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User Manual
MELAquick
MELAquick
Steam sterilizer
from software version 5.20
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
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance 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.
®
12+
®
12+ p
Germany", we guarantee that these demands will be met. Our certified quality man-
0197
"competence in
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Summary of Contents for MELAG MELAquick 12+
- Page 1 0197 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.
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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................................ 9 Program overview................................ 10 4 Description of the device.............................. 12 Scope of delivery ................................ 12... - Page 4 Contents Storing sterile material ............................... 38 8 Logging .................................... 39 Batch documentation ................................. 39 Output media .................................. 40 Outputting logs immediately and automatically ......................... 42 Subsequent log output............................... 43 Displaying the log memory .............................. 44 Deleting logs in the internal log memory.......................... 45 Reading logs correctly ............................... 45 9 Function checks ................................. 47 Automatic functional checks .............................. 47 Manual functional checks .............................. 47 Batch-related checks ................................. 47...
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Page 5: General Guidelines
Make sure that you always have access to digital or printed version of the user manual. Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from MELAG down- load centre at www.melag.com. -
Page 6: Safety
Germany e.g. from the DGSV). Only ever use packaging material and systems which have been cleared by their manufacturer for steam steriliza- tion. Use only original MELAG accessories or those from other suppliers authorised for use by MELAG. - Page 7 Please note that all serious accidents which occur in connection with the medical product (e.g. death or serious dete- rioration in the state of health of a patient) which were presumably caused by the product, must be reported to the manufacturer (MELAG) and the relevant authority of the member state, in which the user and/or patient resides.
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Page 8: Performance Specifications
Only ever use the steam sterilizer for the applications as foreseen in the technical documentation and only in connection with the devices and components as recommended by MELAG. Like the preceding instrument reprocessing, the sterilization of instruments with this steam sterilizer (in Germany according to §2... -
Page 9: Safety Equipment
3 Performance specifications Safety equipment Internal process monitoring 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 Overview
3 Performance specifications Program phase Description 3. Sterilization phase The sterilization phase begins as soon as the pressure and temperature correspond to the program-dependent nominal values. The sterilization time is indicated on the display. 4. Pressure release The end of the sterilization phase is followed by pressure release with simultaneous emptying. - Page 11 SETUP menu: Function hh:mm:ss Initial state 0.00 bar 89°C Press both keys simultaneously No output medium MELAprint SETUP Menu Function: MELAflash MELAnet graphic data (MELAnet Box) Computer Last batch Autom. Feed water Total batches Date / Time number output preheating supply Last batch number Total batches...
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Page 12: 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 ▪ MELAquick 12+/MELAquick 12+ p ▪ User manual ▪ Warranty certificate ▪... - Page 13 4 Description of the device View from rear Device fuse Cable connection for monitoring the water level in the feed water container Cable connection for monitoring the water level in the wastewater container Connection for wastewater container Slot for emergency release Spring safety valve Connection for feed water container Mains supply for IEC plug...
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Page 14: Symbols On The Device
4 Description of the device Symbols on the device Type plate Manufacturer of the product Date of manufacture of the product Label as medical product Article number of the product Serial number of the product Observe user manual or electronic user manual Do not dispose of product in household waste In affixing this CE mark, the manufacturer declares that this medical product fulfils the basic 0197... -
Page 15: Operating Panel
4 Description of the device Operating panel The operating panel consists of a two-row alphanumerical LED display and four membrane keys. 12:27:12 0.02 bar 25 °C Programm Start - Stop Chamber pressure (bar) and (steam) temperature (°C) Time (hh:min:ss) 2-row LED display for displaying the program status and parameters Start –... - Page 16 4 Description of the device Holder for insert baskets The holder is placed on the work surface. For cooling the instruments after sterilization, the universal basket or the holder with round mounts/ISO adapters can be placed on this holder. Package holder for wrapped instruments The package holder is used to hold up to 3 separately wrapped instruments (packaging according to 868-5).
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Page 17: Installation Requirements
Failure to comply with the setup conditions can result in injuries and/or damage to the steam sterilizer. The steam sterilizer should only be setup, installed and commissioned by persons authorised by MELAG. The steam sterilizer is not suitable for operation in explosive atmospheres. - Page 18 5 Installation requirements Space requirements NOTICE Failure to observe the space requirements can result the build-up of heat. This could adversely affect the function of the device and entail the shortening of the components' lifetime and result in extended program times.
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Page 19: Mains Connection
Improper installation may lead to a short-circuit, fire, water damage or electrical shock. This could result in serious injury. Only have the device set up, installed and commissioned by people authorised by MELAG. Comply with the following for safe handling: Never damage or alter the power plug or cable. -
Page 20: Compressed Air Connection (Only Melaquick 12+)
Water stop For insurance reasons, MELAG recommends the installation of a water stop with a cut-off valve (e.g. from MELAG), as the MELAdem 40 / MELAdem 47 are under constant hydraulic pressure from the domestic water supply. Compressed air connection (only MELAquick 12+) A compressed air connection is provided for MELAquick 12+. -
Page 21: System And Network Safety
MELAflash CF-Card-Printer Writing log data on a CF card NOTICE When performing a device software update, use only the update data authorized by MELAG for the corresponding device type. Operating the device with memory media To prevent data loss, only use memory media to save the log data with the following characteristics: Functional capability (without malware etc.) - Page 22 5 Installation requirements Operating the device in the local network (LAN) NOTICE Do not connect the device to a public network (e.g. the internet). An Ethernet/IP-based network connection (LAN) is required to operate the device in a local network. In its delivery state, the MELAnet Box IP address is 192.168.40.100.
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Page 23: First Steps
The responsible stockist is to complete the record of installation and setup as proof of the correct setup, installation and commissioning. A copy is to be sent to MELAG. This is a constituent part of any guarantee claim. Feed water supply... - Page 24 6 First steps Feed water connection Insert the inlet hose (Ø 6 mm, pos. f) into the feed water connection at the rear of the device as far as it will go and secure the hose with the union nut. To check the water level in the tank (pos.
- Page 25 6 First steps Installation examples MELAdem 40 The feed water is fed from the MELAdem 40 ion exchanger. The water is discharged into the wastewater container. 5.1.1 Position Description Art. no. contained in Mounting set EN 1717 for MELAdem ME49600 Safety combination EN 1717 incl.
- Page 26 6 First steps MELAdem 47 The feed water is fed from the MELAdem 47 reverse osmosis unit. The water is discharged into the wastewater contain- 2.4.1 Position Description Art. no. contained in Safety combination EN 1717 incl. holder ME82375 MELAquick 12+/12+ p Connection for water level monitoring in the wastewater MELAquick container...
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Page 27: Switching On The Steam Sterilizer
6 First steps Position Description Art. no. contained in Cooling water outlet fitting Vacuklav Tap water supply hose EN 1717 ME24930 Vacuklav Water stop (optional) ME01056 Water tap with safety combination (on site) Connecting compressed air (only MELAquick 12+) NOTICE According to 13060, the steam sterilizer must not be operated without the sterile filter integrated ... -
Page 28: Opening And Closing The Door
6 First steps Opening and closing the door Opening the door After the end of a program, the request Acknow. with '+' key is displayed. Unlock the door with the '+' key. Ê The door unlocks audibly. PLEASE NOTE The door can only be opened when the twist grip is fully turned by 90°. If it was unintentionally attempted to open the door while the door was still locked, the twist grip must first be turned back until the groove is perpendicular to the longitudinal axis. -
Page 29: Settings
6 First steps Manual door emergency-opening 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 30 6 First steps You can increase or reduce the value using the '+' and '-' keys. Confirm with the 'P' key in order to save the value. Ê The current value set no longer flashes on the display. Proceed in a similar fashion to alter the other parameters. After completing the settings, press the 'S' key to leave the menu.
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Page 31: Sterilization
7 Sterilization 7 Sterilization Preparing the load Always clean and disinfect properly before sterilization. Only in this way is it possible to guarantee the subsequent sterili- zation of the load. The materials used, cleaning agents and reprocessing procedure are of decisive significance. ... - Page 32 7 Sterilization For sterilization of very small loads, e.g. in the endodontic field (e.g. Hedström files, reamers, K-files), use the semicircular small parts insert. Hang the small parts insert either higher or lower in the universal basket. When using the holder with ISO adapters and the holder with round mounts, up to 7 unwrapped straight and contra- angle handpieces or turbines can be sterilized.
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Page 33: Selecting The Program
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... -
Page 34: Selecting Additional Drying
7 Sterilization Press the 'P' key to confirm. Ê The display will show the option currently set e.g. Preheating YES. Pressing the 'P' key again makes the display switch to Preheating NO. Ê The preheating function has been deactivated. Press the 'S' key twice to leave Function: Autom. preheating and return to the initial state. -
Page 35: Program In Progress
7 Sterilization Program in progress After starting the program, you can follow the program run (see Program sequences [} page 9]) on the display. It shows the temperature and pressure of the sterilization chamber as well as the time until the end of sterilization / the drying time which has passed. - Page 36 7 Sterilization Program abort before the start of drying WARNING Danger of infection from early program abort Aborting a program before the drying phase begins means that the load is unsterile. This endangers the health of your patients and practice team. Re-pack the load if necessary.
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Page 37: Program Is Ended
7 Sterilization Confirm the following security query Immediate removal 'Stop' by pressing the 'S' key again. Ê The display confirms the abort with Drying stopped. At the end of the program, the message Universal-Program S run successfully alternates with Last batch number xx and Last batch number 7 Acknow. -
Page 38: Storing Sterile Material
7 Sterilization Comply with the following specifications when removing the sterile material: Never use force to open the door. This could damage the device or result in the emission of hot steam. Use a basket handle to remove the universal basket. Never touch the sterile material, the sterilization chamber, package holder, the holders or the inside of the door with bare hands. -
Page 39: 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. The device internal log memory saves such data as the program type, batch and process parame- ... -
Page 40: 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 41 8 Logging Press the 'P' key again. Ê If an output medium has yet to be chosen, the display will show the Log output - No output medium notification. Navigate using the '+' or '-' key until the display shows Output medium Computer.
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Page 42: 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 automatically after the end of a program on an output medium, use the func- tion Immediate output YES. -
Page 43: Subsequent Log Output
PLEASE NOTE If immediate output is unable to issue a log, for example, because the output medium activated is not connected, a warning will appear. MELAG recommends using the immediate log output function. 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. -
Page 44: Displaying The Log Memory
8 Logging Navigate using the '+' or '-' key until the display shows: Output stored cycles Programm Start-Stop Press the 'P' key in order to start the output of the selected program. During the output the message Output will be displayed. -
Page 45: Deleting Logs In The Internal Log Memory
8 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 menu Function by pressing the '+' and '-' keys simultaneously. - Page 46 8 Logging Example for a text log of a successfully completed program --------------------------------------- Device type --------------------------------------- Program started Current date Time at program start Batch number of the day Serial number --------------------------------------- Preheating temperature Feed water conductivity VALUES OF THE PROGRAM STEPS Program run phases with the associated values for pressure, temperature and time (relative to the program start) ---------------------------------------...
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Page 47: Function Checks
Batch-related checks Helix test body system MELAG recommends testing the functional reliability of the steam sterilizer using a Helix test body system at least once a month. For this purpose, stockists offer specific dental test body systems as indicator and batch monitoring systems, e.g. Dental BMS (batch monitoring system) by GKE. -
Page 48: Maintenance
To maintain the value of your device and to avoid persistent soiling and deposits, MELAG recommends weekly cleaning of the surfaces such as the sterilization chamber including the door gasket and wiping rubber (e.g. with the MELAG chamber cleaning set). - Page 49 10 Maintenance Check if the entire door gasket is properly inserted in the groove. The door gasket may not show any waves, otherwise push it back into the groove using a rounded object. Next, start a sterilization program without a load. Sieve tray of the sterilization chamber A heavily soiled sieve tray can trigger malfunction messages.
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Page 50: 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, fittings and valves of the device and deposit themselves on the instruments and in the sterilization chamber as deposits and stains. -
Page 51: Maintenance
10 Maintenance Maintenance NOTICE Continuing operation beyond the maintenance interval can result in malfunctions in the device! Maintenance should only be performed by trained and authorised technicians. Maintain the specified maintenance intervals. Regular maintenance is vital to ensure reliable operation and value retention of the steam sterilizer. All function and safe- ty-relevant components and electrical units must be checked during maintenance and replaced where necessary. -
Page 52: 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 sterile material, you can load the steam sterilizer again and start a new program. ... -
Page 53: Recommissioning After Relocation
11 Pause times Recommissioning after relocation When recommissioning after changing the location of the device, proceed as for initial commissioning, see First steps [} page 23]. -
Page 54: System 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 55: Warnings
12 System malfunctions Event Possible causes What you can do Poor drying results The steam sterilizer is overloaded. In addition to an orderly device function, the drying depends to a large extent on the correct setup and loading of the steam sterilizer. Comply with the maximum permissible load quantities, see Selecting the program... - Page 56 When using a MELAG water treatment unit: The message will be displayed after a MELAdem 40: program start. The installed flow monitor Check the water treatment unit and if necessary, does not close.
- Page 57 Feed water supply [} page 23]. When using a MELAG water treatment unit: The mixed-bed resin is exhausted. MELAdem 40: Replace the mixed-bed resin (art. no. ME61026), see the user manual of the MELAdem 40 water treatment unit.
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Page 58: Malfunction Messages
12 System malfunctions Event Possible causes What you can do Log memory full The internal log memory of the device is The message is displayed upon program start. full (max. 40 logs possible). Repeated pressing of the 'S' key removes the message and the program starts. - Page 59 Sieve tray of the sterilization chamber [} page 49]. When using a MELAG water treatment unit: Residual air is in the feed system of the Acknowledge the malfunction message and start the water treatment unit after initial...
- Page 60 Move the float switch up and down and try to make it move smoothly again. When using a MELAG water treatment unit: The feed water supply is set to internal. Set the feed water supply to external in the Function...
- Page 61 Empty and clean the container. was used. Fill the container with water of appropriate quality (EN 13060, Appendix C). When using a MELAG water treatment unit: MELAdem 40: Replace the mixed-bed resin (art. no. ME61026), see the The mixed-bed resin cartridge is exhausted.
- Page 62 12 System malfunctions Event Possible causes What you can do see event F26/F27 The required chamber pressure was Comply with the maximum permissible load quantities, see exceeded during sterilization. Selecting the program [} page 33]. The steam sterilizer is overloaded. The sieve tray in the sterilization chamber is Remove the sieve tray from the sterilization chamber, soiled.
- Page 63 12 System malfunctions Event Possible causes What you can do The sterilization temperature on temperature Comply with the maximum permissible load quantities, see sensor 2 was undercut. Selecting the program [} page 33]. The steam sterilizer is overloaded. The sieve tray in the sterilization chamber is Remove the sieve tray from the sterilization chamber, soiled.
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Page 64: Technical Tables
13 Technical tables 13 Technical tables Nominal value tolerances Step Quick- Universal-Pro- Prion- All values in mbar Program S gram S Program S 1. fractionation 2700 -30/+160 ◄ ◄ ◄ ◄ Steam intake Fractionation 1250 -390/+30 ◄ ◄ ◄ ◄ Steam off-flow x. -
Page 65: Pressure-Time Charts
13 Technical tables Pressure-time charts Universal-Program S (134 °C and 2.1 bar) Pressure (mbar rel.) 2170 Quick-Program S (134 °C and 2.1 bar) Pressure (mbar rel.) 2170... -
Page 66: Feed Water Quality
13 Technical tables Prion-Program S (134 °C and 2.1 bar) Pressure (mbar rel.) 2170 Feed water quality Minimum requirements to the feed water following 13060, Appendix C Substance/property Feed water Evaporation residue ≤ 10 mg/l Silicon oxide, SiO ≤ 1 mg/l Iron ≤ 0.2 mg/l Cadmium ≤ 0.005 mg/l... -
Page 67: Technical Data
14 Technical data 14 Technical data Device type MELAquick 12+ MELAquick 12+ p Device dimensions (W x H x D): 19.5 x 43 x 47 cm 20.5 x 43 x 46 cm Empty weight 23 kg 24 kg Operating weight approx. -
Page 68: Accessories And Spare Parts
15 Accessories and spare parts 15 Accessories and spare parts You can obtain the specified articles and an overview of further accessories from your stockist. Article Art. no. MELAquick MELAquick 12+ p Accessories Holder with ISO adapters for 7 instruments ME00122 Holder with round mounts for 7 instruments ME00123... -
Page 69: Glossary
Authorised technician An authorised technician is a person intensively trained DIN 58953 and authorised by MELAG who has sufficient specific de- Standard – sterilization, sterile equipment supply vice and technical knowledge. to perform maintenance and installation work on MELAG devices. Only they may carry Distilled water out this work. - Page 70 Glossary pH Value The pH value is a measure of the strength of the acid or alkali effect of a watery solution. Process evaluation system Also known as the self-monitoring system – this observes itself and compares the various sensors during a current program.
- Page 71 Certificate of Suitability According to the recommendations of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute Manufacturer: MELAG Medizintechnik GmbH & Co. KG Address: Geneststraße 6-10 10829 Berlin Country: Germany Product: MELAquick 12+/MELAquick 12+ p ®...
- Page 72 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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