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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:

MELA

quick

®

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 & H Synea WA-99LT
-  W & H Alegra WE-99 LED G
-  KaVo GentleSilence LUX 8000B
-  KaVo IntraCompact 25 LHC
-  Sirona T1 Line
-  Sirona T1 Control
-  Handpieces with comparable qualities (material, weight, geometry)

References to loading quantities and loading variations are outlined in the user manual and
must be observed.

Manufacturer instructions regarding the medical devices stipulated for sterilization in
accordance with DIN EN ISO 17664 must be observed.

Berlin, 08/01/2016

--------------------------------------------

Dr. Steffen Gebauer

(General Management)

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Содержание MELAquick 12+

Страница 1: ...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 demand...

Страница 2: ...ent BA_quick12 _12 p_EN_v12 docx Rev 12 17 2441 Date of update 2017 12 13 We reserve the right to technical alterations For doctors physicians assistants and service personnel Please read this User Ma...

Страница 3: ...ed in the glossary The glossary is listed alphabetically It can be found at the end of this manual Universal Program S Software citation Words or phrases appearing on the display of the steam steriliz...

Страница 4: ...is 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 The symbol of the struck out...

Страница 5: ...aterials and systems which are suitable for steam sterilization according to the manufacturer s information Program termination Take heed that when opening the door after terminating a running program...

Страница 6: ...h all relevant disposal specification in terms of possibly contaminated waste Accessories and consumption media Packaging The packaging protects the device against transport damage The packaging mater...

Страница 7: ...31 Drying phase 31 Program is finished 32 Display batch number 32 Remove sterilized items 32 Storage of sterilized items 33 Chapter 5 Logging 34 Batch documentation 34 Setting the date and time 35 Use...

Страница 8: ...es or similar may not be sterilized in the this steam sterilizer Danger of burning Observe the following instructions for using the steam sterilizer Do not sterilize any liquids with this steam steril...

Страница 9: ...e dried with the pulsating overpressure drying method This way you achieve optimal drying results for wrapped objects as well Optimized total operating time The steam sterilizer works with an electron...

Страница 10: ...N 13060 Type S Type S Type S Dynamic pressure test of the sterilization chamber X X X Empty chamber test X X X Solid load X X X simple hollow items hollow body B X X X Dental transfer instruments1 X X...

Страница 11: ...anty certificate Manufacturer s inspection report Record of installation and setting up 1 Basket lifter 1 Sieve tray 1 Support plate 1 Feed water container with connecting hose and cable for water lev...

Страница 12: ...se 6 Cable connection for water level monitoring in the feed water container 7 Cable connection for water level monitoring in the waste water container 8 Serial interface RS232 9 Sterile filter and co...

Страница 13: ...struments can be removed from the steam sterilizer chamber using the basket lifter by hooking into the upper holes Fig 3 Universal basket with small parts insert optional Fig 4 Package holder optional...

Страница 14: ...nd four membrane keys Function key and to select set and display special functions print date time preheating total batches conductivity acknowledge error KEY for unlocking the door Program selection...

Страница 15: ...d water container If you employ the feed water container for the feed water supply you must from time to time fill it manually At the given point in time the steam sterilizer outputs an appropriate me...

Страница 16: ...uld amount to max 80 at 31 C decreasing in a linear fashion up to a relative humidity of max 50 at 40 C We recommend an ambient temperature of between 5 40 C recommended max 25 C The load capacity of...

Страница 17: ...d waste water container should be installed in immediate proximity below the steam sterilizer and easily accessible The length of the connection hoses and the cables amounts to 1 5 m During installati...

Страница 18: ...half of the amount recommended by the manufacturer in order to preserve the material of the condensate coil This is required during initial commissioning and after every emptying of the waste water c...

Страница 19: ...e starting position of the display At initial delivery the Feed water supply is set to Internal Installation examples for connecting a water treatment unit Example 1 MELAdem 40 1 7 2 4 6 8 11 3 5 9 10...

Страница 20: ...00 4 Cooling water inflow fitting 5 Leak monitor with shut off valve and probe Art No 01056 optional recommended with fixed water connection 6 Connection for water level monitoring in the waste water...

Страница 21: ...sterilizer issues Error 42 Drying drying pump or is a program is aborted without the compressed air supply having been completed at this point the program is viewed as not having been completed succes...

Страница 22: ...lar objects to fixate a cable If the mains cable or the power plug is damaged turn off the steam sterilizer Mains cables or power plugs may only be replaced by authorised persons If these points are n...

Страница 23: ...r the end of a program After the end of a program the request Acknowledge with button is displayed Press the KEY to unlock the door After unlocking the door you can open the door and remove the steril...

Страница 24: ...nd 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 Attention Never push the sliding do...

Страница 25: ...r of appropriate quality see page 44 Use qualitatively high grade feed water If you employ a water treatment unit e g MELAdem 40 MELAdem 47 and the water feed is closed then open it up If the MELAdem...

Страница 26: ...ion instructions of the instrument manufacturer Ultrasonic units Maintenance appliances for hand pieces and angle pieces Washer disinfectors Loading the steam sterilizer Only if the steam sterilizer i...

Страница 27: ...outside If the seal seam tears open during sterilization then it might be that the wrapping was too small If this is the case re wrap the instruments and sterilize them once again The packaging should...

Страница 28: ...water supply for example We reserve the right to technical modifications After a cold start this can take up to 2 min longer 2 For further information please refer to the certificate of suitability in...

Страница 29: ...l as the remaining duration until end of sterilization respectively the expired drying time is displayed Evacuation phase In the evacuation phase the fractionated flow method with pulsating repeated s...

Страница 30: ...release of the device is carried out An appropiate display is shown on the screen After the pressure release is carried out there is a request for an acknowledgement of the program termination The scr...

Страница 31: ...s displayed in alternation with the specification of the pressure and temperature Sterilization not successfully finished The sterilization is not successful if it was terminated by the operator or th...

Страница 32: ...neous pressing of the KEYS and The display shows Function Last batch number Navigate with the KEY or up to the display where the submenu Batch counter is shown Press the KEY P You see the current coun...

Страница 33: ...y in the opened steam sterilizer for approx 1 to 3 minutes Storage of sterilized items Exclusively employ packaging which complies with standards for the sterilized materials Do not store sterilized i...

Страница 34: ...he day Capacity of the internal log memory The capacity of the internal storage suffices for about 40 logs If the internal log memory is full when starting the next program the respectively oldest log...

Страница 35: ...enu On the display the Function Date Time are again displayed By pressing the S KEY again you leave the menu completely and the display shows its starting position again Use log printer as output medi...

Страница 36: ...start the output press the P KEY An appropriate display with Test output appears In order to cancel the test output or leave the menu after finished printout press the KEY S The display shows Functio...

Страница 37: ...to employ a computer as output medium the computer must be connected via the serial interface to the steam sterilizer The software MELAview MELAtrace from software version 3 can be installed for the l...

Страница 38: ...utput after program end Switch on the steam sterilizer at the mains Select the menu Function by simultaneous brief pressing of the KEYS and The display shows Function Last batch number Navigate with t...

Страница 39: ...he last three steps In order to leave the submenu without outputting press the KEY S In order to leave the menu after the output press the KEY S The display shows the menu Function Batch output By aga...

Страница 40: ...erify how many logs are already saved in the log memory of the steam sterilizer Proceed as follows Select the menu Function by simultaneous brief pressing of the KEYS and The display shows Function La...

Страница 41: ...team entry 1 71 130 0 05 20 Press release 0 25 108 2 05 36 8 Fractionation Steam entry 1 72 130 0 06 13 Press release 0 24 108 8 06 30 9 Fractionation Steam entry 1 71 130 0 07 08 Press release 0 23 1...

Страница 42: ...is not hot Use a soft and lint free cloth Use chlorine and vinegar free cleaning agents Employ neutral liquid cleaning agents to clean the door gasket No cleaning agents may get into the piping syste...

Страница 43: ...and turn it by a full rotation so that the insulating plug sits securely in the opening of the sterile filter Avoid formation of spots Formation of spots due to improperly cleaned instruments Only if...

Страница 44: ...ry to observe the instructions provided with the door gasket spare part with the article no 12550 Remove the worn door gasket from the groove Insert the new door gasket in accordance with the instruct...

Страница 45: ...if available the water feed of the water treatment unit and the compressed air supply Shut down If you would like to shut down the steam sterilizer put it out of operation for a longer period of time...

Страница 46: ...ed 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 In case of non observance damages to the steam steri...

Страница 47: ...ameters exceed defined limit values the steam sterilizer outputs warning messages or malfunction messages If necessary it interrupts the program with a corresponding message When the program has ended...

Страница 48: ...d until the display shows the conductivity The conductivity is stated in S cm As soon as you release the KEY the display returns to its previous status e g initial state Pre heating temperature of the...

Страница 49: ...ion occurs during a program run the program will be interrupted Danger of infection If a program is discontinued during the sterilization phase the load is unsterile Repackage and repeat the steriliza...

Страница 50: ...ng No feed water Check feed water quality The warning message appears after program start The built in flow monitor doesn t close PLEASE NOTE At the first start up or re start up this message can occu...

Страница 51: ...out by MELAG customer service or service of the specialist dealer Possibly the pre and activated carbon filter must also be exchanged Mixed bed resin pellets in reverse osmosis unit consumed For diff...

Страница 52: ...edly press the KEY S to delete the message and the program starts The oldest log is then deleted An output medium is registered and in the menu Batch output the option Immediate output NO is set Set p...

Страница 53: ...Fault 10 Overheat Steam generator Capillary tube regulator level control is opened at program start malfunction message immediately after start or during a program run until the end of the sterilizat...

Страница 54: ...essage occurs after the operating voltage is again available Check building side installation If no defects are detectable notify MELAG customer service Disconnection of the steam sterilizer during a...

Страница 55: ...additional drying without a load and after re connection of the compressed air supply Upon repeated occurrence inform your stockist MELAquick 12 p Check the insulating plug on the sterile filter if n...

Страница 56: ...d Activate the pre heating see page 28 Select automatic pre heating Employ the function Additional Drying see page 29 Select additional drying Open door in case of a power failure Attention Absolutely...

Страница 57: ...utton Stop program Press Stop Program runs Manually terminate during drying Immediate removal Press Stop Drying stopped S Manually terminate before drying Acknowledge with button Unlocking door with b...

Страница 58: ...x Last batch number S Last batch number xx P P S Date Time Month xx Date Time Minute xx Date Time Second xx Date Time Day xx Date Time Year xx Date Time s o s o s o s o s o Date Time Hour xx Allocated...

Страница 59: ...team entry 1250 160 50 Steam flow off 3050 50 70 Heat up 3050 50 70 Sterilization start 3170 90 90 Sterilization 1200 140 50 Pressure release Quick Progr S Universal Progr S Prion Progr S Fractio nati...

Страница 60: ...Technical tables 60 Fig 14 Pressure time chart for Quick Program S 134 C and 2 1 bar Fig 15 Pressure time chart for Prion Program S 133 C and 2 1 bar Press mbar rel Press mbar rel...

Страница 61: ...Iron 0 2 mg l Cadmium 0 005 mg l Lead 0 05 mg l Heavy metals except for those named above 0 1 mg l Chloride 2 mg l Phosphate 0 5 mg l pH value 5 7 Appearance colourless clean without sediment Hardness...

Страница 62: ...ed max 25 C Relative humidity max 80 with temperatures up to 31 C max 50 at 40 C in between decreasing in a linear fashion Max altitutde height to 2000 m Installation category II Feed water quality de...

Страница 63: ...868 8 European standard Packing materials and sytems for medical devices to be sterilized DIN EN ISO 11140 1 European standard Sterilization of products for health care chemical indicators Part 1 Gene...

Страница 64: ...nitoring system observes itself acts during the programs compares sensors with each other Pulsating overpressure drying Drying method which removes moisture from the chamber and the items to be steril...

Страница 65: ...for 7 instruments 00123 Water treatment units MELAdem 40 ion exchanger 01049 MELAdem 47 reverse osmosis unit 01047 For documentation MELAflash CF card printer incl MELAflash CF card and card reader 01...

Страница 66: ...g instruments wrapped and unwrapped in accordance with DIN EN 13060 class S W H Synea WA 99LT W H Alegra WE 99 LED G KaVo GentleSilence LUX 8000B KaVo IntraCompact 25 LHC Sirona T1 Line Sirona T1 Cont...

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