Matachana sc500s1000 Operating Manual [PDF]

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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 3.2 Description 3.3 Standards and CE-Conformity 3.4 Pressure device examination 3.5 Guarantee



13 13 14 15 17



4.



19



TECHNICAL DATA



4.1 General data 4.2 Pressure vessel data 4.2.1 Chamber - jacket set 4.2.2 Electrical steam generator (E models only) 4.3 Ambient conditions 4.4 Media supply and connections 4.4.1 Electrical power supply 4.4.2 Steam supply 4.4.3 Treated water 4.4.4 Water for Vacuum system 4.4.5 External water cooling connection (optional) 4.4.6 Pressurized air supply 4.4.7 Drain



19 21 21 21 22 22 23 23 24 25 25 26 26



5.



27



INSTALLATION, CONNECTION AND START UP



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 I sc500_s1000_12_s_01_en



6.1.11 Videorecorder, NSA (optional) 6.1.12 USB connector (optional) 6.2 Sterile area (SA) 6.2.1 Control panel, SA 6.2.2 Emergency Stop push-button, SA 6.2.3 Manometer, SA  6.2.4 Indicators icons SA  6.2.5 Sterilizer door, SA  6.2.6 Lock front service door, SA  6.2.7 Coupler automatic unloading assistance module (optional)  7.



42 42 43 45 46 47 47 48 49 49



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



8.1 Connecting the sterilizer 8.2 Operating the sterilizer doors 8.2.1 One door models 8.2.2 Two door models 8.2.3 Automatic locking mechanism 8.3 Program selection 8.3.1 Select a sterilization program 8.3.2 Program start  8.3.3 Indication of program status and process variables 8.3.4 End of program 8.3.5 Program start and program end options 8.3.5.1 Machines with automatic loading / unloading systems (option available ONLY for S1000) 8.3.5.2 Machines with confirmation of cycle end (optional) 8.3.5.3 Machines with autostart (optional) 8.3.5.4 Machines with recurrent cycles (optional) 8.3.5.5 Machines with introduction of batch number (optional) 8.3.6 Cycle summaries processing of the printer 8.4 Keypads 8.5 User selection menu 8.6 Main screen for advanced users 8.6.1 Selecting a Test program 8.6.2 Information 8.7 Settings menu 8.7.1 Staff settings II sc500_s1000_12_s_01_en



65 65 65 67 68 68 69 69 71 72 75 77 77 79 79 80 80 81 84 85 87 87 88 89 91



8.7.1.1 8.7.1.2 8.7.1.3 8.7.1.4 8.7.2 8.7.2.1 8.7.2.2 8.7.3 8.7.3.1 8.7.3.2 8.7.3.3 8.7.3.4 8.8



Sensors display 91 Edit programs 92 Edit date and time 93 Edit general options 94 Administrator settings 95 Edit passwords 95 Edit languages 95 TAS maintenance settings 96 TAS settings display 96 Printer settings display 97 Brightness setting displays98 Process status display with tas user 98 Connecting to batch documentation system (optional) 100



9.



ALARM, WARNING AND ERROR MESSAGES



103



9.1 managing the alarm, warning and error messages 9.2 Alarms 9.3 Warnings 9.4 Errors 9.5 Interferences with operational readiness



104 105 112 119 125



10. MAINTENANCE



127



10.1 Maintenance Schedule 10.2 Maintenance by the operator 10.2.1 Daily 10.2.2 Weekly 10.3 Maintenance by the service technician 10.3.1 Semiannual maintenance 10.3.2 Annual maintenance  10.3.3 Efficiency Test, performance evaluation  10.3.4 Recurrent Inspections of pressure vessel 10.4 Special procedures 10.4.1 Cleaning and replacing door gasket 10.4.2 Placing printer paper roll 10.4.3 Recorder 10.5 Shutdown of the sterilizer (for long periods of time) 10.6 Disposal Information and recycling



128 132 132 133 135 136 137 138 139 140 140 141 141 142 142



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



III sc500_s1000_12_s_01_en



ANNEX I: INSTRUCTIONS FOR PREPARING AND PACKAGING OF THE STERILIZATION LOAD159 1. 2. 2.1 2.2 3. 4.



Cleaning the sterilization material prior to sterilization  Wrapping and loading the sterilization material Wrapping of solid material (Instruments) Wrapping porous and temperature-sensitive materials  Loading of the material to be sterilized Subsequent treatment of sterile material



159 159 160 160 161 161



ANNEX II: P  ROCEDURES AND DEVICES FOR TESTING THE EFFECTIVENESS OF THE STERILIZATION PROCESS



163



1. Bowie & Dick Test 1.1 General 1.2 Bowie & Dick Test for porous material 1.2.1 The Test pack according to EN 285 1.2.2 Chemical Indicators for the B&D Test 1.2.3 Performing the B&D Test 1.2.4 Evaluation of the Controls 1.3 The B&D Test for hollow material 1.3.1 Test systems for hollow loads 1.3.2 Performing the Test for hollow loads 1.3.3 Test Evaluation for hollow loads 2. Routine monitoring with chemical and biological indicators 2.1 Chemical Indicators 2.2 Biological Indicators 3. Validation 4. Air detector (optional) 4.1 General 4.2 Function description of the air detector 4.3 Calibrating the air detector



163 163 163 164 164 165 165 166 166 167 167 167 167 168 169 170 170 170 170



IV sc500_s1000_12_s_01_en



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 T aspects regarding application of the unit and/or the system as a whole. The individual chapters are selfcontained 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 menustructures 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. 1 sc500_s1000_12_1_01_en







●  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.



2 sc500_s1000_12_1_01_en



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.



3 sc500_s1000_12_2_01_en



 his instruction manual also contains important instructions which must be given special attention. They T 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.



4 sc500_s1000_12_2_01_en



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



5 sc500_s1000_12_2_01_en



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]



6 sc500_s1000_12_2_01_en



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] 7 sc500_s1000_12_2_01_en



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] 8 sc500_s1000_12_2_01_en



NOTE: Liquids 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). 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 warning message is displayed that requires confirmation (pressing ) before starting the cycle (see 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 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. [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 sc500_s1000_12_2_01_en



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 sc500_s1000_12_2_01_en



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 sc500_s1000_12_2_01_en



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: ● 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. 3.2 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 sc500_s1000_12_3_01_en



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 sc500_s1000_12_3_01_en



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



3.4



AD 2000-Code



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 sc500_s1000_12_3_01_en



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 at 134 ºC



Programs runs at 121 ºC



Programs runs at 134 ºC



Programs runs 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.



16 sc500_s1000_12_3_01_en



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 sc500_s1000_12_3_01_en



4.



TECHNICAL DATA



4.1



GENERAL DATA SC500 V-1 SC500 V-2 SC500 E-1 SC500 E-2



MODEL



SC501 V-1 SC501 V-2 SC501 E-1 SC501 E-2



SC502 V-1 SC502 V-2 SC502 E-1 SC502 E-2



LOADING CAPACITY (sterilization modules) 1



Capacity



1.5



2



DIMENSIONS OF CHAMBER (mm) Height



500



500



500



Width



500



500



500



Depth



675



1020



1300



Height



460



460



460



Width



460



460



460



Depth



670



1010



1285



USABLE SPACE (mm)



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



MODEL



1004 V-1 1004 V-2 1004 E-1 1004 E-2



1006 V-1 1006 V-2 1006 E-1 1006 E-2



1008 V-1 1008 V-2 1008 E-1 1008 E-2



1010 V-1 1010 V-2 1010 E-1 1010 E-2



1012 V-1 1012 V-2 1012 E-1 1012 E-2



8



10



12



LOADING CAPACITY (sterilization modules) 4



Capacity



6



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



20 sc500_s1000_12_4_01_en



4.2



PRESSURE VESSEL DATA



4.2.1



CHAMBER - JACKET SET Volume (liters) 1/2 doors



Chamber Jacket



SC500



SC501



SC502



167



252



321



31 / 29



49 / 47



60 / 58



Table 4.2 (1) - Chamber and jacket volume SC500 Volume (liters) 1/2 doors



Chamber Jacket



1004



1006



1008



1010



1012



279 / 285



445 / 445



565 / 578



774 / 773



893 / 892



42 / 40



69 / 66



89 / 88



122 / 119



142 / 138



Table 4.2 (2) - Chamber and jacket volume S1000



4.2.2



●



Permissible operating pressure - Chamber - Jacket



-1 / 3 bar 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







ELECTRICAL STEAM GENERATOR (E MODELS ONLY)



Sterilizer model



Steam generator model Steam generator volume (liters)



SC500 SC501 SC502 18 kW 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



21 sc500_s1000_12_4_01_en



1004



Sterilizer model



1006



Standard Optional Standard



1008



1010 1012



Optional Standard Optional Standard



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



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



Steam generator model



Category PED 97/23/EC



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.



22 sc500_s1000_12_4_01_en



4.4.1



ELECTRICAL POWER SUPPLY



Voltage / frequency: 400 V 3~ 50 Hz. SC500 E SC501 E SC502 E



1004 E



1006 E



1008 E



1010 E



1012 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 SC502 V



1004 V



1006 V



1008 V



1010 V



1012 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



Flow (kg/min) Consumption (kg/cycle)



SC500



SC501



SC502



1.3



1.8



2.1



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 sc500_s1000_12_4_01_en



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 --≤ 0.1 mg/l ≤ 0.1 mg/l ≤ 0.005 mg/l ≤ 0.05 mg/l ≤ 0.1 mg/l ≤ 0.1 mg/l ≤ 0.1 mg/l ≤ 3 µS/cm 5-7 ≤ 0.02 mmol/l



Evaporation residues Silicate (SiO2) Iron Cadmium Lead Rest of heavy metals Chlorides (Cl-) Phosphates (P2O5) Conductivity (at 25 °C) pH Hardness (Σ alkali earth ions) Appearance



Feeding water ≤ 10 mg/l ≤ 1 mg/l ≤ 0.2 mg/l ≤ 0.005 mg/l ≤ 0.05 mg/l ≤ 0.1 mg/l ≤ 2 mg/l ≤ 0.5 mg/l ≤ 5 µS/cm 5 - 7.5 ≤ 0.02 mmol/l



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 sc500_s1000_12_4_01_en



4.4.4



WATER FOR VACUUM SYSTEM



Used as water for the pump and in the cooling circuits. ● ● ● ●



Supply pressure: Temperature: Quality: Hardness:



2.5 a 4 bar < 15 °C Drinking water 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.



Flow (liters/min) Consumption (liters/cycle)



SC500



SC501



SC502



8



8



8



170



200



260



Table 4.9 (1) - Data on water supply for the vacuum system SC500



Flow (liters/min) Consumption (liters/cycle)



1004



1006



1008



1010



1012



8



8



8



8



8



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.



25 sc500_s1000_12_4_01_en



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: Quality:



6 - 8 bar abs. 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: Dimensions: Temperature:



26 sc500_s1000_12_4_01_en







In specific cases up to 18 l/min DN40 (SC500), DN50 (S1000) Resistant up to approximately 80  °C (temporarily up to a maximum of 100 °C)



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.



1



2



4



3



Figure 5.1 - Transport and unloading



27 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 crossbeam or sufficient long ropes to ensure an opening angle | |



|



*



-



7



8



9



u



v



w



x



y



z



:



,



_



+



@



[



]



#



:



Shift



Del



0 .



OK



Shift



Del



0 .



, 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



999.9 °C



Tch



Pch



999.9 °C



999.9 kPa



Known user



Staff



Admin



Figure 8.42 - User selection (screen 1) Press the



999.9 kPa



BD



BD Usager



Pch



Known user



Staff



Admin



TAS maintenance



Figure 8.43 - User selection (screen 2)



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



2



1



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



999.9 °C



BD



Pch



999.9 kPa



P st. gen. L 999.9 kPa LWL



Go to program selection menu



1



2



Go to test selection menu



Figure 8.47 - Main screen non-basic users From this screen you can access the list of standard programs by pressing pressing .



or test programs by



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 8.6.1



key gives you access to the information screen (see paragraph 8.6.2).



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



999.9 °C Test selection menu



Pch



999.9 kPa L LWL



1



2



VT Vacuum Test



Preheating Program



1



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



999.9 °C Information IP



196.196.11.233



Unit



E-0000026538



Version



XXXX



Recipe



EH100H5_R01



Pch



999.9 kPa L LWL



1



2



01/01/2010



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



Statistics



L LWL



999.9 °C



999.9 kPa 1



Operating hours:



121 ºC Cycles:



1234



1234



Cycle counter: 1234



134 ºC Cycles: 1234



2



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



999.9 °C



Tch



Pch



999.9 °C



999.9 kPa



01/01/2010 11:53:46



W2 Water tank temperature sensor faillure



28/01/2013 10:59:26



W3 Heat exchanger pressure decrease temperature sensor failure



Pch



999.9 kPa



Filter Alarms



1



Last “X” Alarms



Time - Date older than



Time - Date newer than



Type



2



0



0 - All Alarms; X - Latest



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 8.7



key.



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



999.9 °C



Pch



999.9 kPa



BD



1



Visualize sensors



Edit programs



Time settings



2



General options



Figure 8.53 - Staff settings display (first level settings) Tch



999.9 °C



Pch



999.9 kPa



BD



1



Edit passwords



2



Edit languages



Figure 8.54 - Administrator settings display (second level settings) Tch



999.9 °C



Pch



999.9 kPa



BD Settings



1



Printer settings



2



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



Control



Documentation



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



T load 2



999.0



ºC



T load 2



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



999.9 °C Control



Pch



999.9 kPa Documentation



T load 3



0.0



ºC



T load 3



0.0



ºC



T load 4



0.0



ºC



T load 4



0.0



ºC



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



Figure 8.57 - Display 2 sensors



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



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 8.58 - Display 3 sensors 8.7.1.2



EDIT PROGRAMS



To access the program editing display, press the program editing key from the Staff settings 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). Edit programs



Tch



999.9 °C



Pch



999.9 kPa



Edit program



1



2



Standard 121 ºC



Standard 134 ºC



Rapid



Containers



Special P



Silicone Implants



Waste Sterilization



Waste 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



999.9 °C



Pch



999.9 kPa



BD B&D Test



Program which parameters are indicated or/and modified



1



2



0 AUXILIARY PARAMETER MIN.:



0 ºC



MAX.:



0 ºC



0



Nº of parameter, description of parameter Value of the current parameter



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). 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”. Time settings



Use the key to save the changed value to be used from that point forward. Press to the Staff setting display.



to return



93 sc500_s1000_12_8_01_en



Tch



999.9 °C



Pch



999.9 kPa



Set date and time 01-01-2010



Change date



01/01/2010 11:53:46 11:53:46



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 display (figure 8.53). General 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



999.9 °C



Tch



Pch



999.9 °C



999.9 kPa



General options



1



2



Loading system



Unloading system



Automatic unloading door



Figure 8.62 - General options display 1



999.9 kPa



General options 10.0 ºC



Steam generator



Pch



F: Z



1 121.0 ºC



F: Tref.



2



30.0 ºC



Vacuum tank



Figure 8.63 - General options display 2



When one of these options is selected, it is shown with white text on blue background is not selected,it is shown with blue text on light blue background .



. If the option



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 display to display, press



94 sc500_s1000_12_8_01_en



key, the changed value of that point onwards is saved. To move from . To return to the Staff setting display, press .



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 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. Edit passwords



Tch



999.9 °C



Pch



999.9 kPa



Passwords User name



Group 0



1



2



Password



-



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: ● ● ● ● ● Using the



Group 0 Group 1 Group 2 Group 3 Group 4



Delete user Basic user identified (no password can be assigned to this user) Staff Administrator TAS maintenance



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 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). Edit languages



95 sc500_s1000_12_8_01_en



Tch



999.9 °C Languages



English



Français



Pch



999.9 kPa English



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 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. Settings



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 sc500_s1000_12_8_01_en



Tch



Pch



999.9 °C



Tch



999.9 kPa



999.9 °C



TAS



Conditioned doors



999.9 kPa



TAS



PC connection



Screen saver



Buzzer end cycle



Buzzer alarm



Figure 8.66 - TAS display 1







Pch



Show initial config. display



Figure 8.67 - TAS display 2



When one of these options is selected, it is shown with white text on blue background is not selected, it is shown with blue text on light blue background .



. If the option



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 Maintenance settings display (figure 8.55). The TAS user can modify the configuration of printing functions from this menu, which consists of two displays. Printer settings



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



Tch



Pch



999.9 °C



999.9 °C



999.9 kPa



Printer settings



1



2



SERIAL Printer availability



Graphical printer



Port



Figure 8.68 - Printer settings display 1



Printer settings



Pch



999.9 kPa 1



2



129.136.128.128



Change printer IP



Figure 8.69 - Printer settings display 2



97 sc500_s1000_12_8_01_en



When one of these options is selected, it is shown with white text on blue background is not selected, it is shown with blue text on light blue background .



. If the option



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 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). Display settings



Tch



999.9 °C



Pch



999.9 kPa



Display settings



2



1



0



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 (see figure 8.71). Tch



999.9 °C



BD PROCESS STOPPED



key by which the cycle can be put in a pause mode Pch



999.9 kPa



P st. gen. L 999.9 kPa LWL



1



2



Pause



Figure 8.71 - Process display 1 with TAS user



98 sc500_s1000_12_8_01_en



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



BD



999.9 kPa



P st. gen. L 999.9 kPa LWL



1



2



Pause



PROCESS STOPPED



Figure 8.72 - Process display under pause In process status display 2 the allows it (see figure 8.73).



key allows to skip to the next phase, provided that the sequence



Tch



Pch



999.9 °C



BD



999.9 kPa



EXHAUSTING



2



1



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



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



min



Figure 8.73 - Process display 2 with TAS Maintenance user



99 sc500_s1000_12_8_01_en



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



999.9 °C Bar code



Tch



Pch



999.9 °C



999.9 kPa L LWL



Bar code



2



1



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.



1



1



Figure 8.74 - Bar code display (incorrect)



Delete all codes



Pch



999.9 kPa L LWL



1



2



Delete last code



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



999.9 °C Bar code



Pch



999.9 kPa L LWL



1



User code Last code Load code 100/100 Nonexistent user inside system.



1



Figure 8.76 - Incorrect user display



100 sc500_s1000_12_8_01_en



2



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



999.9 °C Bar code



Pch



999.9 kPa L LWL



1



2



User code last code Load code 100/100 Successfully completed.



1



Standard 134 ºC



Containers



Figure 8.77 - Correct end of reading and recommended programs



101 sc500_s1000_12_8_01_en



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.



103 sc500_s1000_12_9_01_en



9.1



MANAGING THE ALARM, WARNING AND ERROR MESSAGES



When the condition provoking an alarm, warning or error message is shown, a continuous audible signal occurs (as long as the audible alarm function is not deactivated) and on the control display from the NSD (6.1/2) the “Message window” appears (figure 9.1). The message code number and its corresponding text are displayed automatically on the central box of the screen, in red and as indicated in figure 9.1. If another message is simultaneously triggered, this latter appears in the place of the previous one. On the upper left of the screen is shown the warning icon featuring the number of active messages (1 in this example). Once the message is acknowledged, provided the condition that caused it is still being active, the icon remains visible in order to remind the operator that the condition is still valid.



Tch



999.9 °C 1



L LWL



Pch



999.9 kPa PROCESS STOPPED



A2 PLC Communication interrupted



Note: To confirm please, touch the message.



Figure 9.1- message window



1



1



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). Makes the lower keypad hide. Accept the message that is visualized. Go to the next message. Go to the previous message. ● Once accepted, the message text change from red to blue colour (figure 9.3).



Tch



999.9 °C 1



L LWL



The message remains active until the condition causing it has been dealt with, while the operator has acknowledged the message. ATTENTION: Contact the respective MATACHANA Technical Assistance Service if failures are indicated and their cause can not be eliminated. 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).



999.9 kPa PROCESS STOPPED



A2 PLC Communication interrupted



Figure 9.2 Tch



999.9 °C 1



L LWL



Pch



999.9 kPa PROCESS STOPPED



A2 PLC Communication 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 message window by pressing (figure 9.4). Subsequently, whenever there exist any active message it is possible to gain access to the message window by pressing the icon (figure 9.5).



Pch



Figure 9.3 Tch



999.9 °C 1



L LWL



Pch



999.9 kPa PROCESS STOPPED



A2 PLC Communication interrupted



Figure 9.4 Tch



999.9 °C



Pch



999.9 kPa



P st. gen. L 999.9 kPa LWL Standard 134 ºC EXHAUSTING



Remaining time



2



00:45



Figure 9.5 104 sc500_s1000_12_9_01_en



1



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



A14:



Load temperature 1.2 too low



A41:



Load sensor 2.2 failure



A15:



Load temperature 2.1 too low



A42:



Load sensor 3.1 failure



A16:



Load temperature 2.2 too low



A43:



Load sensor 3.2 failure



A17:



Load temperature 3.1 too low



A44:



Load sensor 4.1 failure



A18:



Load temperature 3.2 too low



A45:



Load sensor 4.2 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



Remark [1]: T  he alarm configuration depends on the model of sterilizer and its available options. Based on this configuration, some of the following alarms may be disabled.



105 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. Triggerable: Whenever a cycle is running 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. Triggerable: Anytime ALARM A6: CHAMBER PRESSURE P2 TOO HIGH Condition: The chamber pressure measured by pressure sensor 2 has exceeded the limit of 360 kPa. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau).



106 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. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). 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. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A12: CHAMBER TEMPERATURE T2 TOO LOW Condition: During the holding time, the chamber temperature measured by T2 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. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A13: LOAD TEMPERATURE 1.1 TOO LOW Condition: During the holding time, the temperature measured by product sensor 1.1 (optional): 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 product 1.1 temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A14: LOAD TEMPERATURE 1.2 TOO LOW Condition: During the holding time, the temperature measured by product sensor 1.2 (optional): 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 product 1.2 temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A15: LOAD TEMPERATURE 2.1 TOO LOW Condition: During the holding time, the temperature measured by product sensor 2.1 (optional): 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 product 2.1 temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A16: LOAD TEMPERATURE 2.2 TOO LOW Condition: During the holding time, the temperature measured by product sensor 2.2 (optional): 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 product 2.2 temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). 107 sc500_s1000_12_9_01_en



ALARM A17: LOAD TEMPERATURE 3.1 TOO LOW Condition: During the holding time, the temperature measured by product sensor 3.1 (optional): 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 product 3.1 temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A18: LOAD TEMPERATURE 3.2 TOO LOW Condition: During the holding time, the temperature measured by product sensor 3.2 (optional): 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 product 3.2 temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A19: LOAD TEMPERATURE 4.1 TOO LOW Condition: During the holding time, the temperature measured by product sensor 4.1 (optional): 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 product 4.1 temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A20: LOAD TEMPERATURE 4.2 TOO LOW Condition: During the holding time, the temperature measured by product sensor 4.2 (optional): 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 product 4.2 temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). ALARM A21: CONDENSATE TEMPERATURE TOO LOW Condition:  During the holding time, the condensates temperature measured by the sensor (optional): 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 condensate temperature drops below the preset sterilization temperature. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). 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. Triggerable: Whenever a cycle is running ALARM A23: CHAMBER TEMPERATURE T2 TOO HIGH Condition: Chamber temperature measured by T2 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. Triggerable: Whenever a cycle is running 108 sc500_s1000_12_9_01_en



ALARM A24: LOAD TEMPERATURE 1.1 TOO HIGH Condition: Temperature measured by product temperature sensor 1.1 (optional): 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. Triggerable: Whenever a cycle is running ALARM A25: LOAD TEMPERATURE 1.2 TOO HIGH Condition: Temperature measured by product temperature sensor 1.2 (optional): 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. Triggerable: Whenever a cycle is running ALARM A26: LOAD TEMPERATURE 2.1 TOO HIGH Condition: Temperature measured by product temperature sensor 2.1 (optional): 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. Triggerable: Whenever a cycle is running ALARM A27: LOAD TEMPERATURE 2.2 TOO HIGH Condition: Temperature measured by product temperature sensor 2.2 (optional): 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. Triggerable: Whenever a cycle is running ALARM A28: LOAD TEMPERATURE 3.1 TOO HIGH Condition: Temperature measured by product temperature sensor 3.1 (optional): 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. Triggerable: Whenever a cycle is running ALARM A29: LOAD TEMPERATURE 3.2 TOO HIGH Condition: Temperature measured by product temperature sensor 3.2 (optional): 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. Triggerable: Whenever a cycle is running ALARM A30: LOAD TEMPERATURE 4.1 TOO HIGH Condition: Temperature measured by product temperature sensor 4.1 (optional): 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. Triggerable: Whenever a cycle is running ALARM A31: LOAD TEMPERATURE 4.2 TOO HIGH Condition: Temperature measured by product temperature sensor 4.2 (optional): 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. Triggerable: Whenever a cycle is running



109 sc500_s1000_12_9_01_en



ALARM A32: CONDENSATE TEMPERATURE TOO HIGH Condition: Temperature of condensates measured by its temperature sensor (optional): 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. Triggerable: Whenever a cycle is running 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. Triggerable: Anytime ALARM A34: PRESSURE SENSOR P2 FAILURE Condition: The input signal of chamber pressure P2 is under 0,5 kPa, or communication with the corresponding analogical input module is faulty. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Anytime ALARM A39: LOAD SENSOR 1.2 FAILURE Condition: The product temperature sensor 1.2 (optional) records incorrect values (temperature rises above 148 °C or is under 1 °C), or communication with the corresponding analogical input module is faulty. Triggerable: Anytime ALARM A40: LOAD SENSOR 2.1 FAILURE Condition: The product temperature sensor 2.1 (optional) records incorrect values (temperature rises above 148 °C or is under 1 °C), or communication with the corresponding analogical input module is faulty. Triggerable: Anytime ALARM A41: LOAD SENSOR 2.2 FAILURE Condition: The product temperature sensor 2.2 (optional) records incorrect values (temperature rises above 148 °C or is under 1 °C), or communication with the corresponding analogical input module is faulty. Triggerable: Anytime 110 sc500_s1000_12_9_01_en



ALARM A42: LOAD SENSOR 3.1 FAILURE Condition: The product temperature sensor 3.1 (optional) records incorrect values (temperature rises above 148 °C or is under 1 °C), or communication with the corresponding analogical input module is faulty. Triggerable: Anytime ALARM A43: LOAD SENSOR 3.2 FAILURE Condition: The product temperature sensor 3.2 (optional) records incorrect values (temperature rises above 148 °C or is under 1 °C), or communication with the corresponding analogical input module is faulty. Triggerable: Anytime ALARM A44: LOAD SENSOR 4.1 FAILURE Condition: The product temperature sensor 4.1 (optional) records incorrect values (temperature rises above 148 °C or is under 1 °C), or communication with the corresponding analogical input module is faulty. Triggerable: Anytime ALARM A45: LOAD SENSOR 4.2 FAILURE Condition: The product temperature sensor 4.2 (optional) records incorrect values (temperature rises above 148 °C or is under 1 °C), or communication with the corresponding analogical input module is faulty. Triggerable: Anytime 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. Triggerable: Anytime ALARM A47: LOW DOOR 1 SEAL PRESSURE Condition: Insufficient pressure in the gasket from door 1. Triggerable: Whenever a cycle is running 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. Triggerable: Anytime 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. 111 sc500_s1000_12_9_01_en



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.



112 sc500_s1000_12_9_01_en



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 corresponding analogical input module is faulty. Triggerable: Anytime WARNING W2: WATER TANK TEMPERATURE SENSOR FAILURE Condition: The temperature sensor of water emptying tank records incorrect values (temperature rises above 148 °C or is under 1 °C), or communication with the corresponding analogical input module is faulty. Triggerable: Anytime 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. Triggerable: Anytime 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 input module is faulty. Triggerable: Anytime 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 input module is faulty. Triggerable: Anytime 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. Triggerable: Anytime 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 analogical input module is faulty. Triggerable: Anytime 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. Triggerable: Anytime



113 sc500_s1000_12_9_01_en



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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Available only in sterilizers with supplies alarm option. Triggerable: Anytime 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. Available only in sterilizers with supplies alarm option. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). 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. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau).



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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. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). 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. Triggerable: Operates only during the exposure time (sterilization phase or sterilization plateau). WARNING W21:[not assigned] WARNING W22:[not assigned] WARNING W23:[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 FTPserver 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: During the automatic loading process. 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Anytime WARNING W38:LOW WATER LEVEL VACUUM SYSTEM Condition: Insufficient water level is detected in the emptying system tank during more than 5 minutes. Triggerable: Anytime



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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. Triggerable: Anytime WARNING W41:[not assigned] 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Whenever a cycle is running 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: During the automatic loading process. 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. Triggerable: Anytime 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. Triggerable: Anytime 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. Triggerable: Anytime



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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 manufacture verification



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 manufacture verification



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 Only in 2 door-versions. 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 Only in 2 door-versions. 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 Only in 2 door-versions. 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. ERROR E25: ALARM A34 PENDING MANUFACTURE VERIFICATION Alarm A34 has been triggered “Failure P2 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. ERROR E26: ALARM A35 PENDING MANUFACTURE VERIFICATION  Alarm A35 has been triggered “Failure jacket 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. ERROR E27: ALARM A36 PENDING MANUFACTURE VERIFICATION Alarm A36 has been triggered “Failure T1 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 E28: ALARM A37 PENDING MANUFACTURE VERIFICATION Alarm A37 has been triggered “Failure T2 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 E29: ALARM A38 PENDING MANUFACTURE VERIFICATION Alarm A38 has been triggered “Failure 1.1 product 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 E30: ALARM A39 PENDING MANUFACTURE VERIFICATION Alarm A39 has been triggered “Failure 1.2 product 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.



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ERROR E31: ALARM A40 PENDING MANUFACTURE VERIFICATION Alarm A40 has been triggered “Failure 2.1 product 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 E32: ALARM A41 PENDING MANUFACTURE VERIFICATION  Alarm A41 has been triggered “Failure 2.2 product 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 E33: ALARM A42 PENDING MANUFACTURE VERIFICATION  Alarm A42 has been triggered “Failure 3.1 product 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 E34: ALARM A43 PENDING MANUFACTURE VERIFICATION Alarm A43 has been triggered “Failure 3.2 product 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 E35: ALARM A44 PENDING MANUFACTURE VERIFICATION Alarm A44 has been triggered “Failure 4.1 product 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 E36: ALARM A45 PENDING MANUFACTURE VERIFICATION Alarm A45 has been triggered “Failure 4.2 product 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 E37: ALARM A46 PENDING MANUFACTURE VERIFICATION 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 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.



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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 element is confirmed. 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 element is confirmed. ERROR E43: M  ODULE PRESSURE DOCUMENTATION PLC, PENDING MANUFACTURE VERIFICATION Analogue module pressure of the documentation 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.



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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.



128 sc500_s1000_12_10_01_en



NO.



COMPONENT / SYSTEM TO CHECK



INSPECTION / MAINTENANCE TASK



PROCEDURE WHO?



WHEN?



1



- Internal walls of the chamber - Door gaskets - Drain filters



Visual inspection and cleaning



According to Operator paragraph 10.2.1



Daily, before operation



2



- Printer - Recorder (optional)



- Check they are operational - Check that there is sufficient paper



According to paragraphs 10.2.1, 10.4.2 and 10.4.3



Operator



Daily, before operation



3



- Deaeration - Steam penetration



Perform B&D Test



According to paragraphs 7.3.1.2, 10.2.1 and Annex II



Operator



Daily, before operation



4



- Inner chamber - Drain filter - Door gaskets - External surfaces of sterilizer



Cleaning and visual inspection



According to Operator paragraph 10.2.2



Weekly before operation, and if necessary



5



System tightness



Perform Vacuum test



According to paragraphs 7.3.1.2 and 10.2.2



Weekly before operation, and if necessary



6



- Emergency stop - Door safety bar



- Check they are operational - Check they work properly



According to Maintenance technician paragraph 10.2.2



Weekly, and if necessary



7



Tightness control



Visual control for leakfree



According to Maintenance technician paragraph 10.2.2



Weekly



8



Pressure switches



 ontrol and setting, if C required



According to MATACHANA Technical paragraph 10.3.1 Assistance Service



Semiannual



9



Water tank



Empty and clean



According to MATACHANA Technical paragraph 10.3.1 Assistance Service



Semiannual



10



Electro-cabinets



Compressed air cleaning



According to MATACHANA Technical paragraph 10.3.1 Assistance Service



Semiannual



11



Steam traps



Check and clean



According to MATACHANA Technical paragraph 10.3.1 Assistance Service



Semiannual



12



Door sensors



Control and setting, if required



According to MATACHANA Technical paragraph 10.3.1 Assistance Service



Semiannual



13



Filters



Check and clean



According to MATACHANA Technical paragraph 10.3.1 Assistance Service



Semiannual



14



Chamber, components and ducts



Tightness inspection



According to MATACHANA Technical paragraph 10.3.1 Assistance Service



Semiannual



15



Door gasket



Check and clean Replace, if necessary



According to paragraphs 10.3.1 and 10.4.1



MATACHANA Technical Assistance Service



Semiannual



16



- Door guides - Locking bolts



- Grease - Check their operation



According to paragraph 10.3.1



MATACHANA Technical Assistance Service



Semiannual



17



Complete sterilizer



Technical safety tests



According to paragraph 10.3.1



MATACHANA Technical Semiannual Assistance Service



18



Sterilizer



Checking phase According to changes for all programs paragraph 10.3.1



MATACHANA Technical Semiannual Assistance Service



19



- Non-return valves - Pneumatic valves



Clean and inspection



Operator



According to MATACHANA Technical Yearly paragraph 10.3.2 Assistance Service 129 sc500_s1000_12_10_01_en



NO.



COMPONENT / SYSTEM TO CHECK



INSPECTION / MAINTENANCE TASK



PROCEDURE WHO?



20



Sterile air filter



Replace



According to MATACHANA Technical Yearly paragraph 10.3.2 Assistance Service



21



Ducts and water supply components



Inspection, remove and clean if required



According to MATACHANA Technical Yearly paragraph 10.3.2 Assistance Service



22



Door pneumatic cylinders



Replace door gaskets



According to MATACHANA Technical Yearly paragraph 10.3.2 Assistance Service



23



Door gasket/s



Replace



According to paragraphs 10.3.2 and 10.4.1



24



Chamber and jacket safety valves



Check and activate



According to MATACHANA Technical Yearly paragraph 10.3.2 Assistance Service



25



Sterilizer



- Check operation - Calibration



According to paragraph 10.3.2



MATACHANA Technical Yearly, Assistance Service and if necessary



26



Sterilizer



Effectiveness test, performance evaluation (revalidation)



According to section 10.3.3 and annex II



MATACHANA Technical Yearly, Assistance Service or and if necessary accredited validation entity



27



Pressure vessel



Periodical internal inspections, verification and hydrostatic test



According to paragraphs 10.3.4 and 3.4



Expert from accredited entity







WHEN?



MATACHANA Technical Yearly Assistance Service



As specified according to the 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.



130 sc500_s1000_12_10_01_en



NO. COMPONENT / SYSTEM TO CHECK



OPERATION TO BE PERFORMED



PROCEDURE



WHO?



WHEN?



(INTEGRATED STEAM GENERATOR)







1



Visual indicator of water level



 isual check of the V level



According to paragraph 10.2.1



Operator



Daily, and on connecting the unit



2



Steam generator manometer



 isual check of presV sure



According to paragraph 10.2.1



Operator



Daily, and on connecting the unit



3



Minimum safety level



 heck if it is working C correctly



According to paragraph 10.2.2



Maintenance technician



Weekly



4



- Water supply to the generator - Water inside the vessel



 heck of the water C quality supplied to the steam generator, and the water inside it



According to paragraphs 4.4 and 10.2.2



Maintenance technician



Weekly



5



Vessel



Desalination (partial drainage of the water in the vessel)



According to paragraph 10.2.2



Maintenance technician



Weekly



6



Safety pressure switch



 heck if it is working C correctly



According to paragraph 10.3.1



MATACHANA Technical Assistance Service



Semiannual



7



Intake water tank



Drain and clean



According to paragraph 10.3.1



MATACHANA Technical Assistance Service



Semiannual



8



Safety Valve



Check and activate



According to paragraph 10.3.2



MATACHANA Technical Assistance Service



Yearly



9



Vessel



 mpty the steam E generator and fill it again



According to paragraph 10.3.2



MATACHANA Technical Assistance Service



Yearly



10



 team generator (thermal S Visual check and insulation, electrical installation, complete revision safety components, etc.)



According to paragraph 10.3.2



MATACHANA Technical Assistance Service



Yearly



11



Pressure vessel



Expert from accredited entity



According to specification by the competent authority



Periodical internal According to inspections, verification paragraphs 10.3.4 and hydrostatic test and 3.4



Table 10.2 - Maintenance tasks carried out on the steam generator (only on E models)



131 sc500_s1000_12_10_01_en



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.



132 sc500_s1000_12_10_01_en



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! 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.



●



 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: 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.



●



 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.



133 sc500_s1000_12_10_01_en



●



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.







-







-  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.



Press the Emergency stop (6.1/4).



●



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.



134 sc500_s1000_12_10_01_en



 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.



135 sc500_s1000_12_10_01_en



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.



136 sc500_s1000_12_10_01_en



●



 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



137 sc500_s1000_12_10_01_en



●



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.



138 sc500_s1000_12_10_01_en



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.



139 sc500_s1000_12_10_01_en



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.



140 sc500_s1000_12_10_01_en



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 heatsensitive 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.



141 sc500_s1000_12_10_01_en



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.



142 sc500_s1000_12_10_01_en



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



41603.8



Thermal paper roll for printer with MATACHANA serigraphy, 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



143 sc500_s1000_12_11_01_en



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 Start



[min] 1 0+01



3 2



5 4



7 6



9 8



11 13 10



15



12 14



17 16



19 18



21 20



23 22



25 24



27 26



29 28



30



End of process



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. Nº



PHASE



PRESSURE [kPa] P0 = Pamb (80 - 108)



TEMPERATURE DURATION [s] [°C]



REMARKS



0’



Process running (closed door) Wait for steam 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



--



4



Steam injection



70 (± 10)



not specified



max. 600



--



5



Prevacuum



15 (± 1,5)



not specified



max. 1200



--



6



Steam injection



70 (± 10)



not specified



max. 600



7



Prevacuum



15 (± 1,5)



not specified



max. 1200



8



Steam injection



70 (± 10)



not specified



max. 600



9



Prevacuum



15 (± 1,5)



not specified



max. 1200



10



Steam injection



70 (± 10)



not specified



max. 600



Not in program 06 - RAPID Not in program 06 - RAPID Not in program 06 - RAPID Not in program 06 - RAPID Not in program 06 - RAPID



0



not specified



max. 300



--



--



--



max. 600



--



145 sc500_s1000_12_12_01_en



Nº



PHASE



PRESSURE [kPa]



TEMPERATURE DURATION [s] [°C]



REMARKS



11



Prevacuum



15 (± 1,5)



not specified



max. 1200



12



Steam injection



70 (± 10)



not specified



max. 600



13



Prevacuum



15 (± 1,5)



not specified



max. 1200



14



Steam injection



70 (± 10)



not specified



max. 600



15



Prevacuum



15 (± 1,5)



not specified



max. 1200



180 (± 3) programs at 134 ºC 125 (± 3) programs at 121 ºC



Not in program 06 - RAPID Not in program 06 - RAPID Not in program 06 - RAPID Not in program 06 - RAPID Not in program 06 - RAPID



not specified



max. 600



--



110 (± 5)



not specified



max. 600



--



180 (± 3) programs at 134 ºC 125 (± 3) programs at 121 ºC



not specified



max. 600



--



110 (± 5)



not specified



max. 600



--



200 (± 3) programs at 134 ºC 130 (± 3) programs at 121 ºC



not specified



max. 600



--



110 (± 5)



not specified



max. 600



--



not specified



max. 1200



--



not specified



30



--



max. 1200



--



P04/46: 300 (± 5) P06: 300 (± 5) P07: 1080 (± 5)



16



Steam injection



17



Prevacuum



18



Steam injection



19



Prevacuum



20



Steam injection



21



Prevacuum



22



Heating (initial pressure increase)



23



Heating (maintenance)



24



Heating (last pressure increase)



290 (± 3) programs at 134 ºC 190 (± 3) programs at 121 ºC 290 (± 3) programs at 134 ºC 190 (± 3) programs at 121 ºC 312 (± 3) programs at 134 ºC



134 (-0 / +3)



212 (± 3) programs at 121 ºC



121 (-0 / +3)



P03: 215 (± 10)



P03: 121 (-0 / +3)



P03: 1200 (± 5)



P03 (optional configuration): 240 (-7 / +10)



P03 (optional configuration):125 (-0 / +3)



P03 (optional configuration): 1200 (± 5)



133,0 < T < 133,9 °C → W17/18 T < 133,0 °C → A11/12 T > 137,0 °C → A22/23 Optional configuration: T < 134,0 °C → A11/12 T > 137,0 °C → A22/23 120,0 < T < 120,9 °C → W17/18 T 124,0 °C → A22/A23 Optional configuration: T 128,0 °C → A22/A23



10 (± 2)



not specified



max. 1200



--



P04/06/07/46/01: 315 (± 10)



P04/06/07/46/01: 134 (-0 / +3)



P01: 198 (± 5) 25



26



Sterilization



Devaporization



146 sc500_s1000_12_12_01_en



PRESSURE [kPa]



TEMPERATURE DURATION [s] [°C]



Nº



PHASE



27



Drying (vacuum pulse)



10 (± 3)



not specified



180 (± 20)



28



Drying (vacuum pulse)



70 (+ 15/-2)



not specified



max. 600



29



Drying (vacuum pulse)



not specified



not specified



120 (± 30)



REMARKS Not in program 06 - RAPID See Remark 3 Not in program 06 - RAPID See Remark 3 Not in program 06 - RAPID See Remark 3



P04/46: 600 (± 30) P03: 900 (± 30) 30



Drying



not specified



not specified



P06: 480 (± 30) P07: 900 (± 30) P01: 300 (± 30)



31



Vacuum breaking (aeration) Vacuum breaking (extra time)



32



Process end



Pamb - 10



not specified



-



Pamb (80 - 108)



not specified



15



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.



147 sc500_s1000_12_12_01_en



12.2



CONTAINERS PROGRAM PRESSURE [hPa]



3000



2000



1000



TIME



0 Start







0 0’



3 2



0+01







Nº



[min] 1



5 4







7 6



9 8



11 13 15 17 10



12 14 16



19 18



21 20



23 22



25 24



27 26



28



29



31



33+34



30



32



End of process



Figure 12.2 - Profile of the Containers program



PHASE Process running (closed door) Wait for steam generator



PRESSURE [kPa] P0 = Pamb (80 - 108)



TEMPERATURE [°C]



DURATION [s]



REMARKS



not specified



max. 300



--



--



--



max. 600



--



1



Steam injection



210 (± 10)



not specified



max. 600



--



2



Air purge



210 (± 10)



not specified



300



--



3



Prevacuum



15 (± 1,5)



not specified



max. 1200



--



4



Steam injection



70 (± 10)



not specified



max. 600



--



5



Prevacuum



15 (± 1,5)



not specified



max.1200



--



6



Steam injection



70 (± 10)



not specified



max. 600



--



7



Prevacuum



15 (± 1,5)



not specified



max.1200



--



8



Steam injection



70 (± 10)



not specified



max. 600



--



9



Prevacuum



15 (± 1,5)



not specified



max.1200



--



10



Steam injection



70 (± 10)



not specified



max. 600



--



148 sc500_s1000_12_12_01_en



Nº



PHASE



PRESSURE [kPa]



TEMPERATURE [°C]



DURATION [s]



REMARKS



11



Prevacuum



15 (± 1,5)



not specified



max. 1200



--



12



Steam injection



70 (± 10)



not specified



max.600



--



13



Prevacuum



15 (± 1,5)



not specified



max. 1200



--



14



Steam injection



70 (± 10)



not specified



max. 600



--



15



Prevacuum



15 (± 1,5)



not specified



max.1200



--



16



Steam injection



180 (± 3)



not specified



max. 600



--



17



Prevacuum



110 (± 5)



not specified



max. 600



--



18



Steam injection



180 (± 3)



not specified



max. 600



--



19



Prevacuum



110 (± 5)



not specified



max. 600



--



20



Steam injection



200 (± 3)



not specified



max. 600



--



21



Prevacuum



110 (± 5)



not specified



max. 600



--



22



Steam injection



200 (± 3)



not specified



max. 600



--



23



Prevacuum



110 (± 5)



not specified



max. 600



--



24



Heating (initial pressure increase)



290 (± 3)



not specified



max.1200



--



25



Heating (holding)



290 (± 3)



not specified



30



--



26



Heating (last pressure increase)



312 (± 3)



134 (-0 / +3)



max.1200



--



27



Sterilization



315 (± 10)



134 (-0 / +3)



300 (± 5)



133,0 < T < 133,9 °C → W17/18 T < 133,0 °C → A11/12 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



--



29



Drying (vacuum pulse)



10 (± 3)



not specified



180 (± 20)



30



Drying (steam pulse)



70 (+15/-2)



not specified



max. 600



31



Drying (vacuum pulse)



not specified



not specified



120 (± 30)



32



Drying



not specified



not specified



900 (± 30)



Not in program 06 - RAPID See Remark 3 Not in program 06 - RAPID See Remark 3 Not in program 06 - RAPID See Remark 3 --



149 sc500_s1000_12_12_01_en



Nº



PHASE



33



Vacuum breaking (aeration) Vacuum breaking (extra time)



34



Process end



Remark 1:



PRESSURE [kPa]



TEMPERATURE [°C]



DURATION [s]



REMARKS



Pamb - 10



not specified



-



-



Pamb (80 - 108)



not specified



15



--



Pamb (80 - 108)



not specified



-



--



Table 12.2 - Parameters for Containers program



 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 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 Nº



PHASE



0



Process running (door closed)



0‘



Wait for steam generator



1



Prevacuum



150 sc500_s1000_12_12_01_en



PRESSURE



TEMPERATURE [°C]



DURATION [s]



REMARKS



P0 = Pamb (80 - 108)



not specified



max. 300



--



--



--



max. 600



--



83 (±3)



not specified



max. 1200



--



[kPa]



Nº



PHASE



PRESSURE [kPa]



TEMPERATURE [°C]



DURATION [s]



REMARKS



2



Steam injection (pressure increase)



190 (±3)



not specified



max. 600



--



3



Steam injection (holding)



190 (±15)



not specified



15 (±5)



--



4



Prevacuum



83 (±3)



not specified



max. 1200



--



5



Steam injection (pressure increase)



190 (±3)



not specified



max. 600



--



6



Steam injection (holding)



190 (±15)



not specified



15 (±5)



--



7



Prevacuum



83 (±3)



not specified



max. 1200



--



8



Steam injection (pressure increase)



190 (±3)



not specified



max. 600



--



9



Steam injection (holding)



190 (±15)



not specified



15 (±5)



--



10



Prevacuum



83 (±3)



not specified



max. 1200



--



11



Steam injection (pressure increase)



190 (±3)



not specified



max. 600



--



12



Steam injection (holding)



190 (±15)



not specified



15 (±5)



--



13



Prevacuum



83 (±3)



not specified



max. 1200



--



14



Steam injection (pressure increase)



190 (±3)



not specified



max. 600



--



15



Steam injection (holding)



190 (±15)



not specified



15 (±5)



--



16



Prevacuum



83 (±3)



not specified



max. 1200



--



17



Steam injection (pressure increase)



190 (±3)



not specified



max. 600



--



18



Steam injection (holding)



190 (±15)



not specified



15 (±5)



--



19



Prevacuum



83 (±3)



not specified



max. 1200



--



20



Steam injection (pressure increase)



190 (±3)



not specified



max. 600



--



21



Steam injection (holding)



190 (±15)



not specified



15 (±5)



--



22



Prevacuum



83 (±3)



not specified



max. 1200



--



23



Heating (initial pressure increase)



290 (±3)



not specified



max. 1200



--



24



Heating (holding)



290 (±15)



not specified



30 (±5)



-



25



Heating (final pressure increase)



312 (±3)



134 (-0 / +3)



max. 1200



--



26



Sterilization



315 (±10)



134 (-0 / +3)



600 (±5)



133,0 < T < 133,9 °C → W17/18 T 137,0 °C → A22/A23 Optional configuration: T 137,0 °C → A22/A23



27



Exhausting



83 (±2)



not specified



max. 1200



--



28



Drying



80



not specified



900 (±20)



--



151 sc500_s1000_12_12_01_en



PRESSURE [kPa]



TEMPERATURE [°C]



DURATION [s]



REMARKS



Vacuum breaking (aeration)



Pamb - 10



not specified



--



--



Vacuum breaking (time extended)



Pamb (80 - 108)



not specified



30



--



Process end



Pamb (80 - 108)



not specified



--



--



Nº



PHASE



29



30



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 Start 0+01



[min] 1 2



3







Nº



4



5



6



7



8



9



10



End of process



11+12



Figure 12.4 - Profile of the Liquids program



PHASE



running 0 Process (closed door) 0’ Wait for steam generator 1 Prevacuum



152 sc500_s1000_12_12_01_en



PRESSURE [kPa] P0 = Pamb (80 - 108)



TEMPERATURE [°C]



DURATION [s]



REMARKS



not specified



max. 300



--



-



-



max. 600



--



20 (± 1,5)



not specified



max. 1200



--



PRESSURE [kPa]



TEMPERATURE [°C]



2 Preheating



120 (± 3)



105 (-2 / + 5)



3 Air purge



120 (± 3)



105 (-2 / + 5)



120 (± 5)



4 Heating (pressure increase) 5 Heating (holding)



122 (± 3)



123 (-0 / +3)



--



122 (± 3)



123 (-0 / +3)



max. 1200



6 Sterilization



121 (± 3)



121 (-0 / +3)



2400 (±5)



7 Devaporization



130 (± 2)



not specified



max.1200



--



8 Cooling



not specified



not specified



max. 2400



up to product 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



-



Vacuum breaking (holding)



Pamb (80 - 108)



not specified



15



Pamb (80 - 108)



not specified



-



Nº



11



PHASE



12 Process end Remark 1:



DURATION [s] max.1200



REMARKS -up to product temperature < 121,0 ºC up to product temperature < 121.3 ºC 120,0 < T < 120,9 °C → W17/18 T 128,0 °C →A22/A23



---



Table 12.4 - Parameters for the Liquids program



 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: Depending on the parameter setting 32, the process steps 9 and 10 are repeated up to 10 times.



153 sc500_s1000_12_12_01_en



12.5



DISINFECTION PROGRAM PRESSURE [hPa]



1000



TIME



0 Start



[min] 0+01



1



2



3 4 5



7 6







9 8



11 13 15



10 12 14



17 16



19



20+21



18



End of process



Figure 12.5 - Profile of the Disinfection program PRESSURE [kPa] P0 = Pamb (80 - 108)



TEMPERATURE [°C]



DURATION [s]



REMARKS



not specified



max. 300



--



-



-



max. 600



--



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



--



4 Steam injection



70 (± 10)



not specified



max.600



--



5 Prevacuum



15 (± 1,5)



not specified



max.1200



--



6 Steam injection



70 (± 10)



not specified



max. 600



--



7 Prevacuum



15 (± 1,5)



not specified



max.1200



--



8 Steam injection



70 (± 10)



not specified



max. 600



--



9 Prevacuum



15 (± 1,5)



not specified



max. 1200



--



10 Steam injection



70 (± 10)



not specified



max. 600



--



11 Prevacuum



15 (± 1,5)



not specified



max. 1200



--



12 Steam injection



70 (± 10)



not specified



max. 600



--



13 Prevacuum



15 (± 1,5)



not specified



max. 1200



--



14 Steam injection



70 (± 10)



not specified



max. 600



--



15 Prevacuum



15 (± 1,5)



not specified



max. 1200



--



16 Heating (initial pressure increase)



125 (± 3)



119 (-2 / + 5)



max.1200



--



Nº



PHASE



running 0 Process (closed door) 0’ Wait for steam generator



154 sc500_s1000_12_12_01_en



PRESSURE [kPa]



TEMPERATURE [°C]



DURATION [s]



17 Disinfection



125 (± 3)



105 (-0 / +3)



600 (± 5)



104,0 - 104,9 °C → W17/18 T < 104,0 °C → A11/A12 T > 108,0 °C → A22/A23



18 Devaporization



10 (± 2)



not specified



max.1200



--



19 Drying



10 (± 3)



not specified



600 (± 20)



--



Pamb - 10



not specified



-



Pamb (80 - 108)



not specified



15



Pamb (80 - 108)



not specified



-



Nº



PHASE



Vacuum breaking (aeration)



20



Vacuum breaking (holding)



21 Process end



REMARKS



---







Table 12.5 - Parameters for the Disinfection program



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. 12.6



VACUUM TEST AND AIR DETECTOR VACUUM TEST PROGRAMS PRESSURE [hPa]



1000



TIME



0 Start







[min] 0



1



2



3



4+5



End of test



Figure 12.6 - Profile of the Vacuum Test and Air Detector Vacuum Test programs



Nº



PHASE



PRESSURE



DURATION [s]



REMARKS



max. 300



--



0



Process running (closed door)



[hPa] P0 = Pamb (80 - 108)



1



Prevacuum (test)



P1 = 7 (± 0,5)



max. 1800



--



2



Preparation



P2 = 7 (± 0,5)



300 (+/- 2)



--



155 sc500_s1000_12_12_01_en



Nº



PRESSURE



PHASE



DURATION [s]



REMARKS



P3



600 (+/- 2)



P02: Test abortion a P3 > P2 + 1,3 kPa



[hPa]



3



Vacuum Test



4



Pamb - 10



--



--



5



Vacuum breaking (aeration) Vacuum breaking (extra time)



Pamb (80 - 108)



30



--



6



Process end



Pamb (80 - 108)



--



P02: warning message (W47) a P3 - P2 = ∆P > 1,3 kPa







Table 12.6 - Parameters for the Vacuum Test and Air Detector Vacuum Test programs



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. 12.7



PREHEATING PROGRAM PRESSURE [hPa]



2000



1000



TIME



0



[min]



Start 0+01







Nº 0 0’



1







2



3



PHASE



Process running (closed door) Wait for steam generator



4



5



6



7



8



9



10



11



12



13



14 +15



End of process



Figure 12.7 - Profile of the Preheating program PRESSURE [kPa] P0 = Pamb (80 - 108)



TEMPERATURE [°C]



DURATION [s]



REMARKS



not specified



max. 300



--



-



-



max. 600



--



1



Prevacuum



15 (± 1,5)



not specified



max.1200



--



2



Steam injection



70 (± 10)



not specified



max. 600



--



156 sc500_s1000_12_12_01_en



Nº



PHASE



PRESSURE [kPa]



TEMPERATURE [°C]



DURATION [s]



REMARKS



3



Prevacuum



15 (± 1,5)



not specified



max. 1.200



--



4



Steam injection



180 (± 3)



not specified



max. 600



--



5



Prevacuum



110 (± 5)



not specified



max. 600



--



6



Steam injection



200 (± 3)



not specified



max. 600



--



7



Prevacuum



110 (± 5)



not specified



max. 600



--



8



Heating (initial pressure increase) Heating (holding) Heating (last pressure increase)



180 (± 3)



not specified



max. 1200



--



180



not specified



30



--



212 (± 3)



121



max. 1200



--



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 (aeration) Vacuum breaking (extra time) Process end



Pamb-10



not specified



max. 300



--



Pamb (80 - 108)



not specified



15



--



Pamb (80 - 108)



not specified



--



--



9 10



15







Table 12.7 - Parameters for the Preheating program



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.



157 sc500_s1000_12_12_01_en



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 papertransparent 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. 160 sc500_s1000_12_an_I_01_en



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 165 sc500_s1000_12_an_II_01_en



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



1 2 3 4 5 6



2 3 4



5



Aufnahmekapsel Dichtung Indilatorsystem Anschlusstuck Offenes Ende PTFE-Schlauch, Di=2mm



6



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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