MELAG MELAtronic 15 EN+ User Manual
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MELAG MELAtronic 15 EN+ User Manual

Autoclave as of software version 5.15
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User Manual
Autoclave
®
MELAtronic
15 EN+
as of software version 5.15
Dear doctor,
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
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 system is subject to close monitoring: one instrument to this end is our annual multi-day audit
conducted in accordance with ISO 13485. 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 MELAtronic 15 EN+

  • Page 1 ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance with strict quality criteria.
  • Page 2 It represents a component of the product. ® MELAtronic 15 EN+ as of software version 5.15 Responsible for the contens: MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany E-Mail: info@melag.de www.melag.com Dokument: BA_15EN+_10615_EN_v7.docx / Revision: 7 – 18/1847...
  • Page 3 Foreword Thank you for having chosen this MELAG autoclave. This manual uses the device description "autoclave“ for the steam Device description sterilizer MELAtronic 15 EN+. The user manual includes important safety information required for User manual operation of the autoclave. Read all the instructions carefully and in the correct order.
  • Page 4 Disposal Electrical and electronic MELAG devices are synonymous for long-term quality. When you eventually need to decommission your MELAG device, we offer a special equipment disposal service. Simply contact your stockist. Dispose of accessories and consumption media which you no longer Accessories and require in the appropriate manner.
  • Page 5 Please read this user manual carefully before commissioning the device. The manual includes important safety information. The functionality and value-retention of this sterilizer depends on the care accorded to it. Please store this user manual carefully and in close proximity to your sterilizer. It represents a component of the product.
  • Page 6 Never unplug by pulling on the power cable. Always take a grip on the plug. ■ Set-up installation and The autoclave should only be set-up, installed and commissioned by MELAG authorized persons. commissioning ■ Never operate the autoclave in areas exposed to the danger of explosion.

  • Page 7: Table Of Contents

    CONTENTS Chapter 1 – Performance Specifications .... 8 Use MELAflash as output medium ....... 31 Use MELAnet Box as output medium ....31 Proper Use ............. 8 Use the computer as output medium ....31 User Benefits ............8 Automatic immediate log output ......31 Overview of the Sterilization programs ....

  • Page 8: Chapter 1 - Performance Specifications

    ■ Only ever use the autoclave for the applications as foreseen in the technical documentation and only in connection with the devices and components as cleared for use by MELAG. Notice ■ As with the preceding instrument treatment, the sterilization of instruments and textiles using this autoclave may only be carried out by competent personnel.
  • Page 9 Chapter 1 – Performance Specifications Internal feed-water provision The autoclave uses both a feed-water circulation system and a feed-water one-way system, using the external condensate container (p. 17, in a circulation and one-way Connecting the external condensate container) system. When using the feed water circulation system, the autoclave saves water, as the feed water is used for multiple sterilization cycles.

  • Page 10: Overview Of The Sterilization Programs

    Chapter 1 – Performance Specifications Overview of the Sterilization programs Type tests Universal- Prion- Gentle- Quick- Program Program Program Program S Program type in accordance with Type S Type S Type S Type S DIN EN 13060 Dynamic pressure test of the sterilization chamber Empty chamber test Massive load unwrapped...

  • Page 11: Chapter 2 - Device Description

    Chapter 2 – Device Description Chapter 2 – Device Description This chapter informs you as to  Which components are included in a standard scope of delivery  The constituent components of the autoclave  The safety features of the autoclave ...

  • Page 12: Views Of The Device

    Chapter 2 – Device Description Views of the device Front (1) Operating and display panel (2) Mains switch (3) Front device foot (adjustable) (4) Reset key overheating protection (5) Storage tank drain valve (6) Door, pivots to the left (7) Twist grip Rear (14) (8) Sterile filter...

  • Page 13: Packing Space

    Chapter 2 – Device Description (1) Upper tank cap with grate (2) Lower tank cap (3) Internal storage tank for feed water (4) Latch (5) Door contact (6) Chamber (7) Door plate (8) Grey door seal Fig. 2: View of the interior Packing space Device type Diameter...

  • Page 14: Feed Water Supply

    Chapter 2 – Device Description The display switches to the basic state after every activation of the device. Basic state This displays the current time and chamber pressure in bar and the (steam) temperature in °C. Feed water supply The autoclave requires demineralised or distilled feed water in accordance with DIN EN 1360 to generate steam.

  • Page 15: Chapter 3 - Commissioning

    Pre-conditions for the set-up, installation and commissioning ■ The autoclave should only be set-up, installed and commissioned by MELAG authorized persons. ■ In accordance with current VDE specifications, the autoclave is unsuitable for operation in areas exposed to the danger of explosion.

  • Page 16: Establishing Connections

    Chapter 3 – Commissioning The distance between the surrounding surfaces and the sides and the rear Distance to the of the autoclave must amount to a minimum of 5 cm. The top of the surrounding surfaces autoclave should be freely-accessible so that the inbuilt storage tank can be filled and good ventilation in ensured.

  • Page 17: Connecting The External Condensate Container

    Further alterations to the program run are possible in each individual case and will still ensure the effectiveness of the sterilization, but may only be performed by authorized persons. Please consult your stockist or MELAG. Preconditions for commissioning The following requirements must be satisfied to commission the autoclave: ...

  • Page 18: Installation And Setup Protocol

    Important The set-up protocol from the responsible person must be filled out and a copy sent to MELAG as proof of the correct setup, installation and commissioning. This is a constituent part of any guarantee claim. Switching on the autoclave Switch on the autoclave at the mains (Fig.

  • Page 19: Chapter 4 - Sterilizing

    Chapter 4 - Sterilizing Chapter 4 - Sterilizing This chapter informs you as to  How to fill fresh feed water  What you should be aware of when preparing the sterilization material  How to load the autoclave correctly ...

  • Page 20: Loading The Autoclave

    Chapter 4 - Sterilizing NOTE Wherever possible, please ensure the separate sterilization of textiles and instruments in separate sterilization containers or sterilization packaging. This leads to better drying results. Please observe the following points when treating textiles and Textiles putting the textiles in sterilization containers: ■...
  • Page 21 Chapter 4 - Sterilizing NOTE Use perforated trays such as those from MELAG. Only in this way can the condensate drain off. The use of a non-perforated base or half-shell to accept the sterilization material can result in poor drying results. Please note that under certain circumstances, the use of paper tray inserts can lead to poor drying results.

  • Page 22: To Observe Before Every Sterilization Run

    2 sterilization containers 15M max. 1 sterilization containers 15G 2 kg 150 g Maximum total *MELAG mounting, trays and sterilization containers. See appendix A – accessories To observe before every sterilization run  Control the storage tank for dirt.

  • Page 23: Selecting The Program

    Chapter 4 - Sterilizing locking pin advances. Only in this way can the door be closed fully. Selecting the program You can switch between the basic state and the desired program using the program selection switch. Now select the sterilization program according to how and whether the sterilization material is packed.

  • Page 24: Selecting Additional Drying

    To end the menu Function: autom. preheating and to return to the basic state, press the (S) key twice. NOTE MELAG recommends activating the function automatic pre-heating. Selecting additional drying The function additional drying extends the drying time by 50%. This is Additional drying suitable for difficult drying tasks.

  • Page 25: Manual Program Abort

    Chapter 4 - Sterilizing Heating phase The heating phase follows the ventilation phase. The continued steam admittance into the chamber leads to an increase in pressure and Heat up temperature which continues until the sterilization parameters have been 1.80bar 117°C reached.

  • Page 26: Sterilization Phase Is Finished

    Chapter 4 - Sterilizing door with ’+’ key and the program previously selected. You can open the door after pressing the (+) key. The log records the note “program aborted / load not sterilized“. You can abort the program during the drying phase without the autoclave Manual abort during drying registering an error.

  • Page 27: Program Is Finished

    Chapter 4 - Sterilizing Observe the contents of the section Loading the autoclave on page 20. Use a film bracket if necessary. Program is finished Once the program has come to an end, the chamber pressure is adapted Universal-Program to the surrounding pressure. When the program has ended successfully, run successfully the corresponding message will be issued on the display.

  • Page 28: Removing The Sterilized Equipment

    Chapter 4 - Sterilizing Removing the sterilized equipment You must observe the following whilst removing the sterilized equipment after a program end: Danger of burns ■ Never use force to open the door. This could damage the autoclave and/or result in the emission of hot steam. ■...

  • Page 29: Chapter 5 - Logging

    Chapter 5 - Logging Chapter 5 - Logging This chapter informs you as to  How and why to document batches  Which output media you can use for batch documentation  How to read logs correctly  How to set the date and time on the autoclave Batch documentation The batch documentation acts as proof of the successful conclusion of the sterilization process and represents an obligatory part of quality...

  • Page 30: Use Printer As Output Medium

    Chapter 5 - Logging keys: hours, minutes, seconds, day, month, year.  To adjust the Hours parameter, press the (P) key to confirm. The current value flashes on the display.  You can increase or reduce the value using the (+) and (-) keys. ...

  • Page 31: Use Melaflash As Output Medium

    MELAflash CF card printer operating instructions. Use MELAnet Box as output medium The MELAnet Box allows you to connect a MELAG autoclave to the Output medium practice or clinic computer network via an Ethernet interface. The logs...

  • Page 32: Subsequent Log Issue

    PLEASE NOTicE If immediate issue is not possible, for example, because the output medium activated is not connected, a warning will appear. MELAG recommends using the immediate log issue function. Subsequent log issue It is possible to issue logs subsequently and independently of the time of the end of the program.
  • Page 33 Chapter 5 - Logging Repeated pressing of the (S) key enables you to leave the menu entirely and return to the display basic state. Printing all saved logs Proceed as follows to issue all the saved logs subsequently:  Select the setup menu Function by pressing the (+) or (-) keys quickly and simultaneously.

  • Page 34: Displaying The Log Memory

    Chapter 5 - Logging Displaying the log memory If a printer or other output medium is connected and initialized, you can Allocated: 40 check how many logs have already been saved in the autoclave log Free: memory. Proceed as follows: ...
  • Page 35 The summary indicates whether the program has been completed successfully. The values of the sterilization time recorded, the sterilization temperature and the pressure (including the maximum deviation) are also displayed. ------------------------------------------ Head MELAG MELAtronic15 EN ------------------------------------------ Program : Universal-Program Program started 134°C wrapped Date: 19.03.2010...

  • Page 36: Chapter 6 - Maintenance

    Chapter 6 - Maintenance Chapter 6 - Maintenance This chapter informs you as to  How to clean the autoclave and which cleaning fluids are suitable for the task  How to avoid stains  What you need to observe in maintaining the autoclave Cleaning Weekly check of chamber, Investigate the chamber, door seal and mounting for the load (see page...
  • Page 37 Chapter 6 - Maintenance Changing the feed water When using the feed water circulation system the feed water must be changed at least once a week. When using the feed water circulation system, you should clean the water Cleaning the water intake filter in the storage tank on a weekly basis.

  • Page 38: Avoiding The Development Of Stains

    Chapter 6 - Maintenance When operating with a feed water circulation system, clean the chamber Cleaning the “pressure filter every three months. Operation with a one-way system requires pump” filter. cleaning every half year. Do so by unscrewing the filter and rinsing under running water.

  • Page 39: Changing The Fuse

    Maintenance ■ Maintenance should only be performed by trained customer services technicians, or stockist technicians. Consult your stockist or the nearest MELAG customer services point. Notice ■ Maintain the specified servicing intervals. Continuing operation despite maintenance messages can result in malfunctions in the autoclave.

  • Page 40: Chapter 7 - Operating Pauses

    Chapter 7 – Operating Pauses Chapter 7 – Operating Pauses This chapter informs you as to  How quickly you can begin consecutive programs  What you need to observe with longer operating pauses  How to decommission, transport and then recommission the device Frequency of sterilization The standard mode of operation is the circulation system.

  • Page 41: Decommissioning

    Chapter 7 – Operating Pauses Decommissioning When decommissioning the autoclave for a long pause (e.g. due to holiday or planned transport), proceed as follows:  Switch off the autoclave at the mains.  Remove the plug from the socket.  Empty the internal storage tank.

  • Page 42: Chapter 8 - Functional Checks

    Chapter 8 – Functional Checks Chapter 8 – Functional Checks This chapter informs you as to  How the autoclave conducts the functional check automatically  What forms of manual functional check are available  Which functional checks you should perform in daily operation ...

  • Page 43: Displaying The Water Quality

    Chapter 8 – Functional Checks Displaying the water quality You can access the water quality on the display at any time during a AIN6: Conductivity current program when the autoclave is switched on. 15 µS/cm To achieve an optimally exact measurement, the conductivity should be measured before the first sterilization at the beginning of the working day, whilst the device is still cold.

  • Page 44: Chapter 9 - Malfunctions

    Chapter 9 – Malfunctions Chapter 9 – Malfunctions This chapter informs you as to  The different types of messages  How to react to malfunctions  What you can do before contacting the hotline  What you can do when the display is empty ...
  • Page 45 Chapter 9 – Malfunctions MELAG customer service provider. To enable us to give the best possible service, please have your autoclave serial number and a detailed description of the error contained in the error message to hand. Warning Possible cause...
  • Page 46 NOTE The maintenance counter is to be reset by customer services. Warning: Battery empty Monitoring of the internal battery The battery is to be changed by MELAG voltage has returned too low a customer services/your specialist stockist value. customer services.
  • Page 47 Chapter 9 – Malfunctions Error message Possible cause What you can do Error 2: Steam generator Autoclave is overloaded Maintain correct loading amounts (see p. Loading the autoclave). Reduced heat production, as the Check the on-site electrical connection. mains voltage is too low Try operating the device on a different electrical circuit.
  • Page 48 The error message is issued after the a program start operating voltage is restored. Check all on-site installations. If you are unable to locate a fault, inform MELAG customer services. Error 33: Pressure loss The maximum runtime of the steam...

  • Page 49: Empty Display

    Check the door seal and the chamber flange for soiling and clean if necessary. If the door seal is recognizably damaged, it should be replaced. Should this occur repeatedly, inform your stockist technician or MELAG customer services. NOTE To avoid leaks, always screw the door tight before starting a program, independently of the display message "door closed".
  • Page 50 Chapter 9 – Malfunctions  The base of the chamber must be free. Remove any instruments, filter paper or other objects which have fallen onto the chamber floor. Ensure that the autoclave is loaded correctly (see page 20, Loading autoclave). ...

  • Page 51: Technical Data

    Technical Data Technical Data Model name MELAtronic 15 EN+ Device dimensions (WxHxD) 44 x 33 x 50 cm (depths without grip) Chamber (Ø x D) 15 x 38 cm Volume (chamber) 7 Litres Volume (storage tank) 3 Litres Weight (empty) 22 kg Electrical connection 220-240V*...

  • Page 52: Glossary

    Deutsche Gesellschaft für Sterilgutverordnung (German Authorized personnel Association for the Sterilized Equipment Ordinance). The medical stockists, depot technicians or MELAG-specified DGSV training centres are specified in DIN 58946, part 6 customer services trained by MELAG as "Requirements of personnel".
  • Page 53 Glossary Feed water Porous full load – test of porous full load is used to produce steam for sterilization. The guide values serves to prove that with the values set in the control, the for water quality in accordance with DIN EN 285 / necessary sterilization conditions are reached within an DIN EN 13060 –...
  • Page 54 Glossary Verband der Elektrotechnik, Elektronik und Informationstechnik e.V. (Alliance of the Electronics, Electrotechnical and IT Industry)

  • Page 55: Appendix A - Accessories

    Appendix A - Accessories Appendix A - Accessories Article Ordering number* Tray mount Mount for 3 trays 40018 Sterilization container with a 15K depth / width / height in cm: 18 / 12 / 4,5 01151 single-use paper filter in 15M depth / width / height in cm: 35 / 12 / 4,5 01152 accordance with...

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