Preparation Before Cleaning - KLS Martin group marSafe Gebrauchsanweisung

5 Disinfecting, Cleaning and Care
5.1 Limitations and restrictions on cleaning, disinfection, and sterilization
The parameters for cleaning and disinfecting the container are to be determined by the operator/
user, e.g. as part of the hygiene plan. The treatment agents must be selected to be compatible
with the container component materials and also effective hygienically and microbiologically. A
thorough final rinse, preferably with demineralized water, must ensure that no cleaning and care
agent residues are left on any of the components of the container.
Observe all national legal requirements, national and international standards and guidelines and
the in-house hygiene regulations for reprocessing.
Observe all applicable national regulations in regard to reprocessing of the products in
•
case of patients suffering from Creutzfeldt-Jakob disease (CJD), suspected CJD or
possible variants of the disease.
• Note that successful reprocessing of this medical product can be guaranteed only after
prior validation of the reprocessing process.
The responsibility for this lies with the operator/reprocessor.
• In the interest of process capability and better and more reliable cleaning results,
machine reprocessing should always be preferred to manual cleaning.
Due to process tolerance, the data provided by the manufacturer serve only as reference
•
values for the evaluation of reprocessing processes carried out by the
operator/reprocessor.
Materials Used
The container tank (7), the grip plate (8) and the locking plate (14) made of aluminum are coated
with an anodized protective layer. The anodized surface increases the abrasion resistance and the
wear resistance. Anodized aluminum is resistant to pH-neutral or alkaline treatment agents up to a
pH = 10.5. Especially in case of machine reprocessing with alkaline cleaning agents greater than
pH = 10.5 and acidic neutralization agents, destruction of the anodized layer by chemical attack
must be expected. The container tank (7) may therefore be cleaned only with pH-neutral or
alkaline agents with a max. pH = 10.5, respectively, or cleaning agents that are explicitly approved
for use with anodized aluminum components. The instructions of the manufacturers of the
treatment agents and washer-disinfectors must be observed.
The color field (12) is made of a special high-performance plastic suitable for sterilization. Both
parts can be processed with the programs that are approved for aluminum products. Thermal
disinfection up to 95 °C is possible without problems.
Color fields must never be treated with acetone/petroleum ether! In addition, be sure to use
cleaning agents only in concentrations that do not exceed the maximum specified by the
manufacturer (this applies to both manual and machine cleaning processes). Note that
acetone/petroleum ether as well as excessive cleaner concentrations cause stress cracking,
thus destroying the material. For the same reason, no disinfectants containing glucoprotamine
should be used for disinfecting the marSafe
corrode the silicone gasket, thus reducing its life or even destroying it completely. Doing so
greatly reduces the life span of the gasket.
5.2

Preparation before Cleaning

• Remove the container cover (1) from the container tank (7) for cleaning purposes.
• In case of the marSafe ® +, the microStop
removed under all circumstances.
• Dried or fixated operation residues may corrode the surface of the products.
− Therefore please note: Ensure short disposal times and do not use fixating pre-
cleaning, nor fixating disinfecting agents.
• The product can be damaged by unsuitable cleaning agents or excessive temperatures.
Therefore please note: Use cleaning and disinfecting agents according to the
−
manufacturer's instructions that are approved for use with plastics, aluminum and
silicones.
• Observe the information regarding concentration, temperature and exposure time!
5.3 Machine Cleaning and Disinfection
For machine-based cleaning processes, use only pH-neutral or alkaline cleaning agents up to a
pH of 10.5 which the respective manufacturer has expressly declared suitable for cleaning
anodized aluminum components. To protect the aluminum surfaces from damage, no acidic
neutralizers should be added. The final rinsing may be carried out using demineralized water only.
Be sure to observe also the instructions provided by the manufacturer of your automatic cleaning
machine as well as those provided by the manufacturer of the products used. Moreover, it is
essential to use only cleaning machines that are suitable for cleaning containers,
16
®
container cover (1) because such agents would
® disk (3) and the holding unit (14) must be
marSafe
allowing safe placement inside the tray baskets and providing adequately arranged spray nozzles
or arms.
Recommendations for machine cleaning and disinfection (validated procedure according to
ISO 15883 and information according to ISO 17664):
Temperature
Phase Step
[°C/°F]
1 Pre- Room
cleaning temperature
(cold) <25/77
2 Cleaning 55/131 (max.
65/149)
3 Interim > 10
rinsing
4 Thermal 90
disinfection
5 Drying --
5.4 Removing Residues
Residues or contamination on the container tank (7) which cannot be removed during the normal
cleaning process (adhesive labels, indicator strips, markings) can be removed using commercially
available anodic cleaning agents. After this special treatment, rinse the container tank or cover or
feed it into the normal cleaning process.
6 Container Loading
The container must be loaded in a manner so that the filter holder (5) or the holding unit (2) with
microStop ® disk (3), respectively remains unobstructed so that the steam can flow freely into the
container. This corresponds to approx. 1 cm below the edge of the container tank. To facilitate
loading, the maximum loading height with imprinted markings is shown in the interior of the
container on the front side.
Information for validation of the container load can be found in the international DGSV guideline
"Validation of packaging processes according to DIN EN ISO 11607-2".
6.1 Functional Check before Loading
Before use, all components of the container must be subjected to a visual check for possible
damage. Pay special attention to the following:
Metal parts, in particular in the area of the container tank seal, are not deformed
•
• Aluminum cover is not warped
Filter holder (5) or holding unit sits fully flush on the edge
•
• microStop ® disk (3) is intact
• Seals are intact
Lock is intact
•
Damaged parts must be replaced or repaired immediately and may not be used. The seal in the
container cover (1) must not show any visible damage, otherwise the container cover (1) must be
replaced. Only cleaned container assemblies may be used. When locking, the seal must sit fully
flush around the tank.
6.2 Loading the Container with Linen or other Textiles
When loading the container with textiles, be sure to pile the folded items (max. 6 kg) upright into
the container. Do not overfill! It should always be easily possible to slide the stretched hand into
the pile. For easy handling and aseptic presentation of the sterilization material, DIN 58953-9
recommends wrapping the laundry items in a suitable interior cover for sterilization material of an
appropriate size.
Use of a gravitation process when loading the container with textiles must be approved by the
manufacturer.
Instructions for Use
and marSafe + Sterilization container system
® ®
Time
Water quality Chemical agent
[min]
Drinking water --
2
10 Fully a) pH-neutral
demineralized e.g. neodisher
water neodisher ®
b) mildly alkaline/alkaline up to
max. pH = 10.5 if cleaner is
approved for aluminum
products, e.g. neodisher
MediClean forte
Working solution 0.5%
Fully --
2 demineralized
water
Fully --
5 demineralized
water
According -- --
to
program
® MediZym /
MediClean
®
Revision 04