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BdAn MST-V 09.02 DGRL EN-US 2017-11-20
BdAn MST-V 09.02 DGRL EN-US 2017-11-20
MST-V 6-6-X
User Manual
These instructions apply to:
Material 107-9813
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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5 Options 58
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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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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:
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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Introduction Steam sterilizer MST-V 6-6-X | © Belimed
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.
DANGER
WARNING
CAUTION
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Steam sterilizer MST-V 6-6-X | © Belimed Introduction
NOTICE
TIP
Tips for use and useful information on the best possible utilization.
• Indicates a list.
a) Indicates a subsection of a list.
b)
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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.
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Steam sterilizer MST-V 6-6-X | © Belimed Safety
• 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.
WARNING
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.
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).
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Safety Steam sterilizer MST-V 6-6-X | © Belimed
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.
WARNING
Insufficient drying
If the sterilized items are not sufficiently dried and they are stored for a lengthy period, sterility is jeop-
ardized.
WARNING
Injury hazard
Bursting bottles can cause injury or damage to the machine.
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.
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Steam sterilizer MST-V 6-6-X | © Belimed Safety
CAUTION
Stay clear of door area during opening and closing of sliding door.
CAUTION
Injury hazard
Broken glass panes have sharp edges and can cause injuries.
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.
CAUTION
Injury hazard
Items can fall down in the course of loading.
Dock the transport cart before the batch cart is transferred into the chamber.
CAUTION
Injury hazard
Items can fall down during unloading.
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.
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
CAUTION
Injury hazard
Batch cart can fall down if the batch cart is not locked.
Only move the docking lever to the right once the transport cart is docked.
Dangerous voltage!
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Caution! Hot!
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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.
2
3
4
1 Control panel
2 Cycle documentation printer (optionally on unloading side)
3 Chamber door
4 Emergency stop button
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Steam sterilizer MST-V 6-6-X | © Belimed Description
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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Description Steam sterilizer MST-V 6-6-X | © Belimed
1 Main switch
2 Switch cabinet
3 Cycle documentation printer
4 Chamber door
5 Servicing door
6 Door motor
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Steam sterilizer MST-V 6-6-X | © Belimed Description
1 Chamber door
2 Servicing door
3 Door motor
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Description Steam sterilizer MST-V 6-6-X | © Belimed
1 Main switch
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Steam sterilizer MST-V 6-6-X | © Belimed Description
3.2.2.1 Overview
1
2
3
5
6
7
8
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
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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Description Steam sterilizer MST-V 6-6-X | © Belimed
Doors closed
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›
Numbers New
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Steam sterilizer MST-V 6-6-X | © Belimed Description
Relocating programs
Cycle information
Program intervention
OK
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Description Steam sterilizer MST-V 6-6-X | © Belimed
3.2.5.1 Overview
1
2
3
In the status bar, certain settings and events are shown by means of signs and data:
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Steam sterilizer MST-V 6-6-X | © Belimed Description
Doors locked
Doors open
Doors closed
Light-emitting diode
Continuous green light: program active
‹Program progress›
Light-emitting diode
Continuous green light: doors locked
‹Door interlock›
The activity bar displays the functions of the activity button. What functions are available depends on
the respective program phase.
Blowing out the door seal Adjust brightness and background illumi-
nation
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* = first bar
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Steam sterilizer MST-V 6-6-X | © Belimed Description
Transport cart
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Description Steam sterilizer MST-V 6-6-X | © Belimed
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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.
NOTICE
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.
NOTICE
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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4.2 Logging on
To operate the sterilizer, the user must log on with a password.
Menu
Log on
OK
Log on
User
ZSVA Leader
Technical service
Admin
OK
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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.
4.3.1.1 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
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.
• 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
DIN 58953-7 is the standard that applies to the packaging of items to be sterilized.
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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
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A B
C D
E F
G H
A B C
D E F
G H I
Fig. 4-2 Double packaging method II: envelope folding
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).
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.
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 the ‹Heavy instruments› program to sterilize heavier packaging units. This has a longer drying
time.
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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 the ‹Heavy instruments› program to sterilize heavier packaging units. This has a longer drying
time.
WARNING
Insufficient drying
If the sterilized items are not sufficiently dried and they are stored for a lengthy period, sterility is jeop-
ardized.
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Per support grida Per batch cartb Per support grid Per batch cart
6-6-6 44
6-6-9 66
1000
6-6-12 88
6-6-18 2 × 66
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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
Items can fall down in the course of loading.
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. 4-5 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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CAUTION
Injury hazard
Batch cart can fall down if the batch cart is not locked.
Only move the docking lever to the right once the transport cart is docked.
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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
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.
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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)
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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.
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
Table 4-4 Guideline for the sterilization of liquids using the MST-V steam sterilizer
Pre-treatment
Post-treatment
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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.
NOTICE
Risk of corrosion
Chlorides can attack stainless steel components.
WARNING
Injury hazard
Bursting bottles can cause injury or damage to the machine.
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.
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WARNING
Injury hazard
Liquids on the floor can lead to injuries due to slipping.
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.
CAUTION
Stay clear of door area during opening and closing of sliding door.
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.
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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
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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.
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. 4-11 Schematic: Transport cart fixed, batch cart free to move
CAUTION
Injury hazard
Batch cart can fall down if the batch cart is not locked.
Only move the docking lever to the right once the transport cart is docked.
WARNING
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.
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Menu
Log off
Machine information
Messages / errors
OK
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.
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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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TIP
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.
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Program running
Program name
Terminate program
Continue
OK
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.
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.
Press button.
– The main menu is displayed.
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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›.
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.
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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.
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.
5.2.1 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
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2
3
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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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.
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3
8
7
4
5
6
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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3
8
7
4
5
6
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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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
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.
CAUTION
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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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.
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.
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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.
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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Remedy
1 Emergency stop The Emergency stop button on the sterilizer has been 2
activated.
2 Vacuum pump The motor protection switch of the vacuum pump was 2
motor protection triggered due to overloading.
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Remedy
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Remedy
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Remedy
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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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.
63 Integrated Bowie- Integrated Bowie-Dick Test (option) not passed. Air leak- 3
Dick Test failed age or non-condensable gases in steam.
64 Batch control Batch control (option) was unsuccessful. RIF 1–3 too 3
failed great or (T3–T1) >0.5 °C.
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.
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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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).
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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.
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.
220 Error pending An error is pending. • Resolve error and confirm er-
ror resolution.
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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.
For errors with an error message, see Chapter Table 6-2 «Errors with error message».
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7 Cleaning
TIP
Only use a suitable neutral cleaner to clean surfaces (screen, glass, HI-MACS, stainless steel).
Wipe the surfaces to which cleaning agent has been applied dry carefully using a clean white cot-
ton cloth.
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
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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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.
NOTICE
Risk of corrosion
Chlorine or cleaning agents that contain chlorine attack the surface of stainless steel and cause cor-
rosion.
CAUTION
Injury hazard
Broken glass panes have sharp edges and can cause injuries.
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Cleaning Steam sterilizer MST-V 6-6-X | © Belimed
NOTICE
Risk of damage
Aggressive solutions or scouring agents cause damage to the screen and the glass surfaces.
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.
Check the cleaning agents for compatibility with the materials to be cleaned before using them.
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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
NOTICE
Cleaning If necessary, clean the front surfaces of the sterilizer, see Chapter 7
«Cleaning».
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Maintenance work Steam sterilizer MST-V 6-6-X | © Belimed
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 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)»
Leaks in the system • Visual inspection of the piping system in the servicing space (water, air
or steam escaping)
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TIP
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Maintenance work Steam sterilizer MST-V 6-6-X | © Belimed
NOTICE
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
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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Steam sterilizer MST-V 6-6-X | © Belimed Maintenance work
Fig. 8-2 Opening the front flap of the cycle documentation printer
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
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9 Technical data
9.1 General
Series MST
Height 660
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Technical data Steam sterilizer MST-V 6-6-X | © Belimed
Height 563
Weight [kg] 12 15 18
per
Maximum loading capacitya[kg] 30 45 60
support grid
Height 393
Height 29
Width 600
Each extendable shelf [mm]
Depth 600 900
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Recommended
Maximum value
value
pH 6.5–8.0 6.0–8.5
Recommended Maximum
Value Value
Table 9-6 Requirements with regard to the cooling water quality for cooling water switch-over (option)
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Technical data Steam sterilizer MST-V 6-6-X | © Belimed
Table 9-7 Contamination in the feed water for a dedicated steam generator
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Substance/property Condensate
Steam properties
Required value
as defined in EN 285
Overheating 25 K
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Technical data Steam sterilizer MST-V 6-6-X | © Belimed
Frequency [Hz] 50 / 60
Pre-fuse [A] 10 16
IP protection type IP 20
Table 9-10 Electrical connection specifications for steam sterilizer (3N~200–230 V, 50/60 Hz)
Frequency [Hz] 50 / 60
Pre-fuse [A] 10
IP protection type IP 20
Table 9-11 Electrical connection specifications for steam sterilizer (3N~380–420 V, 50/60 Hz)
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9.5.1 Operation
Use Indoors
9.5.2 Storage
Storage Indoors
Atmosphere Non-corrosive
Roll diameter 50 mm
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OBJ_DCL-0000000632-004.dcl
Belimed AG | Grienbachstrasse 11 | 6300 Zug | Switzerland | +41 41 449 78 88 | +41 41 449 78 89 | www.belimed.com