MELAG Vacuklav 31 B+ User Manual
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MELAG Vacuklav 31 B+ User Manual

Steam sterilizer
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User Manual
Vacuklav
Vacuklav
Steam sterilizer
from software version 5.17
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 treatment and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing
hygiene"
and
"Quality – made in
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance with ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance with
strict quality criteria.
The MELAG management and team.
®
23 B+
®
31 B+
Germany", we guarantee that these demands will be met. Our certified quality man-
"competence in

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  • Page 1 5.17 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 2 Safety..................................... 6 3 Performance specifications .............................. 8 Intended use .................................. 8 Sterilization procedure ................................. 8 Safety equipment ................................. 8 Overview of sterilization programs ............................ 9 Program sequences ................................ 10 Overview of programs ................................ 11 4 Description of the device.............................. 13 Scope of delivery................................ 13 Views of the device ................................ 14 Symbols on the device ............................... 15...
  • Page 4 Contents Deleting logs in the internal log memory .......................... 36 Reading logs correctly................................ 37 9 Function tests .................................. 39 Automatic functional checks............................... 39 Manual functional checks.............................. 39 Batch-related tests ................................ 39 Vacuum test .................................. 39 Bowie & Dick test ................................ 40 Checking the quality of the feed water .......................... 40 Checking the preheating temperature of the chamber....................... 41 10 Maintenance.................................. 42 Servicing intervals ................................ 42...

  • Page 5: General Guidelines

    Please store these user manual carefully and in close proximity to your device. It represents a compo- nent of the product. Should the user manual no longer be legible, damaged or lost, please obtain a new copy from MELAG. State the device type and your address in an e-mail.

  • Page 6: Safety

    Set-up, installation and commissioning Check the device for any damage suffered during transport after unpacking. The device should only be set-up, installed and commissioned by MELAG authorized technicians. The connections for electrical provision and water supply and discharge must be set-up by trained personnel.
  • Page 7 (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 This steam sterilizer is designed for application in a medical context, e.g. general practitioners and dental practices. According to DIN EN 13060, this steam sterilizer is considered as a steam sterilizer with type B cycles.

  • Page 9: Overview Of Sterilization Programs

    3 Performance specifications Overview of sterilization programs The results in this table show which inspections were performed on the steam sterilizer. The marked field shows compliance with all the applicable sections of the standard DIN EN 13060. Type tests Universal- Quick- Quick- Gentle-...

  • Page 10: Program Sequences

    3 Performance specifications Program sequences Regular sterilization program A program runs in three phases: air removal, sterilization and drying phase. 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 / the drying.

  • Page 11: Overview Of Programs

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

  • 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 ▪ Vacuklav 23 B+ or Vacuklav 31 B+ ▪ User manual ▪...

  • Page 14: Views Of The Device

    4 Description of the device Views of the device Operating and display panel Door, swings open to the left Locking slider Power switch Front device foot (adjustable) Fig. 1: View from front Tank lid Slot for optional upgrade with the safety combination EN 1717 Spring safety valve Sterile filter Emergency overflow hose...

  • Page 15: Symbols On The Device

    4 Description of the device Chamber Door locking pin Chamber sealing face 2x Device fuse Serial data and printer connection (RS232) Connection for emptying the internal storage tank - feed water Connection for emptying the internal storage tank - wastewater Door seal 21 20 Round blank...

  • Page 16: Operating Panel

    - it must be delivered to the vendor to be disposed of. 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 17: Load Mounts

    4 Description of the device Load mounts The steam sterilizer is always delivered with a mount for holding trays or cassettes. Detailed information regarding the various mounts, their combinability with various load holders and their application can be found in the document “Usage instructions for mounts”. Mount A “Plus”...

  • Page 18: First Steps

    The record of installation and setting up is to be completed by the responsible stockist and a copy sent to MELAG as proof of the correct set-up, installation and initial commissioning. This is a constituent part of any guarantee claim.

  • Page 19: Wastewater Connection

    5 First steps Wastewater connection The wastewater can either be collected in the internal storage tank on the wastewater side (left) and be removed manually or be let out automatically via the one-way outlet. An upgrade kit can be ordered to connect the steam sterilizer to the wastewater.
  • Page 20 5 First steps For example, to adjust the hour parameter, press the 'P' key to confirm. Ê The current value flashes on the display. You can increase or reduce the value using the '+' and '-' keys. Confirm with the 'P' key to confirm. Ê...

  • Page 21: Loading The Steam Sterilizer

    6 Loading the steam sterilizer 6 Loading the steam sterilizer Preparing the sterilization material Cleaning and disinfection must always have been performed before sterilization. Only in this way is it possible to guarantee the subsequent sterilization of the sterilization material. The materials used, the cleaning fluid and treatment procedures used are of decisive significance.
  • Page 22 Insert trays or cassettes in the chamber only with their appropriate mount. Use perforated trays such as those from MELAG. Only in this way can condensate drain off. The use of a non-perforated base or half-shell to accommodate the sterilization material can result in poor drying results.
  • Page 23 Ensure that the perforations are not covered when stacking the containers. Tip: MELAG sterilization containers fulfil the requirements of DIN EN 868-8 for successful sterilization and drying. They have a perforated lid and base and are fitted with disposable paper filters.

  • Page 24: Sterilization

    (see above). The use of another test system in accordance with DIN EN 867-5 is possible. The number of the available test systems means that MELAG is not able to provide technical support when using a different system. The indicator test strips used need not be stored.

  • Page 25: Selecting The Program

    7 Sterilization Selecting the program You can switch between the initial state and the desired program using the program selection key 'P'. Now select the sterilization program according to how and whether the sterilization material is wrapped. It is also necessary to take into account the temperature resistance of the sterilization material. The following table shows which program is to be selected for which sterilization material.

  • Page 26: 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 Function by pressing the '+' and '-' keys simultaneously until the display shows Function: Last batch number.

  • Page 27: 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 un- wrapped sterilization material.

  • Page 28: Program End

    7 Sterilization The steam sterilizer provides excellent drying of the sterilization material. If difficult-to-dry items require better drying, you can undertake the following steps to improve drying: Load the steam sterilizer properly. Stand e.g. the transparent and paper sterilization packaging upright.
  • Page 29 7 Sterilization Proceed as follows to abort the program during drying: Press the 'S' key. Confirm the following security query Stop program? by pressing the 'S' key repeatedly. PLEASE NOTE The security query will be displayed for approx. five seconds. If the 'S' key is not pressed again, the program will continue with the usual program run.

  • Page 30: Removing The Sterilized Equipment

    7 Sterilization Removing the sterilized equipment 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 31: Logging

    8 Logging 8 Logging Batch documentation The batch documentation serves as proof of the successful conclusion of the program and represents an obligatory part of quality assurance (MPBetreibV). 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 32: Output Media

    8 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/MELAview software (optionally with MELAnet Box) ▪...
  • Page 33 8 Logging Reading out text logs on the computer You can use the MELAtrace/MELAview 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 '+' and '-' keys simultaneously.

  • Page 34: Outputting Logs Immediately And Automatically

    8 Logging Mark the editor and confirm with “OK”. Ê You can then open files with this ending via a double-click in Windows Editor. Alternatively, you can open all text logs with the documentation software MELAtrace/MELAview (from MELAview 3). Outputting logs immediately and automatically Text logs If you want to output the associated text log on an output medium automatically and immediately after the end of a program, use the following function: Immediate output YES.

  • Page 35: Subsequent Log Output

    PLEASE NOTE If immediate output is unable to output a log, for example, because the output medium activated is not connected, a warning will appear. MELAG recommends using the immediate log output function. For log output immediately after program end, comply with the following: In SETUP menu Function: Log output MELAnet+graphic data must be selected as the output...

  • Page 36: Displaying The Log Memory

    8 Logging Navigate using the '+' or '-' keys until the display shows: Output stored cycles Press the 'P' key in order to start the output of the selected program. Once the issue has been performed, the display will show: Output. Ê...

  • Page 37: Reading Logs Correctly

    8 Logging To cancel the submenu without deleting, press the 'S' key. Press the 'P' key to leave the menu after deletion. The display will show Function: Log output. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display basic state.
  • Page 38 8 Logging ---------------------------------------------------------- --------------------------------------- Steam sterilizer type MELAG Vacuklav 31-B ---------------------------------------------------------- --------------------------------------- Program : Universal-Program Program started 134°C wrapped Current date Date : 29.08.2018 Time upon program start Time : 10:39:08 (Start) Daily batch number Batch number: : 201831-B4321 Serial number...

  • Page 39: Function Tests

    9 Function tests 9 Function tests 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 40: Bowie & Dick Test

    9 Function tests The current daily batch number and Acknow. with '+' key is displayed. You can open the door after pressing the '+' key. PLEASE NOTE If a log printer or another output medium is connected and the setting Immediate output YES is set, a log printout will be issued at the same time.

  • Page 41: Checking The Preheating Temperature Of The Chamber

    9 Function tests Checking the preheating temperature of the chamber Press the '-' key twice. When pressing the first time, press shortly. When pressing the second time, hold the key depressed. AIN4: Temp. preheat. 120°C Ê The conductivity display disappears and the preheating temperature in the chamber will be displayed.

  • Page 42: Maintenance

    10 Maintenance 10 Maintenance Servicing intervals Interval Measure Device components Daily Check for soiling, deposits or Chamber inc. door seal and chamber damage sealing face, door lock, mount for the load After 24 months or Maintenance By the authorized customer services 1000 cycles working in accordance with the maintenance instructions...
  • Page 43 10 Maintenance Internal storage tank Should you use the internal storage tank for the feed water supply, perform regular checks and cleaning as follows: Interval Upon every refill Check the storage tank for soiling. If necessary, use a cloth and fresh feed water to clean the storage tank before filling.

  • Page 44: Avoiding Staining

    10 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, nozzles and valves of the steam sterilizer and deposit themselves on the instruments and chamber as deposits and stains.

  • Page 45: Replacing Or Sterilizing The Sterile Filter

    10 Maintenance Insert the door seal in the groove of the round blank. PLEASE NOTE Make sure that the broad seal face faces the chamber. The door can only be shut correctly and the chamber sealed, if the door seal sits correctly in the groove. Replacing or sterilizing the sterile filter The sterile filter must be replaced regularly within the scope of the maintenance.
  • Page 46 10 Maintenance Replace the sterile filter or sterilize the current sterile filter, see Sterilizing the sterile filter [} page 46]. 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.

  • Page 47: Cleaning The Filter In The Chamber

    10 Maintenance Cleaning the filter in the chamber Screw out the condensate return filter (pos. a) and the chamber filter (pos. b) anti-clockwise from the opening in order to perform a check. Unscrew the chamber filter (pos. b) using the chamber filter wrench included in the scope of delivery (pos. c). Rinse the filter (a and b) for cleaning with water.

  • Page 48: Pause Times

    11 Pause times 11 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 sterilized equipment, 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 49: 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 authorized MELAG customer service provider. Please have your device serial number and a detailed description of the malfunction contained in the notification to hand.

  • Page 50: Warnings

    The installed flow authorized customer services / stockist monitor does not close. technician. When using a MELAG water treatment unit: The warning will be displayed after a MELAdem 40/53/53 C: program start. The installed flow Check the water treatment unit and open monitor does not close.
  • Page 51 Conductivity ≥ 40 µS/cm When using a MELAG water treatment unit: The mixed-bed resin is exhausted. MELAdem 40/53/53 C: Replace the mixed-bed resin (art. no. 61026), see the user manual of the MELAdem 40 water treatment unit.
  • Page 52 12 Malfunctions Incident Possible causes What you can do Log memory full The internal log memory of the The message is displayed upon program device is full (max. 40 logs possible). start. Repeated pressing of the 'S' key removes the message and the program starts. The oldest log will be deleted in the process.

  • Page 53: Malfunction Messages

    12 Malfunctions Malfunction messages Incident Possible causes What you can do The door seal and/or the seal face on Check the door seal and the seal face on the the sterilization chamber is soiled or the sterilization chamber for soiling and foreign bodies door seal is defective.
  • Page 54 12 Malfunctions Incident Possible causes What you can do The steam sterilizer is overloaded. Comply with the maximum permissible load quantities, see Loading the steam sterilizer [} page 21]. The incline of the steam sterilizer is too Check the incline of the steam sterilizer to the rear. flat.
  • Page 55 (feed water side from below in the tank) up and down repeatedly to restore its free- movement. When using a MELAG water treatment unit: Residual air is in the feed system of the Acknowledge the malfunction message and start the...
  • Page 56 (feed water side) and fill it with water of the required quality (DIN EN 13060, Appendix C). When using a MELAG water treatment unit: MELAdem 40: MELAdem 40/53/53 C: The mixed-bed resin cartridge is Replace the MELAdem 40 mixed-bed resin cartridge exhausted.
  • Page 57 12 Malfunctions Incident 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 ...
  • Page 58 12 Malfunctions Incident Possible causes What you can do Insufficient feed water in the right-hand Check the water level of the feed water in the right- chamber of the internal storage tank. hand chamber of the internal storage tank and refill with feed water if necessary.

  • Page 59: Opening The Door In An Emergency Following A Power Outage

    12 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 60: Replacing The Device Fuses

    12 Malfunctions Replacing the device fuses If the device fuses have been tripped, proceed as follows to change them: Switch off the steam sterilizer at the mains and remove the plug from the socket. Open the door manually, see Opening the door in an emergency following a power outage [} page 59].

  • Page 61: Technical Data

    Wastewater connection Max. water temperature 70 °C Volume (internal storage tank, left-hand chamber) Optional when using a water treatment unit. In Prion-Program with porous full load. Optional: automatically via the one-way outlet with the MELAG upgrade kit for the tank drain.

  • Page 62: Accessories And Spare Parts

    14 Accessories and spare parts 14 Accessories and spare parts You can obtain the specified articles and an overview of further accessories from your stockist. Category Article Art. no. Chamber Chamber depth depth 45 cm 35 cm Mounts Mount A "Plus" 82630 82620 for 5 trays or 3 standard tray cassettes or 3 MELAstore-Box 100...

  • Page 63: Glossary

    (German Society German Society for ployee of a customer service provider or stockist Sterile Supply). The DSGV training centres are who has been trained and authorized by MELAG specified in DIN 58946, part 6 as "Requirements of to perform maintenance and installation work on personnel".
  • Page 64 Glossary Dynamic pressure test of the sterilization chamber Product with narrow lumen Serves to prove that the rate of pressure variations An article open on one side to which the following during a sterilization cycle does not exceed a par- applies: 1 ≤...
  • Page 65 Glossary Vacuum In common parlance, an area devoid of all material
 In the technical sense: volumes with a reduced gas pressure (at least air pressure)
  • Page 66 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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Vacuklav 23 b+

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