Gima S.p.A.

- Via Marconi, 1 - 20060 Gessate (MI) Italy

Italia: tel. 199 400 401 - fax 199 400 403
Export: tel. +39 02 953854209/221/225 fax +39 02 95380056
[email protected] - [email protected]
PROFESSIONAL MEDICAL PRODUCTS www.gimaitaly.com

CONTENITORI PER LA STERILIZZAZIONE

STERILIZATION CONTAINER SYSTEM
RÉCIPIENTS DE STÉRILISATION
CONTENEDORES DE ESTERILIZACIÓN
Manuale d’uso - User Manual
Notice d’utilisation - Manual del usuario

ATTENZIONE: Gli operatori devono leggere e capire completamente

questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely understand
the present manual before using the product.
AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant
d’utiliser le produit.
M-37000-I-EN-F-E-Rev.0.07.12

ATENCIÓN: Los operadores tienen que leer y entender completamente

este manual antes de utilizar el producto.
z
z

Ceylan Tibbi
19 Mayis Sanayi Sitesi 71. Sokak No. 32
Kutlukent/Samsun ­ Turkey
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VALIDITY
These instructions of use are valid for all GIMA aluminium sterilizing
containers and accessories, sold by GIMA. GIMA aluminium sterilizing
containers and accessories are in compliance with its current catalog.

DESCRIPTION
GIMA aluminium containers are reusable, metal, sterilization containers.
They are designed for holding operating room instruments and/or textiles
during vacuum-steam sterilization procedures and for maintaining sterility
during storage and transport under proper hospital conditions. (EN 285,
EN 868-1, EN 868-8). Sterilization containers consist of three main parts such
lid, bottom and filter retainers. The sterilization containers should be
handled by qualified personnel who are trained and instructed about
sterilization containers, hospital hygiene and sterilization technology, in order
to prevent damage to the containers, fasteners, seals and sterilization filters,
during usage.
This user manual describes important instructions on the proper usage
and maintenance of GIMA aluminium containers, and possible hazards
that could result from failure to observe the instructions.
Endoscopes, instruments with lumen, compressed air driven instruments
or power systems and canalized instruments should be prepared
and sterilized according to manufacturer’s instructions. Container lids
are offered in six different colors in order to ease identification of the
instruments that are used by different departments in hospitals. The colored
identification labels that are used with containers provides information about
the content and where these instruments are used.

FILTER SYSTEM
GIMA aluminium containers are available with an unperforated base
and perforated filter lid or with perforated bottom and lid (can be covered
by an unperforated lid). They are designed to be used with single use
(disposable) filters or reusable textile filters. It’s necessary to use same type
of filters during usage of the containers. In case of use of filters, which
are not supplied from GIMA, the user must validate the permeability
and barrier properties of the filters himself.

Filters:
Disposable single use paper sterilization filters have to be changed before
each new sterilization.
Long-term textile filters can be used for about 45-50 sterilization cycles.
Visually deformed and dirty textile should not be used. Permanent filters
(PTFE) can be used for over 1000 sterilization cycle.
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During storage after sterilization, in order to prevent damage (puncture, tear)

to sterilization filters, sharp and pointed objects should not be placed
on the containers. GIMA recommends usage of safety lids on the containers
during transportation and the storage of the containers in order to prevent
contamination risks that may be caused by such negative situations.

CONTROL BEFORE USAGE

During storage, usage of metal sterilization containers is safer than other
storage method of sterile materials in regards to protection against
contamination. Like all reusable equipment, GIMA aluminium containers
needs to be treated with care in order to ensure that their protective qualities
are preserved. The relevant personnel (including delivery and collection
services) must therefore be familiar with the correct handling practices.
CAUTION: Careless handling or the use of inappropriate chemicals can
cause damage on the containers, thereby putting at risk the ability to attain
and preserve sterility. GIMA aluminium containers therefore require regular
visual and, if necessary, functional checks. If cautions and the instructions
in the user manual are followed, containers may serve for 1000 sterilization
cycles and seals may serve for 500 sterilization cycles.

Undamaged shape:
- Containers must be checked visually before each usage.
- Container bottoms, container lids and the surfaces where the seals sit must
be free of dents and visible deformations.
- Do not use any spray, oil or solvents on the lid seals.
- The seal in the inner lid must be completely inserted and undamaged.
If any kind of damage is detected lids should not be used.
- When the container is closed, tray, lid and locking parts have to be stable
(No “wobble”).
- Maintenance and repairs of the sterilization containers must be carried out
by qualified personnel. Do not attempt to carry out repairs on containers
lids, fasteners and seals yourself, in order not to jeopardize the safety
in use of the containers.

Filters and filter retainers

These parts must show no visual deformations. These parts must also be
checked visually and for their functionality before usage. Filters should cover
all the perforation holes, properly. Filters retainers should function properly
when mechanically checked and filter retainers should be easily attachable
and detachable.
After any accident (such as a container being dropped on the ground),
it is essential that the sterile container undergo a thorough check.
Make sure that filters and filter retainers are placed into their places
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properly. A “Click” sound that is heard while placing filter retainers by

pressing on them indicates that locking is realized.

SAFETY SEAL
It is recommended and required by DIN 58953-9 that containers are sealed
in such a way as to prevent inadvertent opening of containers and to ensure
that it is evident whether or not a container has been opened. GIMA
aluminium containers can be protected by disposable plastic seals (“security
seals”), which, once attached, can be opened by breaking only.

INTERNAL PACKING
We recommend using GIMA aluminium containers with simple internal
packaging (e.g. cloth wraps or drip sheets). These assist the final drying
stage, allow a longer storage period according to DIN58953-9, and makes
aseptic preservation of the sterile goods possible. The size of the cloth wraps
should be calculated so that when they are unfolded all the external walls
of the container can be covered.
As an alternative to reusable cloth, easily wrap able (non-woven) disposable
materials can also be used. In internal packing case, we recommend
to fix the corners of package materials with adhesive tape. In this way
the package cannot then open during sterilization and block the inlet
and outlet filter holes of the container and raised flow pressure won’t
damage the container. Because of the problem associated with folding,
the use of sterilization paper is not recommended. In order to prevent colors
leaching and thereby staining the containers, non-colored materials (or in the
case of green or blue cloths, previously washed sheets) should be used.

CAUTION: Never sterilize the container wrapped in additional

packaging. Apart from the risk of lack of sterility, the increased flow
resistance could impair the sterilization effect (non-sterility) or even
destroy the container.

STERILIZATION OPERATIONAL LIMITS

- In order to ensure that the lid can close properly, sterilization containers
must not be filled above the level of the lower ridge of the edge indentation
on the container bottoms. The lid must lie flat on the lower section
without being forced and so that it does not wobble even when
the clasps are open. It must also be possible to close the clasps without
additional pressure on the lid. In the case of instrument sterilization,
the load weight (including perforated tray) should not exceed 10 kg for 1/1
size containers. Load weight should be 5 kg for ½ size containers
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and smaller loads should be arranged for smaller containers (DIN 58953-9).
- With cloth loads (or similar), the load weight should not exceed 7-8 kg.
Make sure that folded textile or cloth loads are placed horizontally
in containers (DIN 58953-9). When using internal packaging (nonwoven
or cloth), care should be taken that the correct closing of the lid is not
impeded, for example, by a protruding corner of the packaging.

CAUTION: For example, there is a risk of non-sterility if protruding cloth

corners prevent the container from closing correctly.
CAUTION: If the sterilization procedure causes sterilization containers
to become deformed in any way, then there is no guarantee of sterility.
In such cases, the entire batch must not be used, they should be
sterilized again and an investigation should be started to determine
the cause.

PLACING INTO STERILIZERS

Sterilization containers are made for use in general steam sterilizers (EN 285).
Make sure that heavier containers are placed at the bottom of the sterilization
chamber first. The design of GIMA aluminium containers allows them to be
stacked during sterilization. In order to prevent accidents and mechanical
damages on the containers it is important to work very carefully with the
stacked containers. To prevent condensation collecting on one side (and thus
causing drying problems), the containers should be placed horizontally in the
sterilizer. The loading instructions of the sterilizer should also be observed.

DATA CARDS / INDICATORS

We recommend use of information cards with chemical sterilization indicators
in the outer holding frame of the containers (DIN58953-9).
CAUTION: If chemical sterilization indicators are not used, then other
organizational measures should be taken to ensure validation of the
sterilization and non-sterile containers being used (released) by mistake.

AFTER STERILIZATION
To safeguard against accidents (burns, dropping, etc.) containers that are still
hot should never be handled with bare hands. The containers should not be
cooled to room temperature too rapidly (e.g. do not place on cold surfaces
or expose to a cold draught), as excessively rapid external cooling can lead
to recondensation of the water vapour inside the container with an unwanted
accumulation of condensation.
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STORAGE / TRANSPORTATION
In practice sterility can be maintained for an unlimited period with proper
packaging, during storage in controlled hospital storage room conditions
(temperature, humidity, air filtration etc.). The acceptable storage period
should be determined by responsible hygiene personnel.
Requirements and suggestions of DIN58953-9 should be taken under
consideration while determining storage time and storage conditions.
Depending upon storage duration and conditions, however, external
contamination occurs, and this represents a potential risk during subsequent
use, transport and aseptic presentation. According to DIN 58953/9 this risk
factor can be reduced by the following measures:
- The use of internal packaging.
- Storage under dust protected conditions. The recommendations
of DIN 58953-9 on limitation of storage period.
- Containers with internal packaging, protected storage up to: 6 months.
- Containers with internal packaging, unprotected storage up to: 6 weeks.
- Containers without internal packaging, protected storage up to: 6 weeks.
- Containers without internal packaging, unprotected storage: use “as soon
as possible”.

SPECIAL CASES
When storing or transporting sterile containers under non-standard
conditions (e.g. in case of getting sterilization service for containers from
places such as central sterilization departments), then internal packaging
and transport packaging should be used to reduce the contamination risks
that are associated with outer environment conditions.

ASEPTIC PRESENTATION
If containers are to be opened after a long period of storage or after storage
under non-ideal conditions, then we recommend wiping the unperforated
cover with a disinfectant before handling in order to minimize the risk
of contamination by air-borne particles.

CLEANING AND DISINFECTION

Requirements according to DIN 58953-9:
- Users have to specify by means of a disinfection and cleaning plan, when
and how the sterilization containers have to be cleaned and/or disinfected.
- Containers used for waste disposal have to be cleaned and disinfected
each time after use.
- Cleaning materials should be suitable to available water quality in hand.
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MANUAL CLEANING
- Only use neutral cleaners and disinfectants for cleaning.
- Do not use metal brushes or cleaning materials that may cause chemical
or physical corrosions.
- All part must be rinsed with demineralized water without leaving any stain
or residue on them and dried by hand and stored.

MECHANICAL CLEANING
- Mechanical cleaning of the containers is preferred to manual cleaning.
- Cleaning of the containers with machines is recommended only if the
washing machine has a special washing program for aluminium containers.
- Only use neutral cleaners or neutral disinfectants for cleaning.
Do not use any cleaning solutions that contain soda or caustic soda.
- Do not use additional acidic neutralizers.
- Observe the instructions of the manufacturer of neutral cleaners
and disinfectants for cleaning aluminium containers.
- Use demineralized water for final rinsing since salt in the water may cause
spotting during subsequent sterilizations.
- Cleaning (washing) machine has to be designed for cleaning sterilization
containers. This applies in particular to ensure secure replacement
in the washing baskets and the arrangement of the spray jets or arms.
- Remove the lids and filter retainers before cleaning the containers
and clean them individually.

GIMA WARRANTY CONDITIONS

Congratulations for purchasing a GIMA product.This product meets high
qualitative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace
free of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall
not extend the warranty. The warranty is void in the following cases:
repairs performed by unauthorized personnel or with non-original spare
parts, defects caused by negligence or incorrect use. GIMA cannot be held
responsible for malfunctioning on electronic devices or software due to
outside agents such as: voltage changes, electro-magnetic elds, radio
interferences, etc. The warranty is void if the above regulations are not
observed and if the serial code (if available) has been removed, cancelled
or changed.
The defected products must be returned only to the dealer the product was
purchased from. Products sent to GIMA will be rejected.