MELAG 15K Manual de usuario
User Manual
Sterilization container
according to EN 868-8 and EN ISO 11607-1
EN
Dear customer,
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 reprocessing 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 man-
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance with ENISO13485. This guarantees that all MELAG products are manufactured and tested in accordance with
strict quality criteria.
The MELAG management and team.
Contents
Contents
1 General guidelines ...............................................................................................................................................................4
Symbols used.......................................................................................................................................................................4
Disposal ...............................................................................................................................................................................4
2 Safety.....................................................................................................................................................................................5
3 Product description and application ..................................................................................................................................6
Intended use ........................................................................................................................................................................6
Loading instructions .............................................................................................................................................................6
Views - sterilization container...............................................................................................................................................7
Closing the sterilization container ........................................................................................................................................8
Storing sterile material .........................................................................................................................................................8
4 Maintenance..........................................................................................................................................................................9
Maintenance interval ............................................................................................................................................................9
Cleaning and care ................................................................................................................................................................9
Changing the paper filter....................................................................................................................................................10
Changing the seal ..............................................................................................................................................................11
5 Spare parts..........................................................................................................................................................................13
1 General guidelines
4
1 General guidelines
Please read this user manual before commissioning the sterilizer container. The functionality and value-re-
tention of this sterilizer container depends on the care accorded to it.
Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from
MELAG download centre at www.melag.com.
Symbols used
Symbol Explanation
Indicates a dangerous situation, which if not avoided, could entail slight to life-
threatening injuries.
Draws your attention to a situation, which if not avoided, could result in damage to the
instruments, the practice fittings or the device.
Draws your attention to important information.
Disposal
MELAG devices are synonymous for long-term quality. When you eventually need to decommission your
MELAG device after many years of operation, dispose of it and any spare parts that are no longer used,
such as seals, properly. Comply with all relevant disposal specification in terms of possibly contaminated
waste.
The packaging protects the device against transport damage. The packaging materials have been selec-
ted for their environmentally-friendly and recycling properties and can be recycled. Returning the packag-
ing to the material flow reduces the amount of waste and saves raw materials.
2 Safety
5
2 Safety
When using the device, comply with the following safety instructions as well as those
contained in subsequent chapters. Use the device only for the purpose specified in these
instructions. Failure to comply with the safety instructions can result in injury and/or damage to
the device.
Consumables/spare parts
nOnly use consumables and spare parts approved by MELAG for the sterilization container.
nOnly use MELAG disposable paper filters.
Load
nComply with pre-determined loading patterns established within the scope of the validation procedure.
The load must be arranged in such a way that steam can penetrate unhindered to the load. Only then
can proper sterilization be guaranteed.
Notification requirement
nAll serious incidents occurring in connection with the device must be reported to the manufacturer and
the competent authority of the Member State in which the operator and/or patient is established.
Storage
nStore the sterilization container according to national regulatory requirements. Always store the sterili-
zation container dry and protected from corrosive objects.
Disposal
nShould the sterilization container present signs of wear (e.g. friction, cracks or other wear) which pre-
vent further use, it must be disposed of in a professional manner.
3 Product description and application
6
3 Product description and application
Intended use
This accessory is a sterilization container for holding instruments and/or textiles during vacuum steam ster-
ilization and for maintaining sterility under proper conditions. The sterilization container is not to be used as
a transport container or disposal container. The sterilization container consists of a perforated base made
of anodised aluminium and a perforated cover made of stainless steel. To protect against contamination,
the sterilization container is equipped with disposable paper filters. These must be replaced with each ster-
ilization. The sterilization container is only suitable for use in steam sterilizers with fractionated pre-vacuum
or fractionated flow procedures.
The sterilization container must not be used for:
uHot air sterilization
uGravitation or flow sterilization
uFormaldehyde or ethylene oxide sterilization
uPlasma or peroxide sterilization
uTransport or disposal
NOTICE
Never put the sterilization container into the steam sterilizer with additional outer
packaging! The increased flow resistance could hinder the sterilization process or
destroy the container.
Loading instructions
The sterilization container must be arranged in the steam sterilizer in such a way that the steam can reach
the load unhindered during sterilization.
uObserve the maximum specified loading quantity of the steam sterilizer. Otherwise, the sterilization
result could be compromised.
uLoads wrapped in transparent sterilization sleeves may only touch each other on the paper side in the
sterilization container.
uObserve the information provided in the user manual of the steam sterilizer regarding special
instruments (dental transmission instruments, ophthalmological instruments, instruments with interior
lumen). When using accessories from a different manufacturer, check their general suitability for use.
3 Product description and application
7
Views - sterilization container
Front view 1)
1
2
3
6
5
7
4
1 Bottom (aluminium)
2 Lid (stainless steel)
3 Grip
4 Indicator holder
5 Lid lock
6 Stacking knob
7 Perforation
Interior view of lid 2)
89
10
11
8 Lid seal
9 Grip
10 Lid sieve plate
11 Push rod for filter and sieve plate
holder
Interior view of bottom 3)
12
13
14
12 Push rod for filter and sieve plate
holder
13 Perforation
14 Bottom sieve plate
1) Example view of a closed sterilization container (type 23M)
2) Example view of a sterilization container lid (type 23M)
3) Example view of a sterilization container bottom (type 23M)
3 Product description and application
8
Closing the sterilization container
WARNING
Danger of contamination
If the lid is not closed correctly, there is a risk that the contents will lose their sterile
properties more quickly after sterilization.
nCheck that the container is correctly closed each time it is loaded.
nMake sure that there are no protruding materials when using inner packaging. These may
interfere with closing.
}Close the sterilization container by placing the lid flat
on the container with the locking lugs open. It must be
possible to close the lid without applying pressure to
the container. Lock the sterilization container with the
fasteners on the sides to prevent accidental opening.
PLEASE NOTE! Make sure that there are no
protruding materials when using inner packaging.
These may interfere with closing.
After every sterilization
CAUTION
Danger of burns!
The sterilization container may be hot after sterilization.
nWear suitable protective gloves when removing the sterilization container.
A too rapid external cooling of the sterilization container can lead to an unfavourable accumulation of con-
densate.
uAllow the sterilization container to cool down slowly after the sterilization process has been completed.
uDo not place the sterilization container on cold surfaces.
Storing sterile material
The maximum storage time is dependent on the packaging and the storage conditions. Please observe the
regulatory requirements for the storage period of sterile materials (in Germany e.g. DIN 58953, Part 8 or
the DGSV guidelines) as well as the following listed criteria:
PLEASE NOTE
Responsibility for the storage conditions and length as well as for their compliance rests
with the operator of the equipment.
uComply with the maximum storage duration in accordance with the packaging type.
uWe recommend protected storage in cupboards or drawers.
uThe rooms must be dry, cool and easy to clean.
uThe rooms must not be accessible to the general public.
uStack a maximum of four sterilization containers of the same type on top of each other. The total
weight must not exceed 15 kg.
4 Maintenance
9
4 Maintenance
Maintenance interval
Frequency Measure
before every use ▪ Check seal in lid and replace if damaged
▪ Check the sterilization container, surfaces and lid for damage
▪ Check that the lid is closed
▪ Check fittings such as handle plates, locking lugs etc. to ensure that they are tight
▪ Check seal in lid for correct position and damage
▪ Check filter holding plate for deformation; the inserted filter must completely cover
the perforation of the lid
WARNING
Danger of contamination!
If the sterilization container or seal is damaged, there is a risk of contamination of the
sterile material.
nReplace the damaged sterilization container.
nReplace the damaged seal.
Cleaning and care
NOTICE
Damage to the device!
Hot, softened water can attack the aluminium, resulting in white deposits.
nDo not use tap water or softened water for cleaning in the washer-disinfector.
Comply with the manufacturer’s specifications of the cleaning fluid and disinfectants when cleaning and
disinfecting the sterilization container. Clean the sterilization container regularly and thoroughly both inside
and out. The cleaning fluid used for this purpose must be pH-neutral (pH value 6-8).
MELAG does not recommend automatic treatment in a washer-disinfector, as this could place the material
of the sterilization container under even greater strain. Under certain circumstances, this will lead to a re-
duction in its life-expectancy. We always recommend that you use manual cleaning and disinfection with
suitable resources.
Manual cleaning (recommended)
uDo not use abrasive cleaning fluids, metal brushes or similar items for cleaning.
uRemove all cleaning fluid residues by rinsing thoroughly with demineralised water.
uAllow all parts of the sterilization container to dry completely after cleaning and/or disinfection.
4 Maintenance
10
Mechanical cleaning
uThe sterilization container may only be processed using demineralised water in the washer-disinfector.
uThe sterilization container can be cleaned with demineralised water up to 95 °C.
uUse pH-neutral enzymatic cleaning fluids (pH 6-8) for machine cleaning and/or disinfection and for
washing.
uPlace the sterilization container and the lid in the machine basket separately and at an angle. The
opening of the sterilization container should face downwards.
uThe sterilization container is made of anodised aluminium and more chemically resistant stainless
steel. The anodised protective layer must not be damaged with pointed or sharp-edged objects. When
choosing cleaning agents and disinfectants, make sure that they are compatible with aluminium.
Changing the paper filter
Paper filters are available from MELAG as disposable paper (1 PU 4) = 100 pcs). The corresponding tests
to ensure germ resistance were only carried out for these filters. Only use undamaged paper filters of the
prescribed size. The paper filter must be changed after each sterilization!
PLEASE NOTE
Sterilization containers in which cotton filters were originally used cannot be converted
to paper filters.
NOTICE
Do not switch the paper filter and the sieve plates of the lid and the container!
Replace the paper filter as follows:
1. Loosen the locking lugs on both sides from the
sterilization container and remove the lid.
2. Press the sieve plate down slightly and push it to the
side. The push rods should now be in the larger
opening.
4) PU = packaging unit
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