MELAG MELAdoc, Руководство по эксплуатации

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Operating Manual MELAdoc label printer
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Chapter 1 – What does the MELAdoc do?
MELA doc 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. The clearance procedure consists of the steps procedure clearance,
batch clearance and clearance of the sterilized equipment.
1. Documentation of the procedure clearance
2. Documentation of the batch clearance
3. Labelling and clearance of the sterilized equipment
4. Storage
5. Post-application documentation
Documentation of the procedure clearance
Daily routine inspection and commissioning of large steam sterilizers is described in DIN
58946-6:2002. 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),

Cooling water provision, electricity provision

Printer paper
Steam penetration test

For large steam sterilizers: Bowie&Dick test.

For small steam sterilizers of the class “B”: Helix test.

For small steam sterilizers of the class “S”: Follow manufacturer’s instructions.
For the MELAG Euroklav
®
, you can use a Bowie&Dick test on porous basis of e.g. 3M.
Background: Daily routine inspection using a Bowie&Dick test is described in DIN 58946-
6:2002 (operating large steam sterilizers). The norm design for the operation of small steam
sterilizers is oriented around the norm for large steam sterilizers. Differing from this, for class “B”
autoclaves instead of the Bowie&Dick test, we recommend a Helix test according to EN 867-5.