MELAG MELAdoc Operating Manual
Hide thumbs Also See for MELAdoc:

Advertisement

Quick Links

Operating Manual
MELAdoc 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

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the MELAdoc and is the answer not in the manual?

Questions and answers

Summary of Contents for MELAG MELAdoc

  • Page 1 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.”...
  • 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: Table Of Contents

    Operating Manual MELAdoc label printer Contents Chapter 1 – What does the MELAdoc do? ........................ 4 Documentation of the procedure clearance........................4 Documentation of the batch clearance.......................... 5 Labelling and clearance of the sterilized equipment...................... 5 Storage..................................6 Chapter 2 – Batch documentation ..........................7 Post-application documentation ............................
  • Page 4: Chapter 1 - What Does The Meladoc Do

    Operating Manual MELAdoc label printer Chapter 1 – What does the MELAdoc do? MELAdoc serves the: Documentation of the clearance decision Labelling the medical product Traceability. Clearance: Instrument preparation ends with the documented clearance for storage and use (according to RKI: “Hygiene requirements for the treatment of medical products”). The respective clearance decisions may only be carried out by authorized and expert personnel and must be documented.
  • Page 5: Documentation Of The Batch Clearance

    Operating Manual MELAdoc label printer Documentation of the batch clearance Batch clearance assesses and documents the success of the sterilization procedure. Assessing the success of the process The success of the sterilization procedure is assessed using the protocol print out, the ...
  • Page 6: Storage

    Operating Manual MELAdoc label printer Storage Loss of sterility is dependent less on the length of the storage time as from external  influences during storage, as well as transport and handling. When opening the packaging, dust and microorganisms deposited on the packaging during the storage time can fall on the instruments, thus contaminating them.
  • Page 7: Chapter 2 - Batch Documentation

    Operating Manual MELAdoc label printer Chapter 2 – Batch documentation Batch documentation completes the batch clearance. The documentation in the batch control sheet is to be completed with a label, entries and a signature. An unsuccessful clearance must also be documented.
  • Page 8: Chapter 3 - Commissioning

    Operating Manual MELAdoc label printer Chapter 3 – Commissioning Overview – Assembly of the label printer A) Setting wheel for setting date B) Release button to open C) Label ejection D) Hinged top section E) Label printing trigger...
  • Page 9: Inserting The Label Roll

    Operating Manual MELAdoc label printer Inserting the label roll Opening the label printer Press the black release button (see page 8, overview, B)) located on the housing and open the upper section of the label printer backwards. Inserting the label roll: 1.
  • Page 10 Operating Manual MELAdoc label printer 4. Close the label printer. Ensure that the strip is held in position so that it is not pulled into the machine. This is important to ensure faultless central pressure. 5. Kink the free end of the label strip downwards.
  • Page 11: Removing Jammed Labels

    4. Shut the label guide. 5. If necessary, use a standard label remover to remove adhesive residue. 6. The label roll can then be returned to the MELAdoc label printer.
  • Page 12: Setting The Date

    Operating Manual MELAdoc label printer Setting the date 7. Pull out the setting wheel to change the personal number, date etc. 8. Move the marker (see detailed diagram) to the position to be changed. Turning the black wheel sets the desired value.
  • Page 13: Removing The Inking Roller

    Operating Manual MELAdoc label printer Removing the inking roller Before removing the inking roller, it is necessary to open the label printer. 1. Open the MELAdoc label printer as described above. 2. Hold the inking roller by its ends as depicted. Depress the lever-shaped ejector button with the small arrow.
  • Page 14: Measures For Use - Example

    Operating Manual MELAdoc label printer Measures for use - example...
  • Page 15 Operating Manual MELAdoc label printer...
  • Page 16: Glossary

    This also serves to pre-warm the sterilizer. Whether empty chamber sterilization is necessary is determined by the respective manufacturer. MELAG autoclaves do not require empty chamber sterilization. Indicators The impossibility of making a certain prediction of the appearance (return discolouration) of a coloured indicator (Helix test or Bowie&Dick test) after five or more years means that...
  • Page 17: Appendix - Accessories

    Operating Manual MELAdoc label printer Appendix - Accessories MELAdoc labels 6 replacement rolls with 750 labels, including an inking roller (Article No. 01096*). MELAdoc documentation sheets 1 block contains 100 sheets. We recommend using a single sheet per day and per autoclave.

Table of Contents