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User Manual
Steam sterilizer
MELAquick
MELAquick
From software version 5.15
EN
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 and ISO 9001. This guarantees that all MELAG products are
manufactured and tested in accordance with strict quality criteria.
The MELAG management and team.
®
12+
®
12+ p
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Table of Contents
Related Manuals for MELAG MELAquick 12+ p
Summary of Contents for MELAG MELAquick 12+ p
- Page 1 ISO 13485 and ISO 9001. This guarantees that all MELAG products are manufactured and tested in accordance with strict quality criteria.
- Page 2 ® User manual MELAquick 12+/12+ p ® Valid MELAquick 12+/12+ p From software version 5.15 Responsible for content: MELAG Medizintechnik oHG Geneststraße 6 – 10 10829 Berlin Germany Email: info@melag.com www.melag.com © 2017 Document: BA_quick12+_12+p_EN_v12.docx / Rev.: 12 – 17/2441...
- Page 3 Disposal MELAG devices are synonymous for long-term quality. When you Electrical and electronic 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 4 Symbols on the steam sterilizer In affixing this CE mark, the manufacturer declares that this medical product fulfils the basic requirements of the medical device directive. The four-digit number confirms that this is monitored by an approved certification agency. Manufacturer of the medical device date of manufacture of the medical device Serial number of the medical device by the manufacturer This User Manual contains important safety informations.
- Page 5 ■ Have the maintenance and repair done only by →authorized persons. Maintenance and repair ■ When exchanging spare parts, you may use only the original MELAG components. ■ Use the supplied carrying straps to transport the steam sterilizer and Carrying the steam sterilizer attach them to the sides e.g.
- Page 6 ■ Disposal 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. ■ Dispose of accessories and consumption media which you no longer Accessories and require in the appropriate manner.
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Page 7: Table Of Contents
CONTENTS CONTENTS Chapter 1 – Performance Specifications .... 8 Employing MELAflash as output medium ..36 MELAnet Box as output medium ....... 37 Proper use ............8 Computer as output medium ......37 User benefits ............9 Automatic immediate log output ......38 Overview of sterilization programs .... -
Page 8: Chapter 1 - Performance Specifications
■ 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. Attention ■ The sterilization of instruments with this steam sterilizer, like the foregoing instrument preparation, is only to be done by competent personnel. -
Page 9: User Benefits
Chapter 1 – Performance Specifications User benefits The steam sterilizer sterilizes on the basis of the →fractionated flow Universal use method. This method ensures the complete and effective wetting or penetration of the items to be sterilized with saturated steam. The procedure can also be used to safely and quickly sterilize wrapped instruments. -
Page 10: Overview Of Sterilization Programs
Chapter 1 – Performance Specifications Overview of sterilization programs The results of this chart indicate which tests were performed at the steam sterilizer. The marked fields show compliance with all applicable sections of the Standard → DIN EN 13060. Type tests Universal-Program S Quick-Program S Prion-Program S... -
Page 11: Chapter 2 - Device Description
Chapter 2 – Device Description Chapter 2 – Device Description In this chapter you learn Which components are included in a standard scope of delivery Which components the steam sterilizer contains What safety devices the steam sterilizer has ... -
Page 12: Device Views
(1) Twist grip (2) Operating and display field (3) Mains switch (4) Suction fitting for drying air with insert (only MELAquick 12+ p) Rear side (5) Device fuse (6) Cable connection for water level monitoring in the feed water container... -
Page 13: Accessories
Chapter 2 – Device Description Top view, open Wiping rubber (under sliding door) Door gasket Sieve tray Fig. 2: Top view Accessories Universal basket for up to 12 handpieces with The package holder for wrapped instruments can be semicircular insert for universal use. Instruments removed from the steam sterilizer chamber using the up to a length of 20 cm can be sterilized in the basket lifter by hooking into the upper holes. -
Page 14: Effective Capacity
Chapter 2 – Device Description Support with round holders for 7 handpieces Support with ISO adapters 7 handpieces Fig. 7: Support with round holders (optional) Fig. 8: Support with ISO adapters (optional) Effective capacity Device type Diameter Depth Volume ∅... -
Page 15: Supply With Feed Water
Chapter 2 – Device Description Initial state The display switches to the initial state after every switch-on, where the current time and the chamber pressure in bar and the (steam) temperature in °C are displayed. Supply with feed water The steam sterilizer requires →demineralised or →distilled →feed water for steam production according to →DIN EN 13060, Appendix C. -
Page 16: Chapter 3 - Initial Commissioning
Pre-conditions for the set-up, installation and commissioning ■ 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 explosive areas. -
Page 17: Establishing Connections
Chapter 3 – Initial Commissioning Space requirements MELAquick 12+ MELAquick 12+ p Width A= 19.5 cm A= 20.5 cm Height B= 43 cm B= 43 cm Depth C=47 cm C=46 cm D= 29 cm D= 29 cm E= 9 cm... - Page 18 Waste water container Feed water container Fig. 9: Connections Requirements placed on All MELAG water treatment units comply with the following requirements: the water treatment unit The water pressure at the output of the water treatment unit amounts to min. 0.5 and max. 10 bar.
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Page 19: Installation Examples For Connecting A Water Treatment Unit
Chapter 3 – Initial Commissioning Next, you must switch the feed water supply to External in the "Function" menu. Select the menu Function by simultaneous brief pressing of the Function: Feed water supply (+) and (-). The display shows Function: Last batch number. ... - Page 20 Chapter 3 – Initial Commissioning Example 2 – MELAdem 47 Purified water from the reverse osmosis unit MELAdem 47 Drain via waste water container (18) (10) (13) (17) (12) (11) (15) (14) (16) Fig. 11: Feed water supply from the reverse osmosis unit MELAdem 47 Rear view Vacuklav 40 B+ Safeguard combination, consisting of return flow inhibitor and pipe aerator according to EN 1717 Y piece 3/4”...
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Page 21: Compressed Air Connection (Only Melaquick 12+)
Chapter 3 – Initial Commissioning Compressed air connection (only MELAquick 12+) A compressed air connection is intended for MELAquick 12+. Connect a free end of the compressed air hose (Ø 6 mm) to the quick coupling piece of the sterile filter pre-fitted to the steam sterilizer and the other end to the on-site compressed air supply. -
Page 22: Electrical Connection
Provide the following electrical connections for the steam sterilizer: Electric circuit with 220-240 V (max. voltage range 207 - 253 V) and 50/60 Hz (MELAquick 12+) and 50 Hz (MELAquick 12+ p, see name plate) 10 A separate fuse protection – at least Automat Type B ... -
Page 23: Switch On The Steam Sterilizer
Chapter 3 – Initial Commissioning Switch on the steam sterilizer Turn the mains switch on to power the steam sterilizer (see Fig. 1/(3)). Switch on mains After switching on the steam sterilizer with the mains switch, the → After switching on display shows in alternation to the initial state the message Unlocking door with button (+), if the door is closed. -
Page 24: Closing The Door
Chapter 3 – Initial Commissioning Closing the door When closing the door of the steam sterilizer, observe the following instructions: Pull the sliding door on the twist grip forward to the end and lock the door by turning the twist grip 90° clockwise. In correctly locked condition, the groove in the door grip must be perpendicular to the longitudinal axis. -
Page 25: Chapter 4 - Sterilization
Chapter 4 – Sterilization Chapter 4 – Sterilization In this chapter you learn Which prerequisites should be created for a smoothly-running sterilization What you should observe when preparing the items to be sterilized How to correctly load the steam sterilizer ... -
Page 26: Loading The Steam Sterilizer
Chapter 4 – Sterilization Observe the following instructions for treating used and brand new Instruments instruments: ■ Follow without fail the instructions of the instruments manufacturer for treatment and sterilization, and observe the relevant standards and directives of your country (in Germany, e.g. →BGV A1, →RKI Danger of infection! und →DGSV). - Page 27 Chapter 4 – Sterilization →Soft sterilization wrapping must always be sterilized using the Soft sterilization wrapping package holder. When using soft sterilization packages such as MELAfol 1002. observe the following instructions: ■ Arrange →soft sterilization wrapping standing vertically in the package holder to ensure that the paper side of the outer wrapping points to the outside.
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Page 28: Selecting The Program
(P) once again, switch the display to Pre-heating 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. PLEASE NOTE MELAG recommends the activation of automatic pre-heating. -
Page 29: Select Additional Drying
Chapter 4 – Sterilization Select additional drying For difficult drying tasks you can extend the drying time of a program by Additional drying selected 50% with the function Additional drying. For this proceed as follows: When starting the program, simultaneously press the K (+). -
Page 30: Manual Program Termination
Chapter 4 – Sterilization Manual program termination You can manually terminate a running program in any of the phases. PLEASE NOTE Do not interrupt a running program by switching off the mains switch! In case of non-observance, an malfunction message of power loss is displayed when the steam sterilizer is switched back on. -
Page 31: Sterilization Phase Is Finished
Chapter 4 – Sterilization PLEASE NOTE The confirmation prompt is shown for about 5 seconds on the display. If the key is not pressed again, the program continues with the normal process. After the ventilation of the chamber with a corresponding display text the Last batch number 7 Acknowl. -
Page 32: Program Is Finished
Chapter 4 – Sterilization Program is finished At the end of a program run the chamber pressure is adapted to the Universal-Program S ambient pressure. If the program was successfully finished, an appropriate run successfully notification appears on the →display. The report of the completed program is issued to the selected output Immediate output medium for activated immediate output (see page 34,... -
Page 33: Storage Of Sterilized Items
Chapter 4 – Sterilization If you remove the →sterilized items from the steam sterilizer directly after Condensate residues on the the end of the program, it can happen that slight quantities of condensate sterilized items moisture are found on the sterilized items. According to →DIN 58953, Part 7: Smaller quantities of water which are found on the upper side of paper bags and clear plastic sterilization packages are unobjectionable if they dry out within 30 minutes after... -
Page 34: 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 How to read logs correctly How to set the date and time at the steam sterilizer Batch documentation The batch documentation is indispensable as documentation for the successfully completed sterilization process and as an obligatory measure... -
Page 35: Setting The Date And Time
Chapter 5 – Logging Setting the date and time Observe changing the clock 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: ... -
Page 36: Employing Melaflash As Output Medium
PLEASE NOTE 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 printer via the serial interface (similar to the log printer MELAprint 42/44, see page 35). -
Page 37: Melanet Box As Output Medium
Chapter 5 – Logging MELAnet Box as output medium The MELAnet Box enables the connection of the steam sterilizer to the Output medium MELAnet+graphic data computer network of the practice or clinic via an Ethernet interface. The logs which are created during a program run can be saved by means of a →FTP server or over →TCP via the MELAnet Box on the computer. -
Page 38: Automatic Immediate Log Output
PLEASE NOTE 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. -
Page 39: Subsequent Log Issue
Chapter 5 – Logging Subsequent log issue You also have the option of outputting the logs subsequently and independently from the time of program end. You can select whether selected or all saved logs (up to 40 logs) should be printed. For this purpose the connected output medium is used, e.g. -
Page 40: Display Protocol Memory
Chapter 5 – Logging Delete saved logs In order e.g. to suppress the warning text Protocol memory full for preset option Immediate output No, the saved logs can be manually deleted. In the following example you can read how you can delete all saved logs. ... - Page 41 Chapter 5 – Logging --------------------------------------- Header MELAG MELAquick 12+ --------------------------------------- Program : Universal-Program S Started program 134°C wrapped Current date Date : 13.03.2015 Time at program start Time of day : 12:16:14 (Start) Batch number: Daily batch number : 201512+p1017...
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Page 42: 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 gasket ... -
Page 43: Avoid Formation Of Spots
Insulating plug on the sterile you can remove this using the plastic bracket and then remove it from the filter (only MELAquick 12+ p) bracket. If necessary, clean the insulating plug in the sterile filter with clean water and allow it to dry before inserting. -
Page 44: Use Qualitatively High-Grade Feed Water
Maintenance ■ Maintenance should only be performed by trained customer services technicians, or stockist technicians. Consult your specialist dealer or the nearest MELAG customer services point. Attention ■ Maintain the specified servicing intervals. Malfunctions at the steam sterilizer can occur on continuation of operation despite the servicing message. -
Page 45: 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 with longer operating pauses How to put the steam sterilizer out of operation, transport it and re-start it Sterilization frequency Pause times between individual programs are not necessary. -
Page 46: Recommissioning After Relocation
Chapter 7 – Operating pauses Observe the following when transporting the steam sterilizer, e.g. when moving or shipping the steam sterilizer or for the transport within the practice: Attention ■ Empty the feed water and waste water container. ■ When using a water treatment unit, close the water feed and remove the hose connections on the back of the device. -
Page 47: Chapter 8 - Function Test
Dental BMS (batch monitoring system) by GKE. This consists of a test body, the Helix, and an indicator strip, and is used with the MELAquick 12+/MELAquick 12+ p in the Universal-Program S. Prior to program start the door gasket should be cleaned. -
Page 48: Display Water Quality
Chapter 8 – Function test Display water quality The water quality can be displayed on the display of the switched on AIN6: Conductivity 7 µS/cm steam sterilizer at any time - even while a program is running. (-) pressed until the display shows the → To do this keep the K conductivity. -
Page 49: Chapter 9 - Malfunctions
Chapter 9 – Malfunctions Chapter 9 – Malfunctions In this chapter you learn Which type of messages exist How to react to errors What you can do before calling the hotline What you can do if no display appears ... - Page 50 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 for us to help you, keep the serial number of your steam sterilizer and a detailed error description of the malfunction message ready.
- Page 51 MELAdem 47) and examine the water treatment unit. On repeated occurrence, have maintenance carried out by MELAG customer service or service of the specialist dealer. Possibly the pre- and activated carbon filter must also be exchanged. For different water treatment units:...
- Page 52 PLEASE NOTE Service counter is reset by customer service. Warning/Battery empty Monitoring of the device's internal The battery must be exchanged by MELAG battery voltage determined a too customer service or service of the specialist low voltage value. dealer.
- Page 53 Chapter 9 – Malfunctions Malfunction message Possible cause What you can do Fault 2: Steam generator Steam sterilizer is overloaded Pay attention to the correct loading quantities (see page 26, Loading the steam sterilizer). Decreased heating power, since supply voltage too low Check building-side electrical installation;...
- Page 54 Check building-side installation. If no defects are detectable, notify MELAG customer service Disconnection of the steam sterilizer Only terminate a running program with K during a running program (S), see also page 30.
- Page 55 Upon repeated occurrence, inform your stockist. MELAquick 12+ p: Check the insulating plug on the sterile filter; if necessary clean the insulating plug in the sterile filter with clean water and allow it to dry before inserting.
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Page 56: No Display On The Screen
Chapter 9 – Malfunctions No display on the screen After switching on the steam sterilizer the display remains empty. Check whether the power plug is correctly plugged in the socket and What you can do the IEC plug on the steam sterilizer. ... -
Page 57: Overview Of Programs
Overview of programs Overview of programs MAIN MENU Main Menu Function* *see next page 1st time press Initial state – AIN6: Conductivity hh:mm:ss 5 µS/cm 0.00 bar 89°C release 2nd time press – AIN4: Temp_preheat. 120°C release Quick-Program S 134°C unwrapped Additional drying selected Manually terminate... -
Page 58: Menu: Function
Overview of programs hh:mm:ss Initial state 0,00 bar 89°C Menu: Function Press both keys simultaneously Function: *1) No output medium MELAprint MELAflash MELAnet+graphic data Computer Last Batch counter Date/Time Feed water autom. Batch output batch number supply Pre-heating Last batch number Batch counter. -
Page 59: Technical Tables
Technical tables Technical tables Nominal value tolerances ◄ same meaning as in Universal-Pr. S Quick-Progr. S Universal-Progr. S Prion-Progr. S Step Press. P Tolerance Tol. Tol. All values in mbar 2700 - 30/+160 ◄ ◄ ◄ ◄ Steam entry 1. F. 1250 -390/+ 30 ◄... - Page 60 Technical tables Press. (mbar rel.) Fig. 14: Pressure-time chart for Quick-Program S, 134 °C and 2.1 bar Press. (mbar rel.) Fig. 15: Pressure-time chart for Prion-Program S, 133 °C and 2.1 bar...
- Page 61 Technical tables Feed water quality ≤ Evaporation residue mg/l ≤ Silicon oxide, SiO mg/l ≤ Iron mg/l ≤ Cadmium 0.005 mg/l ≤ Lead 0.05 mg/l ≤ Heavy metals except for those named mg/l above ≤ Chloride mg/l ≤ Phosphate mg/l pH value 5 –...
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Page 62: Technical Data
Technical data Technical data Model name MELAquick 12+ MELAquick 12+ p Device dimensions (WxHxD) 19,5 x 43 x 47 cm 20,5 x 43 x 46 cm ∅ 9 x 20 cm Chamber (Ø x T) Volume (chamber) 1.35 l Weight (empty) -
Page 63: Glossary
– chemical indicators – Part 1: General requirements Medical specialist dealers, technician from depots or with DIN EN ISO 11607-1 customer service designated by MELAG, who were trained Standard – Requirements on materials, →sterile barrier by MELAG systems and packaging systems; this standard is a... - Page 64 Glossary Single wrapping the steam generator before the sterilization process starts; Wrapped once, e.g. instruments sealed in a foil - duration depends on the temperature of the sterilization contrasted to: →Multiple wrapping process Hollow body A Simple hollow items →Narrow lumen An article open on one side to which the following applies: 1 ≤...
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Page 65: Appendix A - Accessories
Appendix A - Accessories Appendix A - Accessories Article Article number* MELAquick 12+ MELAquick 12+ p Accessories Universal basket including small part insert 00125 Package Holder 00126 Basket lifter 10003 Holder 00127 Frame 00128 Support with ISO adapters for 7 instruments... - Page 66 Certificate of suitability ® ® MELAquick 12+/MELAquick 12+ p Manufacturer: MELAG Medizintechnik oHG Address: Geneststraße 6-10 10829 Berlin Country: Germany Product: Steam sterilizer (steam sterilizer) ® Type of device: MELAquick 12+/12+ p Classification: Class IIb medical device We declare that the sterilizer specified above is suitable for the steam sterilization of the following instruments (wrapped and unwrapped) in accordance with DIN EN 13060 class S: - W &...
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