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Operating Manual

 

MELA

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 Label Printer 

 

 

 

 

Dear doctor, 

With your purchase of MELAdoc, you have acquired a device which only a few years ago was not to be found in a 
doctor's or dentist's practice. The majority of your colleagues would doubtless have dismissed it as a "bureaucratic 
inanity.”  
The situation has changed fundamentally. 

Hygiene standards for doctor's and dental practices have become very strict. It is especially important to observe the 
recommendations from the Robert Koch Institute "Hygiene requirements for the treatment of medical products," and 
§4 clause.2 of the Medical Devices Operations Ordinance, which requires that the “operator“ (i.e. yourself) 
“…prepares the instruments in a suitable and validated procedure which ensures its verifiable success…“ 

Compliance with these requirements will be verified. The Infections Protection Act gives government authorities the 
right to subject practices to rigorous inspection without any grounds for suspicion. Health authorities, local authorities 
etc. are making increased use of this right in the form practice inspections, usually announced in advance. 

Using MELAdoc and the corresponding labels means that you are able to label sterile equipment in terms of its 
sterilization date, expiry date, batch number and clearance of the sterilized product, and enables you to fulfil all the 
valid legal requirements. 

 

Your MELAG team 

 

Summary of Contents for MELAdoc

Page 1: ...ices Operations Ordinance which requires that the operator i e yourself prepares the instruments in a suitable and validated procedure which ensures its verifiable success Compliance with these requirements will be verified The Infections Protection Act gives government authorities the right to subject practices to rigorous inspection without any grounds for suspicion Health authorities local auth...

Page 2: ...Operating Manual MELAdoc Label Printer MELAG Medical Technology Geneststraße 7 10 10829 Berlin Germany E mail info melag de www melag de Document BA_GB_MELAdoc doc Revision 0 09 1981 ...

Page 3: ...f the sterilized equipment 5 Storage 6 Chapter 2 Batch documentation 7 Post application documentation 7 Chapter 3 Commissioning 8 Overview Assembly of the label printer 8 Inserting the label roll 9 Removing jammed labels 11 Setting the date 12 Inserting the inking roller 12 Removing the inking roller 13 Measures for use example 13 Measures for use example 14 Glossary 16 Appendix Accessories 17 ...

Page 4: ... 2002 The norm for the operation of small steam sterilizers is currently being formulated We recommend A visual inspection Visual inspection of the autoclave chamber the door seal door lock and where necessary further checks in accordance with the manufacturers instructions Inspection of the operating materials Quality of the feed water automatically with MELAG Euroklav Vakuklav and Cliniklav 25 C...

Page 5: ...or after five or more years return discolouration means that it is necessary to make a written record of the successful colour change It is not necessary to store the indicators Documentation of the daily procedure clearance in the batch control sheet consisting of label entry and signature Labelling and clearance of the sterilized equipment Every sterilization package must be controlled and clear...

Page 6: ...ckaging is the packaging containing one or more medical products each of which enclosed in its own primary packaging DIN EN 868 1 1997 05 Responsibility for maintaining the specified storage requirements and times rests with the facility operator Storage length according to DIN 58953 8 from October 2003 Storage period Sterilized material packaging Packaging type Unprotected storage1 Protected stor...

Page 7: ... to be completed with a label entries and a signature An unsuccessful clearance must also be documented Post application documentation After use of the medical product the labels can be removed from the packaging and fixed to the operation protocol or in the patient records This enables traceability via the patient records from the application to sterilization process ...

Page 8: ...anual MELAdoc label printer 8 Chapter 3 Commissioning Overview Assembly of the label printer E Label printing trigger C Label ejection B Release button to open A Setting wheel for setting date D Hinged top section ...

Page 9: ...e label roll 1 Remove the new label roll from its packaging extend around 18 cm and dispose of the first 12 labels 2 Push the roll into the bracket until it clicks into position 3 Lay the free strip over the label guide and extend it c 15 cm The first label on the strip must finish directly on the guide To ensure an improved grip at this point kink the strip see detail left and hold it in position...

Page 10: ...s is important to ensure faultless central pressure 5 Kink the free end of the label strip downwards This makes it easier to feed the free strip into the label printer as will be described 6 Guide the hanging strip below into the opening of the lower shaft located underneath the white guide roll see detailed diagram left and push in as far as is possible ...

Page 11: ...ed over several times The MELAdoc is now ready to print Removing jammed labels 1 Open the MELAdoc see page 9 Opening the label printer and pull out the label roll 2 Remove all loose labels in the interior of the label printer 3 Open the label guide upwards and to the left as shown in the diagram on the left In this way you can access and remove the jammed labels 4 Shut the label guide 5 If necessa...

Page 12: ...he value return the wheel to its starting position Inserting the inking roller Open the device to insert the inking roller see page 9 Opening the label printer 1 Open the packaging of the inking roller and remove it 2 Hold the inking roller horizontal by its ends as depicted 3 Insert the inking roller in the bracket using a little pressure until it clicks Note Do not touch the inking roller at any...

Page 13: ...ibed above 2 Hold the inking roller by its ends as depicted Depress the lever shaped ejector button with the small arrow This releases the ends of the inking roller from its anchoring and it can be removed 3 The empty inking roller can be disposed as domestic waste Maintenance To guarantee faultless functioning add a drop of standard silicone based lubricant at the locations indicated ...

Page 14: ...Operating Manual MELAdoc label printer 14 Measures for use example ...

Page 15: ...Operating Manual MELAdoc label printer 15 ...

Page 16: ...escribed shorter test intervals e g daily With small steam sterilizers this test only serves the purpose of trouble shooting when errors occur e g upon a failed Helix test As long as the manufacturer has not issued any further specifications the test should not be performed on a daily basis Empty chamber sterilization This procedure removes any condensate remaining in the steam conduits of a large...

Page 17: ...ngle sheet per day and per autoclave Article No 01091 MELAcontrol Batch control system MELAcontrol is a test system for the purpose of batch control and testing the functioning of the fractionation of a pre vacuum of a class B autoclave or a MELAG Cliniklav 25 in accordance with EN 867 5 The practice set consists of 1 test body Helix and 250 indicator strips Article No 01080 Exclusively available ...

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