Matachana sc500s1000 Operating Manual

Steam Sterilizers
OPERATING INSTRUCTION MANUAL

SC500/S1000
ORIGINAL INSTRUCTIONS
Doc.: M_SC500_S1000_12_01_00_en
Date: 02/06/2015 Rev.: 01_00
ANTONIO MATACHANA, S.A.
C. Almogàvers, 174
E-08018 Barcelona
ESPAÑA
www.matachana.com
COPYRIGHT
All the rights reserved. Antonio Matachana, S.A. claims the intellectual property of the content of this document.
No part of it may be used or copied without the prior permission of its legal representative, including its translation,
reproduction or manipulating by using any means or through any support, whatsoever.
A non-authorized use of the information contained into this document, as well as any infringement of intellectual or
industrial property rights held by Antonio Matachana, S.A., will lead to facing the legally established responsibilities.
CONTENT
Due to the constant evolution of our devices, the content of this documentation may be submitted to modification. In
this case, the user has to read the document entitled Modification and updating note handed with the equipment’s
documentation (see General Index).
Some features and/or user’s instructions may vary according to each device and the options available. In this case, the
user has to read the document entitled Special features of your device (see General Index).
© Antonio Matachana, S.A.

TABLE OF CONTENTS
1. INTRODUCTION 1
1.1 Content of this Instruction Manual 1
2. SAFETY INSTRUCTIONS 3
2.1 General remarks 3
2.2 Safety indications4
2.3 Symbols and Safety indications 5
2.4 Warnings 6
3. DESCRIPTION AND USE OF THE STERILIZER 13

3.1 Intended use 13
3.2 Description 13
3.3 Standards and CE-Conformity 14
3.4 Pressure device examination 15
3.5 Guarantee 17
4. TECHNICAL DATA 19
4.1 General data 19
4.2 Pressure vessel data 21
4.2.1 Chamber - jacket set 21
4.2.2 Electrical steam generator (E models only) 21
4.3 Ambient conditions 22
4.4 Media supply and connections 22
4.4.1 Electrical power supply 23
4.4.2 Steam supply 23
4.4.3 Treated water 24
4.4.4 Water for Vacuum system 25
4.4.5 External water cooling connection (optional) 25
4.4.6 Pressurized air supply 26
4.4.7 Drain 26
5. INSTALLATION, CONNECTION AND START UP 27

5.1 Installation 27
5.2 Connection 28
5.3 Start up29
6. CONTROL ELEMENTS OF THE STERILIZER 31

6.1 Non Sterile Area (NSA) 34
6.1.1 On/Off switch 34
6.1.2 Touch screen 34
6.1.3 Printer 36
6.1.4 Emergency Stop push-button, NSA 39
6.1.5 Manometers, NSA 40
6.1.6 Lock front service door, NSA 40
6.1.7 Level indicator of steam generator (E models only from the S1000) 41
6.1.8 Indicators icons, NSA 41
6.1.9 Sterilizer door, NSA 42
6.1.10 Coupler automatic loading module assistance (optional)42
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6.1.11 Videorecorder, NSA (optional) 42
6.1.12 USB connector (optional) 42
6.2 Sterile area (SA) 43
6.2.1 Control panel, SA 45
6.2.2 Emergency Stop push-button, SA 46
6.2.3 Manometer, SA 47
6.2.4 Indicators icons SA 47
6.2.5 Sterilizer door, SA 48
6.2.6 Lock front service door, SA 49
6.2.7 Coupler automatic unloading assistance module (optional) 49
7. PROGRAMS51
7.1 Function principle 51
7.2 Program overview 52
7.3 Program description 53
7.3.1 Test programs 53
7.3.1.1 Bowie & Dick Test (B&D Test) 53
7.3.1.2 Vacuum Test 54
7.3.1.3 Preheating 55
7.3.1.4 AutoStart (optional)56
7.3.1.5 Air Detector Calibration (optional) 56
7.3.1.6 Air Detector Vacuum Test (optional)57
7.3.2 Sterilization programs 57
7.3.2.1 Standard 121 ºC 58
7.3.2.2 Standard 134 ºC 59
7.3.2.3 Containers 59
7.3.2.5 Special P 60
7.3.2.6 Silicone Implants (optional) 61
7.3.2.7 Disinfection (optional) 61
7.3.2.8 Liquids (optional) 62
8. OPERATING THE SYSTEM 65

8.1 Connecting the sterilizer 65
8.2 Operating the sterilizer doors 65
8.2.1 One door models 67
8.2.2 Two door models 68
8.2.3 Automatic locking mechanism 68
8.3 Program selection 69
8.3.1 Select a sterilization program 69
8.3.2 Program start 71
8.3.3 Indication of program status and process variables 72
8.3.4 End of program 75
8.3.5 Program start and program end options 77
8.3.5.1 Machines with automatic loading / unloading systems (option available ONLY for S1000) 77
8.3.5.2 Machines with confirmation of cycle end (optional) 79
8.3.5.3 Machines with autostart (optional) 79
8.3.5.4 Machines with recurrent cycles (optional) 80
8.3.5.5 Machines with introduction of batch number (optional) 80
8.3.6 Cycle summaries processing of the printer 81
8.4 Keypads 84
8.5 User selection menu 85
8.6 Main screen for advanced users 87
8.6.1 Selecting a Test program 87
8.6.2 Information 88
8.7 Settings menu 89
8.7.1 Staff settings 91
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8.7.1.1 Sensors display 91
8.7.1.2 Edit programs 92
8.7.1.3 Edit date and time 93
8.7.1.4 Edit general options 94
8.7.2 Administrator settings 95
8.7.2.1 Edit passwords 95
8.7.2.2 Edit languages 95
8.7.3 TAS maintenance settings 96
8.7.3.1 TAS settings display 96
8.7.3.2 Printer settings display 97
8.7.3.3 Brightness setting displays98
8.7.3.4 Process status display with tas user 98
8.8 Connecting to batch documentation system (optional) 100
9. ALARM, WARNING AND ERROR MESSAGES 103

9.1 managing the alarm, warning and error messages 104
9.2 Alarms 105
9.3 Warnings 112
9.4 Errors 119
9.5 Interferences with operational readiness 125
10. MAINTENANCE 127

10.1 Maintenance Schedule 128
10.2 Maintenance by the operator 132
10.2.1 Daily 132
10.2.2 Weekly 133
10.3 Maintenance by the service technician 135
10.3.1 Semiannual maintenance 136
10.3.2 Annual maintenance 137
10.3.3 Efficiency Test, performance evaluation 138
10.3.4 Recurrent Inspections of pressure vessel 139
10.4 Special procedures 140
10.4.1 Cleaning and replacing door gasket 140
10.4.2 Placing printer paper roll 141
10.4.3 Recorder 141
10.5 Shutdown of the sterilizer (for long periods of time) 142
10.6 Disposal Information and recycling 142
11. SPARE PARTS AND CONSUMABLES 143
12. SWITCHPOINTS AND TOLERANCES OF THE PROGRAMS 145

12.1 STANDARD 121 ºC, STANDARD 134 ºC, RAPID, SPECIAL P, AIR DETECTOR
CALIBRATION AND B&D Test Programs 145
12.2 CONTAINERS Program 148
12.3 SILICONE IMPLANTS Program 150
12.4 LIQUIDS Program 152
12.5 DISINFECTION Program 154
12.6 VACUUM TEST and AIR DETECTOR VACUUM TEST Programs 155
12.7 PREHEATING Program156
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ANNEX I: INSTRUCTIONS FOR PREPARING AND PACKAGING OF THE STERILIZATION
LOAD159
1. Cleaning the sterilization material prior to sterilization 159
2. Wrapping and loading the sterilization material 159
2.1 Wrapping of solid material (Instruments) 160
2.2 Wrapping porous and temperature-sensitive materials 160
3. Loading of the material to be sterilized 161
4. Subsequent treatment of sterile material 161
ANNEX II: P
ROCEDURES AND DEVICES FOR TESTING THE EFFECTIVENESS OF THE
STERILIZATION PROCESS 163
1. Bowie & Dick Test 163
1.1 General 163
1.2 Bowie & Dick Test for porous material 163
1.2.1 The Test pack according to EN 285 164
1.2.2 Chemical Indicators for the B&D Test 164
1.2.3 Performing the B&D Test 165
1.2.4 Evaluation of the Controls 165
1.3 The B&D Test for hollow material 166
1.3.1 Test systems for hollow loads 166
1.3.2 Performing the Test for hollow loads 167
1.3.3 Test Evaluation for hollow loads 167
2. Routine monitoring with chemical and biological indicators 167
2.1 Chemical Indicators 167
2.2 Biological Indicators 168
3. Validation 169
4. Air detector (optional) 170
4.1 General 170
4.2 Function description of the air detector 170
4.3 Calibrating the air detector 170
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1. INTRODUCTION
MATACHANA, S.A., an enterprise of the Matachana group, thanks you for putting your confidence
in us by deciding to use one of our products. We hope that we are able to fulfil your requirements with
this product.
All our products are developed, manufactured and tested within a strict quality control acc. to the
International Standard EN ISO 9001, as well as the International Standard EN ISO13485 Standard for
the sterilizers marked as medical device). Our equipment for sterilization and disinfection fulfil the basic
requirements in force on safety issues. This is documented by a respective Declaration of Conformity
and the applied CE-marking. Thus it is ensured that they can be installed and operated for their intended
use without endangering the user or other persons, provided this takes place strictly according to the
indications of this Operating Instruction Manual.
In chapter 3 you can find information on the general provisions related to the warranty. Our guarantee is
based as much on the quality level demonstrated both by our products and our technical team, as well
as on the customer service. A list of our Technical Assistance Service network can be found with this
manual.
This manual must be kept during the entire life of the equipment.
1.1 CONTENT OF THIS INSTRUCTION MANUAL
his Operating Instruction Manual gives the operator comprehensive information about all relevant
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aspects regarding application of the unit and/or the system as a whole. The individual chapters are self-
contained and shall permit a large understanding even without deeper knowledge of the other ones.
Nevertheless, it is not possible to avoid frequent references to these other chapters or sections or if
necessary to repeat texts in different ones.
●
Chapter 2 describes the warnings and safety instructions to be taken into consideration
when operating the equipment. Paragraph 2.4 is specifically important as it contains a
list of all the safety warnings which are then indicated throughout the manual.
●
Chapter 3 shows a description of the equipment and states its specific use. It also gives
some brief indications on the machine’s EC conformity, including the relevant data to be
taken into account concerning pressure vessel and warranty scope.
●
Chapter 4 includes the technical data of the machine: dimensions, operating
environmental conditions, necessary supplies, etc.

●
Chapter 5 offers details of the necessary operations for the installation and commissioning
of the equipment.
●
Chapter 6 gives a description of the existing operating and display elements of the
device fronts and their respective functions.
●
Chapter 7 describes the provided programs, their application areas and most significant
process Parameters.
●
Chapter 8 explains in detail all operating functions of the display and operating units,
including as much the standard as the optional ones. Although the usage of menu-
structures and soft keys is made to make the operation mostly self-explaining, the
content of this chapter is important and helpful for a secure and experienced application
of the system as well as full utilization of the available possibilities.
●
Chapter 9 describes the various alarm, error and warning messages.
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●
Chapter 10 contains instructions for maintenance, including daily care and upkeep by
the user, as well as preventive maintenance to be undertaken by the technician in
charge of the maintenance and the MATACHANA Technical Assistance Service.
●
Chapter 11 includes a basic spare parts and consumable list.
●
Chapter 12 provides details on the phases for each program, together with the most
relevant process parameters, the authorized tolerance for each one of those parameters,
etc.
●
The annexes contain important technical information on some options of the equipment,
and other detailed information related to the process which can be helpful in some routine
operation of the machine. The outstanding annexes offer advice on the preparation of
material to be sterilized, proper packaging, efficacy tests to be executed on the machine
periodically, recommendations for process validation, etc.
Some of the functions described in this manual are optional. In order to know which options
are fitted into your sterilizer, see the Technical Data Sheet provided along with the equipment
documentation.
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2. SAFETY INSTRUCTIONS
2.1 GENERAL REMARKS
This Operating Instruction Manual gives the user information about a device which may imply hazards
due to electric voltage and currents as well as because of mechanical, thermal and in some cases
depending on the options incorporated in the equipment, chemical ones, for reasons inherent to the
machine itself or to the sterilization process. Physical injury or property damage may result.
Therefore, the following hazard symbols, the instructions and warnings indicated in this manual and on
the machine itself must always be observed!
In order to operate the equipment correctly, knowledge of the Safety Instruction and warnings in this
manual is a mandatory part. During the training of all users of sterilizers, it is most important to include
an explanation on the safety instructions. We especially refer to the warnings in paragraph 2.4, because
- as a result of the risk analysis on the equipment - they refer to possible endangerment which can not
be reduced by technical measurements alone.
This operating instruction manual is the basis for the training of the machine’s operator. The information
is necessary for the use and maintenance of equipment The property of the device is responsible for
proper instruction/training of all users and e. g. yearly repetition of the training.
The equipment operator must monitor the operation of the sterilizer, and, if equipped, also the integrated
steam generator. It is the responsibility of the owner of the equipment that carefully maintenance, routine
tests of control and safety and technical revisions established by the manufacturer are made. For
example, routinely check by the technician on the operation of safety devices, monitoring of quality feed
water and of the generator’s boiler (for details, see chapter 10 on maintenance).
The user must keep a daily record (machine’s handbook), containing the relevant reports for each cycle,
such as a printer report, graphs or reports of the graphic chart (if it is incorporated in the sterilizer), as
well as testing executed, inspections, maintenance and repairs.
There should not be a shift change of operators of the equipment until the person who takes over the
task has been informed of its operation and if applicable, of the incidents occurred and the measures
taken.
The machine must not be put into operation if the fault found can have an influence on people’s safety
or process development.
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his instruction manual also contains important instructions which must be given special attention. They
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are designated with the words “CAUTION”, “ATTENTION”, or “NOTE”.
CAUTION:
Designates working or operating procedures which shall be followed exactly in order to
exclude endangerment of persons. This also includes information on special risks while using
the unit.
ATTENTION
Refers to working and operating procedures which shall be followed exactly in order to avoid
damage to the unit. This also applies to work procedures which must be carried out regularly
after unusual demands are made on the unit or in case of unusual types of operation.
NOTE:
Applies to application related technical requirements to which the user must pay particular
attention.

The text contains references to the illustrations. The position numbers indicated therein, and shown in
parentheses, e.g. (3/5) means figure 3, position nº 5.
2.2 SAFETY INDICATIONS
●
The unit may be applied only for the intended use which is determined in paragraph 3.1.
●
The operator of the machine must meticulously adhere to the information in the Instruction
Manual. Improper use may cause physical injury or property damage.
●
Read these instructions carefully before beginning installation or assembly work or operation
of the unit.
●
Installation, preparatory steps for operating the unit and other tasks prior to the use
of the machine, must only be carried out by the user or specially trained personnel,
respectively.

●
Be careful never to put the device into operation if it is clearly or presumably defective or
damaged. Contact the Technical Assistance Service of MATACHANA immediately.
●
Maintenance and repair work must be carried out only by qualified and trained personnel only
who carefully observe:
- this Operating Instruction Manual.
- all other guidebooks (manuals, guides, drawings, etc.) provided by MATACHANA for
starting up the machine.
- currently applicable national/local regulations in terms of industrial safety and work
accident prevention.
●
The user must ensure adherence to the service intervals. When external maintenance is
carried out, care must be taken that it is carried out only by the Technical Assistance Service
of MATACHANA, or persons authorized by them.
●
When internal maintenance is carried out by the user, adherence to the maintenance
regulations must be ensured by taking suitable safety precautions.
● It is not allowed to remove covers, lids or similar protection elements that can affect the
original safety measures on the equipment.
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2.3 SYMBOLS AND SAFETY INDICATIONS
Following safety indications can be found in the Operating Instruction Manual and placed as stickers on
some parts of the device. They have the following meanings:
This indication shows the existence of specific warnings or

precautions associated with a component of the equipment or
with the whole machine.
This warning indication shows the presence of surfaces may be

hot, so there is a risk of burns.
This indication shows that the use of personal protective gloves

is mandatory, particularly for thermal hazards.
This warning indication shows the hazard of getting jammed or

trapped.
This warning indication shows the existence of electrical hazard.
This symbol is indicated on the device’s protective earth terminal.
This symbol indicates the need to read this instruction manual

carefully and particularly the indications related to safety, as well
as the rest of the documentation provided.
This symbol indicates that some of the documents which are part
of the instructions for use of the device are provided in electronic
form in a CD enclosed with the documentation provided in paper.
Table 2.1 - Symbols and safety indications
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2.4 WARNINGS
In this operating instruction manual important warnings and instructions are given in different places.
They are stated in the following summary.
CAUTION:
● Materials other than those indicated in this manual for each of the programs must not be sterilized.
● Clean and thoroughly dry the material prior to sterilization.
● Never place flammable or explosive materials in sterilizer chamber
● It is not allowed to sterilize liquids, unless the sterilizer is specially designed and equipped with respective
programs and functions.[3.1] [7.1]
NOTE:
To calculate the frequency of the test pressure vessel, it can be considered that in the routine use of the
equipment about 1800 cycles per year approximately are reached. [3.4]
NOTE:
While it is recommended that the ambient temperature where the equipment is installed has to be 15
to 35 °C, the safety features of equipment are secured when the ambient temperature range is of 5 to 40 °C.
[4.3]
NOTE: It is recommended that the sound pressure level is measured or calculated by a competent body
once the equipment is installed (in the operator’s position in normal use as well as in an installation
1 meter from the device), since the value of the actual sound pressure will vary depending on the
configuration of the final location of the device. [4.3]
NOTE:
Excessive moisture in suspension in the steam supplied to the sterilizer may be the cause of wet loads,
while too little moisture can not compensate for the overheating of the steam during expansion in the
chamber, so that the conditions for sterilization would not be the suitable. [4.4.2]
NOTE:
The steam must not contain a sufficiently high amount of contaminants capable of affecting the sterilization
process or of damaging the load. Therefore, we recommend the maximum contaminant values stated in the
European Standard EN 285, which we indicate in the following table.[4.4.2]
NOTE:
For proper sterilization, the generator must generate steam from water free of pollutants in a sufficiently
high amount that may adversely affect the sterilization process or damage the load. Therefore, we
recommend maximum contaminant values given in Table 4.7 mentioned in the previous point. [4.4.3]
NOTE:
To ensure the required quality of water supply, it is necessary to install a water treatment system. [4.4.3]
NOTE:
Water temperature of the vacuum system should be as low as possible. Temperatures above 15 °C (up
to a maximum of 22 °C) increase water consumption and process times. This can cause failures (see
chapter 9), particularly with large and/or heavy loads. [4.4.4]
NOTE:
Increased water hardness can cause scaling and corrosion problems in the vacuum system. [4.4.4]
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NOTE:
If the sterilizer has been subjected to temperatures below 15 °C during its transport and/or storage, it
is advisable to make the sterilizer adapt gradually to room temperature for a few hours before starting
it, in order to avoid condensation on the surface of electronic components which may damage the
equipment. [5.3]
NOTE:
There is an option for automatic monitoring of supplies. With this option, a warning message indicates if
any of the supplies to the sterilizer are not available (as soon as power is supplied to the sterilizer). See
chapter 9 for more information on alarm, warning and error. [5.3]
CAUTION:
Concerning equipment installed at high altitude, it may be necessary to enter the local ambient pressure
(see figure 5.3). To do this, see chapter 8. [5.3]
CAUTION
On devices with the option to connect to an automatic loading and/or unloading systems (option
available only for S1000), the sterilizer is supplied with some electrical bridges on the connection of the
emergency stop buttons from the loading/unloading systems, to enable the sterilizer to operate without
the loading/unloading module coupled. Once the loading/unloading system is installed, these bridges
must be removed to allow normal operation in total safety. We recommend keeping these bridges for
maintenance tasks, including in the case that a decommissioning of the corresponding loading/unloading
system is necessary. [5.3]
CAUTION:
The on/off switch does not disconnect the sterilizer from the power supply. The electrical circuits of
some components of the equipment (eg, steam generator or water pumps) remain under tension. To
completely disconnect the machine from the power supply, the main switch must be operated which
is located at the power box of the device, behind the front service panel. This operation can only be
performed by qualified personnel. In sterilizers with an automatic loading module (optional), it is also
possible to disconnect completely the device from the power supply by pressing the “O” button located
next to the control panel of the loading module. For more information, see chapter 10. [6.1.1]
CAUTION:
Press the emergency stop pushbutton in case of danger. Once pressed, the emergency stop can only be
unlocked by the authorized person who is holding the key to unlock it. To restore the sterilizer’s operation,
acknowledge the alarm A54 on the display in the NSA or on the control panel in the SA, preferably from
the side where the stop has been provoked. Unlock the corresponding emergency stop with your key. After
that, a message appears on the screen indicating that prior to resetting the sterilizer, it must be ensured
that unsafe conditions that caused the activation of emergency stop have been fixed. Press in the
NSA to reset the sterilizer. If a cycle is in progress, then the sterilizer runs the recovery program (reset)
until reaching the end of the cycle which allows the opening of the machine safely to remove the load. (see
figures 6.7 and 6.11 respectively).
If one of the sterilizer’s door was in motion while the emergency stop pushbutton has been pressed, when
a reset is executed, the door goes down until it is fully open. [6.1.4] [6.2.2]
CAUTION:
Activate the emergency stop pushbutton in case of major leaks, and large amounts of steam or water
were released which can present a danger, or in other exceptional circumstances which could prevent
the use of the equipment or the safe execution of a process. If necessary, ask your technical service to
interrupt completely the power supply to the equipment, operating the main switch located behind the
front service panel maintenance of the sterilizer from the NSA (6.1/6). [6.1.4] [6.2.2]
CAUTION:
Before entering the chamber (for example, for cleaning the interior walls of the sterilizer chamber),
activate the emergency stop, and keep the key in your possession for safety reasons to prevent the door
from accidentally being closed. [6.1.4] [6.2.2]
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CAUTION:
On the sterilizers fitted with automatic loading and/or unloading modules (option available only for
S1000), the emergency stops from the loading and unloading modules operate in the same way as
for the sterilizer emergency stops. This means that the emergency stop performs the same function,
independently whether it is located on the sterilizer or on the loading/unloading module. Thus, when
pressing any emergency stop, the power supply is automatically disabled to all the sterilizer’s actuators,
the loading/unloading system movement is interrupted and alarm A54 is displayed. After verifying that
the system is safe and that the operation can be resumed, reset the corresponding emergency stop,
and follow the procedure as shown in the operating instruction manual in order to restore the normal
operation of the sterilizer. In addition, the normal operation of the loading/unloading module needs to be
restored, as per the indication stated in the Instruction Manual. [6.1.4] [6.2.2]
CAUTION:
The test programs are not sterilization programs. There Should be no material in the chamber when
running these programs, except the test devices. The material which has been accidentally introduced
into the sterilizer chamber should always be considered NOT STERILE when the program is over.
[7.3.1]
NOTE:
A B&D Test must be executed daily as a procedure for routine monitoring of sterilization. It is for this
reason that by default, and as a reminder, every time the sterilizer is connected a message is displayed
asking if the user wants to perform a B&D Test (see figure 7.3). [7.3.1.1]
NOTE:
The Bowie & Dick Test is usually carried out at 134 °C. If it is required to perform this test with chemical
controls strips calibrated for a sterilization temperature of 121 °C, installing a suitable optional test
program will have to be requested. [7.3.1.1]
NOTE:
It is recommended to run a Vacuum Test at least once a week to ensure that there is no leak in the
sterilizer. [7.3.1.2]
NOTE:
Overloading the sterilizer can significantly affect the sterilization process, which might cause failures
in the system. The maximum loads specified for each program needs to be observed. In case of very
heavy loads (for example, instruments in containers), use the Container program. [7.3.2]
NOTE:
The Rapid program is not an appropriate program for the sterilization of usual loads in a health facility as
described in European Standard EN 285 (wrapped material made of metal, rubber or porous materials).
It is not suitable for the sterilization of porous materials with complex structures or solids (devices with
channels or cavities, hollow, etc.), double wrapped material (two layers), neither for material in boxes
or containers. To verify that it is appropriate for the sterilization of a given load, this program should be
validated with this specific load. As a reminder, when selecting this program, a warning message is
displayed that requires confirmation (pressing ) before starting the cycle. [7.3.2.4]
NOTE:
It can not be assumed that Prions can be completely inactivated just performing the Special P program.
It is necessary to conduct a proper pretreatment prior to sterilization with this program, as recommended
by the World Health Organization (WHO). You can also refer to the respective recommendations of the
Robert-Koch-Institute in Berlin (Germany), published in the “Bundesgesundheitsblatt” (Federal Health
Publication) (http://www.rki.de). [7.3.2.5]
NOTE:
The Disinfection program is not a sterilization program. As a reminder, when selecting this program, a
warning message is displayed that requires confirmation (pressing ) before starting the cycle (see
figure 7.6). [7.3.2.7]
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NOTE:
Liquids program is not an appropriate program for the sterilization of usual loads in a health facility as
To verify that it is appropriate to sterilize a given load, this program should be validated with this load,
determining the test load and the specific test procedure. As a reminder, when selecting this program, a
figure 7.6). [7.3.2.8]
CAUTION:
Special precaution is required when sterilizing liquid loads. To ensure a safe process, the reference
container where the product probe is placed must have the same or a bigger volume than the other
containers to be sterilized. The liquid in the reference container must have the same temperature as the
other loads before starting the program (no residual warmth from previous batches is allowed). [7.3.2.8]
CAUTION:
When unloading the liquid containers, special care is required. Before the end of the program the tem-
perature of the liquid is cooled down below the boiling point. However the container and the liquid are
still hot (up to 90 °C, depending on the selected re-cooling temperature). Protective gloves must be
worn to avoid burns. [7.3.2.8]
CAUTION:
Do not touch the screen while the initialization display appears. [8.1]
CAUTION:
When loading or unloading the sterilizer, the door edges and the chamber can still be hot! There can
therefore be a danger of burns. Protective gloves must always be worn to avoid burns. [8.3.2] [8.3.4]
CAUTION:
The sterilization of liquids or materials which liquefy under heat is not permitted. It is only allowed if the
sterilizer is outfitted with the suitable equipment for sterilization of liquids (optional). [8.3.2]
CAUTION:
When a sterilization process has ended with a failure the processed material has to be regarded as NOT
STERILE. In this case, and if it is a 2-door sterilizer, it will only be allowed to remove the material inside
the chamber from door 1 (NSA). [8.3.4] [9.1]
CAUTION:
For safety reasons, when starting the automatic unloading process and throughout its duration, the
buzzer of the sterilizer is activated intermittently in order to indicate that an automatic operation from the
unloading system is under progress. [8.3.5.1]
ATTENTION:
Contact the respective MATACHANA Technical Assistance Service if failures are indicated and their
cause can not be eliminated. [9.1]
CAUTION:
When a sterilization program ended with failure, the processed material should always be considered as
NON-STERILE. In this case, and if it is a 2-door sterilizer, it will only be allowed to remove the material
inside the chamber by door 1 (NSA). [9.1]
NOTE:
Whenever an alarm occurs, the current cycle is considered as INCORRECT, and therefore the load
must always be considered as NOT STERILE. For this reason, and in the case of 2 door-sterilizers,
after an cycle with failure, only the door 1 (NSA) will be able to open. See paragraph 8.3.4 for more
information about the required operation on reaching the end of the cycle.[9.2]
9
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CAUTION:
The equipment must not be put into operation if the fault found can have implications on the operator’s
safety or process development. [9.5]
NOTE:
Many components of the machine, such as the panels are made of chrome-nickel stainless steel.
Continuous contact with skin may cause irritation due to nickel in particularly sensitive individuals. [10]
ATTENTION:
Modifying the sterilizer is prohibited. Especially the safety relevant components must not be altered.
They must be replaced by components that are identical in construction or with identical features. [10]
ATTENTION:
If cleaning products are used, they must not contain halogenated derivates. Use demineralized or
distilled water to rinse the chamber after cleaning. [10.2.1]
CAUTION:
The inner walls of the chamber and the edges of the door may be hot, so that there is a risk of burns.
It is recommended to execute the inspection and cleaning tasks once the machine is cold, and use
protective gloves against burns. [10.2.1] [10.2.2]
CAUTION:
Before entering the chamber for cleaning, activate the emergency stop, and keep the key in your
possession for safety reasons to prevent the accidental closing of the door. [10.2.1]
CAUTION:
As the machine is not designed for use in potentially explosive atmospheres, outer panels can not be
treated with cleaning agents that can form a potentially flammable mixture when in the presence of air.
[10.2.2]
ATTENTION:
Make sure the water does not come into contact with electrical components of equipment to ensure
proper maintenance and avoid risks to personnel in charge of this task. Do not use pressure water to
clean the sterilizer. [10.2.2]
ATTENTION:
If the quality of tap water is too poor, and if the water treatment supplying the generator is insufficient, as
a precaution we recommend changing the water from the generator weekly. [10.2.2]
ATTENTION:
There is a danger of burns when activating the safety valves; wear protective gloves. [10.3.2]
CAUTION:
Before removing the cylinder door and in any case always whenever there is an intervention in the parts of
the equipment located below the chamber, it is necessary to place the locking bolts to lock the door in its
closed position, thus avoiding its possible fall. [10.3.2]
NOTE:
The 2 door-sterilizers are normally configured with conditional doors, so that the door from the SA can only
open once a sterilization process has been completed without incident. In this case, to change the door
gasket, this condition must be previously established. [10.4.1]
CAUTION:
Clean or replace the door gaskets only if the sterilizer is completely cool to avoid burns. Use protective
gloves when necessary. [10.4.1]
10
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ATTENTION:
To clean the door gasket, do not use aggressive solutions or detergents and do not use silicone oil which
contains benzol. [10.4.1]
NOTE:
Bear in mind that performing an appropriate cleaning, as well as a thorough drying of the material prior
to sterilization is extremely important. [Annex I, 1]
ATTENTION:
The bags and/or rolls made exclusively in plastic material are not suitable for steam sterilization.
[Annex I, 2]
ATTENTION:
You should not use fabric as wrapping material because there is no guarantee on its microbial barrier
qualities, which can compromise the subsequent conservation of sterile product. [Annex I, 2]
NOTE:
When using flat trays, cassettes or containers, it is recommended that they are made from aluminium.
The containers of other materials like polymer or stainless steel dry with less efficiency, so that they
require longer drying times. [Annex I, 2.1]
NOTE:
Test devices for hollow loads can also be used as a control routine with each load to verify and document
proper air removal and steam penetration in each cycle. However, it is not suitable for monitoring Rapid
program or Liquids and Disinfection optional programs. [Annex II, 1.3.1]
NOTE:
The use of chemical indicators can not be used as the only means for the release of sterile product. They
are an additional measure to evaluate the effectiveness of air removal and the penetration of additional
steam for parametric release (pressure control, temperature, sterilization time and condition of saturated
steam). [Annex II, 2.1]
NOTE:
We recommend to carry out an initial validation of sterilization processes used, as well as perform an
annual revalidation of these processes, unless a revalidation is needed beforehand due to repairs or
technical modifications that require such intervention. [Annex II, 3].
11
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3. DESCRIPTION AND USE OF THE STERILIZER
3.1 INTENDED USE
The MATACHANA steam sterilizers of series SC500 and S1000 are used in health care facilities, to
sterilize medical products; especially surgical, dental and otherwise medically used instruments (metal
load), plastic and rubber resistant to steam, as well as textiles at 121 °C or 134 °C, as a rule.
The sterilization is performed using pressurized, flowing saturated steam, operating according to the
fractionated vacuum process. Both the sterilizer chamber as the jacket is heated by saturated steam
from the steam supply, either from a central network or from an “own” steam generator incorporated into
the sterilizer.
The sterilizer and its accessories are designed to be installed and operated in a fixed location (stationary
use, not mobile).
CAUTION:
programs and functions.
3.2 DESCRIPTION
The MATACHANA series SC500 and S1000 sterilizers are equipped with a square-section chamber,
respectively of 500 x 500 mm in series SC500 and 670 x 670 mm in series S1000, whose depth, and
therefore capacity, varies according to the particular model. The sterilizers may have one or two doors
and may, or may not, have their own built-in steam generator. The doors slide upward and downward,
and are pneumatically operated.
The sterilizers are centrally controlled by a programmable automaton with both digital and analog
inputs and outputs. They are also provided with display and printout facilities allowing the operator or
maintenance technician to receive information about the status of the machine and the progress of the
program cycle.
They are equipped with a digital printer and optionally, with a logger. Each sterilizer is provided with preset
sterilization and test programs. There is also the option of supplementary programs as described in
chapter 7. The programs your sterilizer is provided with are specified in the corresponding Technical
Data Sheet, that you will find with this manual.
The code used for designating the different models belonging to the series is described in the following
examples:
Model: SC50 1 E-2
Series SC500
Model:
SC500, SC501, SC502
V: Steam from network (external supply)

E: Steam generator
1: Single-door sterilizer
2: Two-door sterilizer
13
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Model:
1 008 E-2
Series S1000
Indicates capacity of the chamber

in sterilization module SM [1]
V: Steam from network (external supply)

E: Steam generator
1: Single-door sterilizer
2: Two-door sterilizer
3.3 STANDARDS AND CE-CONFORMITY
The steam sterilizers of series SC500 and S1000, which intended use is for the sterilization of medical
devices in healthcare facilities, fall within the scope of the European Medical Device Directives (MDD)
93/42/EEC, and in accordance with Annex IX of this directive are classified as Medical Device class IIb.
In addition, the sterilizers of Series SC500 and S1000 comply with the requirements established in the
European Standard EN 285 for large steam sterilizers. The fulfilment of the medical device Directive has
been verified and certified by the TÜV Rheinland 0197 Notified Body.
Besides, the sterilizer is a pressure equipment of category II or III (depending on its volume) according
to the Pressure Equipment Directive 97/23/EC (Annex II). This implies that pressure vessels and safety
devices are designed and constructed in accordance with all applicable technical regulations for pressure
vessels, and have been submitted to a hydraulic pressure test. The requirements of AD 2000-Code,
together with the European Standards EN 13445 and EN 14222 have been duly considered. In addition,
the Quality Assurance Department of the company Antonio Matachana, S.A carries out an acceptance
test on all the machines comprising a specification test and an equipment test.
Furthermore, the company Antonio Matachana, S.A., has established a quality management system
according to the International Standards EN ISO 9001 and EN ISO 13485, also certified by TÜV
Rheinland.
On this base the sterilizers of series SC500 and S1000 have been applied to a statutory procedure for
evaluation of conformity and have been proved to be compliant with the essential requirements of the
EC Directives 93/42/EEC and 97/23/EC. This results in the authorization to mark CE for the sterilizers of
MATACHANA, as reflected in the nameplate on the equipment, as well as the declaration of conformity,
which can be found among the documents submitted with this manual.
Remark [1]: SM = Sterilization Module (standardized module of 300 x 300 x 600 mm).
14
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Besides, the sterilizers of MATACHANA also fulfil the essential requirements of the following European
Directives:
• European Machine Directive 2006/42/CE

• EMC Directive 2004/108/CE
• European Low Voltage Directive 2006/95/CE
In order to ensure the compliance on the named directives, the following standards, among others, were
taken as a basis:
EN 61010-1 EN 61326-1 EN 285 EN 60204-1

EN 61010-2-040 EN 1717 EN 13445 EN 14222 AD 2000-Code
3.4 PRESSURE DEVICE EXAMINATION
The sterilizer is a pressure equipment which includes a subset consisting of two pressure vessels together
and inseparable (chamber-jacket set) of categories I, II or III as per Annex II of the Pressure Equipment
Directive 97/23/EC (PED), diagram 2 (fluid group 2) and optionally another pressure vessel (steam
generator) of category II or III, according to Annex II, diagram 5 (fluid group 2), including the accessories
related to pressure for which Article 3, section 3 is applicable, and the accessories related to safety of
category IV. Thus, the whole set is classified as Category II or III according to the highest category of
its vessels. Its design, constructive dimensioning, specification of the used materials and manufacturing
as well as the tests carried out are based on the design code AD 2000 and/or the European Standard
EN 13445. The sterilizer has been subdued to a final acceptance test according to section 3.2 of Annex
I of the PED. The sterilizers from series SC500 and S1000 fulfil the technical requirements according
to Article 3 chapter 1 or 2 of the PED, so that the machine has its corresponding CE marking and
declaration of conformity, included in the technical documentation of the device.
Furthermore, the local or national regulations of each country may require that installation and start-up be
authorised by an official inspection body after being checked at the installation site. After this inspection
and a risk analysis, the user may have to define the frequency for the following tests. This frequency may
also be compulsorily set by the official inspection body or be defined in the local regulations themselves.
Recurrent Tests:
For the recurrent tests to be performed by an accredited technician, we refer to the national regulations
on the installation, use, recurrent test, repair and modifications of pressure equipment. Also, Health and
Safety regulations should be addressed.
15
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According to PED, Annex I, 2.2, the European Standard EN 13445-3, section 5.4 as well as to the code
AD 2000-HP 801 nº 15, sterilization pressure vessels are submitted to cyclic pressure load. Thus, a
fatigue analysis according to EN 13445-3 (SC500) or AD 2000 S1/S2 (S1000), has been performed and,
on the basis of a set of typical alternative loads and considering normalised safety coefficients, a fatigue
breakage strength has been verified which is equivalent to:
Nperm SC500 S1000

134 ºC 50 000 sterilization cycles 15 360 sterilization cycles
121 ºC 85 000 sterilization cycles 31 870 sterilization cycles
Table 3.1 - Fatigue breakage strength
Based on these results and on the risk analysis (performed within the range of conformity evaluations)
regarding the known frame conditions for the application of such devices and provided the instructions
stated in this Instruction Manual are strictly followed, the frequency of periodic testing can be determined.
If the respective national legislation or authority does not specify otherwise, the inner examinations of
the pressure vessel have to be specified by the user for the time periods. As a rule, the periodicity to
carry out the internal inspection of a pressure vessel is calculated as a percentage of the theoretical
number of cycles obtained during the fatigue calculations (Nperm). This percentage varies depending
on the design standard applied. To perform this calculation, it is necessary to document the number of
sterilization cycles executed throughout the whole lifespan of the device.
The control system of the sterilizer itself counts the performed sterilization cycles and notifies in advance
when the next test time for the inner examination takes place, provided that the correct basic parameters
have been previously put in. For details see paragraph 8.6.2.
Independently from the automatic recording you can determine the next time in accordance with the
indicated Nperm values, if you use the following example table with mixed mode of operation:
Recurring Tests when reaching the following cycles number:

SC500 S1000
Programs runs Programs runs Programs runs Programs runs
at 134 ºC at 121 ºC at 134 ºC at 121 ºC
10.000 0 7.680 0
8.750 2.125 7.000 1.410
7.500 4.250 6.000 3.485
6.250 6.375 5.000 5.560
5.000 8.500 4.000 7.635
3.750 10.625 3.000 9.710
2.500 12.750 2.000 11.785
1.250 14.875 1.000 13.860
0 17.000 0 15.935

Table 3.2 - Recurring calculation table of the pressure vessel test
NOTE:
To calculate the frequency of the pressure vessel test, it can be considered that in the routine use of the
equipment up to 1800 cycles per year approximately can be reached.
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3.5 GUARANTEE
ANTONIO MATACHANA, S.A. guaranties its equipment against all defects due to a manufacturing or
operation process, during a term of 12 months since the installation’s date of the device, or 15 months
as from the delivery date; whatever situation occurs first, and as per the conditions established below:
1. To replace free of charge any parts that has been proven to have a fault due to the manufacturing
process during the term stipulated above; this includes the spare parts the cost of labour needed
for its replacement as well as the consignment cost. The replacement tasks of the spare parts
will have to be undertaken by Antonio Matachana, S.A. or an authorized service dealer of the
company, based upon written instruction duly sent by the customer. Replaced parts becomes
property of the supplier.
2. The replacement of parts within the warranty period will not imply its extension. Nevertheless, the
warranty may be extended in accordance with the time margin during which the device is not in
operation due to this fault and its subsequent repair.
3.
This guarantee does not cover any breakdown caused by natural wear or accident through
negligence, incorrect or erroneous maintenance, any installation or use not complying with this
Operating Instruction Manual, and any use of consumables not in accordance with the specifications
determined by Antonio Matachana, S.A. It is also understood by a non-compliant or inappropriate
maintenance when the period of time planned for preventive maintenance is not respected or if the
maintenance is performed by a personnel not authorized specifically by Antonio Matachana, S.A.
4. The warranty is not valid for those parts and consumable products required for the correct
operation of the sterilizers such as paper used for the printer, grease and lubricants, sterile air
filter as well as water filters, including sealing gaskets (for door, “clamp”, pneumatic cylinders,
O-ring seals, abutting joints, etc.) and membranes; as well as batteries, fuses, lights and bulbs.
5. he warranty does not cover any case of modifications done to the original spare parts, or in the
T
case repair undertaken with parts different from the ones supplied by Antonio Matachana, S.A.
and executed by non-authorized third parties.
6. Furthermore, the warranty is neither valid for those interventions in which the reported faulty part
has not been detected, nor in the cases of force majeure such as atmospheric and geological
phenomenon, water, fire, etc.
7. In all the cases, the customer’s right to lodge a complaint on the damages produced by impairment
will expire after 6 months.
8. his guarantee does not apply to the repair tasks. This latter are subjected to their own specific
T
conditions.
17
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4. TECHNICAL DATA
4.1 GENERAL DATA
SC500 V-1 SC501 V-1 SC502 V-1

SC500 V-2 SC501 V-2 SC502 V-2
MODEL
SC500 E-1 SC501 E-1 SC502 E-1
SC500 E-2 SC501 E-2 SC502 E-2
LOADING CAPACITY (sterilization modules)
Capacity 1 1.5 2
DIMENSIONS OF CHAMBER (mm)

Height 500 500 500
Width 500 500 500
Depth 675 1020 1300
USABLE SPACE (mm)

Height 460 460 460
Width 460 460 460
Depth 670 1010 1285
WEIGHT OF THE STERILIZER, MODELS V, 1/2 doors (kg, approx.)

Net 575 / 650 650 / 775 725 / 850
With packaging 650 / 725 750 / 875 850 / 975
Full of water 750 / 825 900 / 1025 1050 / 1175
(hydrostatic test)
WEIGHT OF THE STERILIZER, MODELS E, 1/2 doors (kg, approx.)

Net 650 / 725 725 / 850 800 / 925
With packaging 725 / 800 825 / 950 925 / 1050
Full of water 825 / 900 975 / 1100 1125 / 1250
(hydrostatic test)
EXTERNAL DIMENSIONS 1/2 doors (mm)

Height 1824 1824 1824
Width 900 900 900
Depth 995 / 1009 1342 / 1355 1622 / 1635
Table 4.1 (1) - General technical data SC500
19
sc500_s1000_12_4_01_en
1004 V-1 1006 V-1 1008 V-1 1010 V-1 1012 V-1
1004 V-2 1006 V-2 1008 V-2 1010 V-2 1012 V-2
MODEL
1004 E-1 1006 E-1 1008 E-1 1010 E-1 1012 E-1
1004 E-2 1006 E-2 1008 E-2 1010 E-2 1012 E-2
LOADING CAPACITY (sterilization modules)
Capacity 4 6 8 10 12
DIMENSIONS OF CHAMBER, 1/2 doors (mm)

Height 670 670 670 670 670
Width 670 670 670 670 670
Depth 625 / 638 998 / 996 1265 / 1296 1735 / 1733 2000 / 1998
USABLE SPACE, 1/2 doors (mm)

Height 630 630 630 630 630
Width 630 630 630 630 630
Depth 625 / 638 998 / 996 1265 / 1296 1735 / 1733 2000 / 1988
WEIGHT OF THE STERILIZER, MODELS V, 1/2 doors (kg, approx.)

Net 750 / 900 850 / 1000 925 / 1075 1175 / 1325 1275 / 1425
With packaging 925 / 1075 1025 / 1150 1100 / 1275 1400 / 1550 1525 / 1675
Full of water 1050 / 1225 1425 / 1550 1625 / 1800 2125 / 2275 2350 / 2500
(hydrostatic test)
WEIGHT OF THE STERILIZER, MODELS E, 1/2 doors (kg, approx.)

Net 850 / 1000 950 / 1100 1050 / 1200 1300 / 1450 1375 / 1525
With packaging 1025 / 1175 1125 / 1250 1225 / 1375 1525 / 1675 1625 / 1775
Full of water 1175 / 1350 1575 / 1700 1800 / 1975 2300 / 2450 2525 / 2675
(hydrostatic test)
EXTERNAL DIMENSIONS 1/2 doors (mm)

Height 1954 1954 1954 1954 1954
Width 996 (1710*) 996 996 996 996
Depth 958 / 977 1314/1336 1614/1636 2054/2076 2313/2338
(*) Width includes service area.
Table 4.1 (2) - General technical data S1000
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4.2 PRESSURE VESSEL DATA
4.2.1 CHAMBER - JACKET SET
Volume (liters) SC500 SC501 SC502

1/2 doors
Chamber 167 252 321
Jacket 31 / 29 49 / 47 60 / 58
Table 4.2 (1) - Chamber and jacket volume SC500
Volume (liters) 1004 1006 1008 1010 1012

1/2 doors
Chamber 279 / 285 445 / 445 565 / 578 774 / 773 893 / 892
Jacket 42 / 40 69 / 66 89 / 88 122 / 119 142 / 138
Table 4.2 (2) - Chamber and jacket volume S1000
● Permissible operating pressure

- Chamber -1 / 3 bar
- Jacket 0 / 3 bar
● Permissible operating temperature 150 °C
● Category of the set, according to the Pressure Equipment Directive 97/23/EC (PED)
- SC500, SC501, SC502, 1 and 2 doors II
- 1004, 1006,1008,1010,1012, 1 and 2 doors III
4.2.2 ELECTRICAL STEAM GENERATOR (E MODELS ONLY)
SC500
Sterilizer model SC501
SC502
Steam generator model 18 kW

Steam generator volume (liters) 20
Water volume at medium level (liters) -
Water volume at lowest level (liters) 9
Heating surface (m²) 0.06
Power of steam generator (kg/h) 25
Electrical connection power (kW) 18
Category PED 97/23/EC II
Maximum permissible pressure (bar) 3.3
Maximum permissible temperature (ºC) 150
Table 4.3 (1) - Data on built-in steam generator SC500
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1004 1006 1008 1010
Sterilizer model 1012
Standard Optional Standard Optional Standard Optional Standard
Steam generator model K 06 J 06 M 06 L 06 O 06 N 06 O 06
Steam generator volume (liters) 35 35 56 56 75 75 75
Water volume at medium level (liters) 21 21 32 32 42 42 42
Water volume at lowest level (liters) 13 13 21 21 28 28 28
Heating surface (m²) 0.3 0.3 0.5 0.3 0.6 0.5 0.6
Power of steam generator (kg/h) 41 33 65 41 82 65 82
Electrical connection power (kW) 30 24 48 30 60 48 60
Category PED 97/23/EC II II II II III III III
Maximum permissible pressure (bar) 3.3 3.3 3.3 3.3 3.3 3.3 3.3
Maximum permissible temperature (ºC) 150 150 150 150 150 150 150
Table 4.3 (2) - Data on built-in steam generator S1000
4.3 AMBIENT CONDITIONS
Operation Storage and Transport

Temperature 15-35 °C 5-55 °C
Pressure 795-1100 mbar 650-1150 mbar
Humidity 5-85 % relative humidity (condensation free) 0-65 % relative humidity
Table 4.4 - Ambient conditions
NOTE:
While it is recommended that the ambient temperature where the equipment is installed has to be 15
to 35 °C, the safety features of equipment are secured when the ambient temperature range is of 5 to 40 °C.
Electromagnetic compatibility acc. to EN 61326-1, Class A

Mean sound power level acc. to EN ISO 3746: 69 dB(A) (series SC500) / 80.1 dB(A) (series S1000).
Mean sound pressure level acc. to EN ISO 3746: 52 dB(A) (series SC500) / 75.1 dB(A) (series S1000).
NOTE: It is recommended that the sound pressure level is measured or calculated by a competent body
once the equipment is installed (in the operator’s position in normal use as well as in an installation
1 meter from the device), since the value of the actual sound pressure will vary depending on the
configuration of the final location of the device.
4.4 MEDIA SUPPLY AND CONNECTIONS
See also the Installation Drawing and/or the Technical Sheets, delivered with this manual.
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4.4.1 ELECTRICAL POWER SUPPLY
Voltage / frequency: 400 V 3~ 50 Hz.
SC500 E
SC501 E 1004 E 1006 E 1008 E 1010 E 1012 E
SC502 E
Nominal power (kW) 21 33 51 63 63 63
Internal fuse protection (A) 55 63 100 125 125 125
Table 4.5 (2) - Data on electrical power supply E models
SC500 V
SC501 V 1004 V 1006 V 1008 V 1010 V 1012 V
SC502 V
Nominal power (kW) 2 2.5 2.5 2.5 2.5 2.5
Internal fuse protection (A) 10 10 10 10 10 10
Table 4.5 (2) - Data on electrical power supply V models
4.4.2 STEAM SUPPLY
Models without incorporated steam generator only (V models).
● Supply pressure: 2.5 - 3.0 bar

● Steam quality (acc. to European Standard EN 285):
- Non condensable gases: ≤ 3.5 % V/V
- Steam quality: ≥ 0.95 (saturated steam)
- overheating: ≤ 25 ºC
SC500 SC501 SC502

Flow (kg/min) 1.3 1.8 2.1
Consumption (kg/cycle) 8 11 13
Table 4.6 (1) - Data on steam supply SC500
1004 1006 1008 1010 1012

Flow (kg/min) 1.8 2.1 2.6 2.9 3.1
Consumption (kg/cycle) 18 20 25 28 30
Table 4.6 (2) - Data on steam supply S1000
NOTE:
Excessive moisture in suspension in the steam supplied to the sterilizer may be the cause of wet loads,
while too little moisture can not compensate for the overheating of the steam during expansion in the
chamber, so that the conditions for sterilization would not be the suitable.
23
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NOTE:
The steam must not contain a sufficiently high amount of contaminants capable of affecting the
sterilization process or of damaging the load. Therefore, we recommend the maximum contaminant
values stated in the European Standard EN 285, which we indicate in the following table.
Condensate Feeding water

Evaporation residues --- ≤ 10 mg/l
Silicate (SiO2) ≤ 0.1 mg/l ≤ 1 mg/l
Iron ≤ 0.1 mg/l ≤ 0.2 mg/l
Cadmium ≤ 0.005 mg/l ≤ 0.005 mg/l
Lead ≤ 0.05 mg/l ≤ 0.05 mg/l
Rest of heavy metals ≤ 0.1 mg/l ≤ 0.1 mg/l
Chlorides (Cl-) ≤ 0.1 mg/l ≤ 2 mg/l
Phosphates (P2O5) ≤ 0.1 mg/l ≤ 0.5 mg/l
Conductivity (at 25 °C) ≤ 3 µS/cm ≤ 5 µS/cm
pH 5-7 5 - 7.5
Hardness (Σ alkali earth ions) ≤ 0.02 mmol/l ≤ 0.02 mmol/l
Appearance colourless, clear, without sediments colourless, clear, without sediments
Table 4.7 - Permissible amount of contaminations in the condensate and in the feedwater for feeding
the steam generator, acc. to recommendation of European Standard EN 285.
4.4.3 TREATED WATER
Feed water to the integrated steam generator (only E models).
● Supply pressure: 2.5 a 4 bar
SC500 SC501 SC502

Flow (liters/min) 8 8 8
Consumption (liters/cycle) 8 11 13
Table 4.8 (1) - Data on water supply for the steam generator SC500
1004 1006 1008 1010 1012

Flow (liters/min) 8 8 8 8 8
Consumption (liters/cycle) 18 20 25 28 30
Table 4.8 (2) - Data on water supply for the steam generator S1000
NOTE:
For proper sterilization, the generator must generate steam from water free of pollutants in a sufficiently
high amount that may adversely affect the sterilization process or damage the load. Therefore, we
recommend maximum contaminant values given in Table 4.7 mentioned in the previous point.
NOTE:
To ensure the required quality of water supply, it is necessary to install a water treatment system.
24
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4.4.4 WATER FOR VACUUM SYSTEM
Used as water for the pump and in the cooling circuits.
● Supply pressure: 2.5 a 4 bar

● Temperature: < 15 °C
● Quality: Drinking water
● Hardness: Maximum 15 °d (recommendation acc. to EN 285: 0.7 - 2.0 mmol/l).
For further details, please see the Installation Drawing and the sterilizer’s Technical Sheets.
SC500 SC501 SC502

Flow (liters/min) 8 8 8
Consumption (liters/cycle) 170 200 260
Table 4.9 (1) - Data on water supply for the vacuum system SC500
1004 1006 1008 1010 1012

Flow (liters/min) 8 8 8 8 8
Consumption (liters/cycle) 200 240 270 360 360
Table 4.9 (2) - Data on water supply for the vacuum system S1000
NOTE:
Water temperature of the vacuum system should be as low as possible. Temperatures above 15 °C (up
to a maximum of 22 °C) increase water consumption and process times. This can cause failures (see
chapter 9), particularly with large and/or heavy loads.
NOTE:
Increased water hardness can cause scaling and corrosion problems in the vacuum system.
4.4.5 EXTERNAL WATER COOLING CONNECTION (OPTIONAL)
Used for cooling of condensate and pump operating water via heat exchangers.
● Supply temperature: 6 °C
SC500 SC501 SC502

Flow for Δ = 5 ºC (m³/h) 1 1.7 2.3
Peak value for 2 min (kW) 28 32 40
Table 4.10 (1) - Data on cool water supply SC500
1004 1006 1008 1010 1012

Flow for Δ = 5 ºC (m³/h) 1.2 1.7 2.3 2.8 3.4
Peak value for 2 min (kW) 42 58 80 100 120
Table 4.10 (2) - Data on cool water supply S1000
For further details, please see the Installation Drawing and the sterilizer’s Technical Sheets.
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4.4.6 PRESSURIZED AIR SUPPLY
Used to activate the pneumatic cylinders (door drive), activation of the pneumatic valves and to press
the door gasket shut.
● Supply pressure: 6 - 8 bar abs.

● Quality: Dry, filtered at 25 µm, and oilfree over 2 µm
SC500 S1000
Flow (Nm³/min) 0.23 0.35
Consumption (Nm³/cycle) 0.6 0.8
Table 4.11 - Data of pressurized air supply
Optionally, the sterilizer can be equipped with an integrated compressor, so that an external supply of
compressed air is not necessary.
4.4.7 DRAIN
Waste water drain takes place discontinuously in relation to the program steps.
● Flow: In specific cases up to 18 l/min

● Dimensions: DN40 (SC500), DN50 (S1000)
● Temperature: Resistant up to approximately 80 °C (temporarily up to a
maximum of 100 °C)
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5. INSTALLATION, CONNECTION AND START UP
For safety reasons, the installation of the unit, the connection to the power and fluid supplies as well
as initial start up of the unit must be carried out only by specially trained technician. Applicable local or
national regulations may require, as authorization of the installation’s start-up, some specific approval
tests to be performed by an expert from an accredited body.
5.1 INSTALLATION
The location and accessibility of the supply media and the drain pipe must be taken into account when
selecting the place of installation. The sterilizers of series SC500 and S1000 have been designed in such
as way that there is no inconvenience from exhaust steam. Any steam discharge that could eventually be
provoked by the safety valves shall be conducted by a pipe to the drain, so that no damage is produced
to the equipment or the working environment. These pipes are made in the final location of the sterilizer,
according to the result of the risk assessment of the installation. The user is responsible for this aspect.
First, remove the packaging and check that the equipment is in perfect condition. The packing of the
equipment is made of recyclable material that must be disposed of according to local regulations.
Figure 5.1 - Transport and unloading
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sc500_s1000_12_5_01_en
The machine has several elements to make transport and unloading easy:
1. There are 2 or 4 anchorage points, depending on the model (2 in SC500 series, and
in models 1004, 1006 and 1008 from S1000, whereas 4 in models 1010 and 1012
from S1000), available at the top of the machine by which to lift it up using a cross-
beam or sufficient long ropes to ensure an opening angle <40°of the lower cables. Load
supporting elements, as for example the rope slings must be able to carry the weight of
the device. The weight as per the sterilizer’s model is indicated in chapter 4.
2. Use a fork-lift truck to transport the assembled machine on a wooden pallet.
3. Before placing the machine where it is going to be installed, remove the screws that are
fastening the sterilizer to the wooden pallet.
4.
Once the machine has been placed where it is going to be installed, it should be levelled with
the aid of the four adjustable legs, and left it at the height indicated in the installation drawing.
5. If you ever need to move the device, use the same means and follow the same
instructions as for installing it. Sterilizers provided with the option of transport wheels
can easily move into or out of its location at the facility.
Media supply and drain mentioned in chapter 4 has to be assured. Especially proper water quality for
internal steam generator or proper quality of steam supply from external source is important.
To avoid faulty operation adequate lighting conditions at installation location are required. Please care
for national regulations.
During device operation, waste heat is given off continuously to the atmosphere, particularly in the area
above the unit. This must be carried off by means of a suitable room air conditioning / hot air exhaust
system.
For further information on installation and necessary media supply, see chapter 4, as well as the
Installation Drawing or the Technical Sheets.
5.2 CONNECTION
Once the sterilizer is installed following the instructions stated in the previous paragraph, it is necessary
to connect the supplies to the sterilizer.
For safety reasons, the installation of equipment and supplies connection and commissioning must be
carried out by specially trained technicians.
Connecting supply intakes (air, water, electricity, etc.) will be made as indicated in the Technical Sheets
of the sterilizer, as well as in paragraph 4.
The power line will be available through a three-phase 400 V + earth, properly protected by a circuit
breaker in accordance with the current legislation in the country of installation. A suitable magneto-
thermal switch also needs to be installed according to the characteristics of the device (see chapter 4
and Data Sheets for more details), located near the equipment and easily accessible for the operator. It
will be marked as disconnecting device of the sterilizer. See the label‘s features on the device, and the
Technical Data Sheet supplied as part of the documentation of the sterilizer, to check the voltage of your
sterilizer, as special voltages can be fitted on request.
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sc500_s1000_12_5_01_en
The protective earth terminal of the sterilizer is indicated by the symbol .The supply terminals are
indicated with the markings L1, L2 and L3 respectively.
The cables shall be sized as indicated in the Technical Sheets of the device, and following the regulations
in force in each country. Before any other connection, you must connect the protective earth terminal to
the protective conductor. Similarly, when it is necessary to disconnect the sterilizer from the power, the
earth terminal must be disconnected last. Network cables (three-phase voltage) must terminate within
their respective terminal so that, in the case of accidentally pulling the cord, the earth cable is the last
one to disconnect.
5.3 START UP
For safety reasons, the initial start-up of the unit must be carried out only by specially trained technicians.
Local or national regulations concerning workers safety and health may require, to authorize the
installation’s start-up, an approval test to be performed by an expert from an independent accredited
body.
NOTE:
If the sterilizer has been subjected to temperatures below 15 °C during its transport and/or storage, it is
advisable to make the sterilizer adapt gradually to room temperature for a few hours before starting it, in
order to avoid condensation on the surface of electronic components which may damage the equipment.
Before the initial start-up of the device a functional test procedure and safety verifications (for further
details see the European Standard EN 285, Table E1, Column “Installation Qualification”) is necessary.
In addition we recommend to perform a complete validation of the unit with the process and the load.
Before using the unit for the first time or when putting it into operation again after long breaks, be sure to
verify that all supply media are properly connected and available (stopcocks, main switches activated,
etc.).
- Water supply valve: open

- Demineralized water supply valve: open
- Compressed air valve: open
- Main switch: ON
- Steam valve (models without steam generator): open
- Emergency stop: ON (pulled out, on both sides)
NOTE:
There is an option for automatic monitoring of supplies. With this option, a warning message indicates if
any of the supplies to the sterilizer are not available (as soon as power is supplied to the sterilizer). See
chapter 9 for more information on alarm, warning and error.
The machine is connected to the mains via the principal switch located in the power box, which is
situated behind the frontal maintenance door of the NSA. The sterilizer turns on and off routinely with
the on/off switch that is in the front panel of the control side (NSA). For more information, see chapter 6.
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Tch Pch
999.9 °C 999.9 kPa
Do not show
Initial configuration again
Enter local distributor.
English
Select
language Date Time
Figure 5.2 - Initial settings display
Press the on/off switch to start the device. Then comes the initial settings display of the sterilizer, allowing
you to select the display language and set the date and time. Press the key with the flag to access the
language selection display, select the required language, press to save your selection and
to return to the previous display. To set the date and time, press the date and time key and modify the
desired value. To prevent this display from appearing every time you start the sterilizer, press the box
“do not show again” and close the display by pressing .
CAUTION:
Concerning equipment installed at high altitude, it may be necessary to enter the local ambient pressure
(see figure 5.3). To do this, see chapter 8.
Tch Pch
999.9 °C 999.9 kPa
Control Documentation
P steam 0.00 bar P load rel. 0.0 kPa

P dig. ch. 0.0 kPa P dig. j. 0.0 kPa
T ambient 0.0 ºC P filter out 0.0 kPa
P ambient 0.0 kPa
Figure 5.3 - STAFF settings, screen 3 sensors
Once the device is switched on, check the phase sequence L1, L2, L3 to verify the direction of the
pumps’ rotation. Modify it, if it is not correct. Afterwards, wait for about 15 minutes for the machine to
warm.
After the initial heating phase of the generator and the jacket, process a first cycle with the Preheating
program empty (without load) (see paragraph 7.3.1.3) in order to expel air and any residual condensate
from the supply lines to the sterilizer and to the supplies.
Once the Preheating cycle is completed, carry out a cycle with the B&D Test program (see paragraph
7.3.1.1), using a standardized Bowie & Dick test pack. During the cycle’s execution, please take special
care to reach and/or maintain the nominal values for pressure and temperature throughout all the phases
of the process (see chapter 12 in which the switchpoints and tolerances of the different programs are
shown). If necessary, repeat this process.
CAUTION:
On devices with the option to connect to an automatic loading and/or unloading systems (option
available only for S1000), the sterilizer is supplied with some electrical bridges on the connection of the
emergency stop buttons from the loading/unloading systems, to enable the sterilizer to operate without
the loading/unloading module coupled. Once the loading/unloading system is installed, these bridges
must be removed to allow normal operation in total safety. We recommend keeping these bridges for
maintenance tasks, including in the case that a decommissioning of the corresponding loading/unloading
system is necessary.
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6. CONTROL ELEMENTS OF THE STERILIZER
The sterilizer may have 1 or 2 doors in order to carry out the material loading and unloading operations.
Next to each of the doors there is a series of command and control elements arranged on the front panel
of the machine that can operate the sterilizer. It is described below.
If the sterilizer is equipped with 2 doors, door 1 denomination corresponds to the one located in the
loading area, also called non sterile area (NSA), whereas door 2 corresponds to the one in the unloading
area, also named sterile area (SA). In case the sterilizer has a single door, it will have the controls
indicated for the (NSA) door 1.
See figures 6.1 (NSA) and 6.9 (SA) in which the indicated elements are shown. Each is designated by a
number corresponding to the final figures of the numbering of the subsections that follow.
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sc500_s1000_12_6_01_en
11
5
4
1
8
3
9
12
Figure 6.1 (1) – Front panel of the sterilizer SC500 NSA
1. On/off switch 6. Lock front service door

2. Touch screen 8. Indicators icons on backlit panel
3. Alphanumeric printer 9. Sterilizer door 1, NSA
4. Emergency stop push-button 11. Recorder, NSA (optional)
5. Manometers 12. USB connector (optional)
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sc500_s1000_12_6_01_en
5
11
4
1
8
3
9
12
10
Figure 6.1 (2) – Front panel of the sterilizer S1000 NSA
1. On/off switch 7. Level indicator of steam generator (E models only)

2. Touch screen 8. Indicators icons on backlit panel
3. Alphanumeric printer 9. Sterilizer door 1, NSA
4. Emergency stop push-button 10. Coupler automatic loading module assistance (optional)
5. Manometers 11. Recorder, NSA (optional)
6. Lock front service door 12. USB connector (optional)
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6.1 NON STERILE AREA (NSA)
6.1.1 ON/OFF SWITCH
The on/off switch (6.1/1) is used to connect and disconnect the sterilizer control system.
When this switch is activated, a blue light around is lit up as well as the backlit panel elements
(MATACHANA logo, manometers, and indicators icons).
CAUTION:
The on/off switch does not disconnect the sterilizer from the power supply. The electrical circuits of
some components of the equipment (eg, steam generator or water pumps) remain under tension. To
completely disconnect the machine from the power supply, the main switch must be operated which
is located at the power box of the device, behind the front service panel. This operation can only be
performed by qualified personnel. In sterilizers with an automatic loading module (optional), it is also
possible to disconnect completely the device from the power supply by pressing the “O” button located
next to the control panel of the loading module. For more information, see chapter 10.
6.1.2 TOUCH SCREEN
The touch screen (6.1/2) enables to control the sterilizer, including the selection and initialization of the
programs. It is a compact touch screen that works with an intuitive menu that guides the operator through
different screens. Mounted on the front of the sterilizer, it has a 5.7“ TFT colour graphic display and backlighting.
It displays the current status of the sterilizer, provides information on program selection and status of the
current cycle, including the display of actual temperature and pressure measured in the chamber, and displays
alarm, warning and error messages. For more details on its use, see chapter 8.
The pages’ layout displayed on the touch-screen is shown in figure 6.2 below. The common elements
composing the pages and their functions are explained in the display pages below. In addition, each one
of them is explained in chapter 8.
Permanent area for generic information and action related to all

the screen
B
Information area
Area of programs, information and functions
Functions’ area
Figure 6.2 - Display-Layout of the touch-screen (NSA)
Area A: This area indicates continuously the temperature and pressure of the sterilizer’s
chamber, and can incorporate 4 different buttons. At least, 2 out of the 4 possible
buttons are always displayed:
Access to “Main menu” Access to the active messages display
Access to “Information” to close the current display
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sc500_s1000_12_6_01_en
Area B: This area includes information on the function and/or program of the current display,
together with the status of doors 1 and 2, the relative pressure of to the steam
generator and the status of the steam generator’s water level sensors. The pressure
of the steam generator appears blinking when the pressure is between 3 and 3.3 bar,
and in red if it exceeds the limit of 3.3 bar.
he generator level sensors are symbolised as “L” for the work level sensor and
T
“LWL” for the safety level sensor.
The “LWL” icon may indicate the following states:

LWL Water level above the safety level
LWL Water leve below the safety level
LWL intermittent: Water leve below the safety level, sensor failure
The “L” icon may be accompanied by the “+” or “-” signs and indicate the following:
L Water level between the maximum and minimum
L intermittent: Water level between the maximum and minimum, sensor failure
L- intermittent: Water level below the minimum, filling
L- Water level below the minimum, steam generator failure
L- intermittent: Water level below the minimum, steam generator failure
L+ intermittent: Water level above maximum
L+ intermittent: Water level above maximum, sensor failure
Area C: This area includes information on the machine’s functions. It also contains program
selection buttons, error messages and warnings, etc. During the execution of a cycle,
this area contains relevant information about the cycle running.
Area D: Space for functional buttons
The Help display can be accessed any time by pressing . There is a specific support display for each
one of the screens menu of the device.
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
Help Contact information
Matachana Local distributor
Almogàvers, 174
08018 Barcelona
Spain
info@matachana.com
Tel. +34 934 868 700

Fax +34 933 098 692

Figure 6.3 - Help display Figure 6.4 - Contact information display
Press from the Help display to enter a new screen from which all the contact information on the
factory and distributor can be visualized. Press .to return to the menu display, from which assistance
has been requested.
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6.1.3 PRINTER
The data printer (6.1/3) mounted on the front panel of the NSA of the sterilizer allows a printout of
recording cycle run. As can be seen in figure 6.5, the log printer contains the most relevant data cycle
run, such as the serial number of the sterilizer, the date, the name of the program carried out, the cycle
number, total cycle, time, pressure and temperature within the chamber in each phase change, etc.
If an alarm or warning message appears during the course of the cycle, the message is printed on the
printer’s report in white text on black background, indicating the number and description of the message
and the time that it has occurred.
The control system can set some aspects of printing, for example, the printing format of the process, the
printout or not of the process parameters, etc. For more information about print settings, see paragraph
8.3.6.
The printer uses special thermal paper that ensures retention and readability of the records for a period
of not less than 11 years when stored under the conditions established by the manufacturer. As a
general rule, it should be stored in a dry place at room temperature, away from heat and sunlight. It
cannot be stored in plastic bags or wrapping material, and no adhesive tape must be used on it. The
MATACHANA code for the printer’s roll paper can be found in chapter 11.
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PROCESS SUMMARY
Date: 01-03-2012 09:51:01 Date, Time End of Process
Name: Standard 134 °C Program Name
Program: 4 Program Nº
Ste. No.: E-0090000002 Serial Nº of the sterilizer
Version: EH100002 Version Nº of software
Operator: María Operator code
Cycle: 914 Process Number
Batch: 45FGW5 Batch number (optional)
Start: 01-03-2012 09:12:35 Date and time of cycle start

Cycle duration: 00:38:26 Cycle duration
Ster. duration: 00:04:00 Duration of the sterilization phase
MIN ster. temp.: 134.4 °C Minimun temperature during sterilization phase
MAX ster. temp.: 134.6 °C Maximun temperature during sterilization phase
MIN ster. press.: 303.2 kPa Minimum pressure during sterilization phase
MAX ster. press.: 305.7 kPa Maximum pressure during sterilization phase
F chamber: 231.1 min F value chamber
F min: 231.1 min Minimum F value
F ref.: 121.0 °C Reference temperature for F calculation
F Z: 10.0 °C Z value for F calculation
WITHOUT INCIDENTS
Time, temperature and chamber pressure when starting each phase
00:00:00 T 74.0°C P 102.1 kPa Phase name
START
00:00:06 T 74.0°C P 102.3 kPa
EXHAUSTING
00:01:04 T 73.5°C P 102.4 kPa
PREVACUUM
00:05:38 T 98.6°C P 15.0 kPa
STEAM INJECTION
00:05:42 T 98.2°C P 67.9 kPa
PREVACUUM
00:06:42 T 94.2°C P 15.3 kPa
STEAM INJECTION
00:06:47 T 93.3°C P 69.4 kPa
PREVACUUM
00:07:07 T 88.6°C P 15.0 kPa
STEAM INJECTION
00:07:12 T 85.4°C P 70.4 kPa
PREVACUUM
00:07:25 T 85.5°C P 15.5 kPa
STEAM INJECTION
00:07:30 T 81.7°C P 69.5 kPa
PREVACUUM
00:07:42 T 84.1°C P 15.5 kPa
STEAM INJECTION
00:07:47 T 81.1°C P 69.0 kPa
PREVACUUM
00:07:59 T 84.2°C P 14.9 kPa
STEAM INJECTION
00:08:04 T 82.0°C P 68.8 kPa
PREVACUUM
00:08:17 T 84.9°C P 15.2 kPa
STEAM INJECTION
00:08:22 T 81.6°C P 69.0 kPa
PREVACUUM
00:08:35 T 82.9°C P 15.0 kPa
STEAM INJECTION
00:08:56 T 114.7°C P 176.5 kPa
PREVACUUM
00:09:13 T 102.4°C P 100.0 kPa
STEAM INJECTION
00:09:24 T 114.7°C P 178.5 kPa
PREVACUUM
00:09:41 T 102.1°C P 100.7 kPa
STEAM INJECTION
00:09:58 T 119.1°C P 197.4 kPa
PREVACUUM
00:10:16 T 104.1°C P 110.6 kPa
HEATING
00:22:13 T 134.6°C P 305.9 kPa
STERILIZATIION
00:26:13 T 134.6°C P 304.7 kPa
EXHAUSTING
00:27:38 T 55.3°C P 15.1 kPa
DRYING
00:26:13 T 78.8°C P 3.3 kPa
VACUUM BREAKING
00:26:13 T 75.8°C P 102.5 kPa
CYCLE END
Figure 6.5 - Sample of a short protocol printout from the integrated printer
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The printer has the following control elements:
1) Key OFF/Next
This key may not be available on your printer.
The key OFF / Next is used to adjust the print parameters. This key should only be used by staff
of the MATACHANA Technical Assistance Service. Otherwise, the printer may not work correctly.
If the configuration menu has been called by accidentally, it is not allowed to make any further
adjustments in order to avoid error of configuration.
For at least 10 minutes it is not allowed to perform actions at the printer (e. g. press keys, remove
paper etc.). After 10 minutes the printer exits the configuration menu independently.
2) Line feed
Via this key the printer can be roused from sleep-mode and the paper can be fed forward.
By pressing the key once the paper is fed forward by one line. Pressing the key permanently for
more than 2 seconds results in a continuous paper feed.
Self test:
The printer can be tested for proper function by starting a self test. For this, with the sterilizer
disconnected, the key paper feed must be pressed continuously while the power supply is switched
on by means of the sterilizer’s on/off switch (6.2/1). If the paper feed key is released, the self test
starts. Only the circuit and inner functions are tested, but not the interfaces communications ones.
3) Status Led
The Led indicates the operational printer status.
- Printer operational: The Led is blinking green for a short time, approx. every 3 seconds
- End of paper: The Led is blinking green every second.
- Printer failure: The Led is blinking red.
1 2 3
Figure 6.6 - Printer
Optionally, it is possible to configure the printing so that an external printer can be used. For more
details, see paragraph 8.7.3.2.
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6.1.4 EMERGENCY STOP PUSH-BUTTON, NSA
By pressing the emergency stop push-button (6.1/4) located on the front panel of the sterilizer, it
automatically turns off the power to all actuators installed in the sterilizer, which means that it stops any
possible door operation, it deactivates the injection of steam into the chamber and the steam generation
is interrupted.
To indicate that the emergency stop has been pressed, the display shows the alarm A54 “emergency stop”
and lights a flashing yellow light around the button.
Emergency stop has a key that allows to unlock it. This key should not be put in place, but must always
be removed during the daily operation of the sterilizer and shall be placed under the care of an authorized
person, for example the manager or supervisor of the sterilization central.
CAUTION:
Press the emergency stop push-button in case of danger. Once pressed, the emergency stop can only be
figures 6.7 and 6.11 respectively). If one of the sterilizer’s door was in motion while the emergency stop
push-button has been pressed, when a reset is executed, the door goes down until it is fully open.
Tch Pch
999.9 °C 999.9 kPa
0 P st. gen. L
999.9 kPa LWL 1 2
T max. load 99.9 ºC P jacket 150.0 kPa
P st. gen. 0.01 bar P st. gen. max. 3.30 bar
CAUTION!
Verify safety confirm pushing icon to
reset
Figure 6.7 - Display for sterilizer resetting (emergency stop push-button NSA)
CAUTION:
Activate the emergency stop push-button in case of major leaks, and large amounts of steam or water
front service panel maintenance of the sterilizer from the NSA (6.1/6).
CAUTION:
from accidentally being closed.
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CAUTION:
restored, as per the indication stated in the Instruction Manual.
6.1.5 MANOMETERS, NSA
2 manometers are located on the front panel of the sterilizer (6.1/5):
● Chamber manometer: Range -1 to +4 bar
his manometer shows the pressure in the sterilization chamber. This pressure also varies
T
depending on the process and lies between -1 and 2.2 bar.
The maximum permissible operating pressure for the sterilization chamber (3 bar) is
designated by a red line and shall not be exceeded.
● Steam manometer: Range -1 to +4 bar
his manometer shows the pressure of the steam supply for the sterilizer. The steam is
T
supplied - depending on the model - either by an external source (external steam supply) or
by an integrated steam generator (built-in steam supply). In case of an external steam supply,
the steam pressure must be approximately between 2.5 and 3 bar. If the sterilizer is fitted
with a built-in steam generator, the manometer should indicate a pressure between 1.4 and
1.6 bar while executing a sterilization program at 121 ºC, and between 2.5 and 2.7 bar for a
sterilization program at 134 ºC (during use, the steam pressure may briefly descend below
the recommended values).
In case of a built-in steam supply the maximum permissible operating pressure of the steam
generator (3.3 bar) is designated by a red line and shall in no cases be exceeded.
When the sterilizer is on, both manometers are illuminated by a soft blue light.
6.1.6 LOCK FRONT SERVICE DOOR, NSA
Closing the service front door (6.1/6) prevents access to components inside the machine that may
be under dangerous tension and/or temperatures. This access door is to be used exclusively by
maintenance personnel.
The closing of the door is locked by a key. When the front service door is open, the sterilizer door is locked
for safety reasons and can not be moved.
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6.1.7 LEVEL INDICATOR OF STEAM GENERATOR (E MODELS ONLY FROM THE S1000)
In the S1000 sterilizers fitted with their own steam generator, a level indicator for the water in the generator
is located on the front panel (6.1/7). This indicator allows to visualize the water level inside the steam
generator at any time.
Some marks on the front panel indicate the minimum and maximum working level of the generator and the
minimum safety level.
6.1.8 INDICATORS ICONS, NSA
On the backlit panel from the sterilizer’s front panel are a set of indicators icons (6.1/8) which permit to
know at all times the current status of the sterilizer and indicate the existing hazards, etc, as described
below.
Figure 6.8 – Backlit panel on the front of the sterilizer, NSA
Here are the icons on the backlit panel. Their meaning is explained under. Depending on the condition that
the sterilizer is, some of these icons can be turned off, lighting where appropriate. When the sterilizer is
off, all these icons are off.
Process status
This hourglass-shaped icon indicates that a sterilization or test cycle is being carried out.
Throughout the cycle, this icon blinks. When the machine is in stand-by, that is, when no
cycle is being performed, this symbol is “off”.
Warning
This warning signal indicates that an alarm, warning or error message has occurred
in the control system of the machine, which requires the operator’s intervention. For
more information on the messages, their meaning and how to deal with them when they
appear, see chapter 9. When there is no active message, this symbol is “off”.
Wear protective gloves

Wear protective gloves against the influence of thermal contact whenever the operator
needs to access the chamber for loading / unloading operations as the sterilized material,
the chamber walls and the edges of the door may be hot.
This icon is lit whenever the door is not closed and locked.
Warning, crushing of hands

This warning symbol warns of danger of a body part being trapped by the door of the
sterilizer, when this latter moves upward during its closing operation. Care must be taken
not to bring hands or arms or any other body parts in the door’s trajectory.
Warning, hot surface!

This warning signal notifies that the interior walls of the chamber and the edges of the
door may be hot, so that there is a risk of burns. Take particular care not to touch these
surfaces. Use protective gloves when performing loading/unloading operations.
This icon is lit whenever the sterilizer is “on”.
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Pending repair
This icon indicates the need for intervention by maintenance personnel to resolve any
incidences with respect to the machine. When this icon is “on”, the sterilizer is blocked,
so that you can not start a cycle until the sterilizer is unlocked.
Supplies alarm
This icon indicates that one of the media supply to the sterilizer is missing (water, air,
steam, etc.), provided that the sterilizer is equipped with this option of supplies alarm. In
this case, a cycle can not be started.
6.1.9 STERILIZER DOOR, NSA
The door of the sterilizer (6.2/9) slides vertically and allows access to the chamber for introducing and /
or removing the load.
The sterilizer’s door has a safety contact bar which prevents some body parts as a hand or arm from
being caught by accident. Specifically, if during the closing operation of the door a force greater than
150 N is applied on the upper edge of the door, its movement reverses until it is fully opened.
The door is equipped with the following safety devices to avoid possible risks during handling:
● If there is pressure inside the chamber, the door cannot be opened.
● The final position of the door closing is detected by a limit switch monitored by the control
system of the sterilizer.
● You can not open a door when another door is already open or has been given the order to
open (two-door models).
● The force for closure is limited to 150 N by a safety plate (bar) that acts by contact.
● The door key must be pressed continuously when closing it, so if you stop pressing, it
reverses the motion until it is fully open.
● The sterilizer door is locked when the front service door is open.
6.1.10 COUPLER AUTOMATIC LOADING MODULE ASSISTANCE (OPTIONAL)
If the sterilizer is fitted with an automatic loading system, the anchorage of the loading module is inserted
into a metal groove (6.2/10) located in the bottom of the device which acts as support for fixing the loading
platform. This option is only available on the S1000.
6.1.11 VIDEORECORDER, NSA (OPTIONAL)
Optionally, the sterilizer may have a 3-channel videorecorder which produces a continuous graphic chart
of pressure and temperature in the sterilizer chamber during the cycle run. The cycle’s register is performed
in a specific digital format, compressed and encoded which can not be modified in the device itself. Using
the videorecorder software, these files can be viewed and transferred to a PC for analysis and storage,
and can generate graphs and data tables.
For details, see the videorecorder Instruction Manual that comes with this manual.
6.1.12 USB CONNECTOR (OPTIONAL)
Optionally, the sterilizer can have a USB connector on the front panel which lets you download the
cycles executed. For details about this function, see paragraph 8.3.6.
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6.2 STERILE AREA (SA)
2
4
3
Figure 6.9 (1) - Front panel of the sterilizer SC500 SA (Two door-version only)
1. Control panel 5. Sterilizer door, SA

2. Emergency stop push-button, SA 6. Lock front service door 2, SA
3. Manometer, SA 7. Coupler automatic unloading module assistance (optional)
4. Indicators icons, SA
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3
2 4
Figure 6.9 (2) - Front panel of the sterilizer S1000 SA (Two door-version only)
1. Control panel 5. Sterilizer door 2, SA

2. Emergency stop push-button, SA 6. Lock front service door, SA
3. Manometer, SA 7. Coupler automatic unloading module assistance (optional)
4. Indicators icons, SA
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6.2.1 CONTROL PANEL, SA
In the sterile or unloading area, the equipment is operated by a compact module with an LCD display
with 4 lines of characters and 7 function keys (6.9/1). This panel displays the current operating status,
program selection information, the current process, the values of pressure and temperature, including
alarm, warning and error messages which, if required, can be acknowledged here. The operation of this
module is detailed in chapter 8.
ACK (confirm)
Cursor keys for switching

LCD display displays
Door 2 opening key Settings key
Door 2 closing key Silence buzzer
Figure 6.10 - SA Control unit
The keys shown in figure 6.10 have the following functions:
● Door keys and :

These keys allows to open and close door 2 (SA). They also allow to disable the
audible alarm signal or end of cycle. For more information about the operation of door 2, see
paragraph 8.2.
● Buzzer :
This key disables the audible signal of the message or end of cycle. The led of this key is lit
when there is an active message (not acknowledged).
● Confirm :
If an alarm, warning or error is activated, you can use this key to acknowledge the appropriate
message. It also serves to confirm the actions which are needed to be carried out from the
screen.
● Arrow keys and :

The arrow keys allow the operator to scroll up and down through the various lines and character
fields of the menus.
● Settings :
This key is used to enter the Settings menu of the control panel, from which you can change
the language of this panel. The led of this key is lit when the operator has entered into the
setting menu.
Optionally, the equipment may have a second touch-screen in place of the control panel. In this case,
its structure and functioning would be analogous to the one indicated for the Non-Sterile Area (see
paragraph 6.1.2).
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6.2.2 EMERGENCY STOP PUSH-BUTTON, SA
By pressing the emergency stop push-button (6.9/2) located on the front panel of the sterilizer, it
automatically turns off the power to all actuators installed in the sterilizer, which means that it stops any
possible door operation, it deactivates the injection of steam into the chamber and the steam generation
is interrupted.
To indicate that the emergency stop switch has been pressed, the touch screen and control panel show
the alarm A54 “emergency stop” and light a flashing yellow light around the button.
Emergency stop has a key that allows to unlock it. This key should not be put in place, but must always
be removed during the daily operation of the sterilizer, and shall be placed under the care of an authorized
person, for example, the manager or supervisor of the sterilization central.
CAUTION:
Press the emergency stop push-button in case of danger. Once pressed, the emergency stop can only be
figures 6.7 and 6.11 respectively). If one of the sterilizer’s door was in motion while the emergency stop
push-button has been pressed, when a reset is executed, the door goes down until it is fully open.
Tch Pch
999.9 °C 999.9 kPa
0 P st. gen. L
999.9 kPa LWL 1 2
PROCESS STOPPED
T max. load 99.9 ºC P jacket 150.0 kPa
P st. gen. 0.01 bar P st. gen. max. 3.30 bar
CAUTION! Reset from opposite side
Figure 6.11 - Display for sterilizer resetting (emergency stop SA)
CAUTION:
Activate the emergency stop push-button in case of major leaks, and large amounts of steam or water
front service panel maintenance of the sterilizer from the NSA (6.9/6).
CAUTION:
from accidentally being closed.
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CAUTION:
restored, as per the indication stated in the Instruction Manual.
6.2.3 MANOMETER, SA
1 manometer is located on the front panel of the sterilizer (6.9/3):
● Chamber manometer: Range -1 to + 4 bar
his manometer shows the pressure in the sterilization chamber. This pressure also varies
T
depending on the process and lies between -1 and 2.2 bar.
The maximum permissible operating pressure for the sterilization chamber (3 bar) is
designated by a red line and shall not be exceeded.
When the sterilizer is ON, this manometer is illuminated by a soft blue light.
6.2.4 INDICATORS ICONS SA
On the backlit panel from the sterilizer’s front panel are a set of indicators icons (6.9/4) which permit to
know at all times the current status of the sterilizer and indicate the existing hazards, etc, as described
below.
Figure 6.12 – Backlit panel on the front of the sterilizer, SA
Here are the icons on the backlit panel. Their meaning is explained under. Depending on the condition that
the sterilizer is, some of these icons can be turned off, lighting where appropriate. When the sterilizer is
off, all these icons are off.
Process status
This hourglass-shaped icon indicates that a sterilization or test cycle is being carried out.
Throughout the cycle, this icon blinks. When the machine is in stand-by, that is, when no
cycle is being performed, this symbol is “off”.
Warning
This warning signal indicates that an alarm, warning or error message has occurred
in the control system of the machine, which requires the operator’s intervention. For
more information on the messages, their meaning and how to deal with them when they
appear, see chapter 9. When there is no active message, this symbol is “off”.
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Wear protective gloves
Wear protective gloves against the influence of thermal contact whenever the operator
needs to access the chamber for loading / unloading operations as the sterilized material,
the chamber walls and the edges of the door may be hot.
Warning, crushing of hands

This warning symbol warns of danger of a body part being trapped by the door of the
sterilizer, when this latter moves upward during its closing operation. Care must be taken
not to bring hands or arms or any other body parts in the door’s trajectory.
Warning, hot surface!

This warning signal notifies that the interior walls of the chamber and the edges of the
door may be hot, so that there is a risk of burns. Take particular care not to touch these
surfaces. Use protective gloves when performing loading/unloading operations.
This icon is lit whenever the sterilizer is “on”.
Pending repair
This icon indicates the need for intervention by maintenance personnel to resolve any
incidences with respect to the machine. When this icon is “on”, the sterilizer is blocked,
so that you can not start a cycle until the sterilizer is unlocked.
Supplies alarm
This icon indicates that one of the media supply to the sterilizer is missing (water, air,
steam, etc.), provided that the sterilizer is equipped with this option of supplies alarm. In
this case, a cycle can not be started.
6.2.5 STERILIZER DOOR, SA
The door of the sterilizer (6.9/5) slides vertically and allows access to the chamber for removing the load.
The sterilizer’s door has a safety contact bar which prevents some body parts as a hand or arm from
being caught by accident. Specifically, if during the closing operation of the door a force greater than
150 N is applied on the upper edge of the door, its movement reverses until it is fully opened.
The door is equipped with the following safety devices to avoid possible risks during handling:
● If there is pressure inside the chamber, the door cannot be opened.
● The final position of the door closing is detected by a limit switch monitored by the control
system of the sterilizer.
● You can not open a door when another door is already open or has been given the order to
open (two-door models).
● The force for closure is limited to 150 N by a safety plate (bar) that acts by contact.
● The door key must be pressed continuously when closing it, so if you stop pressing the door
lock key, it reverses the motion until it is fully open.
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6.2.6 LOCK FRONT SERVICE DOOR, SA
Closing the service front door (6.9/6) prevents access to components inside the machine that may be
under dangerous tension and/or temperatures. This access door is to be used exclusively by maintenance
personnel.
The closing of the door is locked by a key. When the front service door is open, the sterilizer door is locked
for safety reasons and can not be moved.
6.2.7 COUPLER AUTOMATIC UNLOADING ASSISTANCE MODULE (OPTIONAL)
If the sterilizer is fitted with an automatic unloading system, the anchorage of the unloading module is
inserted into a metal groove (6.9/7) located in the bottom of the device which acts as support for fixing the
unloading platform. This option is only available for S1000.
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7. PROGRAMS
7.1 FUNCTION PRINCIPLE
The MATACHANA sterilizers of series SC500 and S1000 are equipped with several preset programs.
These programs, their respective processes and parameters as well as the material that can be sterilized
inside of each one, and specific application areas are described below.
Here, a process is defined as a sequence of process steps, which are implemented by the sterilizer
from program start (starting up) to program end. Processes are regulated by parameters. The most
important parameters of the available processes are those related to pressure, temperature and time.
Even if the sterilization processes are performed according to the same procedure (e. g. fractionated
vacuum process), the various programs differ regarding the number and set points of the fractionating
steps, as well as sterilization temperature, sterilization plateau time and drying time.
Paragraph 7.2, specifies the programs standardly included with delivery of the sterilizer as well as the
programs that can optionally be provided. Details for application of these programs see paragraph 7.3.
For execution of the programs (selection, start and status display) we refer to chapter 8.
CAUTION:
programs and functions.
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7.2 PROGRAM OVERVIEW
The following table lists the programs that you can have your sterilizer. Check the Technical Data Sheet
supplied with this manual the programs included in your sterilizer.
There are two types of programs:
● T Test Programs (programs to verify the correct operation of the sterilizer)
● P Production Programs (sterilization programs or production programs of sterile material)
Holding
Plateau period
Type Prog. Nº Description Icon temperature
[min]
[°C]
T 01 B&D Test BD 134 3,3
-- 10
T 02 Vacuum Test VT
(pressure 7 kPa) (test time)
T 09 Preheating 121 2
T 46 Air Detector Calibration* 134 5
-- 10
T 47 Air Detector Vacuum Test* VT
(pressure 7 kPa) (test time)
121
T 48 Autostart* 2
(7 kPa)
P 03 Standard 121 ºC 121 [1] 20
P 04 Standard 134 ºC 134 5 [1]
P 05 Containers 134 5 [1]
P 06 Rapid[2] 134 5
P 07 Special P[2] 134 18
P 11 Silicone Implants* Si 134 10
P 22 Disinfection* 105 10
P 14 Liquids* 121 20
Table 7.1 - Standard and optional programs
Programs marked with an asterisk (*) are optional.
Remark [1]: Some sterilizers with optional setting whereby the device’s programs can differ in some parameters. See below in the
explanation of each of the programs.
Remark [2]: These programs can be deactivated by default in some sterilizers with optional setting
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7.3 PROGRAM DESCRIPTION
Check on your Technical Data Sheet delivered with this manual the programs installed in your sterilizer.
7.3.1 TEST PROGRAMS
The test programs enable the operator to examine certain aspects of the correct sterilizer’s operation
or sterilization processes. They are used as (daily) routine test or if necessary, i.e. if there are certain
reference points for a malfunctioning.
Since these programs are not sterilization programs, their access is on a separate screen separated
from the sterilization programs, restricted to Staff user (except Bowie & Dick Test that needs to be done
each day at the beginning of the day, so this program is on the screen of regular programs). For more
information about selecting these programs, see Chapter 8.
CAUTION:
The test programs are not sterilization programs. There Should be no material in the chamber when
running these programs, except the test devices. The material which has been accidentally introduced
into the sterilizer chamber should always be considered NOT STERILE when the program is over.
As a reminder, when selecting a test program a warning message is displayed which requires confirmation
press before starting the cycle.
Tch Pch
999.9 °C 999.9 kPa
This is a TEST PROGRAM

The material will not be sterile!
Run this test?
Figure 7.1 - Confirmation of test program screen
7.3.1.1 BOWIE & DICK TEST (B&D TEST)
BD The Bowie & Dick Test (Test B&D) is designed to serve as a daily routine for checking
the performance of the sterilizer, particularly its ability to eliminate the air and reach the right steam
penetration in the load (see also paragraph 10.1, which details the maintenance operations to be
performed daily by the machine operator). The program profile of the B&D Test is equal to sterilization
programs (see below) but with the following parameters:
● Holding temperature: 134 °C

● Plateau period: 3.3 minutes
● Fractionating vacuum steps: 8+3
● Drying time: 5 minutes
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NOTE:
A B&D Test must be executed daily as a procedure for routine monitoring of sterilization. It is for this
reason that by default, and as a reminder, every time the sterilizer is connected a message is displayed
asking if the user wants to perform a B&D Test (see figure 7.3).
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
P st. gen. L P st. gen. L
999.9 kPa LWL 1 2 1 2
999.9 kPa LWL
Run a Preheating
program? Run a B&D Test?
1 1

Figure 7.2 - Confirmation Preheating screen Figure 7.3 - Confirmation B&D screen
The B&D Test should be performed with the chamber previously preheated. To facilitate this, by default,
each time you connect the sterilizer a message appears on screen, requesting if you want to run the
Preheating program (provided the chamber is not already hot enough, above 65 °C) (see figure 7.2).
Once the preheating program is executed, the control system asks if you want to perform a B&D Test.
If it is required to perform this program at any other time, this can be selected in the program selection
menu (see figure 8.6). For more information, see chapter 8.
The Bowie & Dick test is usually performed with a standard textile test packet or equivalent. For more
information on how to perform this test, the test material needed, etc., see Annex II of this manual.
NOTE:
The Bowie & Dick Test is usually carried out at 134 °C. If it is required to perform this test with chemical
controls strips calibrated for a sterilization temperature of 121 °C, installing a suitable optional test
program will have to be requested.
7.3.1.2 VACUUM TEST
VT The Vacuum Test is used to test the leak-tightness of the sterilization chamber. The leaks can
inhibit the penetration of steam into the load to be sterilized. The Vacuum test is used whenever there
are indications that a leak is present, e.g. when there is damage to the seal, after the seal has been
replaced, or in case of a technical defect. Failure to pass the B&D Test (see above) can also indicate
that the system has a leak.
NOTE:
It is recommended to run a Vacuum Test at least once a week to ensure that there is no leak in the
sterilizer.
The Vacuum Test must be performed with a preheated and empty chamber (without load). If necessary
the Preheating program is to be run before.
If running this program is required, it will be necessary to gain access to the selection of test programs
under the Staff user (see paragraph 8.5 for the change of user).
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The following figure shows the curve of the Vacuum Test.
PRESSURE
[hPa]
1000
TIME
0 [min]
Start 0 1 2 3 4+5 End of test
Figure 7.4 - Pressure course in the Vacuum Test
The Vacuum Test starts with an evacuation phase (vacuum) (1), followed by an equilibration phase (2) of
5 minutes duration. At the end of this phase, during t2 time, the controller records the absolute pressure
p2 in the chamber. Then, follows the test phase (3) during a period of 10 minutes. During this phase, the
pressure into the chamber is continuously monitored by the controller, and the pressure p3 is measured
at its point of time t3. Subsequently, the system is levelled up in the chamber with the atmospheric
pressure (ambient pressure) by means of air injection into the chamber. The control system calculates
and displays the leakage rate as a result of the pressure difference p3-p2, which must be under 1,3 kPa
to ensure a correct result.
During the testing phase if one obtains a reading of the chamber pressure indicating a difference regards
to p2 higher than 1,3 kPa, a warning message (W47) is triggered indicating a failure in the Vacuum Test,
and the program is aborted, allowing the chamber pressure to balance the atmospheric pressure.
The message that appears in this case when the cycle is completed is a message of incorrect cycle. In
this case, the test has to be repeated to verify that the same result is obtained and that there is indeed
a leak. Contact the Technical Assistance Service to solve this fault.
7.3.1.3 PREHEATING
The preheating program must be used at the start of a working day to preheat the sterilizer’s
chamber. It is also used to eliminate the air that might be left in the pipes and in the jacket of the sterilizer.
It allows to prepare the sterilizer for the B&D Test and for routine operation.
The main parameters for this program are the following:

● Plateau period: 2 minutes
By default, each time you connect the sterilizer, a message is displayed asking if you want to perform
a Preheating program (see figure 7.2). This indication does not appear when the chamber temperature
exceeds 65 ºC. If it is required to perform this program at any other time, it will be necessary to access
the test programs’ selection under the Staff user. For more information, see chapter 8.
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7.3.1.4 AUTOSTART (OPTIONAL)
The Autostart program allows to program the sterilizer to perform automatically a Vacuum test
program and a Preheating program when starting the working day. This program is optional.
When you select this program, the sterilizer is set to start automatically at the scheduled time and date,
for example in the morning, one hour before the start of the day. Normally this program is selected the day
before, after finishing the working day.
The Autostart program consists of a vacuum test followed by the preheating program. Both programs
require a total of approximately 40 minutes. Since both programs are executed automatically before the
start of the day, this option allows to increase the productivity of the sterilization central.
It is necessary that at the scheduled time, the sterilizer is turned on and all supplies are available.
To activate the Autostart program, select this program on the selection screen of the test programs (see
figure 8.48), and enter the date and start time on the next screen. For more information, see paragraph
8.3.5.3.
7.3.1.5 AIR DETECTOR CALIBRATION (OPTIONAL)
If the sterilizer is equipped with the option Air Detector, this specific program is available in
order to calibrate the air detector. Calibration and test are performed according to the specifications of
the European Standard EN 285, chapter 19.
The Air Detector is used to determine if, due to a leak or a deficient supply of steam, there are non-
condensable gases (NCG) in the steam in a sufficiently high amount to make the sterilization process
non effective. If during a sterilization process, the air detector detects that the maximum calibration level
has been exceeded, the program will end with failure. See in the Annexes for more information on the
air detector.
Since special knowledge is required for this, the program can only be called upon by specially authorized
and trained personnel, preferably from the Technical Service. In addition, to select this program it is
necessary to access the selection menu of test programs under the Staff user. See Annex II related to
the description of the air detector.
This test is a standard sterilization program at 134 °C with a plateau of 5 minutes, which generates a
calibrated leak through a special device. The result of this test is the reading average value of the air
detector during the sterilization plateau. This value is displayed on the screen and is also printed on the
log printer.
A continuous printout of this reading may be obtained through the EasyLOOK (or CSSDoc) data
documentation software (see paragraph 8.8).

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7.3.1.6 AIR DETECTOR VACUUM TEST (OPTIONAL)
VT If the sterilizer is equipped with the option Air Detector, this specific program is available in
order to execute a specific leak test for the Air Detector. Calibration and test are performed according to
the specifications of the European Standard EN 285, chapter 19.
Since special knowledge is required for this, the program can only be called upon by specially authorized
and trained personnel, preferably from the Technical Service. In addition, to select this program it is
necessary to access the selection menu of test programs under the Staff user. See Annex II related to
the description of the air detector.
This test consists in performing a Vacuum Test but in which a leak is generated by means of a special
device.
7.3.2 STERILIZATION PROGRAMS
The following chart shows the pressure curve which is usually representative of the sterilization programs.
PRESSURE
[hPa]
3000
2000
1000
TIME
0 [min]
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29
Start End of process
0+0 1
2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 31+32
Figure 7.5- Pressure course in a sterilization program
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The most important programs‘ parameters are indicated in the programs descriptions of the following
sections:
When a process starts, the sterilization cycle proceeds as per the following stages:
●
tage of fractionate vacuum pulses, which successively alternates prevacuums with
S
steam injection in order to remove the air from the chamber while heating the material
and facilitating the steam penetration. This phase consists of two distinct stages. First,
it performs a series of vacuum pulses and steam injection below atmospheric pressure
(subatmospheric pulses), and then performs a series of vacuum pulses and steam
injection above atmospheric pressure (hyperatmospheric pulses). The number of
fractionate vacuum pulses of each type is indicated in the description below of each one
of the programs.

These steps may be repeated several times and between different pressure values
depending on the program. This way, the fractionate vacuum phase is being completed.
● Heating stage is performed in the last entry in the steam chamber until it reaches the
pressure corresponding to the saturated steam to the sterilization temperature.
● Maintaining the corresponding pressure, according to the saturated steam curve, to the
sterilization temperature for the duration of the sterilization plateau. The sterilization time
begins to run when you reach the selected sterilization temperature.
● Once the sterilization phase is completed, the pressure in the chamber is reduced until
the vacuum is reached (10 kPa). The drying phase starts at this point.
● rying phase during which the vacuum is still carried out in the chamber. For heavy loads
D
or more difficult to dry, we recommend to use the Container program (see paragraph
7.3.2.3).
●
At the end of the drying phase, air input is made possible into the chamber through an
absolute filter in order to level out the chamber pressure with the atmospheric pressure.
The end of process is acoustically announced by a signal tone and optically by the
touch screen from the NSA (6.1/2) in the control panel from the SA (6.5/1).
NOTE:
Overloading the sterilizer can significantly affect the sterilization process, which might cause failures
in the system. The maximum loads specified for each program needs to be observed. In case of very
heavy loads (for example, instruments in containers), use the Container program.
7.3.2.1 STANDARD 121 ºC [3]
This program is appropriate to sterilize wrapped thermosensitive material, usually made of

plastic or polymeric, either solid or with channels or cavities (hollow devices), or any other material as
long as they can withstand temperatures up to 124 °C.
● Sterilization temperature: 121 °C (125 °C on devices with optional setting)

● Fractionating vacuum steps 8+3
Setting of extended drying time is possible in this program; see paragraph 8.7.1.
The maximum load for this program is 7 kg per sterilization module.

Remark [3]: On devices with optional setting, this program is named “Standard 125 ºC”
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7.3.2.2 STANDARD 134 ºC
This program is appropriate to sterilize wrapped materials, either solid instruments or

objects with channels or cavities (hollow devices), or any other materials as long as they can withstand
temperatures up to 137 °C.
● Sterilization temperature: 134 °C

● Plateau period: 5 minutes (18 minutes on devices with optional setting)
Setting of extended drying time is possible in this program, see paragraph 8.7.1.
The maximum load for this program is 7 kg of either metal instruments or textile material per sterilization
module. When sterilizing load in containers or very heavy loads (for example, instruments in containers),
do not use this program, and use the Container program.
7.3.2.3 CONTAINERS
This is a special program used for the sterilization of wrapped solid (massive) or complex
instruments (with cavities) or heavy loads in baskets or sterilization containers which can withstand
temperatures up to 137 ºC. Compared to the 134 ºC Standard program, a heating phase is added to the
Container program after the first steam injection so as to facilitate the heating up of the metal mass, thus
making the load drying easier.
● Heating: 5 minutes
● Plateau period: 5 minutes (18 minutes on devices with optional setting)
Additionally, for very heavy loads with a large metal mass or loads which are not easily dried, this
program enables to activate an expanded drying option with steam pulses. To remove residual moisture,
steam is injected into the chamber during the drying phase under vacuum conditions. The amount of
steam injections, the pressure of the steam injection (by default 70 kPa) and the duration of the final
vacuum drying which follows the pulses can be adjusted. See paragraph 8.7.1.2. Proper adjustment of
these parameters will be determined during validation for a given load and shall not be modified later.
Remark [4]: The Rapid program is disabled by default on those sterilizers with optional setting
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7.3.2.4 RAPID [4]
The Rapid program is specially indicated for single wrapped (one layer only) solid material,
as well as simple instruments, rigid endoscopes, clamps etc., which can withstand temperatures up to
137 °C.
NOTE:
The Rapid program is not an appropriate program for the sterilization of usual loads in a health facility as
It is not suitable for the sterilization of porous materials with complex structures or solids (devices with
channels or cavities, hollow, etc.), double wrapped material (two layers), neither for material in boxes
or containers. To verify that it is appropriate for the sterilization of a given load, this program should be
validated with this specific load. As a reminder, when selecting this program, a warning message is
displayed that requires confirmation (pressing ) before starting the cycle.
Tch Pch
999.9 °C 999.9 kPa
P st. gen. L
1 2
999.9 kPa LWL
Be careful! Non standard cycle.
Figure 7.6 - Confirmation screen Non standard cycle

The maximum load for this program is 8,5 kg per sterilization module.
7.3.2.5 SPECIAL P [5 ]
This program is a special program for sterilization of materials that may be potentially
contaminated with prions i. e. with causal substances or pathogens for (transferable) spongiforme
encephalopathies (TSE), such as BSE (bovine spongiforme encephalopathy), Scrapie or Creutzfeld-
Jakob-Disease. Even if normally when you suspect the possible presence of prions, it is advisable
to employ a single-use material, in certain cases it may be necessary to use reusable material. This
material in any case requires adequate pretreatment and cleaning prior to sterilization, according to
the national guidelines and the recommendations for inactivating prions proposed by the World Health
Organization (WHO). It is suitable for the sterilization of wrapped materials, solid (massive) or complex
instruments, or other materials which can withstand temperatures up to 137 °C.
Remark [5]: T
he Special P program is disabled by default on those sterilizers with optional setting
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● Plateau period: 18 minutes (as per WHO)
The maximum load for this program is 10 kg per sterilization module concerning solid material and 7 kg
per sterilization module for porous material (textile, etc.).
NOTE:
It can not be assumed that Prions can be completely inactivated just performing the Special P program.
It is necessary to conduct a proper pretreatment prior to sterilization with this program, as recommended
by the World Health Organization (WHO). You can also refer to the respective recommendations of the
Robert-Koch-Institute in Berlin (Germany), published in the “Bundesgesundheitsblatt” (Federal Health
Publication) (http://www.rki.de).
7.3.2.6 SILICONE IMPLANTS (OPTIONAL)
Si Silicone Implants is an optional program, especially suited for sterilization of silicone implants
such as breast prothesis.

● Fractionating vacuum steps: 8
7.3.2.7 DISINFECTION (OPTIONAL)
Disinfection program by steam to 105 ºC for the disinfection of textile materials and instruments,
wrapped in bags or paper rolls, mixed or of other materials.
NOTE:
The Disinfection program is not a sterilization program. As a reminder, when selecting this program, a
figure 7.6).
The proper use of this program must be established, as for the needs required for this specific one.

● Disinfection temperature: 105 °C
● Fractionating vacuum steps: 8

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7.3.2.8 LIQUIDS (OPTIONAL)
Sterilization program, suitable to sterilize liquid in non-hermetically sealed recipients. This

program enables to set that the air removal is assisted by an initial prevacuum followed by an air
removal through gravity (purge) or through a gravity process only. The latter case is most appropriate
when the liquids are hot.
When the Liquid program is included in the sterilizer, it is equipped with a product probe which controls
the liquid’s temperature during sterilization. As for the remaining programs which are not liquid ones,
the product probe is simply informative and does not interfere with the sterilization process. Should you
need the probe to interfere with the sterilization, contact the MATACHANA Technical Service for this
purpose.
NOTE:
Liquids program is not an appropriate program for the sterilization of usual loads in a health facility as
To verify that it is appropriate to sterilize a given load, this program should be validated with this load,
determining the test load and the specific test procedure. As a reminder, when selecting this program, a
figure 7.6).

● Prevacuum: Yes
● Cooling temperature: 90 °C
CAUTION:
Special precaution is required when sterilizing liquid loads. To ensure a safe process, the reference
container where the product probe is placed must have the same or a bigger volume than the other
containers to be sterilized. The liquid in the reference container must have the same temperature as the
other loads before starting the program (no residual warmth from previous batches is allowed).
CAUTION:
When unloading the liquid containers, special care is required. Before the end of the program the
temperature of the liquid is cooled down below the boiling point. However the container and the liquid
are still hot (up to 90 °C, depending on the selected re-cooling temperature). Protective gloves must be
worn to avoid burns.
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The chart from figure 7.6 shows the pressure curve which is usually representative of the Liquids
sterilization programs.
PRESSURE
[hPa]
2000
1000
TIME
0 [min]
Start 0+01 1 2 3 4 5 6 7 8 9 10 11+12 End of process
Figure 7.7 - Pressure course in the Liquids program
When a process starts, the sterilization cycle proceeds as per the following stages:
●
Prevacuum: the vacuum pump sucks the air from the chamber and evacuates the
chamber. Optionally, this phase can be cancelled.
● Preheating: the steam penetrates the chamber until it reaches a pressure of 120 kPa.
● Air purge: the steam continues to enter into the chamber while maintaining the
depressurization open to facilitate the removal of air from the chamber.
● Heating: Steam entry into the chamber, until the minimum temperature reaches a
temperature of 2 °C above sterilization temperature. The temperature is maintained
2 ºC above the selected sterilization temperature, in order to speed up the heating of
the material, until the latter reaches the sterilization temperature.
● Sterilization: Once the product has reached the sterilizing temperature selected, it is
maintained during the corresponding time of sterilization.
● evaporization: The pressure in the chamber gradually decreases until reaching 130 kPa.
D
Devaporization then continues through the vacuum system until reaching a temperature of
90 ºC.
● Cooling: then, a series of air pulses and vacuums are carried out so as to cool the load
and eliminate any residual steam in the chamber.
● Vacuum breaking: Finally, the chamber pressure is levelled out with the atmospheric
pressure to allow the door opening and unload the processed material.
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8. OPERATING THE SYSTEM
8.1 CONNECTING THE STERILIZER
When connecting the sterilizer by the “on”/”off” switch (6.2/1), on the touch screen of the NSA, the
initialization screen is displayed for a few seconds as shown in figure 8.1.
Figure 8.1 - Initialization Display
CAUTION:
Do not touch the screen while the initialization display appears.
If the sterilizer is fitted with a built-in steam generator, a waiting phase for the steam generator then
starts until it reaches the required steam pressure. To verify the correct operation of the generator, once
the equipment is started up, a test for the operation of the steam generator has to be executed, as
described in paragraph 10.2.1, which includes checking the water level, pressure control, etc.
Then, the jacket heating of the sterilizer starts, so as to prepare the unit for routine operation (see
paragraph 8.3.1).
8.2 OPERATING THE STERILIZER DOORS
Control and operation of the sterilizer doors depend on the type and model of the sterilizer (one-door
or two-door model), its accessories and options (automatic loading and unloading system, etc.).
When selecting a program and pressing “Start” on the touch screen to start the selected program,
the doors are automatically blocked, which means that they can no longer be opened until the process
has been properly terminated and duly acknowledged by the operator (see paragraph 8.3.4).
Pressurized air is guided behind the gasket in order to seal the doors of the sterilizer. The pressurized
air forces the gasket out of its groove and presses it against the inner side of the door. This bridges the
groove which is required for movement of the door. As long as the gasket is pressed against the door,
the friction resistance - even depressurized doors - is so large that the door can not be moved. After the
ending of the running process, the gasket is sucked back into its initial position by a vacuum; only then
can the door be opened, provided there is no situation preventing it, as indicated under.
The position of the door and of its locking device are monitored by a limit switch which cancels the
operating functions of the program as long as the door is not completely closed and locked.
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Tch Pch
999.9 °C 999.9 kPa
P st. gen. L Doors’ status indication
999.9 kPa LWL 1 2
Standard Standard Container Special P

121 ºC 134 ºC
Door 1 operation key

1
(open or close)
Figure 8.2 - Menu selection of programs 1
The operating panel on the NSA is designed as touch screen (for more information, see paragraph
6.1.2). The symbol indicated on door 1 (open or close) function key shows the action which is about to
be carried out (see figure 8.2):
Close door 1: 1
Open door 1: 1
The doors’ condition are shown by the indicating icons of the doors’ status (see figure 8.2), whose
meaning is explained as follows:
Both doors closed and locked: 1 2
Door 1 (NSA) opened or in motion: 1 2
Door 2 (SA) opened or in motion: 1 2
The operating panel of the SA of the two-door models sterilizers is shown in the following figure 8.3. In
addition to the display, there are 7 function keys for operation (for details see paragraph 6.2.1).
The first two lines of text on the display show the name of the selected program or the last one performed.
The third line indicates the program status or state of alarm, warning or error. The fourth line indicates
the doors’ status.
Figure 8.3 - Operating panel SA
Pressing key opens door 2 (SA). Door 2 can be closed again by pressing continuously
until the door is completely closed.
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The leds of door 2 keys (SA) have the following meaning:
● Open door key:

- Led on: When door 2 is completely open.
- Led intermittent: During door 2 opening process.
- Led off: When door 2 is completely closed or during its closing process.
● Close door key:

- Led on: When door 2 is completely closed and locked.
- Led intermittent: During door 2 closing process.
- Led off: When door 2 is completely open or during its opening process.
The fourth line of the SA display, also indicates the following information concerning the status of doors:
Display Situation
1 <- | -> Door 1 (NSA) is open or is now being opened.
2 <- | -> Door 2 (SA) is open or is now being opened.
1 -> | <- Door 1 (NSA) is closed and locked.
2 -> | <- Door 2 (SA) is closed and locked.
Table 8.1 - Doors’ status
8.2.1 ONE DOOR MODELS
The door can be opened or closed at any time provided that the machine has been supplied with the
required media and is switched on and there is no running cycle.
Press the door key once 1 at the program start display (see figure 8.8) to open the door. The door
then opens automatically. If the door is to be opened after completion of a process, the process end
must be confirmed as described in paragraph 8.3.4. Otherwise the system responds with error message
E1 “Process Running“.
To close the door, press 1 continuously until the door is completely closed. If the key is released too
early, the closing movement stops due to safety reasons and the door opens again. Please see previous
section for further details on the status indication of the door on the touch screen.
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8.2.2 TWO DOOR MODELS
A door can only be opened or closed if the machine is switched on, has been supplied with the required
media and any process which is running is first terminated properly. The sterilizer doors are counter-lock
so that they can never be open at the same time to reduce the risk of contamination of the SA from the
NSA. For this reason certain conditions must be fulfilled in order to open the doors, depending on the
sterilizer configuration, wether the latest process had been a sterilization or a test one or if it has run with
or without fault as it is described in paragraph 8.3.4.
When two door sterilizers are to be used at healthcare facilities for reprocessing of medical products, the
sterilizer configuration setting is for conditioned doors, as per the indications established in European
Standard EN 285. This is:
● Once
a sterilization program has been completed fault free and the process end confirmed as
described in 8.3.4; it is only possible to open the unloading door 2 (SA).
Only door 1 (NSA) can be opened once door 2 (SA) is opened and closed again.
Once door 1 (NSA) has been opened, it is not possible to open door 2 (SA) until a new
sterilization process is completed fault free.
● Once a sterilization program has been terminated with fault or a test program and the program
end has been confirmed according to 8.3.4, it will only be possible to open door 1 (NSA). To
open door 1, follow the same procedure as described for one door sterilizers. (see paragraph
8.2.1).

To open door 2 (SA), press key once on the SA panel, once the end of cycle has been acknowledged.
By pressing continuously the key (of the SA too) until it is completely closed, you can close the door.
If the key is released too early, the closing movement stops due to safety reasons and the door
opens again.
8.2.3 AUTOMATIC LOCKING MECHANISM
Independently wether the sterilizer has one or two doors, the doors are equipped with a safety system
which complies with the relevant standards and regulations in force and has the following characteristics:
1. A safety contact bar on the upper edge of the door stops and then reverses the closing
movement of the door if affected by a force over 150 N. This prevents, for example, bodily
injury due to getting trapped.
2. To close the door, the door closure key must be pressed continuously until the door has
closed completely. Once closed, the door locks itself automatically, and this locking remains
active, even if there is no voltage.

3. Activating the emergency stop causes an immediate stop of all door movements.
4. The safety contact of the front service door prevents opening the sterilizer’s door if the frontal
maintenance door is open.
5. Starting a process, and therefore active steam injection into the chamber is not possible when
the door is open. This prevents injuries which might be caused by an uncontrolled steam
output.
6. The sterilizer’s door can not be opened as long as the pressure inside the chamber is over
20 kPa above the atmospheric pressure.
7. The sterilizer’s door can not be opened when a program is running.
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8. If a door is inadvertently unlocked due to a fault or if the pressure in the door gasket is too low
while a process is running, this latter will be automatically interrupted and the steam supply
intake into the chamber will be stopped.
9. In two-door sterilizers version, it is not possible to open a door as long as the other door is
already open or the command to open has been given.
If the machine has incorporated an automatic loading/unloading system the charging system (option
available only for S1000), see its specific Instructions Manual.
8.3 PROGRAM SELECTION
8.3.1 SELECT A STERILIZATION PROGRAM
Once the machine is started up and when the initializing display is shown (figure 8.1), a display
appears asking the operator if he wants to execute a Preheating cycle on the sterilizer. This display will
appear whenever the chamber is cold (below 65 °C). Nevertheless, whenever needed you can run the
Preheating program from the Test program selection display (see below). Pressing the keys showing
on the screen, you can confirm or cancel the Preheating execution (figure 8.4). In case of
confirming while the door was open, press 1 until the door is fully closed. Press for 3 seconds
to start the Preheating cycle.
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
999.9 kPa LWL 1 2 999.9 kPa LWL 1 2
Run a Preheating
program? Run a B&D Test?
1 1

Figure 8.4 - Preheating confirmation display Figure 8.5 - B&D confirmation display
Once the Preheating cycle is executed or cancelled, another display appears in case the operator needs
to undertake a Bowie & Dick cycle. It is recommended to run it once a day, when starting the working
day. Pressing the keys on the screen, you can confirm or cancel the execution of this cycle
(figure 8.5). Press to confirm or to cancel the running of the B & D program. In case of
confirmation while the door closed, press 1 to open it, insert the Bowie & Dick pack and close the
door by pressing 1
until completely closed. Press for 3 seconds to start the B&D cycle. When
the test is complete, remove the B&D pack and verify that the chemical control has changed correctly
according to the manufacturer’s instructions.
Once the initial cycles are completed or cancelled, you enter the program selection menu (figure 8.2).
This screen displays the sterilization programs that can be selected. Depending on the programs
available in your sterilizer, either 2 or 3 programs’ displays are at your disposal. To scroll from one
screen to another, press .
When the machine has 8 or fewer programs, they are spread over 2 displays (up to 4 programs each)
and are represented by their respective icons and the name of the program (see figures 8.2 and 8.6). If
the sterilizer has over 8 programs, a third display is added which shows the programs’ names (up to 8
programs on this display; see figure 8.7).
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The icons of the programs shown in figures 8.2, 8.6 and 8.7 are just an example and may vary depending
on the programs available to the sterilizer. The description of these programs are described in chapter 7.
The program data are loaded when pressing the key of a program. Automatically, the Initialization
program display is shown (see figure 8.8). From here you can start the selected program.
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9°C 999.9 kPa
999.9 kPa LWL 1 2 999.9 kPa LWL 1 2
BD
Standard Standard Container Rapid B&D Test
Special P
121 ºC 134 ºC
1 1

Figure 8.2 - Program selection menu 1 Figure 8.6 - Program selection menu 2
Tch Pch
999.9 °C 999.9 kPa
P st. gen. L
999.9 kPa LWL 1 2
Standard Standard
Rapid Rapid
121 ºC 134 ºC
Special P Silicone Waste Waste

Implants Sterilization Disinfection
Figure 8.7 - Program selection menu 3
The three main displays for program selection have common keys, which are:
● Press 1 to open or 1
close door 1 for loading the sterilizer (for more details on how to
operate the doors, see also paragraph 8.2).
● Press to access the user’s selection menu (see paragraph 8.5).
● Press to access the printout menu of the cycles summaries (see paragraph 8.3.6).
● Press to access the following programs’ selection display.
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8.3.2 PROGRAM START
If the program to be performed is selected, you get access to the display for program start (see figure
8.8). Here you can open or close door 1 (NSA) and initiate the chosen program.
Steam generator pres-

Steam generator’s levels
sure (relative)
indication
Chamber temperature Chamber pressure (absolute)
Tch Pch
Access to main menu
999.9 °C 999.9 kPa Access to information screen
Program icon P st. gen. L

999.9 kPa LWL 1 2 Indication of doors’status
Program name Standard 134 ºC Remaining time
Number of cycle Cycle 999

00:45 Time left for the cycle
Auto-power off key (optional)
Door 1 operating key Program start key

(open/close) 1
Figure 8.8 - Program start
To open door 1 (NSA) to load the sterilizer with the material to be sterilized, press 1 . To close,
press 1 continuously until the door is completely closed. For further details on door operation, see
paragraph 8.2
CAUTION:
therefore be a danger of burns. Protective gloves must always be worn to avoid burns.
CAUTION:
The sterilization of liquids or materials which liquefy under heat is not permitted. It is only allowed if the
sterilizer is outfitted with the suitable equipment for sterilization of liquids (optional).
Additionally indicated on this display are the icon and the name of the selected program, the cycle
number and its estimated duration.
To start the program press for 3 seconds. The program will start up automatically. If the selected
program is a test one, the operator is required to acknowledge the initializing of the cycle. Upon start
of the program, the process status screen is shown automatically. There program status and process
variables are indicated.
In the case of having the auto-power off option, you can click before clicking the program start key,
so that the equipment will automatically go to the suspend mode when the cycle ends. In the suspend
mode, the equipment stays in an energy-saving state, where the steam generator and other system
control outputs are disconnected, until the touch-screen is touched again.
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8.3.3 INDICATION OF PROGRAM STATUS AND PROCESS VARIABLES
The control system constantly monitors the cycle variables and compares them to the running program
parameters assigned to each program phases. In case of any deviations exceeding the values specified
for these phases, an alarm or warning message is displayed. If necessary, a reset of the cycle currently
in execution will be executed, while an automatic recovery process is being carried out. At this stage, it is
safe to open the sterilizer’s door and remove the load. Then, the problem that caused the cycle abortion
needs to be solved.
Once you have started up a cycle, the display on the process status is shown, displaying the most
important process variables and the current status at all times. During the running cycle you can see 3
process displays (see figures 8.9, 8.10 and 8.11). To scroll from display to display, press .
The three displays of process status have the areas A and B in common for display sharing (see figure
6.1), indicating the chamber temperature and pressure, the icon of the current program, indication of
the program status, the steam generator pressure, the status of the steam generator’s levels and the
doors’ condition.
It is also possible to access the messages’ display, provided one is active by pressing the key.
In addition, display 1 (see figure 8.9) shows the following additional information: details of the remaining
cycle time, name of the current program and name of the current phase and in case of having repetition
of cycles, the indicator of cycles executed and the maximum programmed cycles. There is also a key to
switch users and the possibility of aborting the cycle.
Steam generator pres- Steam generator’s levels

sure (relative) indication
Chamber temperature
Chamber pressure (absolute)
Indication of cycle status: Tch Pch
Information screen
cycle running 999.9 °C 999.9 kPa
intermittent: cycle reset
P st. gen. L
Indication of doors’ status
Program icon 999.9 kPa LWL 1 2
Program name Standard 134 ºC Remaining time
Current phase EXHAUSTING

00:45
User’s change during Cycle abortion
the cycle
Active messages Next page
Figure 8.9 - Process status screen (display 1)
Display 2 (see figure 8.10) shows the following: jacket pressure, steam generator pressure (if any),
maximum relative pressure of the steam generator, F value, programmed sterilization temperature,
sterilization time scheduled and temperature difference of air detector (if any).
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Steam generator pres- Steam generator’s levels
sure (relative) indication
Chamber temperature Chamber pressure (absolute)
Indication of cycle status: Tch Pch Information screen
cycle running 999.9 °C 999.9 kPa
intermittent: cycle reset
P st. gen. L Indication of doors’ status
Program icon 999.9 kPa LWL 1 2
P jacket 150.0 kPa F 21.0 min

P st. gen. 0.01 bar T hold 134.0 ºC
Values of current cycle P st. gen. max. 3.30 bar t hold 5.0 min
dT a.d. 999.0 ºC
Active messages Next page
Finally, display 3 (see figure 8.11) shows the following information (provided the corresponding options
are available): temperature of product 1, product 2 temperature, temperature of product 3, product 4
temperature, absolute pressure of product, product 1 F value, product 2 F value, product 3 F value,
product 4 F value and relative pressure of product. In addition, the cycle chart can be displayed (see
figure 8.13), together with the fluid diagram of the sterilizer (optional, see figure 8.14).
Steam generator pres-

sure (relative)
Chamber pressure (absolute)
Chamber temperature
Indication of cycle status: Tch Pch Information screen

cycle running 999.9 °C 999.9 kPa Steam generator’s levels
intermittent: cycle reset indication
P st. gen. L
Program icon 999.9 kPa LWL 1 2 Indication of doors’ status
T load 1 999.0 ºC F load 1 999.0 min

Values of current cycle T load 3 999.0 ºC F load 3 999.0 min
P load abs. 999.0 kPa P load rel. 999.0 kPa
Fluids diagram (optional) Cycle chart
Next page
Active messages
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If from display 1 of the process status screens the key, the cycle in execution can be stopped.
The system requests confirmation which is done by pressing to confirm cycle abortion or to
cancel the cycle cancellation (see figure 8.12).
Tch Pch
999.9 °C 999.9 kPa
P st. gen. L
999.9 kPa LWL 1 2
EXHAUSTING
Cancel
the program?
Figure 8.12 - Confirming cycle abortion
Once the cycle is aborted, it takes you to a recovery cycle phase and the process cycle ends as incorrect
(see paragraph 8.3.4 for more information on how to acknowledge an incorrect end of a cycle). In case of
cancelling the abortion of the cycle, it will resume from the point is was previously.
On the cycle chart, which is accessed by pressing key, the running phase and the values of
temperature and pressure in the chamber are visualized in graphic mode and in real time. The values of
the last few minutes (depending on the time scale selected) are displayed in scrolling mode, which means
that the right edge of the scale shows the current point in time and the charts are located to the left in the
past.
Clicking on the chart, you can modify its the time scale between 60, 40, 30 or 20 minutes. The scale is
automatically saved so that it always displays the latest one selected (see figure 8.13). Press to close
the graph and return to the previous display.
Chamber temperature
Chamber pressure, absolute
Temperature scale
Pressure scale
Temperature curve (red)
Pressure curve (blue)
Time scale
Figure 8.13 - Cycle chart
If the device is fitted with the corresponding option, it will be possible to access a fluid diagram of the
sterilizer, by pressing the key from display 3 of the process status screen. This display shows a small
fluid diagram, on which are represented the activation and deactivation of the pumps and main valves,
the water level in both the generator and tanks, including temperatures and pressures in chamber and
jacket among others. (see figure 8.14). Press to close the diagram and return to the previous display.
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Chamber temperature
Chamber pressure
Name of current phase
Chamber
Generator
Tank
Doors and gaskets
Figure 8.14 - Fluid diagram
In the two-door sterilizers, during the cycle execution, the control panel of door 2 (SA) displays the name
of the current program. Pressing key you have access to a second display of the control panel,
which displays the remaining time of the cycle. In the following displays, which are accessed by clicking
on you can visualize the pressure in the chamber and jacket, as well as the chamber and product
temperature. The last line of the display constantly shows the door status (see also paragraph 8.2).
8.3.4 END OF PROGRAM
Once a program has ended correctly (fault free), in area C of the screen (depending on the distribution
of the touch screen, see figure 6.2) is displayed in the messages’ information window the indication of
process end through “Cycle completed” message and by means of a fully green background (see figure
8.15).
The acoustic signal can be silenced by pressing the key. If no key is pressed, the acoustic signal
will stop automatically after 30 seconds.
In two-door sterilizers, the acoustic alarm can be silenced both from the NSA and the SA, regardless of
the cycle profile (test or sterilization), but the door which can be opened depends on the configuration
of the sterilizer’s doors.
Then, you can open the corresponding door of the sterilizer (see paragraph 8.2 for more details on how
to operate the doors).
Tch Pch
Tch Pch
999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
P st. gen. L
BD
P st. gen. L
999.9 kPa LWL 1 2 1 2
999.9 kPa LWL
Finishing time Test completed Finishing time
10:37 10:37
Cycle
complete Careful,
not sterile!
1 1

Figure 8.15 - Cycle end without incidents Figure 8.16 - Test cycle end without incidents
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If the program executed is a test one, a message is displayed in area C of the screen (see figure 6.1)
indicating the correct completion of the test cycle with the message “Test completed”, and with a green
text on white background . Also remember that any load having been introduced inside, can not be
considered sterile (see figure 8.16). In this case, only door 1 (NSA) can be opened. For details, see
paragraph 8.2.
The message that indicates the end of cycle will not definitely go away until one of the door is opened,
depending on the configuration of the sterilizer.
If during the course of a cycle some failures occurs (alarms) which force the program to abort, a number
of additional steps and actions on the touch screen of the NSA will be required to allow the opening of
door 1. These actions and additional steps alert the operator that the process has been aborted and that
the sterilization material must be considered non-sterile.
The program end with failure, whether sterilization or test program, is shown in Box C of the display with
the message “Cycle incorrect” on a red background (see figure 8.17).
The operation of the acoustic signal follows the same procedure as when the cycle is correct, which
means that it can be silenced by pressing or it is automatically stopped after 30 seconds.
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
P st. gen. L
999.9 kPa LWL 1 2 Confirm faulty cycle
Finishing time
10:37
Cycle
with fault
Cycle with fault

Figure 8.17 - Incorrect cycle end without confirming Figure 8.18 - Cycle end with faults
Acknowledge the message “incorrect Cycle” by pressing the key. You are requested to reconfirm
the cycle with fault by a new display (see figure 8.18), in which the message “Cycle with failure” on a
white background appears. Press again the key to confirm that you are aware that the cycle was
not properly executed. Then, the operator is back to the end of cycle with incidents, but with the option
of opening doors activated (see figure 8.19). If the cycle with incidents is not acknowledged, press to
cancel, which leads you back to the end of Cycle display unconfirmed (see figure 8.17).
CAUTION:
When a sterilization process has ended with a failure the processed material has to be regarded as NOT
STERILE. In this case, and if it is a 2-door sterilizer, it will only be allowed to remove the material inside
the chamber from door 1 (NSA).
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Tch Pch
999.9 °C 999.9 kPa
P st. gen. L
999.9 kPa LWL 1 2
Finishing time
10:37
Cycle
with fault
Figure 8.19 - Cycle end with faults and cycle confirmed
The message that indicates the end of cycle with faults on a red background will not definitely go away
until, depending on the configuration of the sterilizer, the door is opened.
In either case, when the program ends the printer automatically starts the printing process of the program
summary report. It is recommended to systematically review the summary at the end of the same process,
to verify that the cycle has been developed correctly, that there were no significant alarms / warnings and
that each phase variables correspond to the parameters of the program indicated in chapter 12.
Once the cycle is completed, acknowledge the active messages (should there be any) pressing ,
then you can proceed to open the door and unload the material from the corresponding door. The sterilizer
is ready to start a new process.
CAUTION:
therefore be a danger of burns. Protective gloves must always be worn to avoid burns.
8.3.5 PROGRAM START AND PROGRAM END OPTIONS
8.3.5.1 MACHINES WITH AUTOMATIC LOADING / UNLOADING SYSTEMS (OPTION AVAILABLE

ONLY FOR S1000)
Depending on the options available on the sterilizer, various screens may appear different from those
described in previous sections when starting and finishing a process.
If the device has an automatic loading system (optional), once the cycle has started up and before
skipping to the process status 1 display (figure 8.9), a display indicating information that the sterilizer
is performing the automatic loading. This display appears during the entire loading and automatically
disappears once it is completed. The screen shows an illustration of the loading module in which the
movement executed by this module is displayed throughout the automatic loading process (see figure
8.20). In addition, on this screen the key appears. It allows you to pause the automatic loading
process. When this key is pressed, another screen is displayed where you can give instructions to
continue or cancel the automatic loading operation (see figure 8.21).
77
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Tch Pch Tch Pch
999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
999.9 kPa LWL 1 2
999.9 kPa LWL 1 2
AUTOMATIC LOADING Automatic loading

process paused
Review machine Continue Cancel

Figure 8.20 - Active automatic loading process Figure 8.21 - Automatic loading process in pause
Similarly, if your sterilizer is fitted with an automatic unloading system (optional), when the cycle is
completed without failure, and the automatic unloading process is executed, a screen similar to that
described above is shown, but in this case informing that the automatic unloading process is in progress
(see figures 8.22 and 8.23).
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa

1 2 999.9 kPa LWL 1 2
999.9 kPa LWL
AUTOMATIC UNLOADING Automatic unloading
process paused
Continue Cancel
Review machine

Figure 8.22 - Active automatic unloading process Figure 8.23 - Automatic unloading process in pause
CAUTION:
For safety reasons, when starting the automatic unloading process and throughout its duration, the
buzzer of the sterilizer is activated intermittently in order to indicate that an automatic operation from the
unloading system is under progress.
For more information about the automatic loading and unloading processes, see the user manual for the
automatic loading and unloading systems delivered together with the present manual.
78
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8.3.5.2 MACHINES WITH CONFIRMATION OF CYCLE END (OPTIONAL)
If the sterilizer has the option of confirming the end of the cycle, when a cycle ends correctly a message
is displayed in area C of the screen indicating the correct cycle ends with the message “Program
completed” by means of a green text on white background. To confirm the cycle press the key
(see figure 8.24).
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
BD
P st. gen. L
1 2 Confirm cycle end
999.9 kPa LWL
T hold 3.5 min User name
Program T min. 999.0 ºC
0
completed T max. 999.0 ºC
Password
0
1

Figure 8.24 - Completed program (optional) Figure 8.25 - Completed program confirmation
Once positioned on the confirmation screen of cycle end (see figure 8.25), enter the user name and
password to acknowledge the end of cycle and press the key or key to cancel.
The steps to follow once the cycle is confirmed is described in paragraph 8.3.4.
8.3.5.3 MACHINES WITH AUTOSTART (OPTIONAL)
The sterilizer can also be fitted with an autostart option. This option allows you to schedule a date
and start time to undertake an automatic Vacuum Test and a Preheating (see figure 8.24). For more
information about this program, see paragraph 7.3.1.4.
Tch Pch
999.9 °C 999.9 kPa
P st. gen. L
1 2
999.9 kPa LWL
11:53:46 01/01/2010
Start time & date
Figure 8.26 - Autostart
Select this program and press . The sterilizer starts the cycle automatically on scheduled time
and date. If needed, you may cancel the scheduled start of the cycle before it starts by pressing the
key, so as to cancel the automatic start and run the recovery program. At the end of the recovery
program, confirm the cycle end as being incorrect cycle (see paragraph 8.3.4 for more information).
79
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8.3.5.4 MACHINES WITH RECURRENT CYCLES (OPTIONAL)
There is the option to make various repetitions of the same cycle, that is, you can set the number of
cycles in a row that performs a specific program. This option is intended for testing or special cycles. It
should be noted that the sterilizer will not open the doors between each cycle.
From the Repetition display (see figure 8.27) you can program the number of repetitions required and
the waiting time between cycles. From this display you can also program an Autostart, which operation
is described in the previous section.
Once you have configured the various options on the display, press the start key to begin the cycle
immediately, or enter the date and time without pressing any other key to start automatically. Pressing
the key, the automatic and repetitions are cancelled in such a way that the recovery program is
executed. When completed, confirm the end cycle as being incorrect cycle (see paragraph 8.3.4 for
more information).
Tch Pch
999.9 °C 999.9 kPa
P st. gen. L
1 2
999.9 kPa LWL
0 min 0 11:53:46 01/01/2010
Time
between
repetitions Repetitions Start time & date
Figure 8.27 - Repetitions
8.3.5.5 MACHINES WITH INTRODUCTION OF BATCH NUMBER (OPTIONAL)
If your sterilizer includes the option to enter a batch number for each cycle performed, after pressing the
program start button and before initializing any test or production program, a screen is displayed
requesting the user to enter the batch number (see figure 8.28).
Tch Pch
999.9 °C 999.9 kPa
P st. gen. L
Batch 999.9 kPa LWL 1 2
EST032659780
Introduce Batch
Figure 8.28 - Introduction of batch number on the screen
Click on the blue box to enter the batch number. An alphanumeric keyboard appears which enables
you to enter the corresponding batch number. This number can be up to 20 characters. Once entered,
press to confirm and start the selected program. The batch number assigned will be printed on the
printer’s cycle report.
80
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8.3.6 CYCLE SUMMARIES PROCESSING OF THE PRINTER
When from the main screen (see figure 8.2) the key is pressed, you access the Printer display
(figure 8.29), from which you can manage the process summaries. The sterilizer’s control system can
store the last 1000 cycles performed.
Tch Pch
Tch Pch
999.9 °C 999.9 kPa
999.9 °C 999.9 kPa
Printer
Printer settings 1 2
1 2
Cycle
B&D Test 2
01-01-2010 / 11:53:46
Long Short Process Process
Cycle with fault parameters summary

Figure 8.29 - Printer’s display Figure 8.30 - Printer’s settings display
You can scroll up or down between the cycles carried out one by one using the and keys. There
is the possibility of applying different types of filters for searching. In this case, only these keys move
between cycles selected by the filtering.
The Printer display shows the number of currently selected cycle, the program name and whether it was
correct or not.
Press the key to print the summary of the selected cycle to the printer set.
Pressing the key, you gain access to the Printer settings display (see figure 8.30). On this display
you can select if you want to print the summary process in short format (see figure 6.5) or long. The
difference between these two options is that in the long summary are printed all values of temperature,
pressure and F in each phase change, while the short printout just prints the register temperature and
pressure in chamber. You can also select printing parameters programmed process and if desired print
the summary of the end of each process cycle. When one of these options is selected, it is shown with
white text on blue background , whereas if no option is selected, it displays blue text on light blue
background ( ). Press
Loading
system to return to the previous display.
Press the key to access the filter display printer (see figure 8.31). From this display you can search
for processes through filters, either by the date when the cycle sought was run, or cycle range if you
are able to identify approximately the cycle but not the exact number. Press the key to cancel the
currently active filter. Press to return to the previous display.
Tch Pch
999.9 °C 999.9 kPa
Printer filters 1 2
123
Dates Cycles’ number
Figure 8.31 - Printer’s filters
81
sc500_s1000_12_8_01_en
To filter by date, the menu is accessed by pressing the key. Once in the filter menu by date (figure
8.32) and after selecting the desired date range, press to return to the previous printer’s display
of filters (figure 8.31) and again until reaching the printer’s display (figure 8.26), where all cycles
performed are displayed in the specified date range.
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
Dates
1 2 123 Cycle number
1
01-01-2010 11:53:46 0 0
123 123
From date To date From cycle To cycle
Figure 8.32 - Filter by date Figure 8.33 - Filter by cycle’s
To filter by cycle number, access the menu by pressing the 123 key. Once in the filter screen by cycle
number (figure 8.33), select the desired cycle range; after pressing twice to return to the printer’s
display (figure 8.29), the system will display all the cycles performed in the selected cycle range.
Pressing the key in the printer screen (figure 8.29) accesses the screen to store data: Html files
(figure 8.34). From this screen you can select whether you want to export the process summaries in html
format to an external USB device, or if it is enabled, to an FTP server or a CIFS server.
Tch Pch
999.9 °C 999.9 kPa
Data storage
Html files 1 2
Export to USB Export to FTP Export to

device Server CIFS
Server
Figure 8.34 - Data storage: Html files
From this screen (figure 8.34), pressing the key accesses the screen to store data: summary files
(figure 8.35). From this screen you can select whether you want to export the process summaries to an
external USB device, or if it is enabled, to an FTP server or a CIFS server.
82
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Tch Pch
999.9 °C 999.9 kPa
Data storage
summary files 1 2

device Server CIFS
Server
Figure 8.35 - Data storage: summary files
From the previous screen, press the key to access the data store display: log files (figure 8.36). On
this screen you can select if you want to export the process (log files) charts to a USB, or if it is enabled,
to an FTP server or a CIFS server.
Tch Pch
999.9 °C 999.9 kPa
Data storage
Log files 1 2

device Server CIFS
Server
Figure 8.36 - Data storage: delete files
Press again to access the screen for data storage: delete files (figure 8.37), from which you can
choose to delete the process summary files from the sterilizer’s memory in the three formats they are
stored.
Tch Pch
999.9 °C 999.9 kPa
Data storage
Delete Files 1 2
Delete Delete Delete

Summary files Log files Html files
Figura 8.37 - Almacenar datos: borrar ficheros
Press to return to the Program selection display.
Optionally, the sterilizer can be configured to store records of the cycles executed on an FTP server or a
CIFS server automatically, without having to go to this screen to export the files. Contact the MATACHANA
Technical Assistance Service to set this option up.
83
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8.4 KEYPADS
Four different types of keyboards are available for entering data on the display.
Depending on the type of data that is required to enter, the system displays the numeric keypad or the
alphanumeric one automatically.
There are 3 modes of alphanumeric keypads. By default, the alphanumeric keypad appears in Mode 1.
Pressing the “Shift” key changes to the next mode. Once you are in Mode 3, pressing the “Shift” key brings
you back to Mode 1.
0 _
1 2 3 DEL Esc A B C D E F 1 2 3
4 5 6 CLR G H I J K L M 4 5 6
N O P Q R S T 7 8 9
7 8 9 ESC
U V W X Y Z : 0 ,
+
– 0 , OK Shift Del . OK

Figure 8.38 - Numeric keypad Mode 1 Figure 8.39 - Alphanumeric keypad Mode 1: capital letters
_ _
Esc a b c d e f 1 2 3 Esc ! $ % & / \ 1 2 3
g h i j k l m 4 5 6 ( ) = € ? { } 4 5 6
n o p q r s t 7 8 9 º ^ < > | * - 7 8 9
u v w x y z : 0 , _ + @ [ ] # : 0 ,
Shift Del . OK Shift Del . OK

Figure 8.40 - Alphanumeric keypad Mode 2: small letters Figure 8.41 - Alphanumeric keypad Mode 3
numbers and symbols
All the keyboards have three common generic actions:
● The “ESC“ key allows to exit the keyboard without saving or confirming the inserted values.
● The “OK“ key confirms the inserted values.
● The “DEL“ key deletes the latest character introduced.
84
sc500_s1000_12_8_01_en
8.5 USER SELECTION MENU
To access the switch user screen, press the switch user key. The icon displayed on this key may
be different depending on the user selected at that time. Different users available are sorted from the
least to the most privileged:
● Basic user and anonym
● Identified basic user
● Staff
● Administrator
● TAS Maintenance
After pressing the shift user key, you access the user selection display (see figure 8.38).
Tch Pch Tch Pch
999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
BD BD
Usager Known user Staff Admin Known user Staff Admin TAS
maintenance

Figure 8.42 - User selection (screen 1) Figure 8.43 - User selection (screen 2)
Press the key to access a second display that lists the maintenance user (see figure 8.43).
When you press any of the users that require identification (all but the basic user and anonymous), you
enter the identification screen (see figure 8.44). In this screen you have to enter the user name and
password. If data are entered correctly, the key is shown on the screen to confirm the change of
user, and in the “Accepted to group” box the name of the group to which that user belongs. For further
details on the groups, see paragraph 8.7.2.1.
85
sc500_s1000_12_8_01_en
Tch Pch
999.9°C 999.9 kPa
BD
User name
STAFF
Password Accepted to group

************ Staff
Figure 8.44 - Identification display
If you enter the user name or code incorrectly, the confirmation key will not appear on the display, and in
the “Accepted to group” box, the text “INCORRECT” will appear in red (see figure 8.45).
Tch Pch
999.9 °C 999.9 kPa
BD
User name
STAFF
Password Accepted to group

************ INCORRECT
Figure 8.45 - Incorrect user’s name
Once data has been entered correctly, you can access the main screen to advanced users (see
paragraph 8.6).
The first time you enter into an advanced level user name, you reach a display to change your access
code (see figure 8.46). The initial code can only be generated by a user with privileges to create new
users.
Tch Pch
999.9 °C 999.9 kPa
BD 1 2
This is the first login. Please introduce
a new password.
New password Confirmation

0 0
Figure 8.46 - Insert new password
By default, the session for an identified user will automatically close after 5 minutes of inactivity.
86
sc500_s1000_12_8_01_en
8.6 MAIN SCREEN FOR ADVANCED USERS
Once logged in properly as advanced user, you access the main screen for basic users, or in other
words, advanced users (see figure 8.47).
Tch Pch
999.9 °C 999.9 kPa
BD P st. gen. L
999.9 kPa LWL 1 2
Go to program Go to test
selection menu selection menu
Figure 8.47 - Main screen non-basic users
From this screen you can access the list of standard programs by pressing or test programs by
pressing .
For more information on selecting programs, see paragraph 8.3. To select a test program, see section
8.6.1.
Press the key to access the switch user menu (see paragraph 8.5).
Pressing the , you access the settings menu (see paragraph 8.7), which is specific depending on
the level of the user that accessed. Therefore, this key icon can have one of the following 3 images:
● Staff
● Administrator
● TAS maintenance
Pressing the key gives you access to the information screen (see paragraph 8.6.2).
8.6.1 SELECTING A TEST PROGRAM
The selection of test programs can only be done from this screen (see figure 8.48), which are only
accessible to advanced users, with the exception of the B&D Test, which appears in the selection screen
of standard programs (figure 8.6) to facilitate normal operation.
By default, in the test programs’s display are shown the Vacuum and Preheating programs. However,
they can appear up to eight test programs spread over two screens depending on the options available
to the sterilizer. To move between these two screens, use the and keys. The description of
test programs is provided in chapter 7.
87
sc500_s1000_12_8_01_en
Tch Pch
999.9 °C 999.9 kPa
Test selection L
menu LWL 1 2
VT
Vacuum Preheating
Test Program
Figure 8.48 - Test programs’ selection display
Selecting a test program is carried out in the same way as for the standard programs. Select the desired
test program and run it from the initialization display program (see paragraph 8.3.2 for more information).
8.6.2 INFORMATION
Pressing the key on the main display from advanced users (figure 8.47), you access the information
display, which shows the date and real time, the serial number of the sterilizer and its IP address,
including the recipe software and version (see figure 8.49).
Tch Pch
999.9 °C 999.9 kPa
L
Information 1 2
LWL
IP 196.196.11.233
01/01/2010
Unit E-0000026538
Version XXXX
Recipe EH100H5_R01 11:53:46
Figure 8.49 - Information display
Pressing the key from the Information display you can access the Statistics display (see figure
8.50), which shows the following information:
● Operating hours: Indicates the cumulative operating time (cycle duration) of all cycles
carried out to date.
● Cycle counter: The number of total cycles accumulated by the sterilizer.
● 121 °C cycles: The number of cycles at 121 °C accumulated by the sterilizer.
● 134 °C cycles: The number of cycles at 134 °C accumulated by the sterilizer.
88
sc500_s1000_12_8_01_en
Tch Pch
999.9 °C 999.9 kPa
L
Statistics 1 2
LWL
Operating hours: 121 ºC Cycles:

1234 1234
Cycle counter: 134 ºC Cycles:
1234 1234
Figure 8.50 - Statistics display
Pressing the key allows you to go back to the information display.
Pressing the key from the information display (figure 8.49) gives you access to the messages list
display, which displays a list of all messages that have occurred on your machine (see figure 8.51).
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
01/01/2010 11:53:46 W2 Water tank Filter Alarms 1 2

temperature sensor
faillure
Last “X” Alarms Time - Date older than
28/01/2013 10:59:26 W3 Heat exchanger
pressure decrease Time - Date newer than Type
temperature sensor
failure 0 - All Alarms; X - Latest 0
To scroll,
touch the message.
Figura 8.51 - List of messages display Figure 8.52 - Messages filters display
The list of messages can be printed from the set printer by pressing . Press to enter the
messages filters display (figure 8.52). On this display, you can filter the messages by date, type of
message (alarms, errors or warnings), or you can display the last “x” messages; “x” being a specific
number.
From the list of messages display (figure 8.51), the messages can also be stored in txt format by
pressing or can be exported to a USB if you click .
Return to the information screen by pressing the key.
8.7 SETTINGS MENU
From the main display of the advanced users (figure 8.47) you access the settings menu as a user of
any group of advanced users (Staff, Administrator or TAS maintenance), pressing the key. As
already stated in paragraph 8.6, the icon indicated on this key will vary depending on the active user.
Access is primarily to the first display of Staff settings (see figure 8.53). If the active user is a higher
level, by pressing you access the settings display to the next level, Administrator (see figure 8.54).
If the active user if from a superior level, press the key to access the Maintenance settings display
(see figure 8.55).
89
sc500_s1000_12_8_01_en
From the Staff settings display you gain access to the sensors display menus, edit program parameters,
edit date / time and general options.
From the Administrator settings display, you access the menus to edit passwords and edit languages of
your sterilizer.
From the Maintenance settings display you have access to the printer’s settings menus, general menus
and adjust the screen brightness.
Tch Pch
999.9 °C 999.9 kPa
BD 1 2
Visualize Edit Time General

sensors programs settings options
Figure 8.53 - Staff settings display (first level settings)
Tch Pch
999.9 °C 999.9 kPa
BD 1 2
Edit passwords Edit languages
Figure 8.54 - Administrator settings display (second level settings)
Tch Pch
999.9 °C 999.9 kPa
BD 1 2
Settings Printer settings Display settings
Figure 8.55 - TAS maintenance settings display (third level settings)
90
sc500_s1000_12_8_01_en
8.7.1 STAFF SETTINGS
8.7.1.1 SENSORS DISPLAY
Since the sensors visualizing screen, can see all the values of
temperature and pressure of the sterilizer,
both control and registration (see figures 8.56, 8.57 and 8.58). To access the sensor visualizing screen,
press the sensor visualizing key from the Staff settings display (figure 8.53).
Visualize
sensors
The values are divided into 3 displays, to go from one display to another press the and keys.
To return to the Staff settings screen, press in any of the three displays. In these three displays,
only the values of the sensors installed are shown, depending on the options available to the sterilizer.
The first display shows:
● Data related to the control, chamber temperature, product 1 temperature, exchanger

temperature, air detector temperature and product 2 temperature.
● Data related to the documentation or register, chamber temperature, product 1 temperature,

vacuum tank temperature, condensates temperature and product 2 temperature.
Tch Pch
999.9°C 999.9 kPa
T chamber 999.0 ºC T chamber 999.0 ºC

T load 1 999.0 ºC T load 1 999.0 ºC
T ex. 999.0 ºC T tank 999.0 ºC
T a.d. 999.0 ºC T condensa. 999.0 ºC
Figure 8.56 - Display 1 sensors
The second display shows:
● Data related to the control, product 3 temperature, product 4 temperature, filter temperature,
chamber pressure and jacket pressure.
● Data related to the documentation or register, product 3 temperature, product 4 temperature,

filter temperature, chamber pressure and load absolute pressure.
Tch Pch
999.9 °C 999.9 kPa

T filter 0.0 ºC T filter 0.0 ºC
P chamber 0.0 kPa P chamber 0.0 kPa
P jacket 0.0 kPa P load abs. 0.0 kPa
91
sc500_s1000_12_8_01_en
The third display shows:
● Data related to the control, steam relative pressure, digester’s chamber pressure, room
temperature and ambient pressure.
● Data related to the documentation or register, product relative pressure, digestor’s pressure
and pressure of filter.
Tch Pch
999.9 °C 999.9 kPa
P steam 0.00 bar P load rel. 0.0 kPa

P dig. ch. 0.0 kPa P dig. j. 0.0 kPa
T ambient 0.0 ºC P filter out 0.0 kPa
P ambient 0.0 kPa
8.7.1.2 EDIT PROGRAMS
To access the program editing display, press the program editing key from the Staff settings
Edit
programs
display (figure 8.53). This screen can display the parameters of each program, such as the sterilization
temperature, sterilization time, drying time, etc. Also here can be modified parameters which are defined
as modifiable, such as printing yes / no or the extended drying time. To view the parameters of a
particular program, select the appropriate program by program selection icon (see figure 8.59).
Tch Pch
999.9 °C 999.9 kPa
Edit program
1 2
Standard Standard
Rapid Containers
121 ºC 134 ºC
Special P Silicone Waste Waste

Implants Sterilization Disinfection
Figure 8.59 - Edit programs display
Use the scrolling arrow keys and to scroll from one program display to another one, in
the event that the sterilizer has more than eight programs. To select a program, press the key with its
corresponding name. To return to the Staff settings display, press on any display.
92
sc500_s1000_12_8_01_en
Tch Pch
999.9 °C 999.9 kPa
Program which parameters are indicated or/and modified
BD B&D Test 1 2
Nº of parameter, description of parameter
0 AUXILIARY PARAMETER
Value of the current parameter
MIN.: 0 ºC 0
MAX.: 0 ºC
Parameter selection keys
Save parameters modification

Back to previous display
Figure 8.60 - Program’s parameters display
You can only change a parameter if enabled as modified, depending on the sterilizer’s options and
configuration. In most cases, only the drying time can be modified.
To change a parameter from the program parameters display (figure 8.60), use the scrolling arrow
keys and to select the parameter to modify. To introduce the new parameter value, press
the parameter value. A Keyboard appears for data entry (see paragraph 8.4), where you can enter the
desired value and confirm by pressing “OK.
Each parameter has three lines of information. The first line corresponds to the parameter name, the
second and third lines define the range of allowed values indicating the highest and the lowest, “Min: xx”
and “Max: yy”. If the introduced value is out of the permitted range, a warning signal will appear and the
original value will remain. Otherwise, once stored permanently by the key, the amended parameter
from that point forward. Press to return to the programs edit display.
Depending on the options available, the following parameters can be displayed:
Nº Parameter Modifiable
1 Sterilization temperature no
2 Sterilization time no
62 Drying time yes (extendable)
7 Purge time no
10 Drying vacuum no
Table 8.2 - modifiable parameters
8.7.1.3 EDIT DATE AND TIME
To set the date or time, press the time setting key from the Staff settings display (figure 8.53).
Time
settings
Press the current value of the date or time you want to modify (figure 8.61). Automatically, the data input
keyboard is shown, which lets you enter the correct values and confirm them with “OK”.
Use the key to save the changed value to be used from that point forward. Press to return
to the Staff setting display.
93
sc500_s1000_12_8_01_en
Tch Pch
999.9 °C 999.9 kPa
Set date and 01/01/2010
11:53:46
time
01-01-2010 11:53:46
Change date Change time
Figure 8.61 - Date and time setting display
8.7.1.4 EDIT GENERAL OPTIONS
From this menu composed of two screens, the advanced user can change some general options. To
access the display for general options edit, press the general option key from the Staff settings General
display (figure 8.53).

options
On the first display (see figure 8.62) you can configure the following options that the sterilizer may
have: integrated steam generator, automatic loading and/or unloading system (option available only
for S1000) and if the door 2 is opening automatically at the end of the cycle.
Tch Pch
Tch Pch
999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
General options General options
1 2 1 2
10.0 ºC 121.0 ºC 30.0 ºC
Steam Automatic
Loading Unloading
generator unloading
system system F: Z Vacuum tank
door F: Tref.

Figure 8.62 - General options display 1 Figure 8.63 - General options display 2
When one of these options is selected, it is shown with white text on blue background . If the option
is not selected,it is shown with blue text on light blue background . Loading
system
On the second display you can edit the values for the F calculation (Z and Tref.). Pressing the current
value to be changed, it automatically displays the data entry keypad. Enter the desired value and confirm
with “OK” (see figure 8.63).
On this screen, it is also possible to modify the vacuum water tank temperature. This adjustment must
be performed exclusively by maintenance personnel.
In both displays, using the key, the changed value of that point onwards is saved. To move from
display to display, press . To return to the Staff setting display, press .
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8.7.2 ADMINISTRATOR SETTINGS
8.7.2.1 EDIT PASSWORDS
Access to the Passwords edit display (see figure 8.64) by pressing the passwords editing key Edit passwords
from the Administrator setting display (figure 8.54). From this screen you can create a new user and
assign a password with a minimum length extension of 4 alphanumeric characters and a maximum of
8. The user’s name appears as part of the printed report of the cycle, identifying the sterilizer operator
that has run the cycle.
Tch Pch
999.9 °C 999.9 kPa
Passwords
1 2
Group User name Password
- 0 0
0 - 0 0
0 - 0 0
0 - 0 0
Figure 8.64 - Passwords display
When a new user is created, it must be assigned to an advanced group of users, either as Identified
User, Staff, Administrator or TAS maintenance:
● Group 0 Delete user

● Group 1 Basic user identified (no password can be assigned to this user)
● Group 2 Staff
● Group 3 Administrator
● Group 4 TAS maintenance
Using the key, the created user is saved and can be used from this time onward.
Using the arrow keys and , you can scroll between the lines of users, if you have more than
four. You can create up to 94 new users. Press to return to the Administrator setting display.
Subsequently, the first time you access a new user name, you are given the option to change the initial
password so that it is personal and not transferable. Two users can not have the same password. See
paragraph 8.5 for more information on selecting a user.
8.7.2.2 EDIT LANGUAGES
Access to the Language editing display by pressing the languages editing key from the
Edit languages
Administrator setting display (figure 8.54). From this screen you can select the language of the touch
screen and printer of the NSA (see figure 8.65).
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Tch Pch
999.9 °C 999.9 kPa
Languages English
English Français Español Deutsch
Figure 8.65 - Language display
By pressing the key, changes are saved and the selected language will be used from that moment
onwards. Using the arrow keys and you can move between different language displays when
more than four languages are available. Pressing returns the operator to the Administrator setting
display (figure 8.54).
8.7.3 TAS MAINTENANCE SETTINGS
8.7.3.1 TAS SETTINGS DISPLAY
Access to the TAS setting displays (see figures 8.66 and 8.67) by pressing the settings key from
Settings
the TAS maintenance setting display (figure 8.55). This menu of restricted access consisting of two
displays, allows the maintenance technician to change some options in the sterilizer.
The first display enables or disable certain aspects of the sterilizer’s, such as wether the sterilizer is
equipped with conditioned doors, connection to PC, screen saver and buzzer at the end of cycle (see
figure 8.66).
The option of conditioned doors should always be enabled. Furthermore, it controls at any time which
door is allowed to open on the two-door sterilizers. For example, the door 2 (SA) cannot be opened if a
test cycle or a sterilization cycle has been executed with a failure.
The PC connection option allows to connect the sterilizer to a standard PC via Ethernet. Thus, the PC
continuously receives all the information that is normally printed in the report printer and also additional
technical data, process data and, provided the option is available, batch data (see paragraph 8.8).
Using the software EasyLOOK (or CSSDoc) you can obtain more documentation as well as integrate
the information into an internal data network. For more details about the data acquisition systems,
EasyLOOK and CSSDoc of MATACHANA, see the technical documentation supplied with the software.
The screen saver option, when enabled, allows a display to appear with the remaining cycle time after
a period of inactivity of 30 seconds, whenever a cycle is under execution.
The buzzer option for end of cycle allows to enable or disable the buzzer activation at the end of a cycle.
When this option is enabled, the acoustic signal will automatically stop after 30 seconds to complete the
cycle.
96
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Tch Pch Tch Pch
999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
TAS TAS
Conditioned PC Screen Buzzer end Buzzer Show initial

doors connection saver cycle alarm config. display

Figure 8.66 - TAS display 1 Figure 8.67 - TAS display 2
is not selected, it is shown with blue text on light blue background . Loading
system
On the second display it can be enabled or disabled if the buzzer is activated when an alarm message,
error or warning appears, and if the initial configuration display is shown when turning on the sterilizer
for the first time (see figure 8.67).
Press the key to save the changed value. Using the arrow keys and allows you to
move between the two TAS displays. Press for returning to the TAS Maintenance settings display
(figure 8.55).
8.7.3.2 PRINTER SETTINGS DISPLAY
Access to the Printer settings displays (see figures 8.68 and 8.69) by pressing from the TAS Printer settings
Maintenance settings display (figure 8.55). The TAS user can modify the configuration of printing
functions from this menu, which consists of two displays.
On the first display you can enable or disable the printer, indicate if a printer can print charts and select
the type of connection to the machine, Serial, USB or Ethernet (see figure 8.68).
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
Printer settings 1 2 Printer settings 1 2
129.136.128.128
SERIAL
Printer Graphical
availability printer Port
Change
printer IP

Figure 8.68 - Printer settings display 1 Figure 8.69 - Printer settings display 2
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is not selected, it is shown with blue text on light blue background . Loading
system
From the second display, you can change the IP of the printer, in case it is an external printer via
Ethernet connection (see figure 8.69).
By pressing the key to save changes made. Using the arrow keys and you can move
between the two Printer settings displays. Press to return to the TAS Maintenance settings display
(figure 8.55).
8.7.3.3 BRIGHTNESS SETTING DISPLAYS
Y ou access the Brightness setting display for screen (figure 8.70) by pressing the display setting key
from the TAS Maintenance settings display (Figure 8.54). From this display, the technician can
Display settings
change the screen brightness. Simply press the current value and modify it according to need, taking
into account that the value 0 is the lowest value (minimum brightness) and the value 100 is the highest
value (maximum brightness).
Tch Pch
999.9 °C 999.9 kPa
Display settings 1 2
Brightness
Figure 8.70 - Brightness display settings for screen
8.7.3.4 PROCESS STATUS DISPLAY WITH TAS USER
When the TAS Maintenance display settings is enabled, some special options are shown on the process
status displays.
On the Process status display 1 appears the key by which the cycle can be put in a pause mode
(see figure 8.71).
Tch Pch
999.9 °C 999.9 kPa
BD
P st. gen. L
999.9 kPa LWL 1 2
PROCESS Pause
STOPPED
Figure 8.71 - Process display 1 with TAS user
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The pause mode is indicated by the text “stopped process” in yellow, indicating that the process has
come to a halt. With the process stopped, the cycle can carry on running from where the key was
being pressed, or the cycle can be aborted by pressing (see figure 8.72). All the other keys operate
in the same manner as in the Process display for the other users (see paragraph 8.3.3).
Tch Pch
999.9 °C 999.9 kPa
BD
P st. gen. L
999.9 kPa LWL 1 2
PROCESS Pause
STOPPED
Figure 8.72 - Process display under pause
In process status display 2 the key allows to skip to the next phase, provided that the sequence
allows it (see figure 8.73).
Tch Pch
999.9 °C 999.9 kPa
BD EXHAUSTING 1 2
T ch. 1 999.0 ºC F 21.0 min

P ch. 1 999.0 kPa T hold 134.0 ºC
P jacket 150.0 kPa t hold 3.3 min
P st. gen. 0.01 bar dT a.d. 999.0 ºC
P st. gen. max. 3.30 bar T load 1 999.0 ºC
Figure 8.73 - Process display 2 with TAS Maintenance user
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8.8 CONNECTING TO BATCH DOCUMENTATION SYSTEM (OPTIONAL)
Optionally, you can connect the sterilizer to a batch documentation system using a personal computer
(PC). To do this, you must have the CSSDoc or EasyLOOK software, especially developed by
MATACHANA for documentation and control of the sterilization process.
You can print with this option a label from the PC for each of the units that form the sterilizer load. The
label contains data for load unit corresponding to text and bar code format (name of the load, sterilization
program, date of wrapping, etc.).
To assign a load unit to the sterilization load and also for later release, you must enter the bar code
label with a barcode reader, which can be incorporated into the sterilizer itself or connected to the
PC. To register the bar code label of a loading unit, the operator must previously be identified by his/
her personal code, reading from his/her own label, the personal bar code. For more information about
creating users, see paragraph 8.7.2.1. This brings up the corresponding bar code display, depending
wether the code introduced is correct or incorrect (figures 8.74 and 8.75).
As soon as the bar code display appears, the bar code from the load can be read.
Tch Pch Tch Pch

999.9 °C 999.9 kPa 999.9 °C 999.9 kPa
L Bar code L
Bar code 1 2
LWL 1 2 LWL
User code Last code
Last code Load code
Load code Code number
100/100 100/100
Invalid bar code scanned. Please scan next load code.
Delete Delete last

1 1 all codes code

Figure 8.74 - Bar code display (incorrect) Figure 8.75 - Bar code display (correct)
On this screen, the “User code” field shows the bar code corresponding to the operator. The “Last
Code” filed shows the latest bar code entered. If a reading is made of a wrong code or not allowed by
the system, the error is indicated by a red box (see figure 8.74). Below “Load code” field it shows the
number of loading code readings made so far. If you enter an incorrect user code, the error is indicated
by a yellow box (see figure 8.76).
Tch Pch
999.9 °C 999.9 kPa
Bar code L
LWL 1 2
User code
Last code
Load code
100/100
Nonexistent user inside system.
Figure 8.76 - Incorrect user display
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Reading bar codes ends with the bar code control “End of reading.” This control code automatically leads
to the recommended programs display (figure 8.77). After performing the automatic evaluation of the
bar codes entered, the recommended sterilization program is indicated, as well as an equally suitable
alternative program. By pressing the corresponding program name, you can access the program start
display (see figure 8.8).
In case you do not want to run any of the two proposed programs, the key allows access to the
program selection menu (see paragraph 8.3.1), where you can select any of the programs available if
you think that is right for the load.
Tch Pch
999.9 °C 999.9 kPa
Bar code L
LWL 1 2
User code
last code
Load code
100/100
Successfully completed.
Standard
1 Containers
134 ºC
Figure 8.77 - Correct end of reading and recommended programs
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9. ALARM, WARNING AND ERROR MESSAGES
The operation of the sterilizer is operated at all times by the control system. Any deviation from the
set parameters or operating error will cause the appearance of an informative message on the control
screen of the sterilizer, and is also being printed on the printer log (the alarms and warnings only).
There are 3 types of informative messages:
● Alarms (A): They appear when there was an equipment malfunction, causing an
automatic reset of the current cycle. In addition, you can not start a new
program until the cause of the malfunction is solved.
● Warnings (W) : Warnings occur when there has been an equipment malfunction, but it
does not cause a reset of the current cycle. The cycle will continue up
to the end of it, but it will not be possible to initiate a new program until
the cause of malfunction has been solved.
● Errors (E): Errors occur due to a wrong manipulation by the operator. This type of
message does not cause the reset of the running cycle.
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9.1 MANAGING THE ALARM, WARNING AND ERROR MESSAGES
When the condition provoking an alarm, warning or error message Tch Pch
is shown, a continuous audible signal occurs (as long as the 999.9 °C 999.9 kPa
audible alarm function is not deactivated) and on the control 1
L
LWL
PROCESS STOPPED
display from the NSD (6.1/2) the “Message window” appears

(figure 9.1). A2 PLC Communication
interrupted
The message code number and its corresponding text are

displayed automatically on the central box of the screen, in red and Note: To confirm please,
as indicated in figure 9.1. If another message is simultaneously touch the message.
triggered, this latter appears in the place of the previous one.

Figure 9.1- message window
On the upper left of the screen is shown the warning icon 1
Tch Pch
featuring the number of active messages (1 in this example). 999.9 °C 999.9 kPa
Once the message is acknowledged, provided the condition that L
1 PROCESS STOPPED
caused it is still being active, the icon remains visible in order
1 LWL
to remind the operator that the condition is still valid. A2 PLC Communication
interrupted
The procedure for message acknowledgment is the following:
● Press to deactivate the audible alarm.
● Press the red text message; so as to make the lower keypad
with 4 keys appear which allows to acknowledge the
messages as well as scroll from one to another (figure 9.2). Figure 9.2
Makes the lower keypad hide. Tch Pch
Accept the message that is visualized. 999.9 °C 999.9 kPa
Go to the next message. L
1 PROCESS STOPPED
Go to the previous message. LWL
● Once accepted, the message text change from red to blue A2 PLC Communication
colour (figure 9.3). interrupted
Once all the messages are acknowledged, this means when,

although active, all the messages have changed from red to
blue, make the keypad disappear by pressing , then close the Figure 9.3
message window by pressing (figure 9.4).
Tch Pch
Subsequently, whenever there exist any active message it is 999.9 °C 999.9 kPa
possible to gain access to the message window by pressing the 1
L
PROCESS STOPPED
icon (figure 9.5). LWL
A2 PLC Communication
The message remains active until the condition causing it has interrupted
been dealt with, while the operator has acknowledged the
message.
ATTENTION:
Contact the respective MATACHANA Technical Assistance Figure 9.4
Service if failures are indicated and their cause can not be
Tch Pch
eliminated. 999.9 °C 999.9 kPa
P st. gen. L
CAUTION: 999.9 kPa LWL 1 2
When a sterilization program ended with failure, the processed Standard 134 ºC Remaining time
material should always be considered as NON-STERILE. In this

case, and if it is a 2-door sterilizer, it will only be allowed to remove
the material inside the chamber by door 1 (NSA).
EXHAUSTING
00:45
Figure 9.5
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In the two-door sterilizers, the active messages of alarm, warning and error are also displayed on
the control panel of door 2 (SA). With the cursor keys and you can scroll through the various
messages in case of having more than one active. Use the key to silence the buzzer and to
acknowledge the message.
9.2 ALARMS
The alarms are caused by equipment malfunction that prevents the cycle from being completed
successfully. This type of message produces an automatic recovery cycle, which means it will cancel
the process in progress. While running the program reset, the display will show the control phase of the
process reset (RST). Then the sterilizer will run those phases in the process strictly necessary to reach
the end of cycle and open door 1 of the sterilizer to allow a safely removal of the load.
NOTE:
Whenever an alarm occurs, the current cycle is considered as INCORRECT, and therefore the load
must always be considered as NOT STERILE. For this reason, and in the case of 2 door-sterilizers,
after an cycle with failure, only the door 1 (NSA) will be able to open. See paragraph 8.3.4 for more
information about the required operation on reaching the end of the cycle.
In addition, alarm messages can prevent running a new cycle until the condition that has caused it is
gone.
The following alarm messages can be displayed: [1]
A1: Power failure A28: Load temperature 3.1 too high

A2: PLC communication interrupted A29: Load temperature 3.2 too high
A3: None sterile door 1 open. A30: Load temperature 4.1 too high
A4: None sterile door 2 open. A31: Load temperature 4.2 too high
A5: Chamber pressure P1 too high A32: Condensate temperature too high
A6: Chamber pressure P2 too high A33: Pressure sensor P1 failure
A7: Preheating jacket pressure too high A34: Pressure sensor P2 failure
A8: Pressure sensor P1 / P2 difference A35: Pressure sensor preheating jacket failure
A9: Pressure P1 / temperature T1 not in accordance A36: Temperature sensor T1 failure
A10: Pressure P1 / temperature T2 not in accordance A37: Temperature sensor T2 failure
A11: Chamber temperature T1 too low A38: Load sensor 1.1 failure
A12: Chamber temperature T2 too low A39: Load sensor 1.2 failure
A13: Load temperature 1.1 too low A40: Load sensor 2.1 failure
A19: Load temperature 4.1 too low A46: Condensate temperature sensor failure
A20: Load temperature 4.2 too low A47: Low door 1 seal pressure
A21: Condensate temperature too low A48: Low door 2 seal pressure
A22: Chamber temperature T1 too high A49: Vacuum pump failure
A23: Chamber temperature T2 too high A50: Phase too long
A24: Load temperature 1.1 too high A51: Air detector failure
he alarm configuration depends on the model of sterilizer and its available options. Based on this configuration, some of
Remark [1]: T
the following alarms may be disabled.
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sc500_s1000_12_9_01_en
A25: Load temperature 1.2 too high A52: L3 Alarm
A26: Load temperature 2.1 too high A53: General Alarm
A27: Load temperature 2.2 too high A54: Emergency stop
For each of the alarm messages, the condition to be met for display including its scope, is detailed under.
ALARM A1: POWER FAILURE

Condition: There has been a power cut to the sterilizer.
Triggerable: Whenever a cycle is running
ALARM A2: PLC COMMUNICATION INTERRUPTED

Condition: Failure in the communication of the various components from the control device with
the PLC.
Triggerable: Anytime
ALARM A3: NON STERILE DOOR 1 OPEN

Condition: There is no door closed sensor signal from door 1.
ALARM A4: STERILE DOOR 2 OPEN

Condition: There is no door closed sensor signal from door 2.
Triggerable: Only on two door-sterilizers. Whenever a cycle is running.
ALARM A5: CHAMBER PRESSURE P1 TOO HIGH

Condition: The chamber pressure measured by pressure sensor 1 has exceeded the limit of
360 kPa.
ALARM A6: CHAMBER PRESSURE P2 TOO HIGH

Condition: The chamber pressure measured by pressure sensor 2 has exceeded the limit of
360 kPa.
ALARM A7: PREHEATING JACKET PRESSURE TOO HIGH

Condition: The pressure measured by the pressure sensor in the jacket has exceeded the limit of
360 kPa.
ALARM A8: PRESSURE SENSOR P1/P2 DIFFERENCE

Condition: Pressure difference measured by the chamber pressure sensors P1 and P2 during a
period of 5 seconds is larger than 4 kPa durante.
Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau).
ALARM A9: PRESSURE P1 / TEMPERATURE T1 NOT IN ACCORDANCE

Condition: The theoretical temperature of saturated steam calculated from the pressure measured
in the chamber by P1 sensor, present a deviation higher than 2 ºC from the temperature
measured by the temperature sensor T1 into the chamber.
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sc500_s1000_12_9_01_en
ALARM A10: PRESSURE P1 / TEMPERATURE T2 NOT IN ACCORDANCE
Condition: The theoretical temperature of saturated steam calculated from the pressure measured
in the chamber by P1 sensor, present a deviation higher than 2 ºC from the temperature
measured by the temperature sensor T2 into the chamber.
ALARM A11: CHAMBER TEMPERATURE T1 TOO LOW

Condition: During the holding time, the chamber temperature measured by T1 sensor:
a) Is within 1 ºC below nominal temperature for longer than 2 minutes.
b) Falls more than 1 °C below the nominal temperature.
c) For those devices with optional configuration (see paragraph 7.2), the alarm can
be set to activate whenever the chamber temperature drops below the preset
sterilization temperature.
ALARM A12: CHAMBER TEMPERATURE T2 TOO LOW

Condition: During the holding time, the chamber temperature measured by T2 sensor:
b) Falls more than 1°C below the nominal temperature.
be set to activate whenever the chamber temperature drops below the preset
ALARM A13: LOAD TEMPERATURE 1.1 TOO LOW

Condition: During the holding time, the temperature measured by product sensor 1.1 (optional):
be set to activate whenever the product 1.1 temperature drops below the preset



107
sc500_s1000_12_9_01_en



ALARM A21: CONDENSATE TEMPERATURE TOO LOW

Condition: During the holding time, the condensates temperature measured by the sensor
(optional):
be set to activate whenever the condensate temperature drops below the preset
ALARM A22: CHAMBER TEMPERATURE T1 TOO HIGH

Condition: Chamber temperature measured by T1 temperature sensor:
a) Is 3 °C over nominal temperature during holding time (sterilization phase or sterilization
plateau).
b) Is 5 °C over nominal temperature throughout the cycle running.
ALARM A23: CHAMBER TEMPERATURE T2 TOO HIGH

Condition: Chamber temperature measured by T2 temperature sensor:
plateau).
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ALARM A24: LOAD TEMPERATURE 1.1 TOO HIGH
Condition: Temperature measured by product temperature sensor 1.1 (optional):
plateau).

plateau).

plateau).

plateau).

plateau).

plateau).

plateau).

plateau).
109
sc500_s1000_12_9_01_en
ALARM A32: CONDENSATE TEMPERATURE TOO HIGH
Condition: Temperature of condensates measured by its temperature sensor (optional):
plateau).
ALARM A33: PRESSURE SENSOR P1 FAILURE

Condition: The input signal of chamber pressure P1 is under 0,5 kPa, or communication with the
corresponding analogical input module is faulty.
ALARM A34: PRESSURE SENSOR P2 FAILURE

Condition: The input signal of chamber pressure P2 is under 0,5 kPa, or communication with the
ALARM A35: PRESSURE SENSOR PREHEATING JACKET FAILURE

Condition: The input signal of jacket chamber pressure is under 0,5 kPa, or communication with
the corresponding analogical input module is faulty.
ALARM A36: TEMPERATURE SENSOR T1 FAILURE

Condition: The chamber temperature sensor T1 records incorrect values (temperature rises above
148 °C or is under 1 °C), or communication with the corresponding analogical input
module is faulty.
ALARM A37: TEMPERATURE SENSOR T2 FAILURE

Condition: The chamber temperature sensor T2 records incorrect values (temperature rises above
148 °C or is under 1 °C), or communication with the corresponding analogical input
module is faulty.
ALARM A38: LOAD SENSOR 1.1 FAILURE

Condition: The product temperature sensor 1.1 (optional) records incorrect values (temperature
rises above 148 °C or is under 1 °C), or communication with the corresponding
analogical input module is faulty.



110
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ALARM A46: CONDENSATE TEMPERATURE SENSOR FAILURE

Condition: The temperature sensor of condensates (optional) records incorrect values (temperature
rises above 148 °C or is under 1 °C), or communication with the corresponding analogical
input module is faulty.
ALARM A47: LOW DOOR 1 SEAL PRESSURE

Condition: Insufficient pressure in the gasket from door 1.
ALARM A48: LOW DOOR 2 SEAL PRESSURE

Condition: Insufficient pressure in the gasket from door 2.
Triggerable: Only in two door-sterilizers. It always operates during a cycle execution, and whenever
the sterilizer is equipped with independent gaskets (option).
ALARM A49: VACUUM PUMP FAILURE

Condition: The vacuum pump is out of order or its safety mechanism against overloading is
triggered.
ALARM A50: PHASE TOO LONG

Condition: This alarms is shown when a phase of the cycle lasts longer than twice the maximum
set time for each one of them. See also the description on Warning W46.
Triggerable: Anytime a program is running, in the phases which are not controlled by time.
ALARM A51: AIR DETECTOR FAILURE

Condition: There is a temperature difference between chamber temperature T1 and the air detector
one (optional) over the set value, or below -2 ºC.
Triggerable: Operates during holding time (sterilization plateau), only if the sterilizer is fitted with the
air detector option.
ALARM A52: L3 ALARM

Condition: Only in laboratory devices, if prior to running an L3 cycle with fault the operator intends
to start a non-L3 cycle or test program.
Triggerable: Anytime the sterilizer is connected and it only appears during 5 seconds while the
operator intends to start a non-L3 cycle or test program.
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ALARM A53: GENERAL ALARM
Not used.
ALARM A54: EMERGENCY STOP

Condition: The emergency stop located next to the sterilizer’s door has been pressed, or one of
the emergency stops from the loading or unloading module (option available only for
S1000). See chapter 6.
Triggerable: Anytime. If your device is provided with a UPS for safety power supply of 230 V (option),
this alarm is also indicated, as no three-phase supply is available.
9.3 WARNINGS
The warnings are caused by equipment malfunction. However, they do not cause any reset of the cycle
in progress. The cycle will continue until the end of it, getting the right cycle indication (except in the
case of Warnings W32, W33, W47 and W48) and allowing to unload the load. Nevertheless, it will not
be possible to start a new cycle if the condition which generated the Warning still exists. In this case, on
the program start screen (figure 8.8), the start key program will not appear, and the message icon
will remind the user of the existence of an active incidence pending to be solved.
The following warning messages can be displayed [2]:
W1: Air Detector temperature sensor failure W29: Unloading system failure
W2: Water tank temperature sensor failure W30: Do vacuum test
W3: Heat exchanger pressure decrease temperature W31: Bad water quality
sensor failure
W4: Filter Sterilization temperature 1 sensor failure W32: Phase skipped
W5: Filter Sterilization temperature 2 sensor failure W33: Cycle start cancelled
W6: Load pressure sensor failure W34: Chamber door 1 position switch failure
W7: Steam generator pressure sensor failure W35: Chamber door 2 position switch failure
W8: Digestor chamber pressure sensor failure W36: Door seal pressure switch of door 1 failure
W9: Digestor jacket pressure sensor failure W37: Door seal pressure switch of door 2 failure
W10: Filter outlet pressure sensor failure W38: Low water level vacuum system
W11: Steam supply failure W39: Load reference bottle broken / not present
W12: Water supply failure W40: Replace L3 filter
W13: [not assigned] W41: [not assigned]
W14: Compressed Air supply failure W42: Chamber pressure switch SP14 failure
W15: Ambient temperature too high W43: Steam Generator pressure too high
W16: Failure door drive W44: Level control steam generator
W17: Chamber temperature T1 low W45: Steam generator failure
W18: Chamber temperature T2 low W46: Phase prolonged
W19: Load sensor low W47: Vacuum test failure
W20: Condensate temperature low W48: Cycle with fault
W21: [not assigned] W49: End stop switch loader failure
W22: [not assigned] W50: End stop switch unloader failure
W23: [not assigned] W51: Loading time surpassed
W24: Connection to data server failed W52: Unloading time surpassed
W25: Transfer to data server interrupted W53 Forced gap flap
W26: Low level demineralized water level W54 Gap flap switch failure
Remark [2]: The warning configuration depends on the model of sterilizer and its available options. Based on this configuration, some
of the following warnings may be disabled.
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W27: Load not detected W55: Pressure of steam generator too low
W28: Loading system failure
For each of the warning messages the condition to be met for display is detailed under, including its
scope.
WARNING W1: AIR DETECTOR TEMPERATURE SENSOR FAILURE

Condition: The temperature sensor of the air detector (optional) records incorrect values
(temperature rises above 148 °C or is under 1 °C), or communication with the
WARNING W2: WATER TANK TEMPERATURE SENSOR FAILURE

Condition: The temperature sensor of water emptying tank records incorrect values (temperature
WARNING W3: HEAT EXCHANGER PRESSURE DECREASE TEMPERATURE SENSOR FAILURE

Condition: The temperature sensor of the chamber devaporization (option available only for S1000)
exchanger records incorrect values (temperature rises above 148 °C or is under 1 °C),
or communication with the corresponding analogical input module is faulty.
WARNING W4: FILTER STERILIZATION TEMPERATURE 1 SENSOR FAILURE

Condition: The temperature sensor 1 of the L3 filter records incorrect values (temperature rises
above 148 °C or is under 1 °C), or communication with the corresponding analogical
WARNING W5: FILTER STERILIZATION TEMPERATURE 2 SENSOR FAILURE

Condition: The temperature sensor 2 of the L3 filter records incorrect values (temperature rises
above 148 °C or is under 1 °C), or communication with the corresponding analogical
WARNING W6: LOAD PRESSURE SENSOR FAILURE

Condition: Only in sterilizers with liquids programs.
Pressure measured by a product pressure sensor (optional) is lower than 0,5 kPa, or
communication with the corresponding analogical input module is faulty.
WARNING W7: STEAM GENERATOR PRESSURE SENSOR FAILURE

Condition: Only on machines with built-in steam generator. The pressure measured by the
generator pressure sensor is lower than 1 kPa, or communication with the corresponding
WARNING W8: DIGESTOR CHAMBER PRESSURE SENSOR FAILURE

Condition: The input signal from the digestor chamber pressure sensor (optional) is lower than
1 kPa, or communication with the corresponding analogical input module is faulty.
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WARNING W9: DIGESTOR JACKET PRESSURE SENSOR FAILURE
Condition: The input signal from the digestor jacket pressure sensor (optional) is lower than 1 kPa,
or communication with the corresponding analogical input module is faulty.
WARNING W10:FILTER OUTLET PRESSURE SENSOR FAILURE

Condition: The input signal from the pressure sensor in L3 filter output (optional) is lower than 1
kPa, or communication with the corresponding analogical input module is faulty.
WARNING W11:STEAM SUPPLY FAILURE

Condition: Insufficient steam supply to the sterilizer. The steam pressure to the sterilizer is lower
than 100 kPa during a period over 1 minute or communication with the corresponding
analogical inputs module is faulty.
Available only in sterilizers with supplies alarm option.
WARNING W12:WATER SUPPLY FAILURE

Condition: Insufficient water supply to the sterilizer. The water supply pressure to the sterilizer is
lower than 30 kPa during a period over 1 minute or communication with the corresponding
analogical inputs module is faulty.
WARNING W13: [not assigned]
WARNING W14:COMPRESSED AIR SUPPLY FAILURE

Condition: Insufficient compressed air to the sterilizer. Insufficient pressure in the air supply to the
sterilize is detected (4 bar minimum) during a period over 1 minute or communication
with the corresponding analogical input module is faulty.
WARNING W15:AMBIENT TEMPERATURE TOO HIGH

Condition: The temperature measured by a probe located on the touch screen of the sterilizer is
too high during over 1 minute.
WARNING W16:FAILURE DOOR DRIVE

Condition: The motor operating the door does not work or the safety switch has been activated.
Triggerable: Anytime (only in devices from series 2000).
WARNING W17:CHAMBER TEMPERATURE T1 LOW

Condition: During the holding time, the chamber temperature measured by T1 sensor is within 1 ºC
below nominal temperature for less than 2 minutes.
WARNING W18:CHAMBER TEMPERATURE T2 LOW

Condition: During the holding time, the chamber temperature measured by T2 sensor is within 1 ºC
below nominal temperature for less than 2 minutes.
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WARNING W19:LOAD SENSOR LOW
Condition: During the holding time, the temperature measured by a product sensor (optional) is
within 1 ºC below nominal temperature for less than 2 minutes.
WARNING W20:CONDENSATE TEMPERATURE LOW

Condition: During the holding time, the chamber temperature measured by the condensates
sensor (optional) is within 1ºC below nominal temperature for less than 2 minutes.
WARNING W21:[not assigned]
WARNING W24:CONNECTION TO DATA SERVER FAILED

Condition: During boot procedure, it is not possible to connect to the shared folder (CIFS) or FTP-
server which is configured to store the files from the executed cycles. For further details,
see chapter 8.3.6.
Triggerable: Operate only during the booting of the control system when connecting the sterilizer.
WARNING W25:TRANSFER TO DATA SERVER INTERRUPTED

Condition: There is a data transfer error while sending a cycle record to shared folder (CIFS) or
FTP-server which is configured to store the files from the executed cycles. For further
details, see chapter 8.3.6.
WARNING W26:LOW LEVEL DEMINERALIZED WATER LEVEL

Condition: Only in versions with steam generator.
Insufficient water level in the source tank to the steam generator for more than 10
minutes.
WARNING W27:LOAD NOT DETECTED

Condition: Only in sterilizers equipped with an Automatic Load Transfer System (ALTS) (option
available only for S1000).
Reading the load identification is not possible with the program to be executed which
will then disconnect the load detection system.
Triggerable: During the automatic loading process.
WARNING W28:LOADING SYSTEM FAILURE

Condition: Only in sterilizers with automatic loading system (option available only for S1000).
The thermal controller of the automatic loading system is operated, and prevents the
automatic loading operation.
WARNING W29:UNLOADING SYSTEM FAILURE

Condition: Only in sterilizers with automatic unloading system (option available only for S1000).
The thermal controller of the automatic unloading system is operated, and prevents the
automatic unloading operation.
Triggerable: During the automatic unloading process.
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WARNING W30:DO VACUUM TEST
Condition: The IPLM parameter (pressure increase during drying phase) of the cycle in progress
has detected a pressure increase in the chamber which could be caused by a leak in
the sterilizer’s chamber.
Triggerable: At the end of the drying phase of a sterilization program, whenever the IPLM parameter
is activated.
WARNING W31:BAD WATER QUALITY

Condition: The conductivity sensor of the demineralised water (optional) in the supply tank to the
generator has detected a water quality not in accordance with the set value.
WARNING W32:PHASE SKIPPED

Condition: The button skip is pressed during a process cycle. The error will be reset when the
device turns into stand-by status. When the cycle is completed, an end of cycle with
failure is indicated. In the two-door sterilizer, it will not be possible to open door 2 (SA).
Triggerable: During a cycle in progress.
WARNING W33:CYCLE START CANCELLED

Condition: Having selected an Auto Start program (optional), the reset button of the current cycle
is pressed. When the cycle is completed, an end of cycle with failure is indicated. In the
two-door sterilizer, it will not be possible to open door 2 (SA).
Triggerable: During the execution of a programmed Autostart cycle.
WARNING W34:CHAMBER DOOR 1 POSITION SWITCH FAILURE

Condition: The end switches of opened door and closed door of door 1 have detected a malfunction.
Only on sterilizers with automatic loading system.
WARNING W35:CHAMBER DOOR 2 POSITION SWITCH FAILURE

Condition: Only on two-door sterilizers with automatic loading system. The end switches of opened
and closed door from door 2 have detected a malfunction.
WARNING W36:DOOR SEAL PRESSURE SWITCH OF DOOR 1 FAILURE

Condition: Failure from the gasket’s pressure switch of door 1. The pressure switch indicates that
the gasket holds pressure whereas no instruction to pressurize the gasket has been
given.
WARNING W37:DOOR SEAL PRESSURE SWITCH OF DOOR 2 FAILURE

Condition: Only on two-door sterilizers. Failure from the gasket’s pressure switch of door 2 The
pressure switch indicates that the gasket holds pressure whereas no instruction to
pressurize the gasket has been given.
WARNING W38:LOW WATER LEVEL VACUUM SYSTEM

Condition: Insufficient water level is detected in the emptying system tank during more than 5
minutes.
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WARNING W39:LOAD REFERENCE BOTTLE BROKEN / NOT PRESENT
Condition: Only in sterilizers fitted with liquids programs (optional).
The reading of product temperature sensor indicates a value to close to the chamber
temperature, which could imply that the reference bottle in which the sensor has been
introduced is broken, or that the sensor has not been introduced in any of the recipients.
Triggerable: Only in liquids programs and ensuring that this condition is activated.
WARNING W40:REPLACE L3 FILTER

Condition: Only in sterilizers with L3 option.
The operating time counter for the L3 filter has exceeded the set time. The filter must be
replaced.
WARNING W42:CHAMBER PRESSURE SWITCH SP14 FAILURE

Condition: Failure in pressure switch monitoring the pressure into the chamber.
Triggerable: Anytime. The message disappears when the sterilizer goes back to stand-by status.
WARNING W43:STEAM GENERATOR PRESSURE TOO HIGH

Condition: The steam generator pressure measured by the steam generator pressure sensor 1
exceeds 400 kPa.
WARNING W44:LEVEL CONTROL STEAM GENERATOR

Condition: Only with machines equipped with built-in steam generator.
It appears when the level sensors monitoring the filling of the generator detect
contradictory conditions, or whenever a low water level is detected in the generator
which despite having the generator’s feeding pump activated does not detect a high
level once 10 minutes has elapsed.
WARNING W45:STEAM GENERATOR FAILURE

Condition: Only with machines equipped with built-in steam generator.
It appears when a malfunction is detected in the generator (the pressure measured by
the generator’s safety pressure switch is too high, the motor protection switch from the
water feeding pump to the generator is triggered, the water level into the generator is
below safety minimum level or the protection fuse for levels is open).
Triggerable: Whenever, except the first 15 minutes after the starting up of the sterilizer.
WARNING W46:PHASE PROLONGED

Condition: Appears when a cycle phase during execution lasts longer than the maximum set time.
See also the description of alarm 50.
WARNING W47:VACUUM TEST FAILURE

condición: Pressure increase in the chamber is over 1,3 kPa during the test phase in the Vacuum
Test program. When the cycle is completed, an end of cycle with failure is indicated.
In the two-door sterilizer, it will not be possible to open door 2 (SA). The result of the
Vacuum Test comes out incorrect. A verification is necessary to ensure the absence of
leak in the system.
Triggerable: During the testing time of the Vacuum Test program.
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WARNING W48:CYCLE WITH FAULT
Condition: Appears when the running cycle has finalized with an incident that took place during the
execution of the program. When the cycle is completed, an end of cycle with failure is
indicated. In the two-door sterilizer, it will not be possible to open door 2 (SA).The load
must be considered non sterile and be processed again.
Triggerable: When completing a cycle with fault.
WARNING W49:END STOP SWITCH LOADER FAILURE

Condition: Only on devices with automatic loading system (option available only for S1000).
Malfunction of the end stop switches of the automatic loading module. The loading
operation cannot be carried out.
WARNING W50:END STOP SWITCH UNLOADER FAILURE

Condition: Only on devices with automatic unloading system (option available only for S1000).
Malfunction of the end stop switches of the automatic unloading module. The unloading
operation cannot be carried out.
WARNING W51:LOADING TIME SURPASSED

Condition: Only on devices with automatic loading system (option available only for S1000).
Permissible time for complete loading process is exceeded.
WARNING W52:UNLOADING TIME SURPASSED

Condition: Only on devices with automatic unloading system (option available only for S1000).
Permissible time for complete unloading process is exceeded.
Triggerable: During the automatic unloading process.
WARNING W53:FORCED GAP FLAP

Condition: Only on devices with gap flap (optional).
The position of open gap flap has been detected without having received the opening
instruction.
WARNING W54:GAP FLAP SWITCH FAILURE

Condition: Only on devices with gap flap (optional).
The order to open the flap has been given whereas the opening position is not detected
after 5 seconds have elapsed.
WARNING W55:PRESSURE OF STEAM GENERATOR TOO LOW

Condition: Only on devices with built-in steam generator.
The steam generator pressure is 50 kPa below control pressure:
a) D
uring Stand-by: for more than 10 seconds.
b) D
uring a running cycle: for more than 2 minutes.
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9.4 ERRORS
The errors are caused whenever an appropriate operation from the operation has been produced on the
equipment, for instance trying to open the door when it is not allowed for safety reasons.
This type of message does not generate any reset of the cycle in progress.
The error messages which can be visualized are stated as follows[3]:
E1: Process running E23: Do pressure vessel hydraulic test

E2: Maintenance door 1 open E24: Alarm A33 pending manufacture verification
E3: Maintenance door 2 open E25: Alarm A34 pending manufacture verification
E4: Door open E26: Alarm A35 pending manufacture verification
E5: Forced door 1. E27: Alarm A36 pending manufacture verification
E6: Forced door 2. E28: Alarm A37 pending manufacture verification
E7: Error opening / closing door 1 E29: Alarm A38 pending manufacture verification
E8: Error opening / closing door 2 E30: Alarm A39 pending manufacture verification
E9: Pressure in chamber E31: Alarm A40 pending manufacture verification
E10: Conditioned doors, door opening not possible E32: Alarm A41 pending manufacture verification
E11: Non norm conform door control E33: Alarm A42 pending manufacture verification
E12: Please care for free space at unloading line E34: Alarm A43 pending manufacture verification
E13: No load E35: Alarm A44 pending manufacture verification
E14: Door safety bar activated E36: Alarm A45 pending manufacture verification
E15: Low battery E37: Alarm A46 pending manufacture verification
E16: Recovery program E38: Module 1 temperature Control PLC, pending
manufacture verification
E17: [not assigned] E39: Module 2 temperature Control PLC, pending
E18: Lifetime of filter near to end. Prepare replacement E40: Module pressure Control PLC, pending manufacture
verification
E19 [not assigned] E41: Module 1 temperature Documentation PLC,
pending manufacture verification
E20: Can not read load identification E42: Module 2 temperature Documentation PLC,
pending manufacture verification
E21: Cooling water supply failure E43: Module pressure Documentation PLC, pending
E22: Do preventive Maintenance
Remark [3]: The error configuration depends on the model of sterilizer and its available options. Based on this configuration, some of
the following errors may be disabled.
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For each of the error messages the condition to be met for display is detailed under, including its scope.
ERROR E1: PROCESS RUNNING

Occurs when there is an intend of door opening while the cycle is in progress.
ERROR E2: MAINTENANCE DOOR 1 OPEN

This message is displayed when the front maintenance door is open. This error can
also take place in the case of sterilizers fitted with L3 programs, and when the operator
tries to open the non L3 door without having executed a complete fault-free L3 program
(optional).
ERROR E3: MAINTENANCE DOOR 2 OPEN

Only in 2 door-versions.
This message is displayed when the front maintenance door from the SA (corresponding
to door 2) is open.
ERROR E4: DOOR OPEN

Indicates that there is an intend to open a door while the opposite door is open.
ERROR E5: FORCED DOOR 1

Door 1 has been unlocked and/or manually opened.
ERROR E6: FORCED DOOR 2

Only in 2 door-versions. Door 2 has been unlocked and/or manually opened.
ERROR E7: ERROR OPENING / CLOSING N.S.D, door 1

This error can appear under two conditions: when it has been ordered to open a
chamber door 1, but after 10 seconds the door remains closed or whenever the order is
given for door closure, but the door remains open after 2 minutes have elapsed.
For further details,see paragraph 8.2 Operating the sterilizer’s door.
ERROR E8: ERROR OPENING / CLOSING S.D, door 2

Only in 2 door-versions. This error can appear under two conditions: when it has been
ordered to open a chamber door 2, but after 10 seconds the door remains closed or
whenever the order is given for door closure, but the door remains open after 2 minutes
have elapsed.
For further details,see paragraph 8.2 Operating the sterilizer’s door.
ERROR E9: PRESSURE IN CHAMBER

It occurs when the door opening order is given whereas there is a difference between
chamber pressure P1 and atmospheric pressure over 20 kPa.
ERROR E10: CONDITIONED DOORS, DOOR OPENING NOT POSSIBLE

This error indicates that the door operation system does not allow its opening when the
operator is planning to carry out this function (also see paragraph 8.2.2).
When a sterilization program is completed correctly, door 2 (SA) in order to proceed to
the unloading of the treated material and close the door again before permitting door 1
opening (NSA).
Opening door 2 (SA) after having executed a test program or incorrect sterilization
program is not possible.
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ERROR E11: NON NORM CONFORM DOOR CONTROL
The configuration for the opening of Conditioned doors is deactivated. Therefore, the
opening restrictions of door 2, as stated in Chapter 8 are not valid. Both doors can be
open and closed as required.

ERROR E12: PLEASE CARE FOR FREE SPACE AT UNLOADING LINE
Only on sterilizers with an automatic unloading system (option available only for S1000).
The automatic unloading operation can not be undertaken as there is no free space on
the automatic unloading device.
ERROR E13: NO LOAD

Only on sterilizers with an automatic loading system (option available only for S1000).
The automatic loading operation can not be undertaken as no material to be sterilized
is detected on the automatic loading device.
ERROR E14: DOOR SAFETY BAR ACTIVATED

On sterilizers from series 2000 only (with electrical door operation). During the door
closure operation, the door safety bar has been pressed, inverting this way the closing
movement of the door and avoiding any possible body part being crushed. For further
information, see paragraph 8.2.3.
ERROR E15: LOW BATTERY

The battery of the touch screen must be replaced.
Contact the MATACHANA Technical Assistance Service.
ERROR E16: RECOVERY PROGRAM

During the cycle execution a fault is detected causing its reset and provoking a recovery
program which has taken the machine to a safe condition, allowing the door to be
opened and the material to be withdrawn.
ERROR E17: [not assigned]
ERROR E18: LIFETIME OF FILTER NEAR TO END. PREPARE REPLACEMENT

Only on sterilizers with L3 option.
The time operating counter of the L3 filter has reached 90% of the set time. This error
disappears when the operator acknowledge this situation. However, it appears every
time that a new cycle is run, until the filter is replaced.
ERROR E19: [not assigned]

ERROR E20: CAN NOT READ LOAD IDENTIFICATION
Only on sterilizers with the automatic loading system (option available only for S1000).
The system can not read the load identification code to be inserted into the sterilizer’s
chamber and after 3 attempts.
ERROR E21: COOLING WATER SUPPLY FAILURE

Only on sterilizers with external cooling option.
There is no signal received from the cooling water external supply system during more
than 1 minute.
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ERROR E22: DO PREVENTIVE MAINTENANCE
The number of pre-set hours for next service due has been exceeded.
Contact the MATACHANA Technical Assistance Service to carry out the maintenance
(also see chapter 10). This message is shown on the display when starting up the
sterilizer as a reminder, and until the execution of the maintenance is confirmed.
ERROR E23: DO PRESSURE VESSEL HYDRAULIC TEST

The number of pre-established sterilization cycles permitted has been reached in
accordance with the pressure vessel hydraulic test and as established by the local
regulations.
Appropriate steps must be taken in order to execute the test without delay. This message
is shown on the display when starting up the sterilizer as a reminder, and until the test
is done.
ERROR E24: ALARM A33 PENDING MANUFACTURE VERIFICATION

Alarm A33 has been triggered “Failure P1 pressure sensor”. This alarm requires from
the manufacturer to verify the faulty element. This message is shown on the display
when starting up the sterilizer as a reminder, and until the checking of this element is
confirmed.

Alarm A34 has been triggered “Failure P2 pressure sensor”. This alarm requires from
confirmed.

Alarm A35 has been triggered “Failure jacket pressure sensor”. This alarm requires from
confirmed.

Alarm A36 has been triggered “Failure T1 temperature sensor”. This alarm requires from
confirmed.

Alarm A37 has been triggered “Failure T2 temperature sensor”. This alarm requires from
confirmed.

Alarm A38 has been triggered “Failure 1.1 product sensor”. This alarm requires from
confirmed.

confirmed.
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confirmed.

confirmed.

confirmed.

confirmed.

confirmed.

confirmed.

Alarm A46 has been triggered “Failure condensates temperature sensor”. This alarm
requires from the manufacturer to verify the faulty element. This message is shown on
the display when starting up the sterilizer as a reminder, and until the checking of this
element is confirmed.
ERROR E38: M
ODULE 1 TEMPERATURE CONTROL PLC, PENDING MANUFACTURE
VERIFICATION
Analogue module 1 has been replaced (temperatures) from the control system. This
error requires a check up from MATACHANA or its authorized technical service. This
message is shown on the display when starting up the sterilizer as a reminder, and until
the checking of this element is confirmed.
ERROR E39: M
ODULE 2 TEMPERATURE CONTROL PLC, PENDING MANUFACTURE
VERIFICATION
Analogue module 2 has been replaced (temperatures) from the control system. This
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ERROR E40: M
ODULE PRESSURE CONTROL PLC, PENDING MANUFACTURE
VERIFICATION
Analogue module pressure of the control system has been replaced. This error requires
a check up from MATACHANA or its authorized technical service. This message is
shown on the display when starting up the sterilizer as a reminder, and until the checking
of this element is confirmed.
ERROR E41: M
ODULE 1 TEMPERATURE DOCUMENTATION PLC, PENDING MANUFACTURE
VERIFICATION
Analogue module 1 temperature of the system has been replaced. This error requires a
check up from MATACHANA or its authorized technical service. This message is shown
on the display when starting up the sterilizer as a reminder, and until the checking of this
ERROR E42: M
ODULE 2 TEMPERATURE DOCUMENTATION PLC, PENDING MANUFACTURE
VERIFICATION
Analogue module 2 temperature of the system has been replaced. This error requires a
check up from MATACHANA or its authorized technical service. This message is shown
on the display when starting up the sterilizer as a reminder, and until the checking of this
ERROR E43: M
ODULE PRESSURE DOCUMENTATION PLC, PENDING MANUFACTURE
VERIFICATION
Analogue module pressure of the documentation system has been replaced. This
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9.5 INTERFERENCES WITH OPERATIONAL READINESS
If the sterilizer is not ready for operation when pressing the start key (or before), the following points
must be taken into consideration.
▪ Is there an alarm, warning or error message displayed?

For more details, see previous paragraphs from this chapter.
▪ Were the door/s from the chamber properly closed?

The door must be thoroughly closed (end of course). If this is not the case, the micro
switch does not give the closing order of the door.
▪ Has the power protection of the sterilizer been activated?

Verify the fuses in the electro cabinet and the main fuse of the machine (this task must
be carried out by a technician properly trained to execute this intervention).
▪ Has the protection switch from the vacuum pump motor been activated?
This switch is located in the electro cabinet. It must be on “I” position (this task must be
carried out by a technician properly trained to execute this intervention).
▪ Is steam supply correct?

Check the indication of the “Steam” pressure manometer, minimum pressure 2.2 bar (this
task must be carried out by a technician properly trained to execute this intervention).
▪ Is water supply correct?

Check the water supply pressure, minimum pressure 2.5 bar (this task must be carried
out by a technician properly trained to execute this intervention).
▪ Is compressed air supply correct ?

Check the compressed air supply, minimum pressure 5 bar (this task must be carried
out by a technician properly trained to execute this intervention).
Should you come across any malfunction with the machine, contact the maintenance service. If you can
not detect the original of the problem, establish contact with the MATACHANA Technical Assistance
Service.
CAUTION:
The equipment must not be put into operation if the fault found can have implications on the operator’s
safety or process development.
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10. MAINTENANCE
Maintenance is defined as any task (such as checks, measurements, replacements, adjustments and
repairs) required for maintaining or repairing a piece of equipment, so that it may remain operational.
These tasks may be classified as corrective maintenance, preventive maintenance and periodic
inspections.
Corrective maintenance is defined as any repair action that is carried out for the purpose of returning a
unit that has either failed or malfunctioned to its operational state.
Preventive maintenance has the purpose of ensuring that parts or components which are subjected to
wear and tear are replaced before they can have an adverse effect on the process. These actions also
help maintain the system in a flawless state of operational readiness.
After having carried out repairs or pertinent maintenance tasks, any sterilizer functions that may have
been affected must be tested.
Inspection and maintenance tasks may only by carried out by properly trained personnel. We recommend
that semiannual inspections and maintenance be carried out by the MATACHANA Technical Assistance
Service as well as purchasing of the corresponding maintenance service contract. However, some basic
tasks which will be listed below, must be carried out by the equipment operator.
Also, a series of periodic inspections which are specified in national applicable laws and standards,
must also be carried out. These are:
● National regulations derived from the medical devices Directive (MDD) and the pressure
equipment Directive (PED), specifically for:
- Maintenance
- Safety-related inspections
● egulations related to heath and safety at work, specifically for:

R
- Checking supplies
- Pre-start up checks
- Periodic checks
- Inspections
The requirements that need to be considered in order to ensure the flawless operation of the sterilizer
are:
- The equipment has been installed properly.
- The supplies are maintained within specifications (refer to paragraph 4.4).
- the instructions provided in this Operating Instruction Manual are followed carefully.
This requires carrying out the maintenance inspections and tasks described in the following table:
NOTE:
Many components of the machine, such as the panels are made of chrome-nickel stainless steel.
Continuous contact with skin may cause irritation due to nickel in particularly sensitive individuals.
ATTENTION:
Modifying the sterilizer is prohibited. Especially the safety relevant components must not be altered.
They must be replaced by components that are identical in construction or with identical features.
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10.1 MAINTENANCE SCHEDULE
The following table lists the maintenance tasks that are mandatory to keep the equipment operating
properly. The table lists the component or system of the affected equipment, a description of the action
that is to be carried out, the procedure to follow for carrying out the task, who must carry it out and how
often.
In order to facilitate identifying the person responsible for each of the maintenance tasks, the following
colours have been used:
- With a pink background, the tasks that are to be carried out by the equipment operator, who
operates the equipment on a daily basis.
- With a green background, the tasks that are to be carried out by the hospital’s maintenance
service, technical assistance centre, laboratory, or work centre where the equipment is
installed.
- With a blue background, the tasks that are to be carried out exclusively by the MATACHANA
Technical Service.
- With a yellow background, the tasks that are to be carried out by an expert from an external
control entity that is especially accredited for performing these types of inspections.
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NO. COMPONENT / SYSTEM INSPECTION / PROCEDURE WHO? WHEN?
TO CHECK MAINTENANCE
TASK
1 - Internal walls of the chamber Visual inspection and According to Operator Daily, before
- Door gaskets cleaning paragraph 10.2.1 operation
- Drain filters
2 - Printer - Check they are According to Operator Daily, before
- Recorder (optional) operational paragraphs operation
- Check that there is 10.2.1, 10.4.2
sufficient paper and 10.4.3
3 - Deaeration Perform B&D Test According to Operator Daily, before
- Steam penetration paragraphs operation
7.3.1.2, 10.2.1
and Annex II
4 - Inner chamber Cleaning and visual According to Operator Weekly before
- Drain filter inspection paragraph 10.2.2 operation,
- Door gaskets and if necessary
- External surfaces of sterilizer
5 System tightness Perform Vacuum test According to Operator Weekly before
paragraphs operation,
7.3.1.2 and and if necessary
10.2.2
6 - Emergency stop - Check they are According to Maintenance technician Weekly,
- Door safety bar operational paragraph 10.2.2 and if necessary
- Check they work
properly
7 Tightness control Visual control for leak- According to Maintenance technician Weekly
free paragraph 10.2.2
8 Pressure switches ontrol and setting, if
C According to MATACHANA Technical Semiannual
required paragraph 10.3.1 Assistance Service
9 Water tank Empty and clean According to MATACHANA Technical Semiannual
paragraph 10.3.1 Assistance Service
10 Electro-cabinets Compressed air According to MATACHANA Technical Semiannual
cleaning paragraph 10.3.1 Assistance Service
11 Steam traps Check and clean According to MATACHANA Technical Semiannual
12 Door sensors Control and setting, if According to MATACHANA Technical Semiannual
required paragraph 10.3.1 Assistance Service
13 Filters Check and clean According to MATACHANA Technical Semiannual
14 Chamber, components and Tightness inspection According to MATACHANA Technical Semiannual
ducts paragraph 10.3.1 Assistance Service
15 Door gasket Check and clean According to MATACHANA Technical Semiannual
Replace, if necessary paragraphs Assistance Service
10.3.1 and
10.4.1
16 - Door guides - Grease According to MATACHANA Technical Semiannual
- Locking bolts - Check their operation paragraph Assistance Service
10.3.1
17 Complete sterilizer Technical safety tests According to MATACHANA Technical Semiannual
paragraph Assistance Service
10.3.1
18 Sterilizer Checking phase According to MATACHANA Technical Semiannual
changes for all programs paragraph Assistance Service
10.3.1
19 - Non-return valves Clean and inspection According to MATACHANA Technical Yearly
- Pneumatic valves paragraph 10.3.2 Assistance Service
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NO. COMPONENT / SYSTEM INSPECTION / PROCEDURE WHO? WHEN?
TO CHECK MAINTENANCE
TASK
20 Sterile air filter Replace According to MATACHANA Technical Yearly
21 Ducts and water supply Inspection, remove and According to MATACHANA Technical Yearly
components clean if required paragraph 10.3.2 Assistance Service
22 Door pneumatic cylinders Replace door gaskets According to MATACHANA Technical Yearly
23 Door gasket/s Replace According to MATACHANA Technical Yearly
paragraphs Assistance Service
10.3.2 and
10.4.1
24 Chamber and jacket safety Check and activate According to MATACHANA Technical Yearly
valves paragraph 10.3.2 Assistance Service
25 Sterilizer - Check operation According to MATACHANA Technical Yearly,
- Calibration paragraph Assistance Service and if necessary
10.3.2
26 Sterilizer Effectiveness test, According to MATACHANA Technical Yearly,
performance evaluation section 10.3.3 Assistance Service or and if necessary
(revalidation) and annex II accredited validation
entity
27 Pressure vessel Periodical internal According to Expert from accredited As specified
inspections, verification paragraphs entity according to the
and hydrostatic test 10.3.4 and 3.4 local legislation
Table 10.1 - Maintenance tasks carried out on the sterilizer
If auxiliary equipment or accessories are used, the maintenance instructions included in the corresponding
user’s manuals must also be taken into consideration.
For those units that include a built-in steam generator, in addition to the aforementioned tasks, the
generator maintenance and supervisory tasks listed in the following table must also be carried out. The
tasks that are to be carried out daily and weekly must be carried out by properly trained technicians,
while the tasks that are to be carried out semiannually and annually must be carried out by MATACHANA
Technical Service, or maintenance personnel duly authorized by MATACHANA.
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NO. COMPONENT / SYSTEM OPERATION TO PROCEDURE WHO? WHEN?
TO CHECK BE PERFORMED
(INTEGRATED STEAM
GENERATOR)
1 Visual indicator of water level isual check of the

V According to Operator Daily, and on con-
level paragraph 10.2.1 necting the unit
2 Steam generator manometer isual check of pres-
V According to Operator Daily, and on con-
sure paragraph 10.2.1 necting the unit
3 Minimum safety level heck if it is working
C According to Maintenance technician Weekly
correctly paragraph 10.2.2
4 - Water supply to the generator heck of the water
C According to Maintenance technician Weekly
- Water inside the vessel quality supplied to the paragraphs 4.4 and
steam generator, and 10.2.2
the water inside it
5 Vessel Desalination (partial According to Maintenance technician Weekly
drainage of the water paragraph 10.2.2
in the vessel)
6 Safety pressure switch heck if it is working
C According to MATACHANA Semiannual
correctly paragraph 10.3.1 Technical Assistance
Service
7 Intake water tank Drain and clean According to MATACHANA Semiannual
paragraph 10.3.1 Technical Assistance
Service
8 Safety Valve Check and activate According to MATACHANA Yearly
paragraph 10.3.2 Technical Assistance
Service
9 Vessel mpty the steam
E According to MATACHANA Yearly
generator and fill it paragraph 10.3.2 Technical Assistance
again Service
10 team generator (thermal
S Visual check and According to MATACHANA Yearly
insulation, electrical installation, complete revision paragraph 10.3.2 Technical Assistance
safety components, etc.) Service
11 Pressure vessel Periodical internal According to Expert from accredited According to
inspections, verification paragraphs 10.3.4 entity specification by
and hydrostatic test and 3.4 the competent
authority
Table 10.2 - Maintenance tasks carried out on the steam generator (only on E models)
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10.2 MAINTENANCE BY THE OPERATOR
Some of the tasks included in the maintenance plan must be carried out by the operator or the person
responsible for the sterilizer.
10.2.1 DAILY
The following tasks shall be carried out daily:
● Visual inspection of the chamber walls, chamber base, sieve in the drain spout and the door/s
gasket/s for cleanness. If necessary, remove contaminations using a damp cloth.
ATTENTION:
If cleaning products are used, they must not contain halogenated derivates. Use demineralized or
distilled water to rinse the chamber after cleaning.
CAUTION:
The inner walls of the chamber and the edges of the door may be hot, so that there is a risk of burns. It is
recommended to execute the inspection and cleaning tasks once the machine is cold, and use protective
gloves against burns.
CAUTION:
Before entering the chamber for cleaning, activate the emergency stop, and keep the key in your
possession for safety reasons to prevent the accidental closing of the door.
● Ensure there is enough paper in the printer.

The last 100 cm (approx.) of the paper roll are marked with a red stripe, which runs from left to
right on the paper. If necessary, insert a new paper roll (see paragraph 10.5.1.2).
● Carry out the Bowie & Dick test daily once the equipment is hot and prior to starting the sterilization
in order to verify and record the functionality of the equipment after carrying out the aforementioned
points. See paragraph 7.3.1.1 for more details.
● Functional Test of the Steam generator

Every day, upon starting up the sterilizer equipped with its own steam generator, the following
checks shall be carried out:
- Check the water level of the steam generator indicated on the level indicator located on the
front panel (option available only for S1000, see paragraph 6.1.7). The water level must be
between the MIN and MAX indications.
- A few minutes after starting up the equipment, the pressure gauge that measures the generator
pressure (see paragraph 6.1.5) must indicate a pressure higher than 1 bar, but not exceed 2.7
bar. During the normal operation of the sterilizer, verify that the pressure is always between
the preset values (1.4 and 1.6 bar for sterilization programs at 121 ºC, and between 2.5 and
2.7 bar for sterilization programs at 134 ºC).
In no case shall the pressure exceed 3.3 bar (red mark on the pressure gauge). If this pressure
is exceeded and if the safety valve trips (between 3.0 and 3.3 bar), disconnect the sterilizer
immediately and report the malfunction to maintenance personnel or MATACHANA Technical
service.
If the steam sterilizer has an external steam supply, verify that the pressure indicated by the
steam manometer is at least 2.5 bar.
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10.2.2 WEEKLY
In addition to the daily tasks in accordance with the previous section, the following tasks shall be carried
out once a week:
● lean the outer surfaces of the equipment with a damp cloth and a neutral cleaning agent. Do not
C
use chemical aggressive (alkaline or acidic) detergents.
CAUTION!
As the machine is not designed for use in potentially explosive atmospheres, outer panels can
not be treated with cleaning agents that can form a potentially flammable mixture when in the
presence of air.
ATTENTION:
Make sure the water does not come into contact with electrical components of equipment to ensure
proper maintenance and avoid risks to personnel in charge of this task. Do not use pressure water
to clean the sterilizer.
Contact MATACHANA Technical Service if any dirt or contamination is discovered on surfaces,

which cannot be cleaned in this way.
● ith the sterilizer cold, clean the internal surfaces of the chamber (walls, ceiling and base) with a
W
cloth dampened in water and a neutral soap solution.
CAUTION!
protective gloves against burns.
● nsure there are no residues present in the drain sieve. If necessary, clean it repeatedly under
E
running water.
● lean the outer surface of the door gasket with a damp cloth and a neutral cleaning agent, with
C
the door open and the chamber cold. This task does not require removing the gasket from its
housing.
CAUTION:
protective gloves against burns.
● recommend carrying out the Vacuum Test at least once a week in order to check and record
We
the functionality of the unit after carrying out the aforementioned points.
The tasks described below must be carried out by properly trained personnel. Normally these will be
carried out by maintenance personnel from the centre where the unit is installed.
● heck the process of closing the door. Press the door key on the touch screen to close the door.
C
Make sure that the door movement stops as soon as you stop pressing the door key.
● heck if the safety contact bar is operating properly. Close the door as described in the previous
C
point. While the door is closing, push on the safety bar. You should hear the noise made by the
compressed air coming out of the door cylinder. Verify that the raising of the door stops when a
slight pressure is exerted on the safety bar.
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● Check the operation of the emergency stop (6.1/4 and 6.4/2). To do so, press the door key to open
or close the door. When the emergency stop is pressed, door movement must stop immediately
and Alarm 54 “emergency stop” will be displayed on the touch screen. For more details, see the
paragraphs 6.1.4 and 6.2.2.
● In two-door models, the checks described in the three preceding points must be carried out on
both doors.
● If the sterilizer includes a “Test NCG” option, we recommend this test be carried out weekly to
check and record the quality of the steam supplied to the sterilizer chamber.
● In sterilizers equipped with a built-in steam generator, check the operation of the minimum water
level safety device in accordance with applicable regulations.
The test procedure described below is used to check the steam generator disconnect function for
the purpose of protecting it in the case of an insufficient water level condition.
- Connect the sterilizer in cold (not previously preheated) using the on/off switch (6.1/1).
- Wait until the pressure gauge that indicates the steam generator pressure (6.1/5) reaches 0.5
bar.
- Press the Emergency stop (6.1/4).
-
Alarm A54 message is displayed on the screen (6.1/2) “Emergency stop“. Confirm this
message using the normal procedure (see paragraph 9.1).
- Use a 6 mm Allen wrench to apply 2 to 3 turns to the VM3 generator manual drain valve (the
VM3 valve is accessed by opening the front maintenance door). Also refer to the equipment’s
flow diagram.
- Wait until the level indicator has dropped below the minimum safety limit level (lower safety
level indication marking, LWL) (approximately 4 minutes).
- Close the VM3 generator manual drain valve.
- Reset the emergency stop using the appropriate key.
- Message W45 “Generator level low” must be displayed on the screen. If this message is not
displayed, check if the water level is below the low safety level mark. Otherwise, press the
emergency stop once again and continue draining the generator via manual valve VM3. If the
water level is below the safety low level mark and alarm message W45 is not displayed, turn
off the equipment and report the malfunction to the Technical Assistance Service.
If message W45 is displayed properly, the generator can be returned to its normal operating
status by turning off the sterilizer via the on/off switch (6.1/1). Upon restarting the sterilizer,
acknowledge message W45, after which the generator will begin filing with water. Once the
minimum water level is reached in the generator, reset the generator by pressing the SB3
“Reset” button (this action must only be carried out on the S1000; this pushbutton is located in
the technical area; on the upper right hand corner of the electrical panel cover). After resetting,
the heating elements are connected and controlled automatically.
● Check that there is no leak in all the duct system (steam, water and air) of the sterilizer and built-in
steam generator.
● Check the quality of the feed water to the generator and the water inside the generator itself.
If the contamination level exceeds the limit values (see paragraph 4.4, the generator must be
completely drained of water and re-filled with good quality water.
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ATTENTION:

If the quality of tap water is too poor, and if the water treatment supplying the generator is insufficient,
as a precaution we recommend changing the water from the generator weekly.
Check the state of cleanliness of the water tank and if necessary clean it.
● If a sterilizer with a built-in steam generator, equipped with an external steam by-pass option
is operated with external steam, the built-in steam generator will be switched off. To maintain
the operational readiness of the generator, its water level and water quality must be monitored.
Furthermore, we recommend switching on the built-in steam generator once a week and operating
it with an empty batch (e.g. using the B&D Test program). If maintaining the functionality of the
built-in steam generator is not required, completely empty the generator.
10.3 MAINTENANCE BY THE SERVICE TECHNICIAN
The tasks described below must be carried out by properly trained and authorized personnel.
If not otherwise specified, all the maintenance work must be performed with the supplies closed (see
paragraph 4.4).
To disconnect the unit completely from the electric supply, you must switch the main unit switch on (QF1
in the circuit diagrams) located behind the front maintenance door of the NSA. To access this, open
the front maintenance door with its key (6.1/6). The main switch is on the cover of the power box in the
SC500 or on the cover of the power supply electrical panel in the S1000 (see figure 10.1).
QF1 QF1
Figure 10.1 - Device’s main switch on the sterilizers SC500 and S1000
In sterilizers with an automatic loading module (option available only for S1000) where there is no quick
access to the power supply electrical panel to disconnect the device, it is also possible to disconnect
completely the device from the power supply by pressing the “O” button located next to the control panel
of the loading module (see figure 10.2). To restore the power supply to the sterilizer, it is necessary
to reset the main switch of the equipment (QF1) after having previously removed the loading module.
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O

Figure 10.2 - “O” button of the automatic loading module
If the maintenance technician needs to indicate that a maintenance task is pending and that the unit
should therefore not be used, it is possible to press a button that connects an indicator icon on the front
panel (6.1/8 and 6.2/4). To do so, the maintenance technician must press the red button on the side of
the electrical panel, on the lateral side in the S1000 or on the lateral side of the front electrical panel of
the SC500. Then, the icon will light up on both front panels of the unit. Thus, the generator is locked
and a new cycle cannot be started.
SB21
SB21
Figure 10.3 - Maintenance lock-down button on the sterilizers SC500 and S1000
10.3.1 SEMIANNUAL MAINTENANCE
The following maintenance tasks must be carried out by the Technical Assistance Service of MATACHANA
or by duly trained and technical personnel authorized by MATACHANA.
These tasks should be performed once every six months.
● Examine the pressure switches (if installed):

- SP1: Pressure switch of the treated water supply, 2 bar (optional)
- SP2: Pressure switch of the compressed air supply, 4 bar (optional)
- SP3: Pressure switch of the external steam supply, 1.5 bar (optional)
- SP4: Safety pressure switch of the steam generator, 3 bar
- SP7: Pressure switch of the water supply, 1 bar (optional)
- SP8: Pressure switch of the compressed air in the door gasket, 3 bar
- SP10: Pressure switch of the compressed air in the SA door gasket, 3 bar (optional)
- SP14: Pressure switch of the chamber for opening the doors, 0.2 bar
- SP17: Pressure switch of the external cooling water supply, 1 bar (optional)
We recommend to see the unit's flow diagram, as there may be other elements depending on the
model and its options.
● Empty and clean the water tanks.
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● lean by means of compressed air the elements inside the frontal power box on the SC500 and
C
in the lateral electrical panels and frontal power box on the S1000.
● Examine and clean the steam traps:

- XP1: Air detector steam jacket traps (optional)
- XP2: Steam supply trap (only in V models)
- XP3: Steam jacket trap
To check and clean the traps, they need to be taken apart and cleaned for any particles directly
under running water.
● heck the correct fit and monitoring of the front maintenance door, end of travel and of the
C
sterilizer’s door sensors:
- SQ1: Front maintenance door 1 sensor (NSA)
- SQ2: Front maintenance door 2 sensor (SA)
- SQ3: Door 1 closed sensor (NSA)
- SQ4: Door 2 closed sensor (SA)
- SQ5: Door 1 closed and locked sensor (NSA)
- SQ6: Door 2 closed and locked sensor (SA)
● evise and clean the filters mentioned below (see the unit’s liquid flow diagram, as there may be
R
other filters depending on the model and its options). For this purpose the supplies must be cut
off beforehand:
- ST3: Steam inlet
- ST11: Cooling water inlet (if this option is installed)
- ST5: Chamber drain

ake apart the filters and clean the filter mesh with running water to remove the dirt and absorbed
T
contaminants. Then close the filters carefully and mount them again.
● Examine the chamber, components and pipe and line connections for tightness.
● evise and clean the door gasket of the sterilizer according to paragraph 10.4.1. The sterilizer
R
must be cold. After re-inserting the gasket in its groove, perform a Vacuum Test (see paragraph
7.3.1.2) to check it works properly.

● Grease the door guides with white non-toxic heat-resistant grease.
● Technical safety inspection of the whole sterilizer.
● Examine the setpoints for each phase or programs’ stage (see chapter 12).
10.3.2 ANNUAL MAINTENANCE
The following maintenance tasks must be carried out by the Technical Assistance Service of MATACHANA
or by duly trained and technical personnel authorized by Matachana.
These tasks should be performed once every year.
See the unit's flow diagram, as there may be other elements depending on the model and its options.
● Take apart, clean and examine the body, seatings and gaskets of:
- The non-return valves
- The pneumatic valves
● Replace the sterile aeration filter ST6
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● Inspect and, if necessary, remove and clean the ducts and the water supply components.
● Replace the gaskets of the pneumatic cylinders of the door drive.
CAUTION:
Before removing the cylinder door and in any case always whenever there is an intervention in the
parts of the equipment located below the chamber, it is necessary to place the locking bolts to lock
the door in its closed position, thus avoiding its possible fall.
● Replace the door gaskets.
● Inspection of the safety valve (see the unit’s liquid flow diagram):
- SV1: Safety valve chamber
- SV2: Safety valve jacket
- SV3: Safety valve of the steam generator (only in versions with integrated steam generator)

With the sterilizer in operation, activate the safety valves briefly.
ATTENTION:
There is a danger of burns when activating the safety valves; wear protective gloves.
● Calibration of the indicator instruments (pressure, temperature).
● Microbiological efficiency test of sterilization (if necessary, see Annex II).
● Complete inspection of the built-in steam generator.
10.3.3 EFFICIENCY TEST, PERFORMANCE EVALUATION
The sterilization programs must be validated in conjunction with the implemented sterilization procedure
and the load to sterilize in each of them, to ensure the process obtains a sterile load that meets the
predetermined specifications.
We recommend an initial validation for the sterilization processes used, followed by a yearly revalidation,
unless it has to be previously carried out due to significant technical modifications or in case of having a
process or new material to be sterilized in need of a validation. This way the required level of sterilization
safety for the next operation period until the next validation can be ensured permanently, safely and
repeatedly (see Annex II on validation).
We recommend to carry out the validation after the annual maintenance described in paragraph 10.3.2.
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10.3.4 RECURRENT INSPECTIONS OF PRESSURE VESSEL
According to the European Directive on pressure equipment 97/23/EC and the current national regulations
applicable in the country of installation, the mechanical integrity of the pressurized unit must be inspected
periodically. These intervals are determined in agreement with the local/national legislation applicable in
the country of installation.
The periodical inspections of the pressure vessel must be performed by a technician authorized from an
accredited inspection body in the country where the unit is installed with the support of the MATACHANA
Technical Support Service or another service centre authorized by MATACHANA.
To calculate how often these inspections must be performed, an exhaustive analysis was made of the
maximum quantity of cycles of the pressurized vessels (fatigue test). For more details, see paragraph 3.4
where you will find more data on the fatigue breakage strength of the vessel. In the absence of national/
local regulations to establish the periodicity of these inspections, MATACHANA recommends to perform
an internal inspection every 5 years and a hydraulic test every 10 years, using the test pressure specified
on the technical characteristics plate of the vessel.
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10.4 SPECIAL PROCEDURES
10.4.1 CLEANING AND REPLACING DOOR GASKET
NOTE:
The 2 door-sterilizers are normally configured with conditional doors, so that the door from the SA can only
open once a sterilization process has been completed without incident. In this case, to change the door
gasket, this condition must be previously established.
CAUTION:
Clean or replace the door gaskets only if the sterilizer is completely cool to avoid burns. Use
protective gloves when necessary.
Please proceed as follows:
● Open the corresponding door.
● Press the corresponding emergency stop to disable the door‘s drive.
● Remove the plate of the safety contact bar of the door loosening the two screws inserted in the
upper part. This way, the full length of the gasket can be seen.
● Insert a screwdriver between the gasket and the wall of its groove and lever the gasket out carefully,
without damaging it. If necessary, repeat this process until you can grasp the gasket with your
fingers and then pull it out entirely. Follow these instructions meticulously to avoid damaging the
gasket groove with the screwdriver.
● If you merely wish to clean the gasket, this is best done with a neutral soap solution and, if necessary,
methyl alcohol.
ATTENTION:
To clean the door gasket, do not use aggressive solutions or detergents and do not use silicone oil which
contains benzol.
● If necessary, you can use talcum powder to insert the gasket more easily. Apply the talcum powder
to the side surfaces of the silicone gasket and spread it thinly.
● Place the cleaned or new gasket into the groove. It is best to begin from the middle of the chamber’s
top part. Then, follow along the four corners so that the length of line is uniformly distributed over
the four sides of the upper part of the chamber. Then press the gasket completely into the groove.
If necessary, use the back of the screwdriver handle.
● Re-attach the upper door plate with the safety contact bar and fix it with the two screws you removed
earlier
● Reset the emergency stop using its corresponding key to make the door drive operative again, as
described in the paragraphs 6.1.4 and 6.2.2.
● Open and close the door several times, checking the door and the safety contact bar operate
properly. See paragraph 10.2.2 for more details.
● Perform a Vacuum Test to check the chamber is sealed. See paragraph 7.3.1.2 for more details.
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10.4.2 PLACING PRINTER PAPER ROLL
The paper for the printer must be 57.5 mm wide (Ø 0.5 mm), with a weight of 60 g/m2. The thermal paper
must fulfil the requirements of the European Standard EN 285 regarding the storage of documentation.
This paper is on the list of consumables in chapter 11. Using other types of paper may cause a malfunction
of the printer, including insufficient lifespan of the reports.
The exterior face of the roll of paper is the one that can be printed. If in doubt, test by scratching the
surface of the paper lightly with your fingernail. Due to frictional heat, a blackening occurs on the heat-
sensitive side of the paper.
To fit the roll of paper in the printer, follow the instructions below:
1. Open the cover of the printer by gently lifting the lever up.
2. Lift the shaft together with the lid from the printing unit. Hold the shaft with your thumb and
index finger. Remove the remaining paper from the previous roll, if any is left.
3. Pull the end of the new roll of paper so that approximately 5 or 6 cm of paper are loose.
Keep the layers of the roll held tight.
Put the roll of paper in the printer paper supply pit as shown in the figure.
4. Close the lid with light pressure until you hear a click. Pull the end of paper that is sticking out
to cut it and the printer is ready to print again.
1. 2. 3. 4.
Figure 10.4 - Replacing the roll of paper in the printer
10.4.3 RECORDER
To see the maintenance operations necessary for the recorder (optional), see the Operating Instruction
Manual of the recorder attached figure.
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10.5 SHUTDOWN OF THE STERILIZER (FOR LONG PERIODS OF TIME)

If the sterilizer is to be taken out of operation for a long time, we recommend you carry out the operations
listed below. These tasks must be carried out by duly trained technical personnel.
● Empty the water from all tanks, pipes and lines. We recommend to dry the circuits thoroughly , for
example using compressed air.
● Remove the connection hoses and drain any remaining water.
● Dry the sterilizer chamber well.
● If necessary, clean and dry the chamber guides, the loading trolleys and the baskets and store
them in the chamber. Close and lock the doors.
● Disconnect the main switch of the device.
10.6 DISPOSAL INFORMATION AND RECYCLING
In accordance with European Directive 2012/19/EU on waste electrical and electronic

equipment (WEEE), this device belongs to the category of electrical and electronic
equipment subject to the terms of separate collection and recycling at the end of its
useful life. For this reason, the equipment bears the symbol of selective collection of
electrical and electronic equipment, represented by a wheeled bin with crossed signal.
This means that, at the end if its useful life, it must not be disposed off together with
other urban waste, but must be collected and transported to a waste treatment centre
duly authorized by the competent authority. This equipment should be properly treated,
emphasizing, in this order, reuse, recycling, recovery and disposal, neutralizing any
substances harmful to human health and the environment.
The regulations and laws in force in each country should be observed.
Participating in the selective collection scheme contributes to reducing the misuse of natural resources.
For further information, consult your local authorities (city council, regional government, ministry of
environment, etc.), the manufacturer of the device or your local distributor.
General recommendations regarding disposal of batteries:
● Batteries contain chemical products harmful to the environment. Do not dispose of them with
general household or urban waste.
● Dispose of them at authorized collection points.
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11. SPARE PARTS AND CONSUMABLES
We recommend using only original MATACHANA replacement parts and consumables. Otherwise
flawless function and/or error-free processing cannot be ensured.
The spare parts and accessories are obtainable from the manufacturer or an authorized Technical
Assistance Service. Consult other spare parts on the list of material which is included with the diagrams,
where you can find a comprehensive list of components for your equipment.
IMAGE CODE DESCRIPTION
41184.1 Time- lag glass fuse 6.3 A of 20 mm length
41179.7 Super time - lag glass fuse 0,315 A of 20 mm length
Thermal paper roll for printer with MATACHANA serigraphy,

41603.8
diam. 60 x 57,5 x 9 mm (12A/48 M.)
41608.2 Sterile air levelling filter
41767.8 Door gasket S1000
62021.2 Door gasket SC500
50897.1 Turbogel jar, with 250 gr-teflon grease.
Table 11.1 - Spare parts and consumables
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12. SWITCHPOINTS AND TOLERANCES OF THE PROGRAMS
12.1 STANDARD 121 ºC, STANDARD 134 ºC, RAPID, SPECIAL P, AIR DETECTOR

CALIBRATION AND B&D TEST PROGRAMS
PRESSURE
[hPa]
3000
2000
1000
TIME
0 [min]
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29
0+01 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 31+32
Figure 12.1 - Profile of the standard 134 ºC, Standard 121 ºC, Rapid programs, Special P, Air Detector
Calibration and B&D Test.
PRESSURE TEMPERATURE DURATION [s]

Nº PHASE REMARKS
[kPa] [°C]
Process running P0 = Pamb
0 not specified max. 300 --
(closed door) (80 - 108)
Wait for steam
0’ -- -- max. 600 --
generator
1 Prevacuum 15 (± 1,5) not specified max. 1200 --
2 Steam injection 70 (± 10) not specified max. 600 --
3 Prevacuum 15 (± 1,5) not specified max.1200 --

Not in program
6 Steam injection 70 (± 10) not specified max. 600 06 - RAPID
Not in program
7 Prevacuum 15 (± 1,5) not specified max. 1200 06 - RAPID
Not in program
Not in program
Not in program
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Nº PHASE REMARKS
[kPa] [°C]
Not in program
Not in program
Not in program
Not in program
Not in program
180 (± 3)
programs at 134 ºC
16 Steam injection not specified max. 600 --
125 (± 3)
programs at 121 ºC
17 Prevacuum 110 (± 5) not specified max. 600 --
180 (± 3)
programs at 134 ºC
125 (± 3)
programs at 121 ºC
200 (± 3)
programs at 134 ºC
130 (± 3)
programs at 121 ºC
290 (± 3)
Heating programs at 134 ºC
22 (initial pressure not specified max. 1200 --
increase) 190 (± 3)
programs at 121 ºC
290 (± 3)
Heating programs at 134 ºC
23 not specified 30 --
(maintenance) 190 (± 3)
programs at 121 ºC
312 (± 3)
Heating 134 (-0 / +3)
programs at 134 ºC
24 (last pressure max. 1200 --
increase) 212 (± 3) 121 (-0 / +3)
programs at 121 ºC
P04/46: 300 (± 5) 133,0 < T < 133,9 °C →
P06: 300 (± 5) W17/18
T < 133,0 °C → A11/12
P04/06/07/46/01: P04/06/07/46/01: P07: 1080 (± 5) T > 137,0 °C → A22/23
315 (± 10) 134 (-0 / +3) Optional configuration:
P01: 198 (± 5) T < 134,0 °C → A11/12
T > 137,0 °C → A22/23
25 Sterilization 120,0 < T < 120,9 °C →
P03: P03: W17/18
P03: 1200 (± 5)
215 (± 10) 121 (-0 / +3) T <120,0 °C → A11/A12
T >124,0 °C → A22/A23
P03 (optional P03 (optional P03 (optional Optional configuration:
configuration): configuration):125 configuration): T <125,0 °C → A11/12
240 (-7 / +10) (-0 / +3) 1200 (± 5) T >128,0 °C → A22/A23
26 Devaporization 10 (± 2) not specified max. 1200 --
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Nº PHASE REMARKS
[kPa] [°C]
Not in program
Drying
27 10 (± 3) not specified 180 (± 20) 06 - RAPID
(vacuum pulse) See Remark 3
Not in program
Drying
28 70 (+ 15/-2) not specified max. 600 06 - RAPID
Not in program
Drying
29 not specified not specified 120 (± 30) 06 - RAPID
P04/46: 600 (± 30)
P03: 900 (± 30)
30 Drying not specified not specified P06: 480 (± 30)
P07: 900 (± 30)
P01: 300 (± 30)

Vacuum breaking Pamb - 10 not specified - -
(aeration)
31
Vacuum breaking Pamb (80 - 108) not specified 15
(extra time)
32 Process end Pamb (80 - 108) not specified -
Table P
arameters for the standard 134 ºC, Standard 121 ºC, Rapid programs, Special P, Air Detector
Calibration and B&D Test.
Remark 1: redefined process parameters regulating the process are indicated with bold
P
characters.
Remark 2: Should you exceed the maximum allowed for some of the phases, warning W46 “Phase
prolonged” is displayed. If the phase lasts longer than twice the maximum set time
for that phase will activate, alarm message A50 “Phase too long” is triggered and the
current cycle will be aborted.
Remark 3: Phases 28 and 29 only take place when a program has incorporated an enlarged
drying with steam pulses (programs with parameter 30 activated). Depending on the
configuration of parameter 30, the steps 28 and 29 are repeated up to 10 times.
Remark 4: Process parameters of program AIR DETECTOR CALIBRATION are identical to those
of program STANDARD 134 ºC.
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12.2 CONTAINERS PROGRAM
PRESSURE
[hPa]
3000
2000
1000
TIME
0 [min]
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33+34
0+01 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32
Figure 12.2 - Profile of the Containers program
PRESSURE TEMPERATURE DURATION

Nº PHASE REMARKS
[kPa] [°C] [s]
Wait for steam
0’ generator -- -- max. 600 --
2 Air purge 210 (± 10) not specified 300 --
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Nº PHASE [kPa] [°C] [s] REMARKS
12 Steam injection 70 (± 10) not specified max.600 --
Heating
24 (initial pressure 290 (± 3) not specified max.1200 --
increase)
Heating
25 290 (± 3) not specified 30 --
(holding)
Heating
26 (last pressure 312 (± 3) 134 (-0 / +3) max.1200 --
increase)
133,0 < T < 133,9 °C →
W17/18
T < 133,0 °C → A11/12
27 Sterilization 315 (± 10) 134 (-0 / +3) 300 (± 5) T > 137,0 °C → A22/23
Optional configuration:
T < 134,0 °C → A11/12
T > 137,0 °C → A22/23
28 Devaporization 10 (± 2) not specified max.1200 --
Not in program
Drying
29 10 (± 3) not specified 180 (± 20) 06 - RAPID
Not in program
Drying
30 70 (+15/-2) not specified max. 600 06 - RAPID
(steam pulse)
See Remark 3
Not in program
Drying
31 not specified not specified 120 (± 30) 06 - RAPID
32 Drying not specified not specified 900 (± 30) --
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Nº PHASE [kPa] [°C] [s] REMARKS
Vacuum breaking Pamb - 10 not specified - -
(aeration)
33
Vacuum breaking
Pamb (80 - 108) not specified 15 --
(extra time)
34 Process end Pamb (80 - 108) not specified - --
Table 12.2 - Parameters for Containers program
P
characters.
Remark 3: Phases 29 to 31 are only valid for the extended drying with steam pulses. It is only
activated for programs where the value 30 is set properly. Depending on the configuration
of parameter 30, the steps 29 and 30 are repeated up to 10 times.
12.3 SILICONE IMPLANTS PROGRAM
PRESSURE
[hPa]
3000
2000
1000
TIME
[min]
Start 0+0’ 1 2 34 5 67 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29+30 End of process
Figure 12.3 - Profile of the Silicone Implants program
PRESSURE TEMPERATURE
Nº PHASE DURATION [s] REMARKS
[kPa] [°C]
(door closed) (80 - 108)
Wait for steam
0‘ -- -- max. 600 --
generator
1 Prevacuum 83 (±3) not specified max. 1200 --
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[kPa] [°C]
Steam injection
2 190 (±3) not specified max. 600 --
(pressure increase)
Steam injection
3 190 (±15) not specified 15 (±5) --
(holding)
Steam injection
(pressure increase)
Steam injection
6 190 (±15) not specified 15 (±5) --
(holding)
Steam injection
(pressure increase)
Steam injection
9 190 (±15) not specified 15 (±5) --
(holding)
Steam injection
(pressure increase)
Steam injection
12 190 (±15) not specified 15 (±5) --
(holding)
Steam injection
(pressure increase)
Steam injection
15 190 (±15) not specified 15 (±5) --
(holding)
Steam injection
(pressure increase)
Steam injection
18 190 (±15) not specified 15 (±5) --
(holding)
Steam injection
(pressure increase)
Steam injection
21 190 (±15) not specified 15 (±5) --
(holding)
Heating (initial pres-
sure increase)
24 Heating (holding) 290 (±15) not specified 30 (±5) -
Heating (final pressure
25 312 (±3) 134 (-0 / +3) max. 1200 --
increase)
133,0 < T < 133,9 °C →
W17/18
T <133,0 °C → A11/A12
26 Sterilization 315 (±10) 134 (-0 / +3) 600 (±5) T >137,0 °C → A22/A23
Optional configuration:
T <134,0 °C → A11/A12
T >137,0 °C → A22/A23
27 Exhausting 83 (±2) not specified max. 1200 --
28 Drying 80 not specified 900 (±20) --
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[kPa] [°C]
Vacuum breaking
Pamb - 10 not specified -- --
(aeration)
29
Vacuum breaking (time Pamb
not specified 30 --
extended) (80 - 108)
Pamb
30 Process end not specified -- --
(80 - 108)
Table 12.3 - Parameters of the Silicone Implants program
Remark 1: Predefined process parameters that regulate the process are printed in bold.
Remark 2: If you exceed the maximum time allowed for any phase, the warning W46 “Phase
prolonged” will be displayed. Should this phase last longer than twice the maximum preset
time for it, the alarm message A50 “Phase too long” will be activated, aborting the cycle in
progress.
12.4 LIQUIDS PROGRAM
PRESSURE
[hPa]
2000
1000
TIME
0 [min]
Start 0+01 1 2 3 4 5 6 7 8 9 10 11+12 End of process
Figure 12.4 - Profile of the Liquids program

Nº PHASE REMARKS
[kPa] [°C] [s]
P0 = Pamb
0 Process running not specified max. 300 --
0’ Wait for steam generator - - max. 600 --
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Nº PHASE REMARKS
[kPa] [°C] [s]
max.1200
2 Preheating 120 (± 3) 105 (-2 / + 5)
--
3 Air purge 120 (± 3) 105 (-2 / + 5) 120 (± 5)
4 Heating up to product
122 (± 3) 123 (-0 / +3) --
(pressure increase) temperature < 121,0 ºC
5 Heating up to product
122 (± 3) 123 (-0 / +3) max. 1200
(holding) temperature < 121.3 ºC
120,0 < T < 120,9 °C
→ W17/18
6 Sterilization 121 (± 3) 121 (-0 / +3) 2400 (±5) T <125,0 °C →A11/12
T >128,0 °C →A22/A23
up to product
8 Cooling not specified not specified max. 2400 temperature < 90 ºC
9 Aeration (air pulses) Pamb - 10 not specified - See Remark 3
10 Aeration (vacuum) not specified not specified 120 (±30) See Remark 3
Vacuum breaking (aeration) Pamb - 10 not specified -

11 --
Vacuum breaking (holding) Pamb (80 - 108) not specified 15
Table 12.4 - Parameters for the Liquids program
P
characters.
Remark 3: Depending on the parameter setting 32, the process steps 9 and 10 are repeated up to
10 times.
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12.5 DISINFECTION PROGRAM
PRESSURE
[hPa]
1000
0 TIME
[min]
0+01 1 2 3 4 5 7 9 11 13 15 17 19 20+21
6 8 10 12 14 16 18
Figure 12.5 - Profile of the Disinfection program

Nº PHASE REMARKS
[kPa] [°C] [s]
P0 = Pamb
0 Process running not specified max. 300 --
0’ Wait for steam generator - - max. 600 --
4 Steam injection 70 (± 10) not specified max.600 --
16 Heating 125 (± 3) 119 (-2 / + 5) max.1200 --

(initial pressure increase)
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Nº PHASE REMARKS
[kPa] [°C] [s]
104,0 - 104,9 °C →
W17/18
17 Disinfection 125 (± 3) 105 (-0 / +3) 600 (± 5) T < 104,0 °C → A11/A12
T > 108,0 °C → A22/A23
19 Drying 10 (± 3) not specified 600 (± 20) --

Vacuum breaking Pamb - 10 not specified -
(aeration)
20 --
Vacuum breaking (holding) Pamb (80 - 108) not specified 15
Table 12.5 - Parameters for the Disinfection program
P
characters.
12.6 VACUUM TEST AND AIR DETECTOR VACUUM TEST PROGRAMS
PRESSURE
[hPa]
1000
TIME
0 [min]
Start 0 1 2 3 4+5 End of test
Figure 12.6 - Profile of the Vacuum Test and Air Detector Vacuum Test programs
PRESSURE
[hPa]
0 max. 300 --
1 Prevacuum (test) P1 = 7 (± 0,5) max. 1800 --
2 Preparation P2 = 7 (± 0,5) 300 (+/- 2) --
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PRESSURE
[hPa]
P02: Test abortion
3 Vacuum Test P3 600 (+/- 2) a P3 > P2 + 1,3 kPa
Vacuum breaking
4 Pamb - 10 -- --
(aeration)
Vacuum breaking
5 Pamb (80 - 108) 30 --
(extra time)
P02:
6 Process end Pamb (80 - 108) -- warning message (W47)
a P3 - P2 = ∆P > 1,3 kPa
Table 12.6 - Parameters for the Vacuum Test and Air Detector Vacuum Test programs
P
characters.
12.7 PREHEATING PROGRAM
PRESSURE
[hPa]
2000
1000
TIME
0 [min]
Start 0+01 1 2 3 4 5 6 7 8 9 10 11 12 13 14 +15 End of process
Figure 12.7 - Profile of the Preheating program

Nº PHASE REMARKS
[kPa] [°C] [s]
0 Process running P0 = Pamb
not specified max. 300 --
0’ Wait for steam - - max. 600 --
generator
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Nº PHASE REMARKS
[kPa] [°C] [s]
3 Prevacuum 15 (± 1,5) not specified max. 1.200 --
8 Heating (initial 180 (± 3) not specified max. 1200 --
pressure increase)
9 Heating (holding) 180 not specified 30 --
10 Heating (last 212 (± 3) 121 max. 1200 --
pressure increase)
11 Disinfection 212 (± 3) 121 (-0 / +3) 120 (± 20) --
12 Devaporization 10 (± 2) not specified max. 600 --
13 Drying 7 (+2/-5) not specified 120 (± 30) --
14 Vacuum breaking Pamb-10 not specified max. 300 --

(aeration)
Vacuum breaking Pamb (80 - 108) not specified 15 --
(extra time)
15 Process end Pamb (80 - 108) not specified -- --
Table 12.7 - Parameters for the Preheating program
P
characters.
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ANNEX I:
INSTRUCTIONS FOR PREPARING AND PACKAGING OF
THE STERILIZATION LOAD
1. CLEANING THE STERILIZATION MATERIAL PRIOR TO STERILIZATION
Cleaning constitutes a vital step prior to ensure full efficiency and safety of a sterilization process for the
material treated this way.
This procedure should be performed with appropriate cleaning products to each material and taking into
account some important principles:
• The detergent or chemicals used in cleaning must be completely removed from the materials,
which requires perfect rinsing thereof before sterilization. The final rinse water quality must
also be controlled, preferably demineralized and/or distilled. This in order to avoid deposits
of minerals or chemicals that could cause staining or discoloration of the instruments, which
during the sterilization process may reach the packaging and/or the sterilizer chamber.
•
Drying the pieces once cleaned is the final and indispensable step before they are sterilized.
If the manufacturer of instruments recommends applying previously some type of lubricant,
use only those that are compatible with the sterilization process, and always follow the
manufacturer’s instructions.
• The textile material which have been submitted to hot-ironed or thermally dried processes
must not be packed nor sterilized before they have been allowed to cool and to reach room
temperature.
NOTE:
Bear in mind that performing an appropriate cleaning, as well as a thorough drying of the material prior to
sterilization is extremely important.
2. WRAPPING AND LOADING THE STERILIZATION MATERIAL
The objectives of the wrapping of a medical device is to provide a physical protection to the product
and maintain sterility until the moment of use, allowing sterilization. There are in the market numerous
different types of packaging. Selecting the most suitable type of wrapping must be done considering
various aspects such as the nature of the product and intended use, the method of sterilization
recommended by the manufacturer, the expiration date, transport and storage, etc.
In any case, we recommend using standard packaging materials, according to European and International
existing standards, in particular EN ISO 11607 and the EN 868 series of standards.
Here are some tips on choosing and packing characteristics.
• If bags are used, they must be made of medical grade paper according to the European
Standard EN 868-4, or the so-called mixed bags with one paper side and the other side made
of plastic material, according to European Standard EN 868-5. These wrapping materials are
suitable for loose parts or small sets of instruments or textiles.
ATTENTION:
The bags and/or rolls made exclusively in plastic material are not suitable for steam sterilization.
•
The material to be sterilized needs to be placed inside the bags, in such a way that there is
some slack and separation between the sealing strips and the items. The width of the sealing
band should be at least 6 mm, although a 12 mm width is recommended.
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•
As an alternative, wrapping material sheets of paper and/or plastic type non-woven may
also be used, provided they are compatible and appropriate for the sterilization method.
Specifically, it may be suitable for preparing wrapping trays or perforated trays and also as a
protective material for storage and subsequent transportation.
ATTENTION:
You should not use fabric as wrapping material because there is no guarantee on its microbial barrier
qualities, which can compromise the subsequent conservation of sterile product.
2.1 WRAPPING OF SOLID MATERIAL (INSTRUMENTS)
Instruments and other solid materials can be packaged together as „kits“ or „sets“ within containers
according to European Standard EN 868-8 or sterilization cassettes, depending on how the different
elements are arranged in a mesh tray or perforated tray.
When an instrument set is prepared, ensure that container’s weight with a mesh tray full of instruments
does not weigh more than 7 kg for the standard program at 134 ºC, or 15 kg if you use the Container
program. The shallow trays and the containers must be filled in such a way that the contents do not
protrude beyond the edges of the shallow tray or container. If necessary, the materials should be spread
over two mesh trays, baskets or cassettes. The maximum filling height should be limited so that there
is a minimum gap of 2 cm between the top of the contents and the top edge of the container or the
underside of its lid, or the bottom of the next basket up (when piled up).
The instruments and utensils can also be wrapped individually or in sets, in paper bags or mixed paper-
transparent film bags according to EN 868-4 and EN 868-5, either in simple or double wrapping. Ensure
that they are not placed flat in the sterilization baskets but rather vertically against one of the sides and
supporting each other so that they remain in this position.
Horizontal surfaces should at all time be avoided due to possible condensate formation. Also make sure
that hollow recipients such as shallow dishes, bowls, cups or empty bottles are always positioned with
their openings downward so that any condensate which forms can run off and is not collected within the
recipient.
NOTE:
When using flat trays, cassettes or containers, it is recommended that they are made from aluminium.
The containers of other materials like polymer or stainless steel dry with less efficiency, so that they
require longer drying times.
2.2 WRAPPING POROUS AND TEMPERATURE-SENSITIVE MATERIALS
Cloths, overalls, gauzes and other textiles or similar porous material should be wrapped using the same
materials as for the instruments, that are nonwoven sheets, bags or mixed rolls. The wrappings or
bags always need to be placed in baskets used to be introduced into the sterilizer and for subsequent
handling and storage. The total weight of a loaded cassette should not exceed 7 kg.
For wrapping temperature sensitive materials such as rubber, silicone, etc. and any other kind of material
sensitive to temperature, the same wrapping as for textiles should be used. Here too, it is suitable to
pack the items individually or in sets in the same way as instruments. If gloves are sterilized, especially
if they are wrapped in pairs, it is advisable to use paper bags and place the gloves stretched out inside,
making sure that they do not touch each other.
When metal containers are used, care must be taken that temperature sensitive materials are placed in
them in such a way that there is no direct contact with the metal, as this could cause damage.
Intermediate layers of paper and textile are permissible. This should be applied for the packing of
materials which tend to stick with one another.
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3. LOADING OF THE MATERIAL TO BE STERILIZED
When containers are used, the heaviest should be placed on the lower part of the chamber to prevent
the condensate generated by the heaviest loads from falling upon the containers located below. The
lightest boxes should be placed on top of the heaviest ones, and the containers with absorbent or
porous material inside should be placed above those not containing it.
In the particular case of mixed loads, special care must be taken so that the baskets are placed on top
of the containers and not vice versa.
It is especially important to respect the maximum load per sterilization module, indicated for each
program.
When entering the load into the chamber, it must be avoided that some of the elements from the load
are in contact with the chamber walls, as they could be damaged.
4. SUBSEQUENT TREATMENT OF STERILE MATERIAL
Sterilized material, once extracted from the chamber will contain a certain amount of residual moisture
due to the process of steam sterilization. This moisture will disappear by evaporation into the environment
naturally during the cooling process of the material.
As an orientation, you can follow the guidelines indicated by the European Standard EN 285, where it is
indicated that porous sterilized material can be considered adequately dry if the additional weight due to
the residual moisture, upon removal from the sterilizer is less than 1 %. The limit for metallic instruments
is 0.2 %.
This limit can be critical in the case of containers of stainless steel or chrome metal, compared to those
made of aluminium or with baskets. In this case, we recommend using the Container program, which
has been specially developed for heavy metal loads.
Containers and generally all loads sterilized must cool down naturally before handling and subsequent
storage.
Hot containers must not be positioned on continuous metal surfaces as this provokes condensation and
hence the moisture inside and outside of them. It is highly recommended to use rod shelves as they
facilitate cooling loads naturally.
Another very important point to prevent condensation in the sterilized loads is controlling temperature
and relative humidity of the unloading area. If the temperature is too low, below 20 °C and the relative
humidity is above 60 %, some problems of condensation will arise. Therefore, the values of this zone
must be well controlled. The recommended parameters for the unloading area are a temperature of
21 ºC and 40 % relative humidity.
An adequate wrapping condition of the sterilized material must be taken care of, before storing the
material in the sterile storage room, especially to ensure the integrity of the sealing bands of the wrapping
paper or mixed ones.
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ANNEX II: P
ROCEDURES AND DEVICES FOR TESTING THE
EFFECTIVENESS OF THE STERILIZATION PROCESS
1. BOWIE & DICK TEST
1.1 GENERAL
The Bowie & Dick Test is used for testing of deaeration of the sterilization chamber and steam penetration
into the sterilizers’ material that are working according to the fractionated vacuum process with saturated
steam.
The Bowie & Dick Test is based on the fact that during the sterilization process, the residual air existing
in the chamber including the air that might penetrate due to leaks and the non-condensable gases
(NCG) provided by the steam itself, are collected in the centre of the porous loads. In these areas
in which the air is not extracted correctly, the steam penetration is not appropriate and therefore the
sterilization is not effective.
A Bowie & Dick Test failure may be due to the causes stated below:
- An ineffective air extraction step
- The existence of an air leak during the air extraction step
- The presence of non-condensable gases in the steam supply to the chamber
However, the test result may be affected by other factors that inhibit the penetration of steam, so that in
case of failure of the Bowie & Dick Test, it is necessary to look for other causes of failure and rule them
out.
To verify the correct penetration of steam into the sterilization of porous materials (for example textile),
usually the test is performed at a temperature of 134 °C using a standard test pack as the sole load in
the sterilizer chamber.
For sterilizing hollow products (eg, tubes, complex instruments with narrow channels, etc.), an Helix type
of challenge process device (Process Challenge Device, PCD) is used as the sole load in the sterilizer
chamber.
Both test methods are described as follows.
1.2 BOWIE & DICK TEST FOR POROUS MATERIAL
For sterilization of porous materials (textiles for example), the Bowie & Dick Test is usually done using a
standard test pack, according to that indicated in paragraph 24.1 of the European Standard EN 285, as
the only load in the sterilizer chamber .
The test pack for the Bowie & Dick Test is a reusable component that can be used routinely subject to
compliance with the requirements of cleaning and storage. The test pack consists of plain cotton sheets
folded. In the centre of the test pack is placed a chemical indicator. By means of the loading platform or
module, the package is located at the centre of the chamber, at a height above it between 100 and 200
mm, then the B&D Test program is run (see paragraph 7.3.1.1 for more information). Once the test is
carried out, the colour change of the indicator is analysed.
There are single-use test packs in the market equivalent to the test pack described in European Standard
EN 285. When used, ensure that they comply with International Standard EN ISO 11140-4, and carefully
follow the manufacturer’s instructions. Contact the MATACHANA sales department if you need more
information.
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1.2.1 THE TEST PACK ACCORDING TO EN 285
The test pack must be in accordance with the indications stated in the European Standard EN 285,
paragraph 24.1. It must be made of pure cotton cloths, well bleached and without cuffs with a surface
density of 180 - 190 g/m², measuring approximately 900 x 1200 mm. As a rule, this quality is equivalent
to standard operating theatre clothes.
Before using the cloths for testing, they should have been washed when new or dirty without using any
fabric conditioning agent, which can adversely affect the penetration of steam during the test. The cloths
should be kept in a dry place at room temperature (20 to 30 ºC and 40 to 60 % of relative humidity).
Once equilibrated at ambient conditions, the cloths should be folded to a size of around 220 x 300 mm
(roughly the size of a sheet of A4 paper) and neatly stacked to a height of approximately 250 mm after
compressing them with the hand. A chemical indicator should be placed in the centre of the stack, as
indicated in figure II.1.
Then, wrap the test pack in a cloth of the same material, making sure that the package thereby created
should be secured with adhesive tape specially designed for steam sterilization. The width of these
tapes must not exceed 25 mm and the created test pack should weigh 7 ± 0,14 kg.
test Sheet
approx. 25 cm
approx. 22 cm
approx. 30 cm
Figure II.1 - Standard Test Pack according to Bowie & Dick
1.2.2 CHEMICAL INDICATORS FOR THE B&D TEST
To perform the Bowie & Dick test with the standard test pack, use a chemical indicator of class 2 in
accordance with International Standard EN ISO 11140-3. This type of indicator is composed of a A4 size
test sheet with an ink mark printed on one side.
When the indicator is subject to the conditions of the Bowie & Dick Test, this should show a uniform
colour change as indicated by the manufacturer of the indicator
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1.2.3 PERFORMING THE B&D TEST
The Bowie & Dick Test should be performed each day before starting sterilization, after pre-heating the
chamber. The test can also be executed at any time provide the chamber has the necessary working
temperature. For further details, see also paragraph 7.3.1.1.
To perform the test, select the B&D Test program. Place the test pack into the empty chamber, in the nominal
geometrical chamber centre, at a height between 100 and 200 above the chamber floor at the coldest point
of the sterilization chamber, and execute the cycle. See chapter 8 for more details on how to run a cycle.
After the completion of the B&D Test, check that the cycle has been correct and remove the test pack
from the chamber. Remove the indicator from the test pack and verify the results according to the
manufacturer’s instructions for that indicator.
1.2.4 EVALUATION OF THE CONTROLS
Evaluation of the test sheet, and hence of steam penetration, is implemented by examining the colour of
the test sheet once it has been processed properly in the B&D Test program. As a rule, after undergoing
a B&D Test program, it should be noted a uniform colour change throughout the printed surface of the
indicator according to the pattern provided by the manufacturer. Examples for sufficient and insufficient
colour changes of a typical control are shown below.

indicator without change indicator with correct change
examples of incorrect change
Figure II.2 - Examples of control for the Bowie & Dick Test
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As the indicator changes colour only in the presence of saturated steam and at an appropriate
temperature, areas will appear on the sheet with no change or little change where the presence of
steam has been poor or insufficient (mainly near the centre) and, therefore, there has been insufficient
steam penetration.
This may be due to any of the following causes:
a) Problems related to the equipment:

- Inadequate level of vacuum during the air extraction phase
- Leaks in the door gaskets, in the pipes or fittings connected to the chamber, causing air
to flow into the chamber during the vacuum phases.
b) Problems related to the steam supply:

- Presence of non-condensable gases in the steam (particularly if the supply comes from
a steam supply network external to the sterilizer).
If there are areas with an insufficient change in the test sheet, repeat the test to verify the result. If
the situation does not improve, then the sterilization can not be guaranteed and the cause should be
investigated before proceeding with routine sterilization.
1.3 THE B&D TEST FOR HOLLOW MATERIAL
As complement to the Bowie & Dick Test pack for porous materials, other devices may be used of
Helix type and under certain conditions. So-called test systems for hollow loads are used to verify the
efficiency of air extraction and steam penetration when predominantly instruments with lumens, narrow
canals or complex shapes are normally employed for sterilization.
To perform this test, a Helix test type device is used (Process Challenge Device, PCD) according to
European Standard EN 867-5 and as the only load on the sterilizer chamber, in the Bowie & Dick Test
program.
1.3.1 TEST SYSTEMS FOR HOLLOW LOADS
Systems available on the market consist of a receptacle into which is inserted an indicator strip and a
teflon tube of standard length and diameter. Usually sold in packs containing a device with a certain
amount of suitable chemical controls for the test, and the set according to European Standard EN 867-5.
Usually the device is reusable a number of cycles, and thereafter shall be replaced by a new one; see
the manufacturer’s instructions for more information.
The chemical control is introduced into the capsule according to the manufacturer’s instructions.
NOTE:
Test devices for hollow loads can also be used as a control routine with each load to verify and document
proper air removal and steam penetration in each cycle. However, it is not suitable for monitoring Rapid
program or Liquids and Disinfection optional programs.
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1
2 1 Aufnahmekapsel
2 Dichtung
3 3 Indilatorsystem
4 Anschlusstuck
4 5 Offenes Ende
6 PTFE-Schlauch, Di=2mm
6
5
Figure II.3 - Example of a test device for hollow load (Helix) acc. to EN 867-5
1.3.2 PERFORMING THE TEST FOR HOLLOW LOADS
To perform the test, the test device should be at ambient conditions of temperature humidity. An abrupt
change of these conditions, for example when using a Helix still hot from a previous cycle, can produce
false results.
Open the capsule of the test device and check that there are no drops of water inside, and that the seal
and the thread of the capsule are in excellent condition (if necessary, replace the seal or change the
device). Following the manufacturer’s instructions in the capsule enter the chemical indicator, usually
bent so that the printed ink remains on the inner face. Then close the device.
With the previously hot camera, select the Bowie & Dick Test program and place the Helix at the geometric
centre of the sterilizer chamber on a perforated tray or basket, at a height between 100 and 200 mm on
the basis of the chamber (supported for example on the loading module or on a basket inverted). Then
run the cycle (see chapter 8 for more information on how to start a cycle).
After the B&D test is completed, check that the cycle has been correct and remove the test device from
the chamber. Remove the indicator test device and check the result.
1.3.3 TEST EVALUATION FOR HOLLOW LOADS
After processing the test device in the Bowie & Dick Test program, verify that the chemical indicator
has turned correctly according to the instructions provided by the manufacturer. As a general rule, you
should check that the indicator has changed uniformly on its entire printed surface.
If the indicator does not turn properly, apply the same criteria as in the case of porous loads (see
paragraph 1.2.4 of this annex).
2. ROUTINE MONITORING WITH CHEMICAL AND BIOLOGICAL INDICATORS
2.1 CHEMICAL INDICATORS
Chemical indicators are easy to handle and to assess. They enable the user to examine the performance
of the sterilizer easily.
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NOTE:
The use of chemical indicators can not be used as the only means for the release of sterile product. They
are an additional measure to evaluate the effectiveness of air removal and the penetration of additional
steam for parametric release (pressure control, temperature, sterilization time and condition of saturated
steam).
Generally speaking, chemical indicators comprise a paper or similar, on which is deposited a substance
or chemical agent that changes colour (turns) when certain conditions are met.
On the market there is a variety of chemical indicators, which according to the International Standard EN
ISO 11140 are classified into 6 groups or categories:
- Class 1: Process indicators. They are used in each individual load unit (packet or container) to indicate
they have been exposed to the sterilization process and therefore to enable to distinguish
processed packs from unprocessed ones.
- Class 2: Specific indicators to perform tests, for instance for the Bowie & Dick Test.
- Class 3: Single variable indicators. Are able to detect whether during the sterilization process conditions
are reached in a single critical variable.
- Class 4: Multi-variable indicators. Are designed to detect the reaching of the conditions for at least two
critical variables.
- Class 5: Integrating indicators. Are designed to react to all critical process sterilization variables (time,
temperature and saturated steam), in such a way that they are comparable to biological
indicators.
- Class 6: Emulating indicators. They are designed to react to all critical variables of a given sterilization
process.
Chemical indicators are recommended to document all batches. It is important to verify that the chemical
control chosen is suitable for steam sterilization and the program that will be used. For more information
about the different types of chemical controls available, and to help determine the control that best fits
your process, contact the Commercial Department of ANTONIO MATACHANA S.A.
2.2 BIOLOGICAL INDICATORS
To check the efficiency of the sterilization process in specific cases, biological indicators can be used.
It is advisable that tests with biological indicators are carried out jointly with chemical indicators and
assessment of the physical parameters of sterilization process.
Biological indicators are indicating systems containing viable microorganisms that offer a defined
resistance to a specific sterilization process.
It is recommended to use preferably chemical indicators to document sterilization processes. If the

physical test is not possible or is not significant (for example, in the case of inaccessible geometries)
appropriate biological indicators can be used. It is important to verify that biological control chosen
is suitable for steam sterilization and for the program for which it will be used. For more information
about the different types of biological controls available to help determine the control that best fits your
process, contact the Commercial Department of ANTONIO MATACHANA S.A.
The microorganisms that are used have a high resistance against specific sterilization system,
characterized by the D value. For steam sterilization they are usually used as test germs Bacillus
stearothermophilus spores that meet the requirements specified by the International Standard EN ISO
11138-3.
After processing, biological indicators must be grown according to the instructions provided by the
manufacturer.
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3. VALIDATION
Validation is a documented procedure for obtaining, recording and interpreting the results required to
establish that a process will consistently yield product complying with predetermined specifications
(definition as per the EN ISO 17665-1 International Standard).
Within the scope of the European Medical Device Directive 93/42/EEC, Validation of processes shall:
a) c reate high safety for treatment (cleaning, disinfection, sterilization) of medical devices.

b) verify the efficacy of the processes as pre-condition for the quality assurance for treatment
of medical devices.
Process validation, for instance of steam sterilization must be performed before starting the routine
operation (initial start up). Validation will be that parametric liberation based on process data happens
when a product in its final wrapper is subjected to steam sterilization. For steam sterilization these
relevant parameters are pressure, temperature and time. These values can be measured, reliably
reproduced and documented.
The validation consists of tests with reference loads (commissioning) in order to verify that the sterilizer
complies with the specifications given by the manufacturer and of tests with real integrated load
composed by representative material of the load provided by the user (performance qualification).
Process validation consists of the following stages:

- Clarification of the Pre-Conditions
- Generating and approval of the Validation Plan
- Installation Qualification, IQ
- Operational Qualification, OQ
- Performance Qualification, PQ
- Generating the Validation Report
- Revision and approval of validation

For temperature measurements to be performed during validation, the reference measuring point
(installation place of the chamber temperature sensor) in the sterilizers series SC500 and S1000 are in
the middle central chamber drain.
Validation must be performed by persons who are qualified for such work or by a test laboratory that is
accredited/certified for such work. For more information, contact our the Technical Assistance Service
of ANTONIO MATACHANA S.A.
NOTE:
We recommend to carry out an initial validation of sterilization processes used, as well as perform an
annual revalidation of these processes, unless a revalidation is needed beforehand due to repairs or
technical modifications that require such intervention.
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4. AIR DETECTOR (OPTIONAL)
4.1 GENERAL
The air detector is an optional device used to monitor whether the steam does not contain, due to leaks
at the chamber or deficiencies in the steam supply, any amount of non condensable gases (NCG) such
as air, which may affect the sterilizing efficacy of the process.
The air detector device is calibrated according to the European Standard EN 285 related to large sized
steam sterilizers and can be activated from any standard sterilization program of 121 °C and 134 °C. If
during a sterilization process, the increase in the residual air measured in the chamber exceeds a set
value established as a limit, the process will end with incorrect results (faulty).
4.2 FUNCTION DESCRIPTION OF THE AIR DETECTOR
The operating principle of the air detector is based on the analysis of the temperatures difference
(DTA) between the temperature of the chamber temperature measured in the reference point (T1)
and the temperature measured at the head of the air detector device (T2) during fractionated vacuum
phase, before the sterilization phase.
uring a correct sterilization operation (error-free) the system is capable of bleeding entirely the air
D
detector device in order to measure the DTA. The measured difference of the temperatures T1 and T2 is
ideally equal to 0 as the temperature losses in the measuring head are compensated by the continually
stream flow and draining of the condensates generated.
The temperature difference between T1 and T2 is calibrated for a specific air leakage, as described in
European Standard EN 285, as threshold air detector alarm.
In the case of an air leak during the fractionated vacuum phase or if the steam supplied NCG during the
sterilization phase, the gas and steam flow along the measuring pipe. The NCG builds up at the top of
the pipe, where the measurement’s probe is located, forming a gradually growing bubble. Because of
this bubble, and depending on its size (the length of tube it takes up), the heat supplied by the steam is
reduced. Consequently the top end of the tube will cool down and the DT temperature difference will
increase. This difference is verified during the sterilization phase which triggers an alarm in case of
going over the maximum.
4.3 CALIBRATING THE AIR DETECTOR
Following test and calibration devices are used to calibrate the air detector:
• Standard test pack according. to section 24.1 of the European Standard EN 285
• Thermometric recording instrument, according to section 24.5 of EN 285
• Temperature sensors according to section 24.4 of EN 285
• Metering device according to section 24.9 of EN 285 (built-in into the sterilizer)
The air detector will give an indication of failure (alarm) if the quantity of NCG retained or introduced
into the sterilizer chamber during the air removal phase and steam entry during the sterilization cycle
causes a temperature difference of more than 2 °C between the temperature measured in the standard
test pack and the temperature measured by the chamber sensor at the start of the equalization time.
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During manufacturing tests, the air detector is adjusted according to available supplies. That is, the
metering device is adjusted to generate an air leak that gives, at the start of the sterilization plateau, a
maximum temperature difference of 2 ºC between the average temperature inside a standard test pack
and the temperature measured in the sterilization chamber.
This leak adjustment is performed via a fixed installed metering device incorporated into the sterilizer.
For on-site re-calibration of the air detector, contact the MATACHANA Technical Assistance Service.
The temperature difference TD between the sterilizer’s chamber and the temperature sensor on the
head of the air detector resulting from the calibration is used as alarm level of the air detector on the
sterilizer’s configuration menu. If during a sterilization cycle this threshold is exceeded, an alarm is
triggered and the program ends with a failure indication. Only door 1 from the NSA can be opened. See
paragraph 8.2.2).
The detected amount of air can be recorded via a vacuum leak test in program 47 “air detector vacuum
Test” (See paragraph 7.3.1.6). Thus, the adjustment of the metering device can be recorded. In case of
later tests, the adjustment metering device is fixed and if the triggering threshold is exceeded, the air
detector gives a failure indication.
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Steam Sterilizers

OPERATING INSTRUCTION MANUAL

© Antonio Matachana, S.A.

3. DESCRIPTION AND USE OF THE STERILIZER 13

5. INSTALLATION, CONNECTION AND START UP 27

6. CONTROL ELEMENTS OF THE STERILIZER 31

8. OPERATING THE SYSTEM 65

9. ALARM, WARNING AND ERROR MESSAGES 103

10. MAINTENANCE 127

11. SPARE PARTS AND CONSUMABLES 143

12. SWITCHPOINTS AND TOLERANCES OF THE PROGRAMS 145

1.1 CONTENT OF THIS INSTRUCTION MANUAL

2.1 GENERAL REMARKS

2.2 SAFETY INDICATIONS

This indication shows the existence of specific warnings or

This warning indication shows the presence of surfaces may be

This indication shows that the use of personal protective gloves

This warning indication shows the hazard of getting jammed or

This warning indication shows the existence of electrical hazard.

This symbol is indicated on the device’s protective earth terminal.

This symbol indicates the need to read this instruction manual

Table 2.1 - Symbols and safety indications

3.1 INTENDED USE

Model: SC50 1 E-2

V: Steam from network (external supply)

Indicates capacity of the chamber

V: Steam from network (external supply)

3.3 STANDARDS AND CE-CONFORMITY

• European Machine Directive 2006/42/CE

EN 61010-1 EN 61326-1 EN 285 EN 60204-1

3.4 PRESSURE DEVICE EXAMINATION

Nperm SC500 S1000

Table 3.1 - Fatigue breakage strength

Recurring Tests when reaching the following cycles number:

4.1 GENERAL DATA

SC500 V-1 SC501 V-1 SC502 V-1

DIMENSIONS OF CHAMBER (mm)

USABLE SPACE (mm)

WEIGHT OF THE STERILIZER, MODELS V, 1/2 doors (kg, approx.)

WEIGHT OF THE STERILIZER, MODELS E, 1/2 doors (kg, approx.)

EXTERNAL DIMENSIONS 1/2 doors (mm)

Table 4.1 (1) - General technical data SC500

DIMENSIONS OF CHAMBER, 1/2 doors (mm)

USABLE SPACE, 1/2 doors (mm)

WEIGHT OF THE STERILIZER, MODELS V, 1/2 doors (kg, approx.)

WEIGHT OF THE STERILIZER, MODELS E, 1/2 doors (kg, approx.)

EXTERNAL DIMENSIONS 1/2 doors (mm)

(*) Width includes service area.

Table 4.1 (2) - General technical data S1000

4.2.1 CHAMBER - JACKET SET

Volume (liters) SC500 SC501 SC502

Table 4.2 (1) - Chamber and jacket volume SC500

Volume (liters) 1004 1006 1008 1010 1012

Table 4.2 (2) - Chamber and jacket volume S1000

● Permissible operating pressure

● Permissible operating temperature 150 °C

4.2.2 ELECTRICAL STEAM GENERATOR (E MODELS ONLY)

3. DESCRIPTION AND USE OF THE STERILIZER 13

5. INSTALLATION, CONNECTION AND START UP 27

6. CONTROL ELEMENTS OF THE STERILIZER 31

8. OPERATING THE SYSTEM 65

9. ALARM, WARNING AND ERROR MESSAGES 103

10. MAINTENANCE 127

11. SPARE PARTS AND CONSUMABLES 143

12. SWITCHPOINTS AND TOLERANCES OF THE PROGRAMS 145

Area D: Space for functional buttons