MELAG Euroklav 23 S+ User Manual

MELAG Euroklav 23 S+ User Manual

Steam sterilizer
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User Manual
Euroklav
Steam sterilizer
from software version 5.21
EN
Dear customer,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world's leading manufacturer in the instrument reprocessing and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing
hygiene"
and
"Quality – made in
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with EN ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance
with strict quality criteria.
The MELAG management and team.
®
23 S+
Germany", we guarantee that these demands will be met. Our certified quality
"competence in
0197

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Summary of Contents for MELAG Euroklav 23 S+

  • Page 1 5.21 Dear customer, We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice- based use.
  • Page 3: Table Of Contents

    Contents Contents 1 General guidelines ................................ 5 Symbols used .................................. 5 Formatting rules................................... 5 Disposal .................................... 5 2 Safety..................................... 6 3 Performance specifications .............................. 8 Intended use .................................. 8 Sterilization procedure ................................. 8 Type of the feed water supply.............................. 8 Safety equipment................................. 9 Performance characteristics of sterilization programs ...................... 9 Program sequences................................ 10 Overview of programs................................ 11 4 Description of the device.............................. 13 Scope of delivery ................................ 13...
  • Page 4 Contents Deleting logs in the internal log memory.......................... 36 Reading logs correctly ............................... 36 8 Function checks ................................. 38 Automatic functional checks .............................. 38 Manual functional checks .............................. 38 Bowie & Dick test................................ 38 Checking the quality of the feed water.......................... 39 Pre-heating temperature of the sterilization chamber...................... 39 9 Maintenance.................................. 40 Servicing intervals................................ 40 Cleaning..................................... 40...
  • Page 5: General Guidelines

    Dispose of spare parts that are no longer used, e.g. seals, properly. MELAG draws the operator’s attention to the fact that they are responsible for deleting personal data on the device to be disposed of.
  • Page 6: Safety

    Setup, installation and commissioning Check the device after unpacking for any damage suffered during transport. The device should only be setup, installed and commissioned by MELAG authorised persons. The connections for electrical provision and water supply and discharge must be setup by trained personnel.
  • Page 7 Please note that all serious accidents which occur in connection with the medical device (e.g. death or serious deterioration in the state of health of a patient) which were presumably caused by the device, must be reported to the manufacturer (MELAG) and the relevant authority of the member state, in which the user and/or patient resides.
  • Page 8: Performance Specifications

    3 Performance specifications 3 Performance specifications Intended use The steam sterilizer is intended for use in every kind of general medical field where no sterilization cycles of type "B" are required for the instruments sterilized and the type of packaging used. According to EN 13060, this steam sterilizer is performing sterilization cycles of type "S".
  • Page 9: Safety Equipment

    3 Performance specifications Safety equipment Internal process monitoring A process evaluation system is integrated in the electronics of the steam sterilizer. It compares the process parameters (such as temperature, time and pressure) during a program run. It monitors the parameters in terms of their threshold values during control and regulation and guarantees safe and successful sterilization.
  • Page 10: Program Sequences

    3 Performance specifications Program sequences Regular sterilization program After program start, you can follow the program run on the display. It shows the chamber temperature and pressure as well as the time until the end of sterilization and drying. Program phase Description 1.
  • Page 11: Overview Of Programs

    3 Performance specifications Overview of programs MAIN menu Function Initial state (see next page) Press 1x hh:mm:ss AIN6: Conductivity Press simultaneously to reach the SETUP 0.00 bar 89°C 10 µS/cm menu function Release Select by holding the '-' key depressed Press 2x Unlock the door with the '+' key Universal-Program...
  • Page 12 SETUP menu - Function hh:mm:ss Initial state 0.00 bar 89°C No output medium MELAprint MELAflash Press both keys simultaneously MELAnet graphic data (MELAnet Box) Applies only to Vacuklav 23 B+/ 31 B+, Euroklav S+/ VS+, Vacuvet 23 B+, SETUP menu Computer DAC Professional Function:...
  • Page 13: Description Of The Device

    4 Description of the device 4 Description of the device Scope of delivery Please check the scope of delivery before setting up and connecting the device. Standard scope of delivery ▪ Euroklav 23 S+ ▪ User manual ▪ User manual Accessories for small steam sterilizers ▪...
  • Page 14: Views Of The Device

    4 Description of the device Views of the device Front Tank lid Operating and display panel Door, swings open to the left Slide locking grip Power switch Front device foot (adjustable) Rear panel Spring safety valve Sterile filter One-way outlet Feed water inflow via the internal storage tank Hose bridge for internal feed...
  • Page 15: Symbols On The Device

    4 Description of the device View of the interior Fixing for MELAdem 40 Sterilization chamber Door locking pin Chamber seal face 2 device fuses Overheat protection reset button Serial data and printer connection (RS232)* Connection for emptying the storage tank - feed water Connection for emptying the storage tank wastewater 21 20...
  • Page 16: Operating Panel

    4 Description of the device Electrical connection of the product: Alternating current (AC) Front of the device Bleed valves, internal storage tanks: 1 = Wastewater side 2 = Feed water side Reset button for the overheat protection of the capillary tube controller Symbols on the power switch Switching on device Switching off device...
  • Page 17: Load Mounts

    4 Description of the device Load mounts For detailed information about the different mounts, how to combine them with different load holders and how to use them, please refer to the separate document “User manual Accessories for small steam sterilizers”. Mount A Plus The mount (A Plus) is standard and can accommo- date either five trays or up to three sterilization con-...
  • Page 18: First Steps

    Record of installation and setup The record of installation is to be completed by the responsible stockist and a copy sent to MELAG as proof of the correct setup, installation and initial commissioning. This is a constituent part of any guarantee claim.
  • Page 19: Wastewater Connection

    5 First steps Setting the feed water supply on the steam sterilizer The internal function must be set in order to enable feed water supply via the internal storage tank. The external function must be set in order to enable feed water supply via a water treatment unit. Select the SETUP menu Function by pressing the '+' and '-' keys simultaneously.
  • Page 20: Setting The Date And Time

    5 First steps Setting the date and time Correct batch documentation requires the correct date and time setting on the steam sterilizer. Ensure that you take into account any clock change, as this is not adjusted automatically. Set the date and time as follows: Select the Function menu by pressing the '+' and '-' keys simultaneously.
  • Page 21: Sterilization

    6 Sterilization 6 Sterilization Preparing the load Always clean and disinfect properly before sterilization. Only in this way is it possible to guarantee the subsequent sterilization of the load. The materials used, cleaning agents and reprocessing procedure are of decisive significance. Comply with the following for safe handling: NOTICE Only ever operate the steam sterilizer with a sterile filter inserted.
  • Page 22: Loading The Steam Sterilizer

    This leads to better drying results. The use of paper tray inserts can result in poor drying results. Use perforated trays such as those from MELAG. Only in this way can condensate drain off. Non-perforated bases or half-shells for holding the load lead to poor drying results.
  • Page 23 Ensure that the perforations are not covered when stacking the containers. Tip: MELAG sterile containers fulfil the requirements of EN 868-8 for successful sterilization and drying. They have a perforated lid and base and are fitted with disposable paper filters.
  • Page 24: Selecting The Program

    2 kg / 0.6 kg Maximum total weight** 4 kg / 0.6 kg For MELAG mounts, trays, sterilization containers, see Accessories and spare parts [} Page 58] This applies solid loads (e.g. instruments) including the weights of mounts, trays and sterilization con- tainers.
  • Page 25: Additional Program Options

    PLEASE NOTE The steam sterilizer must remain continually activated for the automatic preheating. MELAG recommends activating the automatic preheating function. To alter this setting proceed as follows: Select the Function menu by pressing the '+' and '-' keys simultaneously until the display shows Function: Last batch number.
  • Page 26: Starting The Program

    NOTICE Unsupervised operation of electrical devices, including this steam sterilizer at the operator’s risk. MELAG accepts no liability what so ever for any damage resulting from unsupervised operation. After having selected a program via the program selection key 'P', the display will show both the selected program and sterilization temperature as well as whether the program is suitable for wrapped or unwrapped loads.
  • Page 27: Program End

    6 Sterilization Load the steam sterilizer properly. Stand e.g. the transparent and paper sterilization packaging upright, see Loading the steam sterilizer [} Page 22]. Use the optional package holder if necessary. Activate the function Additional drying, see Selecting additional drying [} Page 25]. Program end When the program has been completed successfully, the display shows: Universal-Program run successfully...
  • Page 28 6 Sterilization Depending on the time of the abort, pressure will be released or the device will be ventilated. A corresponding display text appears on the display. After pressure release or ventilation, you will be asked to acknowledge the program abort. The display will alternate between Stop / End and Acknowledge with '-' key.
  • Page 29: Removing The Sterile Material

    6 Sterilization Removing the sterile material CAUTION Danger of burns from hot metal surfaces Allow the device to cool sufficiently before opening. Do not touch any hot metal parts. CAUTION Unsterile instruments resulting from damaged or burst packaging. This endangers the health of your patients and practice team.
  • Page 30: Logging

    7 Logging 7 Logging Batch documentation The batch documentation serves as proof of the successful conclusion of the program and represents an obligatory part of quality assurance. The device internal log memory saves such data as the program type, batch and process parameters of all the programs completed. To obtain the batch documentation, you can output the internal log memory and transfer its data to various output media.
  • Page 31: Output Media

    7 Logging Output media You are able to output and archive the logs of the completed programs on the following output media: ▪ MELAflash CF card printer on the CF card ▪ Computer, e.g. with MELAtrace software (optionally with MELAnet Box) ▪...
  • Page 32 7 Logging Reading out text logs on the computer You can use the MELAtrace software to read out the logs. The following settings are required to register the computer on the steam sterilizer: Switch on the steam sterilizer. Wait until the display shows the initial state. Select SETUP menu Function by pressing the ‘+’...
  • Page 33: Outputting Logs Immediately And Automatically

    Pressing the 'S' key once again enables you to leave the menu and return to the display initial state. PLEASE NOTE If immediate output is unable to issue a log, for example, because the output medium activated is not connected, a warning message will appear. MELAG recommends using the immediate log output function.
  • Page 34: Subsequent Log Output

    7 Logging Graphic logs For log output immediately after program end, comply with the following: In Function: Log output, MELAnet+graphic data must be selected as the output medium. The computer or another medium must be connected and initialised. Subsequent log output It is possible to issue logs subsequently and independently of the time of a program end.
  • Page 35: Displaying The Log Memory

    7 Logging Outputting all saved logs Proceed as follows to output all the saved logs subsequently: Select the menu Function by pressing the '+' and '-' keys simultaneously. The display will show the message Function: Last batch number. Navigate using the '+' or '-' key until the display shows Function: Log output and press the 'P' key.
  • Page 36: Deleting Logs In The Internal Log Memory

    7 Logging Deleting logs in the internal log memory Delete the saved logs manually to suppress warnings, e.g. Log memory full, while the option Immediate output is set to NO. The following example shows how to delete all the logs saved. Select the Function menu by pressing the '+' and '-' keys simultaneously.
  • Page 37 7 Logging Example for a text log of a successfully completed program Steam sterilizer type ---------- started program Current date Time at program start Daily batch number Serial number Heating temperature Conductivity of the feed water VALUES OF THE PROGRAM STEPS Program run phases with the associated values for pressure, temperature and time (relative to the program start)
  • Page 38: Function Checks

    8 Function checks 8 Function checks Automatic functional checks The electronic parameter control subjects the interaction of the sterilization-relevant parameters pressure, temperature and time to constant automatic monitoring. The steam sterilizer process evaluation system compares the process parameters during the program with each other and monitors them in terms of their threshold values.
  • Page 39: Checking The Quality Of The Feed Water

    8 Function checks Checking the quality of the feed water You can access the water quality on the display at any time during a current program when the steam sterilizer is switched on. AIN6: Conductivity 15 µS/cm To do so, hold the '-' key depressed until the display shows Conductivity. Ê...
  • Page 40: Maintenance

    Do not use any hard objects for cleaning such as a metal saucepan cleaner or a steel brush. Sterilization chamber, door seal, mount, trays To maintain the value of your device and to prevent persistent contamination and deposits, MELAG recommends weekly cleaning of the surfaces.
  • Page 41 9 Maintenance Housing parts Where necessary, clean the housing parts with a neutral fluid cleaner or spirit. Comply with the following specifications when disinfecting the housing parts: Use wipe disinfectants and not spray disinfectants. This prevents disinfectant from getting into inaccessible places or ventilation slots.
  • Page 42: Avoiding Staining

    9 Maintenance Avoiding staining Only proper cleaning of the instruments prior to sterilization enables you to avoid residue from being released from the load under steam pressure during sterilization. Loosened dirt residue can clog the filter, fittings and valves of the device and deposit themselves on the instruments and in the sterilization chamber as deposits and stains.
  • Page 43: Replacing Or Sterilizing The Sterile Filter

    9 Maintenance Insert the door seal in the groove of the round blank. PLEASE NOTE Make sure that the broad seal face faces the sterilization chamber when inserting. The door can only be shut correctly and the sterilization chamber sealed, if the door seal sits correctly in the groove.
  • Page 44 9 Maintenance Exert a little pressure on the sterile filter and turn to insert it into the holding sockets. Sterilizing the sterile filter Remove the sterile filter by turning and pulling it from the holding sockets simultaneously. Slide a into the steam sterilizer and place the sterile filter vertically on the tray.
  • Page 45: Cleaning The Filter In The Sterilization Chamber

    Maintain the specified maintenance intervals. Continuing operation beyond the maintenance interval can result in malfunctions in the device. Have maintenance performed only by trained and authorised technicians using the original MELAG maintenance set. If components that are not included in the maintenance set have to be replaced during maintenance, only original spare parts from MELAG may be used for the replacement.
  • Page 46: Pause Times

    10 Pause times 10 Pause times Frequency of sterilization Pause times between individual programs are not necessary. After the end/abort of the drying time and removal of the sterile material, you can load the steam sterilizer again and start a new program. Operating pauses Depending on the duration of the operating pauses, the following measures must be maintained: Duration of the operating pause...
  • Page 47: Transport

    10 Pause times Transport Transport within the practice NOTICE Failure to observe these provisions can result in damage to the device and malfunction. Comply with the following provisions when transporting within a room or the practice: When using a water treatment unit and/or an outlet hose, close the water inflow and remove the hose connections on the rear of the device.
  • Page 48: Malfunctions

    Should the following table not contain the relevant event, or your efforts do not redress the problem, you can contact your nearest stockist or a local authorised MELAG customer service provider. Please have the serial number of your device and a detailed description of the message ready.
  • Page 49: Warnings

    The in- thorised customer services / stockist tech- stalled flow monitor does not close. nician. When using a MELAG water treatment unit: The warning message will be dis- MELAdem 40/53/53 C: played after a program start. The in- Check the water treatment unit and open stalled flow monitor does not close.
  • Page 50 11 Malfunctions Event Possible causes What you can do Feed water quality in- Feed water conductivity too high. Start no longer possible. sufficient / Start not See event: Feed water quality bad (Re- Conductivity ≥ 65 µS/cm possible place cartridge/module). Please wait / Preheat- This message appears during the The steam sterilizer starts automatically...
  • Page 51: Fault Messages

    11 Malfunctions Event Possible causes What you can do Notice! Battery empty Monitoring of the internal battery Have the battery replaced by an authorised voltage has returned a low value. technician. Fault messages Event Possible causes What you can do The overheat protection has tripped.
  • Page 52 11 Malfunctions Event Possible causes What you can do The overheat protection of the tubular Allow the steam sterilizer to cool for approx. 2 min heating element has triggered. and then restart the program. PLEASE NOTE: This notification can be issued if a program is started immediately after a malfunction or a program abort.
  • Page 53 11 Malfunctions Event Possible causes What you can do The steam sterilizer was switched off at Replace or sterilize the sterile filter as follows: the power switch during a program run. Remove the sterile filter from the rear panel of the steam sterilizer and sterilize it in the Gentle-Program without continuing loading.
  • Page 54 11 Malfunctions Event Possible causes What you can do The internal memory (EEPROM) has Acknowledge the malfunction message and if suffered data inconsistency or data necessary, reset the date and time, see Setting loss. the date and time [} Page 20]. Start the program again. see event F23 The door seal and/or the seal face on Check the door seal and the seal face on the sterili-...
  • Page 55: Opening The Door In An Emergency Following A Power Outage

    11 Malfunctions Opening the door in an emergency following a power outage WARNING The steam sterilizer must be completely pressure free. Failure to observe this provision can result in scalding/injury. No steam may be permitted to leave from between the sterile filter and the rear panel of the steam sterilizer.
  • Page 56: Replacing The Device Fuses

    11 Malfunctions Replacing the device fuses If the device fuses have tripped, proceed as follows to replace them: Switch off the steam sterilizer at the mains and remove the plug from the socket. Open the door manually, see Emergency door opening in case of power failure [} Page 55].
  • Page 57: Technical Data

    4 l (approx. 7 cycles) feed water side) Wastewater connection Max. water temperature 70 °C Volume (internal storage tank, waste water side) When using a water treatment unit Optional: automatically via the one-way drain with the MELAG upgrade kit for the tank drain...
  • Page 58: Accessories And Spare Parts

    13 Accessories and spare parts 13 Accessories and spare parts You can obtain the specified articles and an overview of further accessories from your stockist. Category Article Art. no. Mounts Mount A Plus ME82630 for 5 trays or 3 sterilization containers Mount D ME46840 for 2 high cassettes or 4 trays...
  • Page 59: Glossary

    DGSV to perform maintenance and installation work on DGSV is the abbreviation for “Deutsche MELAG devices. Only they may carry out this Gesellschaft für Sterilgutversorgung” [German work. Society for Sterile Supply]. The training guidelines of the DGSV are listed in DIN 58946, Part 6 as requirements for personnel.
  • Page 60 Glossary EN 13060 L ≤ 1500 mm. The following applies for an article Standard for “Small steam sterilizers” open on both sides: 2 ≤ L/D ≤ 1500 and L ≤ 3000 mm and which does not correspond to the hollow body B (L = hollow body length, D = hollow body EN ISO 11607-1 Standard for “packaging for medical devices to be...
  • Page 61 Glossary for the aseptic delivery of the product at the point of use. Sterile material Sterile goods are successfully sterilized (i.e. sterile) goods. Sterile goods are also referred to as batches. Sterilization chamber The sterilization chamber is the part of the steam sterilizer where the load is sterilized.
  • Page 62 MELAG Medizintechnik GmbH & Co. KG Geneststraße 6-10 10829 Berlin Germany Email: info@melag.com Web: www.melag.com Original instructions Responsible for content: MELAG Medizintechnik GmbH & Co. KG We reserve the right to technical alterations Your stockist...

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