MELAG Euroklav 23 S+ User Manual

MELAG Euroklav 23 S+ User Manual

Steam sterilizer
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User Manual
Steam sterilizer
®
Euroklav
23 S+
as of software version 5.15
Dear Dr.
We should like to extend our thanks for the expression of trust in our company which you have displayed through
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
treatment and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing
"competence in hygiene" and "Quality – made in Germany", we guarantee that these demands will be met.
Our certified quality management systems is subject to close monitoring: one instrument to this end is our annual
multi-day audit conducted in accordance with ISO 13485 and ISO 9001. This guarantees that all MELAG products
are manufactured and tested in accordance with strict quality criteria.
The MELAG management and team

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Summary of Contents for MELAG Euroklav 23 S+

  • Page 1 Our certified quality management systems is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in accordance with ISO 13485 and ISO 9001. This guarantees that all MELAG products are manufactured and tested in accordance with strict quality criteria.
  • Page 2 The instructions are a part of the product. ® User Manual of Euroklav 23 S+ ® Valid for Euroklav 23 S+ Responsible for the contents: Engineering Department MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany E-mail: info@melag.de www.melag.de © 2017 Document: BA_EN_23S+_v9.docx/ Revision: 9 – 17/0639...
  • Page 3 Foreword Thank you for deciding to buy this MELAG steam sterilizer. Device name The device name "steam sterilizer" is used in this User Manual to designate the steam sterilizer Euroklav23 S+. User Manual The User Manual contains important safety instructions and information which you need to operate the steam sterilizer.
  • Page 4 MELAG devices are synonymous for long-term quality. When you eventually need to decommission your MELAG device, we offer a special disposal service. Simply contact your stockist.
  • Page 5 Setting up, installation, ■ Only have the steam sterilizer set up, installed, and commissioned by people authorised by MELAG. commissioning ■ Only operate the steam sterilizer in areas which are not subject to explosion hazards.
  • Page 6: Table Of Contents

    Contents Chapter 1 – Performance Specification ....7 Employing MELAflash as output medium ..... 32 MELAnet Box as output medium ......32 Proper use .............. 7 Computer as output medium ........ 32 User benefit ............7 Automatic immediate log output ......33 Overview of sterilization programs ......
  • Page 7: Chapter 1 - Performance Specification

    ■ Use the steam sterilizer only for the intended purposes outlined in the related technical documents and only in connection with the devices and components approved by MELAG. Warning! ■ The sterilization of instruments and textiles with this steam sterilizer, like the foregoing instrument sterilization, is only to be done by competent personnel.
  • Page 8 Chapter 1 – Performance Specification Internal feed water supply The steam sterilizer works both according to the feed water one-way system as well as the feed water circulatory flow system. in one-way and circulatory In the one-way system, it uses fresh purified feed water for every flow system sterilization run.
  • Page 9: Overview Of Sterilization Programs

    Chapter 1 – Performance Specification Overview of sterilization programs The results in this table show which inspections were performed on the sterilizer. Fields marked show compliance with all applicable sections of the standard DIN EN 13060. Type tests Universal- Quick- Gentle- Prion- Program...
  • Page 10: Chapter 2 - Device Description

    Chapter 2 – Device Description Chapter 2 – Device Description In this chapter you learn Which components are included in the standard scope of delivery  Which components the steam sterilizer contains  What safety devices the steam sterilizer has ...
  • Page 11: Device Views

    Chapter 2 – Device Description Device views Front side Operating and display field Door (pivots opens to the left) sliding closure grip Mains switch Front foot of the unit (adjustable) Front side below with opened door Serial data and printer connection (RS232)* 2x Device fuses Reset button for overheating protection Connection for emptying the storage tank feed water...
  • Page 12: Effective Capacity

    Chapter 2 – Device Description Interior view Chamber Mounting to hold trays/ cassettes Door locking pin Chamber sealing surface Blue door seal Round blank Fig. 2: Interior view Effective capacity Device type Diameter Depth Volume Euroklav23 S+ 45 cm 22 litres ∅25 cm Mountings for the load The steam sterilizer is always delivered with a mounting to hold...
  • Page 13: Control Panel

    MELAdem47 respective loads. Both MELAG steam sterilizers can be supplemented with a water treatment unit. NOTICE: Please first consult with MELAG if you would like to employ water treatment units of other manufacturers.
  • Page 14: Chapter 3 - Initial Start-Up

    ■ Only have the steam sterilizer set up, installed, and started up by people authorized by MELAG. ■ According to the currently valid VDE standards, this device is not suitable for use in areas subject to explosion hazards.
  • Page 15: Connections Required

    Chapter 3 – Initial start-up Space requirements Euroklav23 S+ Width A= 42.5 cm Height B= 49 cm Depth C= 70 cm D= 43.5 cm E= 9 cm F= 5 cm G= 10 cm Additional space for Other than for the steam sterilizer, the water treatment unit for the feed water supply require space.
  • Page 16 Connected load  NOTICE: In order to prevent water damage, MELAG recommends the use of a leak monitor, e.g. water stop valve from MELAG (Art. No. 01056). Waste-water drain The steam sterilizer is connected to the drain via the one-way drain (see page 11, Fig.
  • Page 17: Prerequisites For Initial Start-Up

    As documentation of proper setting up, installation and setting up as well as for your warranty claim, the record of installation must be filled out by the person responsible and a copy sent to MELAG. Switch on the steam sterilizer...
  • Page 18: Chapter 4 - Sterilization

    Chapter 4 – Sterilization Chapter 4 – Sterilization In this chapter you learn Which prerequisites should be created for a smoothly-running sterilization  How to switch between internal and external feed water supply  How to switch between the one-way and circulatory feed water system ...
  • Page 19: Prepare Items To Be Sterilized

    Chapter 4 – Sterilization You can choose the one-way feed water or circulatory system for your Choose the one-way feed feed water supply from the internal storage tank. To do so, you must water or circulatory system change the setting on the display before starting a program: Select the SETUP Menu by brief simultaneous pressing of the keys ...
  • Page 20: Load The Steam Sterilizer

    NOTICE: Use perforated trays, such as the trays from MELAG. Only this way can condensate run off. If you use closed materials or shell halves to bear the items to be sterilized, you risk bad drying results. Please note that the use of tray insertions made of paper can perhaps likewise lead to worse drying results.
  • Page 21 This can ultimately lead to unsterile instruments and thereby to endangering the health of the patient and the practice team. The sterilization containers from MELAG satisfy all requirements according to DIN EN 868 for successful sterilization and drying. They are perforated in the lid and floor and are equipped with disposable paper filters.
  • Page 22: Close The Door

    3 standard tray cassettes Maximum total weight 4 kg 0.6 kg *Mountings, trays, sterilization containers, norm-tray cassettes from MELAG, see Appendix A – Accessories Close the door When closing the door of the steam sterilizer, observe the following instructions: Close the door with light pressure against the chamber flange and ...
  • Page 23: Select Automatic Pre-Heating

    (P) once again, switch the display to Pre-heating Press the K  No. The pre-heating is deactivated. In order to end the menu Function: autom. Pre-heating  and return to the initial state, press the K (S) twice. NOTICE: MELAG recommends the activation of automatic pre-heating.
  • Page 24: Select Additional Drying

    Start program Unsupervised operation of electrical devices, including this sterilizer at the operator’s risk. MELAG accepts no liability what so ever for any damage Warning resulting from unsupervised operation. If you have selected a program with the program selection button, in...
  • Page 25: Manually Terminate Program

    Chapter 4 – Sterilization Manually terminate program You manually terminate a running program in any of the phases. IMPORTANT! Do not interrupt a running program by disconnecting the power plug! In case of non-observance, an error message of power loss is displayed when the steam sterilizer is switched back on.
  • Page 26: Sterilization Phase Is Finished

    Chapter 4 – Sterilization NOTICE: The confirmation prompt is shown for about 5 seconds on the display. If the key is not repeatedly pressed, the program continues with the normal process. After the ventilation of the chamber with a corresponding display text the message Universal-Program run successfully follows in alternation with Last batch number.
  • Page 27: Display Batch Number

    Chapter 4 – Sterilization Display batch number Display last batch number After every completed program you automatically see on the display the last batch number of the day. This is also shown if the program was terminated by the operator or aborted by the system. You can also allow the display of the last batch number whenever necessary: Select the SETUP Menu Function by short simultaneous pressing...
  • Page 28: Storage Of Sterilized Items

    Chapter 4 – Sterilization Storage of sterilized items Exclusively employ packaging which complies to standards for the sterilized materials. Do not store sterilized items in the preparation room. For the storage of the sterilized items, observe the criteria mentioned below. Storage conditions ■...
  • Page 29: Chapter 5 - Logging

    Chapter 5 – Logging Chapter 5 – Logging In this chapter you learn Why and how you document batches  Which output media you can employ for the batch documentation in which way  How to read the logs correctly ...
  • Page 30: Set Date And Time

    Chapter 5 – Logging Set date and time Observe time re-settings Date and time of the steam sterilizer must be correctly set for proper batch documentation. Observe the time re-settings in autumn and spring ("daylight saving time"), since this is not reset automatically. Set date and time as described below: Select the SETUP Menu Function by short simultaneous pressing ...
  • Page 31 Chapter 5 – Logging Initialisation of the log In order to be able to print out logs on the connected log printer, you must printer MELAprint42 initialise MELAprint42 once by making the following setting at the steam sterilizer: If the steam sterilizer is still not switched on, switch it on. ...
  • Page 32: Employing Melaflash As Output Medium

    You can download a current version of the software on the internet page of MELAG on www.MELAG.de in the download area. Connect the MELAflash CF Card Writer with the serial interface like the log printer MELAprint42 (see page 30). and set at the steam sterilizer as output medium MELAflash in the SETUP Menu.
  • Page 33: Automatic Immediate Log Output

    If it is not possible to output a log report for the immediate output because for example the activated output medium is not connected, a warning message appears. MELAG recommends that you employ the immediate output of logs. Output the logs subsequently You also have the option of outputting the logs subsequently and independently from the time of the end of the program.
  • Page 34 Chapter 5 – Logging Press the K (P) in order to start the output of the selected program.  The display shows Output. After finished printout, the display changes again to its previous setting Last cycle output: No. 25. In order to output additional logs, repeat the last three steps. ...
  • Page 35: Display Protocol Memory

    Chapter 5 – Logging Display protocol memory With a connected and initialised printer or another output medium you can Start-Stop Program verify how many logs are already saved in the log memory of the steam sterilizer. Proceed as follows: Select the SETUP Menu Function by short simultaneous pressing ...
  • Page 36 Chapter 5 – Logging ------------------------------------------ Header MELAG Euroklav 23-S ------------------------------------------ Program : Universal-Program Started program 134°C wrapped Date : 18.10.2015 Current date Time of day : 10:04:00 (Start) time at program start Batch number: daily batch number : 201523-S1070 Serial number Preheating 124.0 °C...
  • Page 37: Chapter 6 - Maintenance

    Chapter 6 – Maintenance Chapter 6 – Maintenance In this chapter you learn How to clean the steam sterilizer and which cleaning agents are suitable  How to avoid the formation of spots  How to exchange the door seal ...
  • Page 38: Avoid Formation Of Spots

    Chapter 6 – Maintenance Notice: Make sure to wipe up and remove any soiling or impurities from the tank with a cloth without leaving any residues. If dirt particles are only detached but not actually removed, they can get into the dirt particle filter integrated into the drain hose while emptying the wastewater tank.
  • Page 39: Use Qualitatively High-Grade Feed Water

    Chapter 6 – Maintenance Remove third-party rust from the instruments with a chlorine-free stainless steel cleaning agent (see page 37, Cleaning) or send the damaged instruments to the manufacturer for reconditioning. The extent of the formation of spots on the instruments also depends on Formation of spots due to the quality of the feed water employed for steam production.
  • Page 40 Chapter 6 – Maintenance Aligning the door seal sealing lip Long periods of storage with the door closed can result in the sealing lips of the door seal becoming stuck. Align the sealing lips to prevent leaks. Proceed as follows: Remove the door seal.
  • Page 41: Replacing Or Sterilizing The Sterile Filter

    Maintenance ■ Have maintenance carried out only by trained field service technicians or technicians of the specialist trade. Turn to your specialist dealers or MELAG customer service in your vicinity. Warning! ■ Comply with the predetermined maintenance intervals. Malfunctions at the steam sterilizer can occur on continuation of operation despite the servicing message.
  • Page 42: Chapter 7 - Operating Pauses

    Chapter 7 – Operating pauses Chapter 7 – Operating pauses In this chapter you learn How quickly you can start sterilization programs in sequence  What you must observe for longer operating pauses  How to put the steam sterilizer out of operation, transport it and re-start it ...
  • Page 43: Pause Times

    Chapter 7 – Operating pauses Pause times Longer operating pauses Switch the steam sterilizer off for longer operating pauses, e.g. overnight or on the weekend, and leave the door ajar. The door seal is relieved and protected from premature wear. Furthermore it prevents the sticking of the door seal.
  • Page 44: Re-Startup After Change Of Locality

    Chapter 7 – Operating pauses Re-startup after change of locality At re-startup of the steam sterilizer after a change of locality, proceed as Chapter 3 – Initial start-up) for an initial start-up (see page 14,...
  • Page 45: Chapter 8 - Function Test

    Chapter 8 – Function test Chapter 8 – Function test In this chapter you learn How the steam sterilizer automatically carries out the function test  Which possibilities you have for the manual function test  Which function tests should be conducted in daily operation ...
  • Page 46: Testing In Daily Operation

    Chapter 8 – Function test Testing in daily operation Bowie & Dick test The Bowie & Dick test serves the verification of the steam penetration of porous materials such as textiles. Diverse test systems are offered by specialist dealers for the Bowie & Dick test.
  • Page 47: Chapter 9 - Errors

    Chapter 9 – Errors Chapter 9 – Errors In this chapter you learn Which type of messages exist  What you should do in case of errors  What you can do before calling the Hotline  What you can do if no display appears ...
  • Page 48: Before You Call

    If you do not find the event in the table below or your efforts do not lead to success, turn to your specialist dealer or the authorised MELAG customer service centre in your vicinity. In order to help you, keep the serial number of your steam sterilizer and a detailed fault description of the fault report ready.
  • Page 49 Operating Manual for the water treatment unit MELAdem47 and examine the unit On repeated occurrence, have maintenance carried out by MELAG customer service or service of the specialist trade. Possibly the pre- and activated carbon filter must be exchanged in addition.
  • Page 50 NOTICE: Service counter is reset by the customer service Warning! Battery empty The monitoring of the device's The battery must be exchanged by MELAG internal battery voltage has customer service or service of the specialist determined a too low voltage trade value.
  • Page 51 Chapter 9 – Errors Error message Possible causes What you can do Error 2: Steam generator steam sterilizer is overloaded Pay attention to the correct loading quantities (see page 20, Load steam sterilizer) Decreased heating power, since Check building-side electrical Installation, supply voltage too low operate device on a trial basis on another electric circuit.
  • Page 52 Sterilize sterile filter of a program Check building-side installation, If no defects are detectable, notify MELAG customer service In the event of power failure after a program has been started in overpressure, an additional request appears to sterilize the sterile filter, since this has become damp and is possibly contaminated with microbes.
  • Page 53 Chapter 9 – Errors Error message Possible causes What you can do Error 34: Sterilization TU1 Shortfall of the minimum Check door seal for wear permissible sterilization On repeated occurrence notify your specialist temperature (temperature dealer sensor 1) Error 35: Sterilization TO1 Exceeding the maximum Carry out vacuum test permissible sterilization...
  • Page 54: No Display On The Screen

    Chapter 9 – Errors No display on the screen After switching on the steam sterilizer the display remains empty. What you can do Check whether the power plug is correctly in the socket. Check the supply voltage at the socket. If necessary, switch the instrument securing at the lower front of the steam sterilizer (see page 11, Fig.
  • Page 55: Glossary

    Medical specialist dealers, technician from depots or with Type B and Type S customer service designated by MELAG, who were trained DIN EN 868 by MELAG European standard: Packaging materials and systems for...
  • Page 56 Glossary Feed water Porous full load – Check of porous full load is required for the creation of water steam for the Serves to verify that for the values set on the control, the sterilization; typical values for the water quality according required sterilization conditions are achieved in porous to DIN EN 285 or DIN EN 13060.
  • Page 57 Glossary Standards-compliant Conformity with all the relevant standards Sterile barrier systems Closed minimum packaging which prevent the occurrence of microorganisms, e.g. bags closed with sealing, closed reusable containers, folded sterilization cloths Sterilized items also designated as batch, if already successfully sterilized: sterile goods Sterilization chamber Interior of a sterilizer...
  • Page 58: Technical Data

    Technical Data Technical Data Device type Vacuklav 23 S+ Device dimensions (HxWxD) 49 x 42,5 x 70 cm Sterilization chamber (diam x depth) Ø 25 cm | 45 cm Volume of sterilization chamber 22.6 litres Volume of storage tank 5 litres Weight (empty) 45 kg Electrical power...
  • Page 59: Appendix A - Accessories

    Appendix A – Accessories Appendix A – Accessories Article Order number* Euroklav23 S+ Tray mounts A for 5 trays or 3 standard-tray cassette 40244 B for 4 standard-tray cassettes 40224 D for 2 high cassettes or 4 trays 46840 Sterilization containers 15K depth/ width/ height in cm: 18/ 12/ 4,5 01151 with single-use paper...

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