Turn docking lever 2 counterclockwise to the left


 Turn the docking lever 2 90° counterclockwise.
– The transport cart is now undocked and can be removed.

Fig. 4-7 Schematic: Transport cart free.

CAUTION

Injury hazard
Batch cart can fall down if the batch cart is not locked.

 Move the docking lever all the way to the left.

 Check that the batch cart cannot fall down.

 Only move the docking lever to the right once the transport cart is docked.

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 Close the chamber door by activating the button.

4.5 Sterilizing
Selecting a program
 When the sterilizer is in starting position, the ‹Program selection› screen is displayed.

Program

Instruments, 134 °C

Textiles, 134 °C

Rubber, 121 °C

Warm up & leak test

OK

 If the desired program is not displayed: Browse using the button until the desired program is
displayed.
 Select the desired program.
The sterilizer is ready to start if the following conditions are fulfilled:
• A program has been selected.
• The chamber doors are closed.
• No errors are pending.
• The minimum steam pressure is present.
• The minimum jacket pressure has been reached.

Starting the program


 Press ‹OK› button.
– If an authorized user is logged on: The process is started.
– If no authorized user is logged on: The ‹Log on› screen appears.
 If no authorized user is logged on: Log on and press the ‹OK› button on the ‹Program selection›
screen.
– The process is started.

4.5.1 Steam sterilizing programs


The sequence of the programs listed conforms to the configuration of the sterilizer at the time of de-
livery. The sequence can be changed by users with user level 4 (Admin) or higher.

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Sterilizing temperature

Recommended
Sterilizing time
Program name

Drying timea

Cycle time b

Procedure
[min]

[min]

[min]

load
[°C]
Instruments, 134 °C 134 5 11 + 2 × 3 62 FRVV-FVT Instruments, packed in cloths
or containers, ≤15 kg per StU
(gross)

Textiles, 134 °C 134 5 6 44 FRVV-VMT Textiles, utensils ≤ 7.5 kg per


StU

Rubber, 121 °C 121 20 6 42 FRVV-VMT Rubber, textiles, utensils


≤7.5 kg per StU

Warm up & leak test 134 5 4 42 VOVV- Empty chamber


VMT-VPR

Bowie-Dick Test 134 3.5 3 26 FRVV-VMT Empty chamber

Leak test – – – 19 VPR Empty chamber

Heavy instruments 134 5 11 + 4 × 3 62 FRVV-FVT Heavy instruments packed in


containers, ≤15 kg per StU
(gross)

Porous items, 125°C 125 20 6 59 FRVV-VMT Textiles, instruments wrapped


in cloths ≤ 7.5 kg per StU

Special, 134°C 134 60 6 110 FRVV-VMT Textiles, utensils, instruments

Liquids, 121 °C 121 45 – 90 GRAV-SAK Liquids in open borosilicate


bottles (type 1) 1000 mL

Warm up 134 5 5 26 FRVV-VMT Empty chamber

Integrated Bowie- 134 3.5 5 26 FRVV-VMT Empty chamber


Dick Test

Bowie Dick function 134 3.5 5 26 FRVV-VMT Empty chamber


test
a. With integrated Bowie Dick test (option), the drying time is approx. 1–2 minutes longer.
b. Standard values assuming recommended load and utilities according to the utility table in the Technical Man-
ual. In this case, based on the example of the 6-6-9 model. These values can deviate greatly, depending on
chamber size and equipment.

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NOTICE

Non-sterile load
In the case of loads that are difficult to dry, such as large individual parts, heavy instruments or plastic
parts, the drying time must be prolonged.
An adequate drying time must be validated.

 Execute only validated programs with appropriate load.

 In the case of loads that are difficult to dry, such as large individual parts, heavy instruments or
plastic parts, extend the drying time and have it validated.

Model Max. volume of the container [mL] Max. number of containers [StU]

6-6-6 1000 44

6-6-9 1000 66

6-6-12 1000 88

6-6-18 1000 132

Table 4-4 Guideline for the sterilization of liquids using the MST-V steam sterilizer

4.5.2 Abbreviations for procedure designations

Pre-treatment

VOVV Pre-vacuum procedure

FRVV Fractionated vacuum procedure

GRAV Gravitational procedure

Table 4-5 Pre-treatment procedure designations

Post-treatment

VMT Vacuum with drying

FVT Fractionated vacuum drying

VPR Air leak test (leakage test)

SAK Self-cooling procedure

Table 4-6 Post-treatment procedure designations

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4.5.3 Instructions for sterilizing liquids

WARNING

Danger to life
The liquids program must not be used for items with direct patient contact. The liquids program does
not conform to the EN 285 standard. Medical devices (medicines) or toxic substances must not be
sterilized with this program.

 Do not sterilize liquids intended for direct patient contact with this sterilizer.

 Do not sterilize any medical devices (medicines) with this program.

NOTICE

Risk of corrosion
Chlorides can attack stainless steel components.

 Do not sterilize liquids that contain chlorides.

WARNING

Injury hazard
Bursting bottles can cause injury or damage to the machine.

 Observe instructions for sterilizing liquids.

 Only use the predefined program for liquids. Other programs are not suitable for sterilizing liquids.
 Use only ventilated (non-closed) containers. Never under any circumstances use containers that
are closed with screw-on caps or stoppers.
 Only use bottles made of Type 1 borosilicate glass which are approved for sterilization. Do not
sterilize ordinary glass bottles.
 After completion of the sterilizing process, wait at least 10 minutes before opening the door.
 Treat hot bottles with care. Hot containers can burst if they are shaken or moved abruptly.
 Never touch or move bottles in which the liquid content is boiling or forming bubbles.

4.5.4 Cycle documentation


A cycle record is printed out by the cycle documentation printer during the active program.
The most important cycle data are indicated on the cycle record, namely:
• Cycle number
• Name of operator
• Equipment number
• Sterilization values achieved
• Name of the program that has been run

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4.6 Unloading the sterilizer


The door on the unloading side can be opened if the following conditions are fulfilled:
• The sterilization program has been completed without any process-relevant errors.
• The difference between chamber pressure and ambient pressure is <80 mbar / 1.16 psi (con-
trolled by the controller).
At the end of the program, an acoustic signal is sounded until the door is opened by pressing the
button. The acoustic signal can be deactivated in the configuration menu.

WARNING

Injury hazard
Liquids on the floor can lead to injuries due to slipping.

 Immediately mop up liquids on the floor.

CAUTION

Burn hazard
When the sliding doors are opened, hot vapors or liquids can escape.

 There must be no persons in front of the sliding doors while the doors are opening.

 Wear protective gloves.

CAUTION

Crushing hazard due to electrically operated sliding door


If hands or arms get stuck, this can lead to injuries.

 Stay clear of door area during opening and closing of sliding door.

 Take heed of adhesive label "Caution! Crushing hazard!".

CAUTION

Burn hazard
The sterilizer and its content are hot after completion of a program cycle.

 Always wear protective gloves and an apron when loading the sterilizer at operating temperature.

 Always wear protective gloves and apron when unloading.

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CAUTION

Injury hazard
The transport cart can roll away due to the floor not being level.

 If the transport cart is not docked onto the sterilizer and is not held firmly by a person, always ac-
tivate the locking brakes on the wheels of the transport cart.

CAUTION

Injury hazard
Injury hazard due to hot steam and pressure in the sterilizing chamber

 If the door cannot be opened, contact Belimed service.

 Never try to open the door with force or tools.

 Check the cycle record with regard to the following points:


 Was the correct sterilization program carried out?
 Was the sterilization program completed without errors?
 Open the chamber door by activating the button.
 Bring the transport cart into position in front of the sterilizer, aligning it so that it is centered on the
sterilizer. Make sure that the docking facilities on the sterilizer engage in the centering blocks of
the transport cart.

Fig. 4-8 Turn docking lever 2 clockwise to the right

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 Turn the docking lever 2 90° clockwise.


– The locking plate of the transport cart engages in the recess on the docking bar of the sterilizer
and docks the transport cart onto the sterilizer.
– The batch cart locking plate 1 is lowered.

Fig. 4-9 Schematic: Transport cart fixed, batch cart free to move
 Pull the cart back slightly in order to make sure that the transport cart is securely docked.

CAUTION

Injury hazard
Items can fall down during unloading.

 Batch cart must be loaded correctly.

 Dock the transport cart before the batch cart is removed from the chamber.

 Withdraw the batch cart from the chamber and push it onto the transport cart up to the stop posi-
tion.
1

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Fig. 4-10 Turn docking lever 2 counterclockwise to the left


 Turn the docking lever 2 90° counterclockwise.
– The batch cart locking plate 1 is raised and holds the batch cart in place on the transport cart.
– The transport cart is now undocked and can be removed.

Fig. 4-11 Schematic: Transport cart fixed, batch cart free to move

CAUTION

Injury hazard
Batch cart can fall down if the batch cart is not locked.

 Move the docking lever all the way to the left.

 Check that the batch cart cannot fall down.

 Only move the docking lever to the right once the transport cart is docked.

 Close the chamber door by activating the button.

4.6.1 Letting the batch cool down


Allow the batch to cool sufficiently
 After removal from the sterilizer, leave the entire load on the batch cart until it has cooled down
sufficiently.
 Do not touch the load or the batch cart while cooling down.
 Leave the batch cart to cool in an area without influx of cold air or air conditioning.

4.6.2 Checking the batch

WARNING

Risk of non-sterile goods


If materials are wet, sterility of the load is endangered.

 Check packaged sterilizing goods for visible signs of moisture after unloading.

 If there is moisture outside or inside the packaging, re-package the sterilizing goods and re-ster-
ilize them with a longer drying time.

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• If sterilizing goods are moist or their packaging is damaged, sterility is no longer ensured. The ster-
ilizing goods must therefore be checked after cooling down.
• As a general rule, the package must be dry after cooling down to room temperature (21°C, 50%
relative humidity) over the course of at least one hour.
• There must be no drops of water or visible moisture on the outer packaging. This does not apply
to waterproof packages (e.g. rigid containers). Wipe off drops of water on waterproof contain-
ers with a clean cloth after unloading.
• There must be no water drops inside the package (foil bags).
• The packaging (e.g., foil bags) must not be damaged.
• Only unpack the sterilized goods shortly before using them and check the chemical indicator for
color change.

4.6.3 Possible causes of wet goods


The following are possible causes of moisture on or inside of packages:
• Insufficient drying time or unsuitable post-treatment
• The chamber is overloaded. Size, density or weight of the package concerned exceeds the dimen-
sions specified in Chapter 4.3.3 «Load capacity».
• Excessively large, solid items were sterilized.
• Tray was sterilized without absorbent cloth.
• Trays were stacked in rigid containers.
• The maximum container weight was exceeded.
• The maximum load was exceeded.
• Materials were used that are not allowed to be sterilized.
• The material was not able to cool down to room temperature within the given time.
• Wet steam in the steam supply line.
• Defective vacuum drying system.
• Leakage in the chamber system.
• The sterilized goods were cooled down too quickly.
• The load was placed warm on an impermeable surface or in a storage space for sterilized goods
that prevented rapid drying.
• The sterilized goods were placed warm in an area with influx of cold air or air conditioning.

4.7 Log off


The user can be logged off on the operating panel to ensure that no unauthorized persons can oper-
ate the sterilizer. The user can only be logged off if no process is active.

 Press the button.


– The ‹Menu› screen appears.

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Menu

Log off

Auto. Start / Auto. Switch-off

Machine information

Messages / errors

OK

 Activate the ‹Log off› button.


 Confirm query as to whether the user is to be logged off with ‹OK› button.

4.8 Changing the program parameters


The sterilizing programs that are installed on Belimed AG's sterilizers at delivery have been validated
by Belimed AG that sterilization of the goods to be sterilized is achieved.
If required, the drying times duration of sterilization of the standard programs can be prolonged by
the Belimed service. Drying times duration of sterilization of copied programs can be prolonged by a
user with user level 4 (Admin).
Sterilizing times must not be prolonged.
The operating company is obliged to validate the modified program each time a change is made.

4.9 Further functions

4.9.1 Inserting and removing the support grid of the batch cart
The support grid of the batch cart can be adjusted for height or removed completely.

Take apart the support grid


 Remove the support grid.
A B C D

Fig. 4-12 Take apart the support grid


 Rotate the holder 90° upward around its own axis and pull it out of the slits in the frame of the batch
cart. The numbering helps to install the support grid horizontally so that the load will not slide.

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Install the support grid


 Rotate the holder 90° upward around its own axis and insert the brackets into the slits in the frame
of the batch cart.
A B C D

Fig. 4-13 Install the support grid


 Rotate the holder 90° downwards around its own axis, so that the brackets engage in the slits of
the frame.
 Place the support grid on the holder.

4.9.2 Automatic start


The ‹Automatic start› function switches the sterilizer on automatically at the pre-set time. The select-
ed program starts with 60 seconds delay (factory setting with external steam). This ensures that suf-
ficient steam is available when the program starts.
The ‹Automatic start› function only starts if the following conditions are fulfilled:
• No other process is active.
• The sterilizer is in starting position.
• The chamber doors are closed.

Procedure
 Access the menu for automatic start or switch-off via the and ‹Auto. start / Auto. switch-
off› buttons.
– The ‹Auto. start / Auto. switch-off› screen appears.
 Activate the ‹Automatic start› button.

Automatic start
Automatic mode
On
Time
16.30
Date
2013-02-08
Program number
P01

OK

 On the screen that follows, select the menu item ‹Automatic mode›. Set the desired value using
the and buttons:

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 Deactivate the automatic start with ‹Off›.


 Activate the automatic start once with ‹On›.
 Activate the automatic start on a daily basis with ‹Daily›.
 Confirm with ‹OK› button.
 Select menu item ‹Time› and set the hours using the and buttons. Switch to the minute
display by activating the button and set the minutes using the and buttons.
 Confirm with ‹OK› button.
 If ‹On› has been selected, select menu item ‹Date›, and set the date using the , and
buttons.
 Confirm with ‹OK› button.
 Select the menu item ‹Program number› and select the desired program. The program numbers
can be found in Chapter 4.5 «Sterilizing».
 Confirm with ‹OK› button.
 Switch the sterilizer off by activating the ‹On/Off› button.

TIP

Chamber is preheated for the integrated Bowie Dick test (option)


If the ‹Integrated Bowie-Dick Test› program (option) is selected, then the ‹Warm up› program is start-
ed first.

4.9.3 Automatic switch-off


If the ‹Automatic switch-off› function is activated, the sterilizer goes into ‹Sleep mode› after the end
of the last cycle. All the valves are closed, the screen display is shut down and any steam generator
connected is switched off.
The ‹Automatic switch-off› function does not function, if:
• A chamber door is open.

Procedure
 Access the menu for automatic start or switch-off via the and ‹Auto. start / Auto. switch-
off› buttons.
– The ‹Auto. start / Auto. switch-off› screen appears.
 Activate the ‹Automatic switch-off› button.

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Automatic switch-off
Automatic mode
On
Time
16.30

OK

 On the screen that follows, select the menu item ‹Automatic mode›. Set the desired value using
the and buttons:
 Deactivate the automatic switch-off function with ‹Off›.
 Activate the automatic switch-off function once with ‹On›.
 Activate the automatic switch-off function on a daily basis with ‹Daily›.
 Select menu item ‹Time› and set the hours using the and buttons. Switch to the minute
display by activating the button and set the value using the and buttons.
 Confirm with ‹OK› button and return to the main menu with .
– The sterilizer can now continue to be operated normally. As soon as the set time has been
reached, the sterilizer is switched off automatically.
– If the sterilizer is still in operation, it switches off approx. 5 minutes after completion of the last cy-
cle.
– If an automation unit (option) is connected, the batch is automatically conveyed out of the chamber
and the sterilizer switches off after approx. 5 minutes.

4.9.4 Program intervention


The following functions can be accessed via the and ‹ Program intervention› buttons:
• Terminate program
• Continue

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Program running
Program name

Terminate program

Continue

OK

4.9.4.1 Terminate program manually

The ongoing process can be terminated prematurely with the ‹Terminate program› button, for exam-
ple, if an incorrect program has been selected or if an error is pending.
By activating the ‹Terminate program› button, the sterilizer is decompressed if required.
A vacuum is then generated so that the steam escapes from the chamber. If an Integrated Bowie-
Dick test (option) is integrated, this vacuum will be held for about 10 minutes.
Then the chamber is ventilated at ambient pressure. The door on the unloading side is not released
and a warning on the operating panel on the loading side indicates that the program has been termi-
nated and the batch is not sterile.
It can take up to 15 minutes for the ongoing program to be terminated.
If a program which includes the post-treatment SAK is aborted, the program switches over to the cool-
ing phase. The cooling phase is completed as normal.

NOTICE

Program termination
Program termination is not always possible.

 Continue the program until it is completed.

4.9.4.2 Continue program

The ‹Continue› button can be used to continue a halted program, for instance after the emergency
stop button has been activated. For this, all pending errors must first have been resolved and ac-
knowledged.

4.9.5 Operating panel settings

4.9.5.1 Changing the operating language

 Press button.
– The main menu is displayed.

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 Activate the button to switch to the second page.


 Select the ‹Settings› button.
 Browse using the button until the menu item ‹User language› appears.
 Select menu item ‹User language›.
 Select the desired language using the and buttons.
 Confirm with ‹OK›.

4.9.5.2 Adjusting the brightness on the operating panel on the loading side

 Press button.
– The main menu is displayed.
 Activate the button to switch to the second page.
 Select the ‹Settings› button.
 Browse using the button, until the menu item ‹Display brightness on loading side› appears.
 Select menu item ‹Display brightness on loading side›.
 Adjust the brightness using the and buttons.
 Confirm with ‹OK›.

4.9.5.3 Adjusting brightness and contrast on operating panel on unloading side

 Press the button on the operating panel on the loading side.


– The main menu is displayed.
 Activate the button to switch to the second page.
 Select the ‹Settings› button.
 Browse using the button until the menu item <Display adjustment, unloading side> appears.
 Select menu item ‹Display adjustment, unloading side›.
 Adjust brightness on the unloading side using the button, and contrast using the button.
 Confirm with ‹OK› on the loading side.

4.9.6 Subsequent cycle documentation


As long as no new program has been started, the record of the last cycle can be printed out once
more if required.

 Press button.
– The main menu is displayed.
 Activate the button to switch to the second page.
 Select the ‹Settings› button.
 Browse using the button until the menu item ‹Reprint› appears.
 Select menu item ‹Reprint›.
– The cycle record of the last cycle is printed out.

4.9.7 Machine information


 Press the button on the start screen.
– The ‹Menu› screen appears.
 Press the ‹Machine information› button.
– The following information is displayed:

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• Machine type
• Machine name
• Equipment
• Cycle counter
 Activate the button to switch to the next page.
– The following information is displayed:
• Date of the last leak test performed
• Date of the last Bowie-Dick Test performed
 Activate the button to switch to the next page.
– The following information is displayed:
• Software version
• CP-TOP software version
 Activate the button to switch to the next page.
– The following information is displayed:
• Maintenance level 1 (active/inactive)
• Maintenance level 2 (active/inactive)
• Maintenance level 3 (active/inactive)

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5 Options
5.1 Steam generator
An interface exists for communication with a steam generator (option), so that the steam generator
can be controlled via the operating panel of the sterilizer.
If there is an error in the steam generator, the latter will be deactivated automatically. After the error
has been resolved and acknowledged, it must once more be activated.

NOTICE

Risk of malfunctions
A separate set of operating instructions is provided for this option.

 Observe the separate operating instructions for the option.

Activating the steam generator


 Press button.
 Activate the button to switch to the next page.
 Select menu item ‹Settings›.
 Tap the button until the entry ‹Steam generator› appears.
 Select menu item ‹Steam generator›.
 Press the button to activate the steam generator.
 Confirm with ‹OK› button.

NOTICE

Deposits
Deposits can form in the steam generator. They can settle on the items being sterilized.

 The steam generator must be emptied when not in use or at least once a week, preferably after
completing the last cycle before the weekend.

 See in this regard the User Manual for the steam generator.

5.2 Automation unit


The automation unit (option) is able to automatically load or unload the sterilizer. The changeover to
automatic mode is described in the User Manual of the automation unit. The automation unit cannot
be operated manually.

5.2.1 Initialization
When the automation unit is switched to automatic mode, the slider moves into basic position. The
basic position has been defined by Belimed service in the course of commissioning and can only be
altered by Belimed service.

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5.2.2 Overview

2
3
4

5
6
7

Fig. 5-1 Automation unit

1 Guide blocks on side facing sterilizer


2 Slider
3 Catch hook
4 Locking pin for batch cart
5 Decoupling device for double batch cart
6 Docking device for transport cart
7 Queue line and transport cart centering device and queue line docking device

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Fig. 5-2 Automation unit (view from below)

1 Roller with locking brake


2 Foot
3 Height adjustment

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2
3

Fig. 5-3 Automation unit sensors

1 Sensor B72: Detects batch cart in the operating space of the sliding door of
the sterilizer
2 Sensor B74: Detects batch cart located before the sliding door
3 Sensor B71: Detects batch cart at locking pin
4 Slider safety bar: prevents jamming
5 Sensor B73: Detects docking of transport cart or queue line

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5.3 Extendable shelves

Fig. 5-4 Sterilizer with extendable shelf (option) and foot switch (option)

1 Operating panel
2 Extendable shelf
3 Foot switch

Extendable shelves2 (option) are permanently installed in the chamber. They are used for direct load-
ing and unloading of the sterilizer. The use of batch carts, transport carts, and automation unit (option)
can be omitted. This in combination with the foot switch 3 (option) is useful because without transport
carts, the front of the sterilizer is freely accessible.

5.3.1 Removing the extendable shelf (option)


For the version with the extendable shelves (option), the top extendable shelf can be removed. This
allows the loading items to be sterilized with height >275 mm on the bottom extendable shelf.

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3
8
7
4

5
6

Fig. 5-5 Dismantling an extendable shelf

1 Extendable shelf
2 Guide rails
3 Oval-head screw M6 × 12
4 Spacer bracket
5 Elbow fitting
6 Frame component
7 Hex nut M6
8 Spacer sleeve

 Carefully pull out the extendable shelf 1with both hands until it stops.
 Pull at an angle 5 upwards.
 Carefully pull out the extendable shelf 1with both hands from the guide rail 2 until it stops.
 Carefully remove the spacer bracket 4.
– The extendable shelf 1is removed.

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5.3.2 Installing the extendable shelf (option)

3
8
7
4

5
6

Fig. 5-6 Dismantling an extendable shelf

1 Extendable shelf
2 Guide rails
3 Oval-head screw M6 × 12
4 Spacer bracket
5 Elbow fitting
6 Frame component
7 Hex nut M6
8 Spacer sleeve

 Carefully insert the spacer bar 4 from the back to the front into the oval-head screw 3.
 Carefully push the extendable shelf 1with both hands into the guide rail 2 until it stops.
 Check that the extendable shelf 1 moves freely.
 If necessary, realign the guide rail 2.
 Pull at an angle 5 upwards.
 Carefully push the extendable shelf 1 in with both hands until it stops.
– The extendable shelf 1 is installed and is prevented from sliding out by the angle 5.

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5.4 Foot switch


The sliding door can be opened and closed using the foot switch (option).

Fig. 5-7 Sterilizer with extendable shelf (option) and foot switch (option)

1 Operating panel
2 Extendable shelf
3 Foot switch

The foot switch 3 (option) in combination with the extendable shelf 2 (option) is useful because with-
out transport carts, the front of the sterilizer is freely accessible. This can be done instead of operation
using the operating panel 1.

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5.5 Scanner
The scanner (option) can be installed on the loading or unloading side. The scanner simplifies the
recording of cycles. Employees can also be identified using the scanner.

2
3

Fig. 5-8 Sterilizer with scanner (option)

1 Sterilizer
2 Scanner holder
3 Scanner

Cycle documentation system ICS 8535 (option) can automatically record cycle data. The data can be
transferred via a serial interface (RS-485) or via an Ethernet interface (TCP/IP) and forwarded to an
IMS system.

5.6 ICS8535-BC documentation system


The ICS8535-BC documentation system (option) is used to record the cycle data electronically, al-
lowing them to be retraced if required. The cycle data can be recorded electronically using the scan-
ner (option). The documentation system uses barcode type EAN13.

CAUTION

Risk of eye injury


The scanner operates with a laser. Lasers can damage the eyes.

 Never look at the laser of the scanner.

 Never direct the scanner towards a person.

 Record the items to be sterilized with the scanner (option) before the sterilizer is loaded.
 Take the scanner out of the holder.
– The button on the scanner lights up green.

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 If not, there is an error; see Chapter 6.6 «Other errors».


 Hold the scanner about 50–150 mm in front of the barcode of each individual batch and press
the green button.
– A beep confirms that the scanning was successful.
 As soon as the first item to be sterilized is read in, the ‹Cycle data› menu opens automatically.
 The cycle data can be compared to the numerical sequence on the barcode of the batch.
 Reading in the batches can be repeated as often as wanted.
 If a batch has been inadvertently read in twice, the last barcode can be removed from the list using
the button.

NOTICE

Risk of damage
If the scanner is not hung on the holder correctly, the scanner can fall down and get damaged.

 Hang the scanner on the holder with the reading side facing the glass pane.

 After scanning all batches, replace the scanner properly in the holder.
 The number of batches that has been read in can be seen on the screen.
 Check that the actual number of batches matches the number that has been read in.
 If not, the entire list can be deleted using the button.
 Confirm the question ‹Delete all data?› using the ‹OK› button.
 Scan all the batches again.
 When all items to be sterilized have been read in, activate the ‹OK› button.
 The desired program can be selected and started.
– After the sterilization, the cycle data are transferred to the ICS 8535-BC documentation system.

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6 Errors
6.1 Process-relevant errors
A process-relevant error is an error that can affect the sterility of the goods to be sterilized. Process-
relevant errors are documented on the cycle record. If a process-relevant error has occurred during
the process, then the batch must be sterilized once more.
As long as a process-relevant error is pending, no program can be started.

6.2 Program intervention


A program can be discontinued or continued via the and ‹Program intervention› buttons. For fur-
ther details, see Chapter 4.9.4 «Program intervention».

6.3 Automatic program termination


The current program is terminated automatically after an error has occurred, if occupational safety or
reliable sterilization is no longer ensured.

WARNING

Infection hazard
If a program is terminated, sterility of the batch is no longer ensured. In 2-door models, the unloading
side is blocked automatically. The batch must be sterilized afresh.

 Once more sterilize the batch.

6.4 Error display


An internal diagnosing program continuously monitors all the important parameters and triggers an
error message as soon as a deviation is detected. The sign appears on the screen. Depending
on the type of hazard, the current program responds as follows:

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Priority Behavior of the sterilizer

1 • The program is discontinued.


• The chamber is ventilated.
• The sterilizer switches to starting position. after execution of the ‹Pressure-relief›
and ‹Drying› phases.
• The error is documented on the cycle record in the program report.
• The message '‹Process-relevant error. Batch not sterile› is displayed on the oper-
ating panel at the end of the process.
• The notice ‹PROGRAM ABORTED -NOT STERIL› appears on the cycle record.

2 • The program is interrupted.


• All valves close.
• All motors switch off.
• The process times are halted.
• The error is documented on the cycle record in the program report.
• The program can be continued after the error has been resolved.
• The message '‹Process-relevant error. Batch not sterile› is displayed on the oper-
ating panel at the end of the process.
• The notice ‹ERRORS HAVE OCCURRED› appears on the cycle record.

3 • The program continues.


• If the temperature is too low, the sterilizing time is halted.
• The error is documented on the cycle record in the program report.
• The message '‹Process-relevant error. Batch not sterile› is displayed on the oper-
ating panel at the end of the process.
• The error may prevent the system from switching on to the next program step be-
cause the conditions for switching on may in certain cases not be fulfilled.
• The notice ‹ERRORS HAVE OCCURRED› appears on the cycle record.

4 • The program continues.


• The error is displayed.
• The error is documented on the cycle record in the program report.

Table 6-1 Priority of the errors

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Process error

Error 1
Emergency stop
Step: Starting position
Date: 25-08-2010
Time: 13.52

Program intervention

Confirm resolution

OK

Active error messages are displayed with the screen shown above. If no errors are pending, the last,
already resolved errors are displayed. The next or the preceding page respectively can be accessed
with the and buttons.

6.5 Error messages


All errors have to be acknowledged.
 To view the current error messages, tap the button.
 Select menu item ‹Messages / errors›.
 If possible, resolve the error.
 Confirm error resolution by activating the ‹Confirm resolution› button.
– If the program has not been halted, the program continues.
– If the program has been halted, the program must be continued via the function ‹Program in-
tervention› / ‹Continue›.
 If an error cannot be resolved or acknowledged, contact Belimed service.

Error messages
The following list describes possible errors and how to resolve them.
If the error appears again after being resolved, or if an error message not included in the list appears,
the in-house technician in charge or the Belimed service must be contacted.

TIP

List of errors
The complete list of error messages along with their possible causes is provided in the Technical
Manual.

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No. Message Cause Priority

 Remedy

1 Emergency stop The Emergency stop button on the sterilizer has been 2
activated.

 Release the Emergency stop button by turning the


red button.
 Acknowledge the error message on the operating
panel.

2 Vacuum pump The motor protection switch of the vacuum pump was 2
motor protection triggered due to overloading.

 Contact the in-house technician or Belimed Service.

3 – This error does not exist for MST-V. 2

 Contact the in-house technician or Belimed Service.

4 Program termina- The ‹Program termination› function was activated. 1


tion
 Acknowledge the error message on the operating
panel.
 Sterilize the batch again. The batch is not sterile
after a program abort!

5 Power failure The electric power supply was interrupted. Program is 3


terminated if chamber is not under positive pressure.

 As soon as power has been restored, acknowledge


the error message on the operating panel.
 Sterilize the batch again. The batch is not sterile
after a power failure!

6 Manual advance The ‹Manual advance› was triggered manually. 1/3

 As soon as power has been restored, acknowledge


the error message on the operating panel.
 Sterilize the batch again. The batch is not sterile
after a power failure!

7 PLC battery sup- The buffer battery of the PLC is empty. 4


ply error
 Do not switch the sterilizer off. Data may be lost!
 Contact the in-house technician or Belimed Service.

8 – This error does not exist for MST-V. –

 Contact the in-house technician or Belimed Service.

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No. Message Cause Priority

 Remedy

9 Time exceeded The monitoring time of a program phase has been 1


exceeded.

 Acknowledge the error message on the operating


panel.
 Restart the program.

10 – This error does not exist for MST-V. –

 Contact the in-house technician or Belimed Service.

11 Sensor T1 defec- Sensor T1 displays invalid values. 1


tive
 Contact the in-house technician or Belimed Service.

12 Sensor T2 faulty Sensor T2 displays invalid values. 3

 Contact the in-house technician or Belimed Service.

13 Sensor T3 faulty Sensor T3 displays invalid values. 3

 Contact the in-house technician or Belimed Service.

14 Sensor T4 faulty Sensor T4 displays invalid values. 3

 Contact the in-house technician or Belimed Service.

15 Sensor T5 faulty Sensor T5 displays invalid values. 3

 Contact the in-house technician or Belimed Service.

16–17 – This error does not exist for MST-V. –

 Contact the in-house technician or Belimed Service.

18 Sensor P1 defec- The chamber pressure measuring circuit P1 for regula- 1


tive tion is interrupted.

 Contact the in-house technician or Belimed Service.

19 Sensor P2 faulty The chamber pressure measuring circuit P2 for record- 3


ing is interrupted.

 Contact the in-house technician or Belimed Service.

20 Sensor P3 faulty The jacket pressure measuring circuit P3 is interrupted. 3

 Contact the in-house technician or Belimed Service.

21 Sensor P4 faulty The steam pressure measuring circuit P4 is interrupted. 4

 Contact the in-house technician or Belimed Service.

22 Temperature T1 The chamber temperature is below the lower tempera- 3


too low ture alarm threshold. This message is only active during
the sterilization phase.

 Contact the in-house technician or Belimed Service.

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No. Message Cause Priority

 Remedy

23 Temperature T3 The chamber temperature is too low or fluctuates. This 3


too high message is only active during the sterilization phase.

 Contact the in-house technician or Belimed Service.

24 – This error does not exist for MST-V. –

 Contact the in-house technician or Belimed Service.

25 Temperature T1 The chamber temperature is above the upper tempera- 3


too high ture alarm threshold. This message is only active during
the heating and sterilization phase.

 Contact the in-house technician or Belimed Service.

26 Temperature T3 The temperature in the Integrated Bowie-Dick Test 3


too high (option) is at or below the lower alarm threshold.

 Check the temperature sensor T3 (B813).


 If necessary, adjust temperature sensor T3 (B813)
at 134°C.
 Replace faulty temperature sensor T3 (B813).

27 Temperature T5 The temperature of the circulation container is > 65°C. 2


too high
 Check cooling water supply for interruptions.
 If necessary, restore cooling water supply.
 Check that the pressure of the cooling water is ade-
quate.
 If necessary, restore the cooling water pressure.
 Check that cooling water temperature is  32°C.
 If necessary, reduce cooling water temperature to
 32°C.
 Check the cooling water valves V618 and V621.
 If necessary, replace cooling water valves V618 or
V621.
 Check the closing of the condensate drain K504.
 If necessary, replace condensate drain K504.
 Check condenser W4.
 If necessary, decalcify condenser W4.
 If necessary, replace condenser W4.

28 Sensors T1/T2 Discrepancy between values measured by sensors T1 3


deviating and T2 during the sterilizing process.

 Acknowledge the error message on the operating


panel.
 If the error occurs again in the course of the next
cycle, contact the in-house technician in charge or
the Belimed service.

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No. Message Cause Priority

 Remedy

29–32 – This error does not exist for MST-V. –

 Contact the in-house technician or Belimed Service.

33 Steam pressure The steam supply pressure is too low. 4


too low
 In the case of sterilizers with external steam supply,
notify the in-house technician responsible for the
external steam supply.

34 Pressure-temp. The temperature is too low in relation to the steam pres- 1


correlation/temp. sure.
too low
 Contact the in-house technician or Belimed Service.

35 Pressure-temp. The temperature is too high in relation to the steam pres- 1


correlation/temp. sure.
too high
 Contact the in-house technician or Belimed Service.

36 Leak test failed The chamber is leaking or moist. 1

 Check door seal frame on loading side and on


unloading side for foreign objects.
 Remove foreign objects.
 Start the leak test again.
 If the error occurs again in the course of the next
cycle, contact the in-house technician in charge or
the Belimed service.

37 Pressure sen- Discrepancy between values measured by pressure 3


sors P1 / P2 devi- sensors P1 and P2 during the sterilizing process.
ating
 Acknowledge the error message on the operating
panel.
 If the error occurs again in the course of the next
cycle, contact the in-house technician in charge or
the Belimed service.

38 LS door - end Door on loading side failed to reach the end position 4
position not within 20 seconds.
reached
 Check door seal frame on loading side and on
unloading side for foreign objects.
 Remove foreign objects.
 If the error occurs again in the course of the next
cycle, contact the in-house technician in charge or
the Belimed service.

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No. Message Cause Priority

 Remedy

39 US door - end Door on unloading side failed to reach the end position 4
position not within 20 seconds.
reached
 Check door seal frame on unloading side and inspect
the unloading side for foreign objects.
 Remove foreign objects.
 If the error occurs again in the course of the next
cycle, contact the in-house technician in charge or
the Belimed service.

40–61 –  Contact the in-house technician or Belimed Service. –

62 Compr. air short- Pressure of compressed air dropped below 4 bar. 3


age
 Inform the in-house technician responsible for com-
pressed air.

63 Integrated Bowie- Integrated Bowie-Dick Test (option) not passed. Air leak- 3
Dick Test failed age or non-condensable gases in steam.

 Acknowledge the error message on the operating


panel.
 If the error occurs again in the course of the next
cycle, contact the in-house technician in charge or
the Belimed service.

64 Batch control Batch control (option) was unsuccessful. RIF 1–3 too 3
failed great or (T3–T1) >0.5 °C.

 Acknowledge the error message on the operating


panel.
 If the error occurs again in the course of the next
cycle, contact the in-house technician in charge or
the Belimed service.

65–80 –  Contact the in-house technician or Belimed Service. –

Table 6-2 Errors with error message

For errors without an error message, see Chapter Table 6-3 «Errors without error message».

Dialog boxes
Dialog boxes appear if certain requirements are not fulfilled. As soon as the requirements are met,
the dialog boxes disappear again.

No. Dialog box mes- Cause Remedy


sage

1 Machine not ready to The sterilizer is not in starting • Open door on unloading side
start position. (option) and close it again.

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No. Dialog box mes- Cause Remedy


sage

2 Door release - One door has already been • Only one door is allowed to be
Unloading side opened. open at any one time.
• Close door on opposite side in
2-door model (option).

3 No zero pressure in The chamber was not aerated to • Wait for 2 minutes, then tap the
chamber ambient pressure at the end of ‹Open door› button.
the program.
• If the dialog box reappears,
contact a Belimed technician.

4 Door not closed One of the doors was not closed • Close door on loading side and
when the program was started. on unloading side (option).

5 Door not unlocked The door seal was not retracted. • Wait for 2 minutes, then tap the
‹Open door› button.
• If the dialog box reappears,
contact a Belimed technician.

7 Opposite door not The door on the opposite side • Close door on opposite side in
closed was not closed when the program 2-door model (option).
was started.

8 Steam pressure too If several consumers are con- • Wait a few minutes until the
low nected up to the same steam net- steam pressure is sufficiently
work, shortages can occur. high.
The steam network is not supply- • Once more start a program.
ing enough steam.
• If the dialog box appears
again, contact a Belimed tech-
nician.

9 Early start-up active Early start has been reached, the • Wait about 10 minutes until the
jacket must be heated up before program starts or select and
the start of the program. start a new program.

10 Program termination The program is presently in a • Wait until the program changes
not possible phase in which termination is not phase; if necessary, activate
possible for reasons of safety. manual advance (only possible
on service level).

18 Power failure The electric power supply was • Wait until power supply has
interrupted. Message only been restored. If necessary,
appears in machines with uninter- notify in-house technician.
ruptible power supply (option).

19 Corrupt program Program parameters no longer • Contact Belimed technician.


parameters conform to the specification.

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No. Dialog box mes- Cause Remedy


sage

36 Jacket pressure too The jacket pressure is too low for • Wait a few minutes until the
low a program to be started. jacket pressure is sufficiently
high.
• Acknowledge dialog box.
• If the dialog box does not ap-
pear again, a program can be
started.
• If the dialog box reappears re-
peatedly, contact a Belimed
technician.

37 Sterilizing or drying It is being attempted after copying • For regulatory reasons, it is not
time too short a program to enter a shorter ster- permitted to shorten the time.
ilizing or drying time.

39 Collective error - The Integrated Bowie-Dick Test • Acknowledge dialog box.


Integrated Bowie- (option) was not passed.
Dick Test

48 Steam generator The steam generator (option) • Switch on external steam gen-
does not react does not give a feedback mes- erator.
sage indicating the operating
state.

49 Steam generator The steam generator (option) is • Switch on external steam gen-
was deactivated switched off. erator.

50 Chamber tempera- The test device must have a tem- • Start warm up program to heat
ture too low, start perature of at least 35 °C for an up the test device.
warm up program Integrated Bowie-Dick Test
(option) to be started.

219 No program selected No program has been selected. • Select program

220 Error pending An error is pending. • Resolve error and confirm er-
ror resolution.

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6.6 Other errors

Error Possible causes Remedy

The loading process is not started. • Connection between automation  Check connectors and cables.
unit (option) and sterilizer has
 Start new sterilizing program.
been interrupted.
 Open the sliding door.
 If the error persists, contact the techni-
cal service or Belimed service agent.

The unloading process is not started. • Connection between automation  Check connectors and cables.
unit (option) and sterilizer has  Start new sterilizing program.
been interrupted.
 Open the sliding door.
 If the error persists, contact the techni-
cal service or Belimed service agent.

Error during or at the end of the load- • Various causes.  Eliminate cause.
ing or unloading process.  Start new sterilizing program.
 Open the sliding door.
 Check connectors and cables.
 If the error persists, contact the techni-
cal service or Belimed service agent.

Scanner does not work. • Cable connection has been inter-  Eliminate cause.
rupted.
 Clean scanner.
• Connector has come loose.  Check connectors and cables.
• Scanner is dirty.  If the error persists, contact the techni-
cal service or Belimed service agent.
– The scanner is ready for use when the
button lights up green.

Table 6-3 Errors without error message

For errors with an error message, see Chapter Table 6-2 «Errors with error message».

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7 Cleaning

TIP

Use suitable cleaning agents


Belimed AG recommends the cleaning agent BELIBLANK (material no. 300 07048) for all surfaces.

 Only use a suitable neutral cleaner to clean surfaces (screen, glass, HI-MACS, stainless steel).

 Apply cleaning agent carefully with a clean white cotton cloth.

 Wipe the surfaces to which cleaning agent has been applied dry carefully using a clean white cot-
ton cloth.

7.1 Overview of the front surface materials

Loading side

1
2
2

2
2

Fig. 7-1 Overview of the front surface materials on the loading side

1 HI-MACS®
2 Glass
3 Stainless steel

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Unloading side

2
2
2
3

Fig. 7-2 Overview of the front surface materials on the unloading side

1 HI-MACS®
2 Glass
3 Stainless steel

7.2 Extendable shelves (option)

WARNING

Burn hazard
The sterilizer and its components are hot after completion of a program cycle.

 Allow the sterilizer and its components to cool down to room temperature.

 Only perform cleaning or maintenance work when the sterilizer and its components have cooled
down.

 Removing extendable shelves (option) for cleaning, see Chapter 5.3.1 «Removing the extendable
shelf (option)».
 Cleaning stainless steel surfaces, see Chapter 7.3 «Chamber and stainless steel surfaces».
 Reinstalling extendable shelves (option), see Chapter 5.3.2 «Installing the extendable shelf (op-
tion)».

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7.3 Chamber and stainless steel surfaces

WARNING

Burn hazard
The sterilizer and its components are hot after completion of a program cycle.

 Allow the sterilizer and its components to cool down to room temperature.

 Only perform cleaning or maintenance work when the sterilizer and its components have cooled
down.

NOTICE

Risk of damage
Use of incorrect means for cleaning can damage the product.

 Never use scouring agents, wire brushes, steel wool or other abrasive materials for cleaning the
chamber, the front panel or the doors.

 Perform dry cleaning with soft, lint-free cloth.


 Perform moist cleaning using neutral cleaning agent (neutral or slightly alkaline pH, e.g. dishwash-
ing agent diluted with water) and sturdy cotton cloth.
 After cleaning the chamber, check for cleaning agent residues.
 If necessary, remove cleaning agent residues.

NOTICE

Risk of corrosion
Chlorine or cleaning agents that contain chlorine attack the surface of stainless steel and cause cor-
rosion.

 Use chlorine-free cleaning agents for stainless steel.

7.4 HI-MACS® surfaces


Remove contaminations with moist cloth or sponge and a mild cleaning agent.

7.5 Screen and glass surfaces

CAUTION

Injury hazard
Broken glass panes have sharp edges and can cause injuries.

 Have broken glass panes replaced immediately by Belimed service.

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Deactivate the screen for cleaning


 Press button and button.
– The second page of the main menu is displayed.
 Activate the ‹Clean screen› button.
– The screen is deactivated for 20 seconds.

Clean the screen and the glass surfaces


 Use a cloth moistened with water or a glass cleaning agent for cleaning.

NOTICE

Risk of damage
Aggressive solutions or scouring agents cause damage to the screen and the glass surfaces.

 Do not use any scouring agents.

 Only use mild solvents.

 Check the cleaning agents for compatibility with the materials to be cleaned before using them.

7.6 Scanner
Cleaning the scanner
 Switch the product off.
 The green button is no longer illuminated.
 Use a cloth moistened with water or a glass cleaning agent for cleaning.

NOTICE

Risk of damage
Aggressive solutions or scouring agents cause damage to the screen and the glass surfaces.

 Do not use any scouring agents.

 Only use mild solvents.

 Check the cleaning agents for compatibility with the materials to be cleaned before using them.

 Switch the product on.


 The button lights up green.

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8 Maintenance work
8.1 Maintenance intervals
Besides the daily and weekly maintenance tasks, 3 maintenance intervals (levels 1–3) are defined.
Regular maintenance of the sterilizer is important in order to avoid malfunctions.
If maintenance is due, the symbol appears on the operating panel of the loading side. If the
symbol is displayed, the Belimed service must be informed. In the ‹Machine information› menu, it
is indicated, what maintenance is due.

 Press button.
 Press the ‹Machine information› button.
 Browse using the or button until the maintenance levels are displayed.
– It is indicated on the screen, which maintenance level is active.
After completion of maintenance, the Belimed service technician resets the message via the web ap-
plication.

Maintenance Display on the operating panel If the hours of operation are not
level reached, maintenance must be per-
formed at the latest after

1 After 650 hours of operation 3 months

2 After 2600 hours of operation 1 year

3 After 5200 hours of operation 2 years

Table 8-1 Maintenance intervals

NOTICE

Testing the pressure vessel


Regardless of the maintenance intervals prescribed by Belimed AG, the pressure vessel must be
subjected to tests on a regular basis in accordance with the applicable legal regulations.

 Perform test as per applicable legal regulations on a regular basis.

8.2 Daily maintenance


A maintenance routine must be performed every day. In the scope of this maintenance routine, the
operator must perform the tasks described below. No maintenance message is displayed for the daily
maintenance routine.

Maintenance item Tasks to be performed

Cleaning If necessary, clean the front surfaces of the sterilizer, see Chapter 7
«Cleaning».

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Maintenance item Tasks to be performed

Cycle documentation Check paper.


printer
• If a red stripe is visible on the paper, replace the paper roll, see Chap-
ter 8.5 «Replacing the paper roll».

Heating up the chamber In the case of a cold chamber, run the warm up program as the first pro-
gram each day.
Alternatively, run the warm up program with subsequent leak test.

Steam penetration test Run ‹Bowie-Dick Test› program with indicator.


• Bowie-Dick indicator must behave as described in the manufacturer's
information, see Chapter 8.4.2 «Bowie-Dick Test».

Steam penetration test In the case of Integrated Bowie-Dick Test (option), run ‹Integrated Bowie-
Integrated Bowie-Dick Dick Test› with empty chamber.
Test (option)
• ‹Bowie-Dick Test passed› must appear on the print-out, see Chapter
8.4.3 «Integrated Bowie-Dick Test (option)»

8.3 Weekly maintenance


A maintenance routine must be performed every week. In the scope of this maintenance routine, the
operator must perform the tasks described below. No maintenance message is displayed for the
weekly maintenance routine.

Maintenance item Tasks to be performed

Leak test Check leakproofness of the system:


In the case of a cold chamber:
• Run the warm up program with subsequent leak test.
In the case of a heated chamber
• Run leak test program.
Run leak test program. See Chapter 4.5 «Sterilizing».

Cleaning Clean the following elements:


• Drainage screen in the chamber floor
• Chamber
• Front surfaces of sterilizer

Door seal Visual inspection:


• When the door is open, the door seal must lie completely in the seal
frame all around the circumference.
• Check door seal for damages

Leaks in the system • Visual inspection of the piping system in the servicing space (water, air
or steam escaping)

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8.4 Maintenance programs

TIP

Door interlock in test programs


In test programs, the door can only be opened on the loading side.

8.4.1 Leak test


In order to ensure faultless function of the sterilizer, a warm up program with subsequent leak test
‹warm up & leak› must be run at least once a week. If the chamber is warm, it is sufficient to carry out
the program <leak test>. This test verifies the integrity of the locked pressure vessel and the associ-
ated piping. It is thereby ensured that no air can enter the chamber during the vacuum phases.
At the end of the test, the leakage rate is automatically calculated and recorded.
If the leakage rate exceeds the permissible value of 1.3 mbar/minute, an error is displayed and re-
corded. The error must be reported to the immediate supervisor, who must then initiate the appropri-
ate measures to resolve the error. Do not continue to use the sterilizer after a failed test until the error
has been resolved.
Perform the test once a week and monitor the leakage rate over a longer period of time. This can help
to deal with leakages at an early stage.

8.4.2 Bowie-Dick Test


The Bowie Dick test provides information on the efficacy of de-aeration and of steam penetration.
This test does not serve to verify an adequate exposure time in relation to the exposure temperature.
Signs of malfunction must be reported to the supervisor, who must then initiate the appropriate mea-
sures to resolve the malfunction. Do not use the sterilizer while the issue is being clarified.

8.4.3 Integrated Bowie-Dick Test (option)


The Integrated Bowie Dick test (option) provides information on the efficacy of de-aeration and of
steam penetration. This test does not serve to verify an adequate exposure time in relation to the
exposure temperature.
The ‹Integrated Bowie Dick test› program is started via the operating panel. The chamber must be
empty for this. The result is recorded on the cycle documentation printer with ‹Bowie-Dick Test
passed› or ‹Bowie-Dick Test failed›. If ‹Bowie-Dick Test failed› appears, the test must be repeated. If
the test fails 2 times in a row, this must be reported to the supervisor, who must then initiate the ap-
propriate measures to resolve the malfunction. Do not use the sterilizer while this issue is being clar-
ified.

8.4.4 Monitoring of the sterilizing process


The operator can optionally monitor the sterilizing process by means of chemical indicators. The in-
dicators are placed with the sterilization batches in accordance with the internal directives. The fol-
lowing points must be observed when doing this:
• The indicators must be checked as specified by the manufacturer upon opening the package.
• If the indicator cannot be clearly read after sterilization, the batch concerned must not be used.

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8.5 Replacing the paper roll

NOTICE

Risk of data loss


If unsuitable types of printer paper are used, the cycle records can become illegible.

 Use only special archive-quality paper that has been validated for a storage period of 11 years.

If the paper roll of the cycle documentation printer has been used up or if red stripes appear on the
paper, replace the paper roll as follows:

2
3

Fig. 8-1 Operating panel with cycle documentation printer

1 Operating panel
2 Printer flap
3 Paper outlet slit
4 Pressure point for unlocking the flap

 Unlock and open the printer flap on the sterilizer by pressing on the button 4 / .

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Fig. 8-2 Opening the front flap of the cycle documentation printer

1 Green button opens front flap

 Activate the green button 1 on the printer.


– The front flap opens.
 Remove empty paper roll.

Fig. 8-3 Inserting the paper roll of the cycle documentation printer
 Insert new paper roll.
 Let loose end of roll protrude at rear and upwards.
 The roll must lie in the printer in such a way that it rolls out of the printer when the loose end
of the roll is pulled.

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Fig. 8-4 Closing the front flap of the cycle documentation printer

1 Button for conveying paper


2 Front flap

 Close front flap 2.


– The front flap must snap into place audibly.
 Convey approx. 7 cm of the paper out of the printer using the button 1.
 Do not pull the paper!
 Close the printer flap of the sterilizer and pass the paper through the paper outlet slit while doing
this.
 Lock the printer flap by pressing on the button.
 Tear off projecting paper.

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9 Technical data
9.1 General

Model 6-6-6 6-6-9 6-6-12 6-6-18

Product name Steam sterilizer MST-V in compliance with EN 285

Series MST

Medical device Class IIb

Chamber volume [L] 300 430 585 880

Excess pressure during opera-


2.7
tion [bar]

Maximum permissible operating


141
temperature [°C]

Noise level according to ISO 3746


69 75
[dBA]

Table 9-1 General technical data

9.2 Dimensions and weights

9.2.1 Steam sterilizer

Model 6-6-6 6-6-9 6-6-12 6-6-18

Height 660

Chamber clearance [mm] Width 660

Depth 700 1000 1354 2000

1-door 720 857 1404 –


Approx. operating weight [kg]
2-door 895 1032 1212 1534

1-door 940 1170 1435 –


Approx. test weight [kg]
2-door 1115 1345 1643 2180

Table 9-2 Dimensions and weights of steam sterilizer

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9.2.2 Batch cart

Model CW 6-6-6 CW 6-6-9 CW 6-6-12

Material Standard 1.4301 (ASTM 304)

Height 563

Dimensions [mm] Width 600

Depth 655 955 1330

Weight [kg] 12 15 18

per
Maximum loading capacitya[kg] 30 45 60
support grid

Total 68 102 136


a. The maximum loading capacity must not be exceeded.

Table 9-3 Dimensions and weights of batch carts

9.2.3 Extendable shelves (option)

Model 6-X-6 6-X-9

Material Standard 1.4301 (ASTM 304)

Height 393

Overall assembly [mm] Width 665

Depth 610 910

Total weight [kg / lbs] 32 / 71 41 / 90

Height 29

Width 600
Each extendable shelf [mm]
Depth 600 900

Individual weight [kg / lbs] 8.5 / 19 12.2 / 27

Of each extendable shelf (both


30 / 66 45 / 99
Maximum loading capacitya installed)
[kg /
lbs]
Bottom extendable shelf (top
60 / 132 90 / 198
extendable shelf uninstalled)
a. The maximum loading capacity must not be exceeded.

Table 9-4 Dimensions and weights of the extendable shelves (option)

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9.3 Quality of utilities

9.3.1 Compressed air quality


The quality of the compressed air must according to EN 285 meet the following requirements:
• Pressure of 5–7 bar
• Free of water in liquid form
• Free of particles >25 m
• Free of oil droplets >2 m

9.3.2 Cold water quality


The cold water for the heat exchanger - version without cooling water switch-over (option) - and the
vacuum pump (all versions) must be of drinking water quality and must meet the requirements spec-
ified in the following table.

Recommended
Maximum value
value

Temperature [°C] 4–20 32

pH 6.5–8.0 6.0–8.5

Hardness (sum of alkaline earth metal ions) [mmol/L] 0.7–2.0 2.0

Total dissolved minerals [mg/L] 50–200 300

Chlorides [mg/L] <70 80

Table 9-5 Requirements for cold water quality

9.3.3 Cooling water quality in systems with cooling circuit (option)

Recommended Maximum
Value Value

Temperature [°C] 4–15 20

Hardness (sum of alkaline earth metal ions) [mmol/L] 0.7–2 2

Chlorides [mg/L] <70 80

Table 9-6 Requirements with regard to the cooling water quality for cooling water switch-over (option)

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9.3.4 Feed water quality for steam generator (option)


The concentration of the respective contaminations in the feed water must not exceed the values list-
ed in the following table. The proposed maximum values for contaminations in the condensate are
specified as follows in norm EN 285, chapter 13.3 and appendix B:

Substance/property Feed water

Residue on evaporation 10 mg/L

Silicates (SiO2) 1 mg/L

Iron 0.2 mg/L

Cadmium 0.005 mg/L

Lead 0.05 mg/L

Rest of heavy metals except iron, cadmium, lead 0.1 mg/L

Chlorides (Cl-) 2 mg/L

Phosphates (P2O5) 0.5 mg/L

Conductivity (at 25 °C, deviating from norm


1 S/cm, 15 S/cm
EN 285)

pH (degree of acidity) 5–7.5

Appearance colorless, clear, with no deposits

Hardness (sum of alkaline earth metal ions) 0.02 mmol/L

Table 9-7 Contamination in the feed water for a dedicated steam generator

9.3.5 Steam quality, external steam supply (option)


Steam from external supply (option) must be free of condensate and must be saturated in order to
achieve good drying of the sterilized goods. The suggested threshold values for contamination in the
condensate as well as the required properties of the steam are specified as follows in EN 285,
Chapter 13.3. and Annex B

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Substance/property Condensate

Silicates (SiO2)  0.1 mg/L

Iron  0.1 mg/L

Cadmium  0.005 mg/L

Lead  0.05 mg/L

Rest of heavy metals except iron, cadmium, lead  0.1 mg/L

Chlorides (Cl-)  0.1 mg/L

Phosphates (P2O5)  0.1 mg/L

Conductivity (at 25 °C) 3 S/cm

pH (degree of acidity) 5–7

Appearance colorless, clear, with no deposits

Hardness (sum of alkaline earth metal ions)  0.02 mmol/L

Table 9-8 Maximum values for contaminations in the condensate

Steam properties
Required value
as defined in EN 285

Dryness value for loads containing metal 0.950.97

Overheating 25 K

Non-condensable gases 3.5 % v/v

Table 9-9 Required properties of the steam

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9.4 Electrical connection specifications

9.4.1 Steam sterilizer (3N~200–230 V, 50/60 Hz)

Model 6-6-6 6-6-9 6-6-12 6-6-18

Operating voltage [V] 3N~200–230

Frequency [Hz] 50 / 60

Nominal current [A] 7.2 / 7.7 9.2 / 12.5

Pre-fuse [A] 10 16

Minimum cross section of con-


1.5
necting lead [mm²]

IP protection type IP 20

Electrical safety EN 61010-1, EN 61010-2-040

Electromagnetic compatibility EN 61326-1

Table 9-10 Electrical connection specifications for steam sterilizer (3N~200–230 V, 50/60 Hz)

9.4.2 Steam sterilizer (3N~380–420 V, 50/60 Hz)

Model 6-6-6 6-6-9 6-6-12 6-6-18

Operating voltage [V] 3N~380–420

Frequency [Hz] 50 / 60

Nominal current [A] 4.5 / 4.7 6.0 / 7.5

Pre-fuse [A] 10

Minimum cross section of con-


1.5
necting lead [mm²]

IP protection type IP 20

Electrical safety EN 61010-1, EN 61010-2-040

Electromagnetic compatibility EN 61326-1

Table 9-11 Electrical connection specifications for steam sterilizer (3N~380–420 V, 50/60 Hz)

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9.5 Surrounding conditions

9.5.1 Operation

Use Indoors

Ambient temperature +5 °C to +40 °C


as per EN 61010-1

Ambient pressure +75 kPa to +106 kPa

Maximum operating altitude 2000 m above sea levela

Maximum relative humidity 80 % for temperatures up to +31 °C,


decreasing linearly to 50 % at +40 °C

Earthquake protection Earthquake-proof construction

Mains voltage fluctuations ±10 % of the nominal voltage


a. When operating the steam generator at altitudes >1500 m above sea level, parameters must be changed.

Table 9-12 Surrounding conditions while in operation

9.5.2 Storage

Storage Indoors

Ambient temperature +0 °C to +50 °C

Ambient pressure +75 kPa to +106 kPa

Relative humidity 10 % to 90 %, non-condensing

Atmosphere Non-corrosive

Storage duration 1 year at most

Table 9-13 Surrounding conditions while in storage

9.6 Cycle documentation printer

Technology Thermal printer

Characters per line 42 characters

Paper width 57.5 mm

Roll diameter 50 mm

Table 9-14 Cycle documentation printer

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Belimed AG | Grienbachstrasse 11 | 6300 Zug | Switzerland | +41 41 449 78 88 | +41 41 449 78 89 | www.belimed.com

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