Instruction of use for SAMMEX Alu-Containers Page 1/ 3
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1. minimise the risk of contamination by airborne particles SAMMEX Sarl 217 Bd Charles Arnould F 51100 Reims T l 33 326 02 64 30 Fax 33 326 02 21 56 www sammex com Instruction of use for SAMMEX Alu Containers Page 3 3 Cleaning and disinfection In the operating room SAMMEX Alu Containers are normally protected from contamination as they are covered with sheets or are removed from the room before the operation starts They must however be routinely cleaned Experience has shown that optically clean containers are not microbiologically burdened bioburden to such an extent that this can influence the effectiveness of sterilization However if this cannot be excluded inspection by hygiene control personnel for example by surface contact there is a theoretical risk of crossinfection In this case the containers should be disinfected before next use even when technically clean Compatibility with materials Container bases inner lids and outer lids are made of anodized aluminium When selecting cleaning and disinfection agents and methods particular attention must be paid to tolerance by aluminium as well as the following points Do not use lathering cleaning substances powder or abrasive metal brushes or similar e Thorough rinsing must remove all cleaning agent residues The individual parts must be thoroughly dried and stored in a dry place following cleaning disinfecti2. then for safety reasons it is nevertheless recommended that the procedure be validated Maintenance During storage sterilization containers are better than disposable soft packages at protecting sterile goods from recontamination caused by for example mechanical load damage Like all reusable equipment however the SAMMEX Alu Containers although robust also needs to be treated with care in order to ensure that its 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 thereby putting at risk the ability to attain and preserve sterility SAMMEX Alu Containers therefore require regular visual and if necessary functional checks Undamaged shape The seating of the seals on the upper rim of the container base tray and on the inner lid must be free of dents and visible deformations Neither the lid nor the tray may show noticeable buckling or holes The seal in the inner lid must be completely inserted and undamaged e Handles closure clasps and similar fittings must not be loose no wobble e Filters or valves may not show visible malformations They are to be subjected to visual and mechanical inspections as shown in the pictures filters must fully cover the visible perforations valves must be blank and free to mo
3. unprotected storage up to 6 weeks e Containers without internal packaging protected storage up to 6 weeks e Containers without internal packaging unprotected storage use as soon as possible Other important points are e Dry storage under controlled conditions low air contamination constant humidity etc e Handling as vibration free as possible Packaging mechanically undamaged If these points are followed then the risk of recontamination will be essentially restricted to the effects of external contamination accumulated during storage Unlike other types of packaging the protective cover concept of the SAMMEX Alu Containers is a simple method of eliminating this potential risk e g by swab disinfection of the protective lid We nevertheless recommend following DIN 58953 9 Operation procedures for sterilization containers SPECIAL CASES When storing or transporting sterile containers under nonstandard conditions e g house external transport strong vibration high humidity or rapid pressure changes due to transportation in aeroplanes or trucks then internal packaging and transport packaging to protect against dust contamination should be used to reduce the associated risks 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
4. when they are unfolded all the external walls of the container can be covered As an alternative to reusable cloths easily wrapable non woven disposable materials can also be used Because non woven materials have a higher flow resistance than cloths we recommend that in such cases the perforated tray be placed in the arch and fixed with adhesive tape before the load is placed into the container The package cannot then open during sterilization and block the inlets and outlets of the container the resulting raised flow pressure could damage the container Because of the problem associated with folding the use of sterilization paper is not recommended In order to prevent colours leaching and thereby staining the containers non coloured materials or in the case of green or blue cloths previously SAMMEX Sarl 217 Bd Charles Arnould F 51100 Reims T l 33 326 02 64 30 Fax 33 326 02 21 56 www sammex com Instruction of use for SAMMEX Alu Containers Page 2 3 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 Sterilisation 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
5. Instruction of use for SAMMEX Alu Containers Page 1 3 Instructions of use for SAMMEX Alu Containers Description SAMMEX Alu Containers are reusable metal sterilization containers They are used 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 The containers are intended for use by specialist trained professionals and their assistants working in the fields of hospital hygiene and sterilization technology This user manual describes important instructions on the proper use and care of SAMMEX Alu containers and without claiming to be comprehensive outlines a number of possible hazards that could result from failure to observe the instructions Filter System SAMMEX Alu Containers are available with a closed unperforated base and perforated filter lid can be covered by a unperforated lid or with perforated bottom and lid They are intended to be used with single use disposable filters or reusable textile filters with known serviceable life Both types of filters cannot be combined because different types of filter holding device must be used for paper and textile filters In case of use of filters which are not supplied from SAMMEX the user must validate the permeability and barrier properties himself For technical reasons relating to design SteriSet conta
6. aged sterilizing container Data cards indicators We recommend the use of documentation cards with chemical process indicators in the outer holding frame of the container see also DIN 58953 9 These cards help substantiate that the containers were treated correctly and facilitate performance documentation CAUTION If procedure indicators are not used then other organisational Measures should ensure that no unsterilized and thus non sterile containers are inadvertently released The additional use of chemical sterilization indicators inside the containers is not absolutely necessary Such indicators are basically able to prove that a sterilization procedure has been performed but are just as unable as an external card to indicate whether the contents of the container actually attained sterility they indicate only that the contents at the location of indicator are sterile If they are used we recommend that they are placed in the middle of the load as this is usually the most critical point The use of for example a single chemical indicator in a specific worst case test receptacle is considered to be a sensible alternative to batch documentation obtained by placing chemical indicators in every single sterile pack If such a worst case pack signals sterile then there is a much smaller probability of the procedure having failed for example as a result of spontaneous changes such as insuffici
7. container tray 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 CAUTION improperly sealed lids can jeopardise sterility e In the case of instrument sterilization the load weight including perforated tray should not exceed 10 kg as residual moisture may otherwise remain even despite the use of materials to assist drying e With cloth loads or similar the load weight should not exceed 6 5 7 kg e 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 e In order to prevent damage to the parts of the container or its load we recommend that the container be transported with its lid closed whenever possible 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 and an investigation started to determine the cause analysis of the sterilization record examination of the sterilizer as well as the other sterile packs investigation into the cause involving functional tests on the dam
8. ent air circulation caused by faulty door seals than if indicators are place in a normal container NOTE The batch documentation does not replace the regular checking and documentation of the sterilizers ventilation tests sterilization tests with chemical and biological indicators vacuum leak tests etc After Sterilisation 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 condensate Storage Transportation Sterility can be maintained inside proper packaging during clean hospital storage for a practically unlimited period 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 e Storage under dust protected conditions e Limitation of the storage period The recommendations of DIN 58953 part 9 May 1987 are therefore e Containers with internal packaging protected storage up to 6 months e Containers with internal packaging
9. iners are suitable for use only in steam sterilizers using fractionated prevacuum or fractionated circulation processes Steam sterilizers using a vacuum process built installed and operated inaccordance with DIN 58946 large sterilisers or EN 285 are suitable Note Table 1 from the hitherto valid German standard DIN 58953 9 Suitability of sterilizing containers for the various sterilizing procedures as well as DIN 58946 Large sterilizers contain further information on applicable combinations of sterilizing containers load types and sterilizing procedures CAUTION If SAMMEX Alu Containers are used in sterilizers which do not conform to EN285 or DIN 58946 or are not operated in accordance with EN285 or DIN 58946 then it is absolutely essential that the sterilization procedure is validated in accordance with the latest technical standards e g EN 554 as it may otherwise not be possible to guarantee the attainment of sterility CAUTION Hot air sterilization gravity or circulation procedures and also formaldehyde or ethylene oxide sterilization or other substitute procedures for the sterilization of thermolabile products such as plasma Sterilization or peroxide sterilization may not be used With loads comprising solely instruments i e containing no porous items such as textile packs etc then simple prevacuum or injection procedures may also be suitable If it is intended to use such a procedure
10. ised aluminium sections be cleaned preferably manually and without using chemicals Machine cleaning Internal and external lids should be separated and placed diagonally in the washing tray The lower section should be inverted and face downwards Disinfectants Disinfectants should be checked not just for chemical tolerance to aluminium see above but also for effectiveness We therefore recommend selecting a disinfectant with proven material tolerance from List VII issued by the Deutsche Gesellschaft f r Hygiene und Mikrobiologie DGHM German Society for Hygiene and Microbiology CAUTION When such substances are applied manually the instructions for use should be followed exactly to ensure that inadequate effect and damage to the material are avoided Specific attention should be paid to ensuring that the substances selected are tolerated by the materials as well as to the mixing ratio exposure time and effect of mixing various different cleaning agents Literature Standards Instrumenten Aufbereitung richtig gemacht edited by Arbeitskreis Instrumenten Aufbereitung 6 Edition e DIN 169 paperback Sterilisation und Desinfektion e DIN 263 paperback Sterilisation von Medizinprodukten e DIN 58946 Sterilisation Autoclaven e DIN 58953 Sterilisation EN 868 The DIN Standards are available at BEUTH Verlag Berlin For further information about cleaning and sterilizati
11. on The selected cleaning agents must be appropriate for the quality of the available water For THERMAL cleaning and disinfection we recommend a in case of fully desalinated water cleaning with i e the pH neutral enzymatic cleaner NEODISHER MEDIZYM at app 45 C and subsequent thermodisinfection during final rinsing by use of fully desalinated water b in case of only softened water cleaning by use of mild alkaline non chlorous substances such as NEODISHER FA liquid or NEODISHER MA powder during simultaneous thermodisinfection For CHEMICAL cleaning and disinfection we recommend a in case of fully desalinated water pHneutral or weak acidic substances such as e g NEODISHER Dekonta a combined cleaning amp disinfection product OR cleaning with NEODISHER MEDIZYM at app 45 C and subsequent disinfection with NEODISHER Septo DN b in case of only softened water use of mild alkaline active chlorousubstances such as NEODISHER ALKA 300 or NEODISCHER FI both combined cleaning amp disinfection products CAUTION The above recommendations are not mandatory Adherence to the recommendations is no guarantee that the material can tolerate the cleaning agent In case of doubt ask the manufacturer of the cleaning agent whether the agent is tolerated by aluminium under the selected conditions of use As there are generally no chemically resistant anodised colours we recommend that coloured anod
12. on visit www a k i org SAMMEX Sarl 217 Bd Charles Arnould F 51100 Reims T l 33 326 02 64 30 Fax 33 326 02 21 56 www sammex com
13. ve when inspected mechanically After any accident such as being dropped on the ground it is essential that the sterile container undergoes a thorough check e According to EN 868 8 all sealings must be replaced after 100 sterilizing cycles or all 6 months Damaged or deformed sealings must be replaced earlier If the closing pressure of the lid is becoming low a replacement of the sealing usually solves the problem Sealing It is recommended and required e g 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 SAMMEX Alu Containers can be protected by disposable plastic seals which once attached can be opened only by breaking Sterilisation SAMMEX Alu Containers can also be sterilised whilst stacked Stack height lt 60 cm To prevent accidents or mechanical damage do not handle stacked containers jerkily To prevent condensation collecting on one side and thus causing drying problems the containers should be placed horizontally in the sterilizer Internal Packing We recommend using SAMMEX Alu 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 DIN 58953 9 and make possible aseptic presentation of the sterile goods The size of the cloth wraps should be calculated so that
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