Usage Advice (EN)
®
MELAstore Box 100
MELAstore® Box 200
Sterile container
Dear doctor!
We should like to extend our thanks for the expression of trust in our company which you have displayed
through the purchase of this MELAG device.
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 treatment 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 management systems is subject to close monitoring: one instrument to this end is
our annual multi-day audit conducted in accordance with ISO 13485 and ISO 9001 conducted by the
certification agency BSI. This guarantees that all MELAG products are manufactured and tested in
accordance with strict quality criteria.
The MELAG management and team.
Contents
Chapter 1 - Product description.......................4
Intended use ................................................................ 4
Mode of operation ........................................................ 4
Views MELAstore-Box 100*......................................... 5
Chapter 2 – Working with the sterile container
.......................................................................6
First use ....................................................................... 6
Set-up .......................................................................... 6
Function checks ........................................................... 6
Operation ..................................................................... 7
Chapter 3 – Cleaning and Disinfection .......... 10
Manual cleaning/disinfecting (recommended) ............10
Mechanical cleaning/disinfecting ................................11
Chapter 4 – Maintenance and Care .............. 12
Maintenance ...............................................................12
Care ............................................................................12
ii
General information
DANGER!
The sealing and its function as a germ barrier will be compromised if the sterile container
is combined with components from other manufacturers.

Only combine MELAG products (e.g. MELAstore-Trays or MELAstore-Boxes) with each
other.

Prior to use, check that the product is in good working order.

To prevent damage caused by improper setup or operation, and in order not to compromise warranty
and manufacturer liability:

Use the product only according to these instructions for use. Please observe the safety
information and maintenance.

Never use damaged or faulty sterile containers. Replace any damaged components immediately
with original spare parts.

If sterile container components are repaired in a way that could affect the sterile container’s
germproof qualities: Inspect the sterile container thoroughly before use.

Ensure that only persons with the requisite training, expertise or experience will handle the sterile
container and its accessories.

Keep the instructions accessible for personnel.

Follow general guidelines! Follow aseptic principles when handling contaminated items that have
undergone or are to undergo sterilization.

For more information please read the instructions for use (C 23381 Edition/01, 2013) by the sterile
container manufacturer http://www.bbraun.de.
3
Chapter 1 - Product description
Chapter 1 - Product description
Intended use
The sterile container is validated for steam sterilization in a sterilizer in accordance with DIN EN 13060,
EN 285/ ANSI/AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993 and EN 554/ISO 13683. Medical devices
can be sterilized, stored and transported in the sterile container. The sterile container can also be used for
transporting medical devices back to the decontamination center after use.
Mode of operation
The sterile container conforms with DIN 58953-9 and EN ISO 11607-1 requirements. Sterile containers
with perforated lids and closed container bottoms are validated for steam sterilization in a sterilizer in
accordance with EN 285 and DIN EN 13060 in fractionated vacuum process.
PLEASE NOTE
The suitability of any specific process must be validated at the site of application.
4
Views MELAstore-Box 100*
Front view
6
5
(1)
Lid
(2)
Bottom
(3)
Plate holder
(4)
Lid lock
(5)
stacking knobs
(6)
Indicator holder
(7)
Plastic latch
(8)
Filter holder
(9)
Filter housing
1
4
2
3
Fig. 1: closed MELAstore-Box 100
Interrior view of the lid
7
11
(10) Latch nose
8
(11) Lid seal
9
10
Fig. 2: Lid of the MELAstore-Box 100
*Views are identical with MELAstore-Box 200
5
Chapter 2 – Working with the sterile container
Chapter 2 – Working with the sterile
container
First use

Thoroughly clean the new sterile container prior to first use, see Chapter 3 – Cleaning and
Disinfection

After cleaning, use a suitable filter (see "Changing the filter in the lid" page 6)
Set-up
Removing the lid

The lid (1) can be removed for cleaning the sterile container.

Open lid lock (4) and remove the lid (1).
Changing the filter in the lid
Replace the filter at the following intervals, depending upon the filter type:

Disposable filter: prior to each sterilization cycle

PTFE permanent filter*: after max. 1 000 sterilizations
*For further information please consult the instructions for use of the permanent filter.
Changing the filter
1. To open filter holder (8) press back plastic latch (7).
2. Remove filter holder (8) once it is unlocked.
3. Replace filter and install filter holder (8) under latch noses (10).
4. Push down filter holder (8) so that it clicks into plastic latch (7).
Function checks
Visually inspect all components of the sterile container before each use to ensure there is no damage, and
check to ensure correct function:
6

metal parts are not deformed

Lid (1) and bottom (2) are not warped.

Filter holder (8) sits in full surface contact.

Lid seals (11) are fully intact (no cracks).

Plastic parts are fully intact (no cracks).

The permanent filter is undamaged.

The disposable filter has been changed.

The lock functions work properly (engages).

The filter holder latch functions work properly (engages).

The seal at filter holder (8) is undamaged (no cracks).

Use sterile containers only if they are in mint condition. Replace any damaged components
immediately with original spare parts, or have the damaged components repaired.
Operation
DANGER
Risk of contamination of sterile materials!


Never carry or lift the sterile container at the lid.
Transport the sterile container in such a way that mechanical damage will not occur.
Loading the sterile container
Please observe the maximum load:

Maximum loading: 2 kg per sterile container*
* Please note the loading instructions of sterilizer manufacturer.
Possible combinations of the sterile containers in MELAG autoclaves

4x MELAstore-Box 100

2x MELAstore-Box 200 and 1x MELAstore-Tray 100

and less
Permitted combinations of sterile container and Washing tray

1x MELAstore-Box 100 and 1x MELAstore-Tray 100

1x MELAstore-Box 100 and 2x MELAstore-Tray 50

1x MELAstore-Box 200 and 1x MELAstore-Tray 100

1x MELAstore-Box 200 and 1x MELAstore-Tray 200

1x MELAstore-Box 200 and 2x MELAstore-Tray 50
Instruments

Store instruments in the washing tray with appropriate storage devices, with hollow items, dishes,
plates, etc. placed at a downward angle.

Load the sterile container in such a way that filter holders (8) are not obstructed.

Please observe the maximum loading height.

Lock lid (1) to bottom (2) using lid lock (4).

Ensure that lid lock (4) clearly engages in detent spring.
Loading the sterilizer
Prepare the sterile container and the sterilizer the following way when loading the sterilizer:
WARNING
Risk of vacuum damage to the sterile container due to inadequate pressure equalization!



Do not use outer packaging for the sterile containers.
Never obstruct air flow through the perforation fields in the bottom and lid.
Do not place foil packaging directly on the sterile container.

Follow the sterilizer manufacturer’s recommendations.

Always place heavy sterile containers at the bottom of the sterilizer.

Always lift or transport the sterile container on the bottom (2).

It is possible to stapel the sterile container in the sterilizer on the stacking knobs (5).

Transport stacks of sterile containers in such a way that the stacks do not topple over.
7
Chapter 2 – Working with the sterile container
Inserting the indification plate and lead seal
After loading the sterile container include an identification plate if necessary.

Slide the identification plate into the plate holder (3).
Fig. 3: Slide identification plate into the plate holder

After sealing the sterile container insert a lead seal at the indicator lock (6) of the closed container.
Fig. 4: Insert a lead seal
Sterilization
DANGER
Risk of contamination!


8
Sterilize the sterile container (anodized surface) only with approved and validated sterilization
processes.
Sterilize expressly marked sterile container only with approved and validated sterilization
processes.

Sterilize with steam, taking note of the following: Sterilization with steam must be carried out with a
validated steam sterilization process (e.g. in a sterilizer in accordance with DIN EN 13060, EN 285,
ANSI/AAMI ST 46-2002 and validated in accordance with ANSI/AAMI/ISO 17665-1).

If sterilizing several sterile containers: Ensure that the maximum load capacity of the steam sterilizer,
as specified by the manufacturer, is not exceeded.

Ensure that the sterilization medium can reach all products stored in the sterile container.
Unloading the sterilizer
WARNING
Risk of burns due to a hot sterile container after sterilization!

Always wear protective gloves when unloading the sterilizer.
Checking and commissioning the sterile materials
The contents of a sterile container can only be considered to be sterile if the sterile container is sterilized,
stored and transported as specified. If this is not the case, the sterile materials must be processed again.
DANGER
Risk of contamination from improperly sterilized materials!

Prior to commissioning the sterile materials, check to ensure that the sterilization was
successful.

Verify that the indicator color has changed (if available).

Make sure that all parts of the sterile container, particularly the lid locks, are intact.

Ensure that the sterile container lead seal on the sterile container is intact.
Storing the sterile containers
PLEASE NOTE
The sterile containers may be stored in stacks.


Store sterile containers in a dry, clean and protected place.
Observe the storage period and storage conditions as per DIN 58953-8 and DIN 58953-9,
see Storage periods for sterile materials: extract from DIN 58953-9.
9
Chapter 3 – Cleaning and Disinfection
Chapter 3 – Cleaning and Disinfection
WARNING
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive
temperatures!
 Following the manufacturer's instructions, use cleaning and disinfecting agents which
 Ensure that cleaning and disinfecting agents are approved for use on aluminum, plastics
and stainless steel.



do not attack softeners (e.g. in silicone).
Observe specifications regarding concentration, temperature and exposure time.
If drying with pressurized air, avoid damage to the permanent filter.
Manual cleaning/disinfecting (recommended)
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 could lead to a reduction in its lifeexpectancy. We always recommend that you use manual cleaning and disinfection with suitable
resources.

Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of
the disinfecting solution.

After manual cleaning/disinfection, check visible surfaces visually for residues.

Repeat the cleaning/disinfection process if necessary.
Table 1: Manual cleaning with disinfecting cleaning by wipe disinfection
T
t
[°C/°F]
[min]
Cleaning
RT (cold)
-
Drying
RT
Wipe
disinfection
Conc
.
Water
quality
Chemicals
-
D-W
-
-
-
-
-
-
>1
-
-
-
II Aldehyde-free
surface disinfection
Final rinse
RT (cold)
0.5
-
FD-W
not
required
Remove cleaning
chemicals without
leaving any residue
V
Drying
RT
-
-
-
-
D-W:
Drinking water
FD-W:
Demineralized water
RT:
Room temperature
Phase
Step
[%]
I
II
III
IV
10
Phase I

Wipe off gross debris prior to cleaning.
Phase II

Dry the instrument with a lint-free cloth or medical compressed air.
Phase III

Carry out wipe disinfection
Phase IV

When using aldehyde-free disinfectants:


After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running
FD water.
Drain any remaining water fully.
Phase V

Dry the product with a lint-free cloth or in a heating cabinet.
Mechanical cleaning/disinfecting

The cleaning and disinfection device must be of tested and approved effectiveness.
Follow the sterilizer manufacturer’s recommendations.

Do not use rinsing agents.

Use appropriate insert racks for machine cleaning according to manufacturer's instructions.

After the specified exposure time rinse the disinfected surfaces under running FD water.

For more information please read the instructions for use (C 23381 Edition / 01, 2013) by the
sterile container manufacturer (http://www.bbraun.de).
11
Chapter 4 – Maintenance and Care
Chapter 4 – Maintenance and Care
Maintenance
PLEASE NOTE
The sterile containers may be tested and repaired only by persons with the appropriate training,
expertise or experience.

In case of visible damage, change the lid seal (11) immediately.

If the lid (1) or bottom (2) is damaged, send the sterile container to your stockist.
Care
Lightly lubricate moving metal parts, e.g. latch or lock hinges, with appropriate maintenance oil for the
respective sterilization process.
12
MELAG Medizintechnik oHG
Geneststraße 6-10
10829 Berlin
Germany
e-mail: info@melag.de
Responsible for content: MELAG Medizintechnik oHG
Date of update: 29/07/2015
Subject to technical alterations
BA_EN_MELAstorebox_100_200_v0.docx | Rev.: 0 – 15/1415
Web: www.melag.de
Download PDF
Similar pages