IFU - Wagner GmbH
Contents
1. As there are generally no chemically resistant anodized colours we recommend that coloured anodized aluminium sections be cleaned preferably manually using neutral cleaning and disinfection substances and fully desalinated water 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 Wagner GmbH Fabrik f r medizinische Ger te Schulstra e 16a D 80634 M nchen Germany Telefon 49 89 121101 0 Fax 49 89 133099 info wagner sterilsysteme de www wagner steriset de VAGNER d2. Henkel Ecolab the Sekumatic family www ecolab com Instructions for the preparation of re useable medical products in accordance with EN 17664 2004 are available on www wagner steriset de Catalogs Recommendations are not mandatory Adherence to the recommendations is no guarantee that the material can tolerate the cleaning agent 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 concentration mixing ratio water quality exposure time temperature and effect of mixing various different cleaning agents In case of doubt ask the manufacturer of the cleaning agent whether the agent is tolerated by aluminium under the selected conditions of use Cleaning machines Internal and external lids should be separated see diagram 5 8 and placed diagonally in the washing basket 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 fur Hygiene und Mikrobiologie DGHM German Society for Hygiene and Microbiology
3. In order to prevent colours leaching and thereby staining the containers colour fast internal packaging or pre washed materials should be used A Close the lid properly improperly sealed lids can Jeopardize sterility A Risk of non sterility For example there is a risk of non sterility if the container is over loaded or protruding cloth corners prevent the container from closing properly A Deformation of containers If the sterilization procedure causes sterili zation 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 investi gation into the cause involving functional tests on the damaged sterilizing container Special linen for drain type bottoms Inner linen No additional external packaging Never use additional external packing or wrap during sterilization as the resulting increase in flow resistance may affect sterilization non sterilization or damage the container implosion In the case of instrument sterilization Sterilization operational limits n 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 indenta tion on the container tray The lid must lie flat on
4. VAGNER d Gebrauchsanweisung Instructions for use Notice d utilisation Instrucciones de Manejo Indicazioni per l utilizzazione Deutsch English Francais Espanol Italiano www wagner steriset de www wagner steriset de VAGNERO _ VV2HM5EL CE Stand 4 2008 gedruckt 3 2015 SteriSet Container erf llen die zutreffenden Anforderungen der Europ ischen Medical Device Directive MDD 93 42 EWG der internationalen Norm ISO 11607 der Europ ischen Norm EN 868 der Deutschen Normen DIN 58952 1 und DIN 58953 9 der Vertriebszulassung in USA FDA 510K Premarketing Notification SteriSet und ThermoLoc sind eingetragene Warenzeichen Technische Anderungen vorbehalten SteriSet Containers meet the following requirements European Medical Device Directive CE mark declared MDD 93 42 EWG International Standard ISO 11607 European Standard EN 868 parts German Standards former DIN 58952 1 and actual DIN 58953 9 FDA 510K Premarketing Notification for USA SteriSet and ThermoLoc are registred trademarks Technical modifications reserved Les conteneurs SteriSet r pondent aux exigences applicables Directive Europ enne relative aux Dispositifs M dicaux MDD 93 42 CE Norme International ISO 11607 Norme Europ ennes EN 868 Normes Allemandes DIN 58952 1 et DIN 58953 9 Autorisation de vente aux U S A Notification Pr marketing FDA 510K SteriSet et ThermoLoc sont d
5. and tear and damage rather than frequent use of the container for its intended purpose and can be identified by the re quired control of function before reuse 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 SteriSet container although robust also needs to be treated with care in order to ensure that its protective qualities are preserved Only use Steriset containers following the instructions in this user manual Relevant personnel must therefore be familiar with the correct handling practices Make sure the user manual is easily accessible for relevant personnel Observe current standards Carefully follow the general guide lines and hygiene principles on handing contaminated products products awaiting sterilization and products which have been sterilized Before using the sterile container or after any accident such as being dropped on the ground it is essential that the sterile container undergoes a thorough visual and functional check for damage Never use a damaged or defective sterile container Deutsch 2 Oa Bn LL Espanol Italiano 10 Control of Function Undamaged shape The seating of the seals on the upper rim of the container base tray and on the inner lid mus
6. to limit storage duration to 6 months dust protected and dry storage provided with or without internal packaging but also references to the responsibility of the medical director to lay down the ac ceptable storage duration individually A Other important points are Dry storage under controlled conditions low air contamination constant humidity etc Handling as vibration free as possible Packaging mechanically undamaged If these points are followed then the risk of recontamination will be essen tially restricted to the effects of external contamination accumulated during sto rage Unlike other types of packaging the protective cover concept of the SteriSet containers is a simple method of eliminating this potential risk e g by swab disinfection of the protective lid or using the S model We nevertheless recommend following DIN 58953 9 2000 Operation procedures for sterilization containers Special cases When storing or transporting sterile containers under non standard hospital conditions e g house external transport strong vibration extreme changes in temperature when there is a danger of contact with fluids 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 The contents of a container can o
7. 68 8 A Validation The latest technical standards require the user to validate the sterilization procedure e g in accordance with EN 554 ISO 13863 even when the sterilizer being used has been built in accordance with one of the above standards as it may otherwise not be possible to guarantee the attainment of sterility With loads comprising solely instruments i e containing no porous items such as textile packs etc then simple prevacuum procedures may also be suitable validation Hot air sterilization gravity or circulation procedures and also formaldehyde or ethy lene oxide sterilization or other substitute procedures for the sterilization of thermo labile products such as plasma sterilization or peroxide sterilization may not be used Careless handling or the use of inappropriate chemicals can cause damage to the steri lization containers thereby putting at risk the ability to attain and preserve sterility Example Never use disinfection solutions containing halogen or chloride there is a danger of corrosion even for stainless steel containers SteriSet containers therefore require regular visual and if necessary functional checks Servicable Life After 5000 cycles of accelerated aging in accordance with EN 868 8 Annex G the tested seal gasket function and barrier properties Steriset Containers showed no functional changes The end of serviceable life tends to be determined by mechanical wear
8. after the lid latch was opened After cool down the seal can be reset without dropping down again Such the first opening since cool down is clearly indicated Sterilization Because of their safety cover design SteriSet containers can also be sterilized 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 packaging Use of simple internal packaging e g cloth wrap can assist the final drying stage and good aseptic presentation of the sterile goods The size of the internal packaging should be calculated so that when Its is 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 stiff paper the use of sterilization paper is expressly not recommended
9. alve with seal attachment must always be properly screwed in and be spring tensioned press with thumb to check spring tension see pics 23 24 After Sterilization To safeguard against accidents burns dropping etc containers that are still hot should never be handled with bare hands even despite the thermally in sulated handles silicon coating After removal from the sterilizer 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 reconden sa tion of the water vapour inside the container with an unwanted accumula tion of condensate A cooling time of 30 minutes should be allowed before handling containers as detailed in DIN 5895379 2000 Storage Transport 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 scientific research see also DIN 58953 9 2000 this risk factor can be reduced by the following measures The use of internal packaging Storage under dust protected conditions Limitation of the storage period DIN 58953 part 9 Sep 2000 table 2 recommends without claim to be comprehensive
10. and outer lids are made of anodized aluminium The fittings and valves and also the protective cover if this option is chosen are made of electrolytically polished chemically resistant stainless steel 1 4301 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 Do not use substances containing halogen or chloride there is a danger of corrosion even on stainless steel Thorough rinsing must remove all cleaning agent residues The individual parts must be thoroughly dried and stored In a dry place following cleaning disinfection The selected cleaning agents must be appropriate for the quality of the available water For thermal cleaning and disinfection first choice we recommend in case of fully desalinated water cleaning with i e the pH neutral enzymatic cleaner NEODISHER MEDIZYM at app 55 C or MediClean up to 60 C or Medi Clean Forte at max 45 C and subsequent thermo disinfection during final rinsing by use of fully desalinated water Note NEODISHER is a registered trademark of Chemi sche Fabrik Dr Weigert Hamburg Germany Cleaning in case of only softened water use of mild alkaline non chlorous substances such as NEODISHER SeptoClean liquid or NEODISHER MA powder at appr 55 oC followe
11. bacteria barrier etc is no longer guaranteed Only combine WAGNER sterile container products Filter or Valve System SteriSet filter containers are containers with a closed unperforated base and perforated filter lid covered by a protec tive lid They are intended to be used with single use disposable filters made from sterilization paper In case of use of filters which are not supplied by WAGNER the user must validate the permeability and barrier properties himself SteriSet valve containers are containers with a closed unperforated base and a permanent stainless steel pressure sensitive valve in the inner lid These sterilization valves react to the change in pressure within the sterilizer during the vacuum phase the valve opens upwards and the air steam mixture flows out of the container during the pressurization phase the valve opens downwards and thus allows steam to flow in The system is automatically flushed and sterilised by the steam rushing through the valve during every sterilization cycle when not in the sterilizer i e during storage and transport under specified conditions see section on Storage the sterilizing valve is closed and a barrier to microorganisms SteriSet containers are suitable for use in validated steam sterilizers using vacuum processes e g DIN 58946 EN 285 ANSI AAMI ISO 11134 1993 ST46 1993 and are evaluated for suitability in accordance with EN 8
12. d by thermodisinfection with fully desalinated water For chemical cleaning and disinfection 2nd choice we recommend Use of pH neutral or weak acidic substances such as NEODISHER Dekonta a combined cleaning amp disinfection product and in case of fully desalinated water Use of a neutral final rinse aid such as neodisher TN in case of only softened water Use of a mild alkaline soft water compatible final rinse aid such as neodisher TS A Waterquality Please note a Regular tap water can only be used cold and thus is unsuitable for washing b Softened water should only be used up to max 60 C H Rinsing only lt lt 60 C H Washing up to max 65 C when suitable cleaner selected see recommendations m Thermodisinfection NOT applicable hot softened water may degrade aluminum white deposit c Desalinated water EN 285 quality appendix B H Rinsing suitable up to 95 C m Washing in combination with a suitable cleaner see recommendations m Thermodisinfection suitable up to 95 C The brochure Proper maintenance of in struments of the German working group Instrument preparation now gives further valuable guidance for re processing of reusable medical devices See i e PDF brochure under www a k i org Suitable cleaners disinfection solutions are i e offered by Chemische Fabrik Dr Weigert the MediClean Medizym Neodisher family www drweigert de
13. es marques d pos es Modifications techniques r serv es SteriSet wird in Deutschland unter einem T V zertifizierten Qualit ts Management System gefertigt SteriSet is Made in Germany under a TUV certified Quality Management System SteriSet est fabriqu en Allemagne encadr par un syst me de management de la qualit certifi par le TUV Qualitats Management 43 zertifiziert nach EN ISO 13485 TUV Quality Management System un certified acc EN ISO 13485 EN ISO 13485 Systeme Management Qualite certifie EN ISO 13485 SteriSet Containers are reusable metal sterilization containers They are used for holding operating room instruments and or textiles during vacuum steam sterilization procedures and for main taining sterility during storage and trans port under proper hospital conditions The containers are intended for use by specialist trained professionals and their assistants working in the fields of hospi tal hygiene and sterilization technology This user manual describes important instructions on the proper use and care of SteriSet containers and without claiming to be comprehensive outlines a number of possible hazards that could result from failure to observe the instructions Compatibility warning If the SteriSet Containers are used in com bination with components or articles filters seals etc from another manufacturer then sterility and or the functioning of the anti
14. led valve The valve opens in 134 C programmes when the tempe rature rises above 130 C thereby allowing condensate to drain out during sterilization During the drying phase the conden sate valve closes while still inside the sterilizer when the temperature first drops below 110 C It re opens only when the temperature again rises above 130 C which means that this option is associated with absolutely no risks at typical removal temperatures of 75 80 C 121 C program Standard condensation valves do not open during the 121 C sterilization programme for the above reasons a condensation valve for 121 sterilization is optionally available Note For containers with condensate drain valves in the base the condensate should be able to drip to the base unimpeded This can be achieved by using cloth wraps with a central hole The recommended dimensions for the hole in the cloth are 40x20 cm or 20x20 cm for half size containers A No prolonged exposure Containers shall be removed from the sterilizer at program end latest within 1 hour after program end if left for a prolonged period in the closed heated chamber the drain s switch temperature could be reached again such re open the drain valve and introduce the risk of non sterility when taking out Specifically in the case of small load sterilization lt 2 kg the container must be removed from the sterilizer promptly at program end The condensate v
15. nly be considered sterile if the container has been correctly sterilized and at the time of opening its lock has not been tampered with If containers are to be opened after a long period of storage or after storage under non ideal conditions then we recommend either using the S model protective cover removable separately as a first stage see Tigs 16 19 or wiping the unperforated cover with a disinfectant before handling In general containers should be handled in such a way that mechanical damage is minimized Both lid latches of the container must opened to allow to lift the lid up completely Opening only one side latch with the other side still closed will very likely damage the still closed latch or closure and as such hamper the integrity of the container 13 In the operating room SteriSet containers are normally protected from direct con tamination with blood or protein as they are covered with sheets or are removed from the room before the operation starts Experience has shown that optically clean containers are therefore 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 person nel for example by surface contact trials containers should be cleaned dis infected before the next use Compatibility with materials Container bases trays inner lids
16. t be free of dents and visible deformations Neither the lid nor filter plate nor the tray may show noticeable buckling or holes Seal The seal in the inner lid and filter plate button filter plate and condensate drain if applicable must be completely inserted and undamaged Handles and clasps Handles closure clasps and similar fittings must not be loose no wobble The closure clasps must lock the lid firmly to the bottom of the container Filters or valves Neither filters valves nor filterplates or valve covers see pic 8 the perforated disc sections may show visible malformations The seals on the filter plates the lock pin on the lid must not be damaged and filters must fully cover the visible perforations in the lid The filters are to be subjected to visual and mechanical inspections see pics 6 8 and 20 22 Containers with condensate drain valves The condensate valve must be screwed in correctly with the attached seal and be spring tensioned check the spring tension by thumb pressure with the valve screwed in position To screw in the valve press vertically downwards whilst at the same time turning clockwise until it clicks into place See pics 23 24 Tamper Proof Sealing Sealing It is recommended and required by the latest technical standards DIN EN ISO 11607 1 5 1 10c that containers are sealed in such a way as to prevent inadvertent opening of containers and to ens
17. 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 and after closing the lid must sit tightly against the rim 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 With cloth loads or similar the load weight should not exceed 6 5 7 kg n 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 As a general rule contains should only be handled after cool down DIN 58953 9 recommends 30 minutes In still air 11 12 Data cards indicators We recommend the use of documen tation 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 bung Doig Does eT ei ae E E r a mi The additional use of chemical sterili zation 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 ac
18. tually attained sterility they indicate only that the contents at the location of indicator were 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 in dicators in every single sterile pack If such a worst case pack signals sterile then there is amuch smaller probability of the procedure having failed for example as a result of spontaneous changes such as insufficient air circulation caused by faulty door seals than If indicators are place in a normal container Note The batch documentation does not replace regular checking and documentation of the sterilizers ventilation tests sterilization tests with chemical and biological indicators vacuum leak tests etc If procedure indicators are not used then other organizational measures should ensure that no unsterilized and thus non sterile containers are inadvertently released Condensation valve Some drying problems with instruments such as overloaded instrument sets can be solved only by using a container fitted with a condensate drain valve in the base Such containers are equip ped with a sump with a central outlet which is tightly closed by a temperature control
19. ure that It is evident whether or not a container has been opened SteriSet containers offer two alternative methods for this 1 Disposable plastic seals which once attached can be open ed only by breaking They are inserted through the horizon tal hole in the closure before sterilization and fastened between thumb and index finger press fully together but do not snap off To unseal open Insert for example an index finger and TWIST do not pull see diagram 1 3 If seals purchased from a company other than Wagner are to be used the user has to make sure 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 2 The automatic sealing option P ThermoLoc Con Z tainers with this type C of closure indicate sealing automatically as a result of the heat during steriliza tion procedure In the sealed condition a diagonal red block appears below the closure To unseal push the block vertically upwards until the red block has disappeared into the housing Only then can the clasp be released see diagram 12 14 Safety note The sealing function of ThermoLoc may only be reset after cool down app 10 minutes after removal from the sterilizer Resetting the seal before cool down would require application of force and gloves to be worn hot and might cause the still hot latch to reappear
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