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Single-use products

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the
time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temper-
atures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the
laser marking becoming unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water
used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in
the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water
and then drying.
Additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are
compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used
for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
ure to do so can result in the following problems:

Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/process solution only needs to be of pH >8 to cause visible surface changes.

Material damage such as corrosion, cracks, fracturing, premature aging or swelling.

Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.

Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-
k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Disassembling the product before carrying out the reprocessing procedure

Disassemble the product immediately after use, as described in the respective instructions for use.

Preparations at the place of use

If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.

Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.

Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

Preparation before cleaning

Dismantle the product prior to cleaning, see Disassembling.

Cleaning/disinfection

Product-specific safety notes on the reprocessing procedure

Do not use oxidizing chemicals (e.g. H

2

O

2

), which could cause bleaching/layer loss of the product.

Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.

Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfecting.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/

disinfecting.

– as an integrated mechanical support measure for mechanical cleaning/disinfecting.
– for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.

Validated cleaning and disinfection procedure

Manual cleaning/disinfection

Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.

After manual cleaning/disinfection, check visible surfaces visually for residues.

Repeat the cleaning /disinfection process if necessary.

Manual cleaning with immersion disinfection

D–W:

Drinking water

FD–W:

Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)

RT:

Room temperature

*Recommended: BBraun Stabimed

Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.

Phase I

Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are
moistened.

Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.

If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.

Mobilize non-rigid components, such as set screws, links, etc. during cleaning.

Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.

Phase II

Rinse/flush the product thoroughly (all accessible surfaces) under running water.

Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

Drain any remaining water fully.

Phase III

Fully immerse the product in the disinfectant solution.

Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.

Phase IV

Rinse/flush the product thoroughly (all accessible surfaces).

Mobilize non-rigid components, such as set screws, joints, etc. during final rinse.

Rinse lumens with an appropriate disposable syringe at least five times.

Drain any remaining water fully.

Phase V

Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfection procedure.

Mechanical cleaning/disinfection with manual pre-cleaning

Note

The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
according to DIN EN ISO 15883).

Note

The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with a brush

D–W:

Drinking water

RT:

Room temperature

*Recommended: BBraun Stabimed

Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.

Phase I

Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are
moistened.

Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.

If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.

Mobilize non-rigid components, such as set screws, links, etc. during cleaning.

Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.

Phase II

Rinse/flush the product thoroughly (all accessible surfaces) under running water.

Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

WARNING

Infection hazard for patients and/or users and impairment of product functional-
ity due to reuse. Risk of injury, illness or death due to contamination and/or 
impaired functionality of the product!

Do not reprocess the product!

Art. no.

Designation

FW343S

Kirschner wire set

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or 
excessive temperatures!

Use cleaning and disinfecting agents approved for, e.g., aluminum, plastics and 
high-grade steel, according to the manufacturer’s instructions.

Observe specifications regarding concentration, temperature and exposure 
time.

Do not exceed the maximum permitted cleaning temperature of 60 °C.

CAUTION

Possible damage to, or destruction of, the threads on the Kirschner wire and the 
removal instrument, caused by cleaning, disinfecting or sterilizing!

Do not clean, disinfect, sterilize or reuse the MACS TL® Kirschner wire set.

Validated procedure

Specific requirements

Reference

Manual cleaning with 
immersion disinfection

Cleaning brush: 260 mm/

: 2.5 mm e.g. TE654202

20 ml disposable syringe

Keep working ends open for clean-
ing.

Drying phase: Use a lint-free cloth 
or medical compressed air 

Section Chapter Manual cleaning/
disinfection and subsection:

Chapter Manual cleaning with 
immersion disinfection

Manual pre-cleaning with 
brush and subsequent 
mechanical alkaline cleaning 
and thermal disinfection

Cleaning brush: 260 mm/

: 2.5 mm e.g. TE654202

20 ml disposable syringe

Place the product in a tray that is 
suitable for cleaning (avoiding rins-
ing blind spots).

Section Chapter Mechanical clean-
ing/disinfection with manual pre-
cleaning and subsection:

Chapter Manual pre-cleaning 
with a brush

Chapter Mechanical alkaline 
cleaning and thermal disinfecting

Phase

Step

T
[°C/°F]

t
[min]

Conc. 
[%]

Water 
quality

Chemical

I

Disinfecting 
cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, 
and QUAT-free concentrate, 
pH ~ 9*

II

Intermediate 
rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, 
and QUAT-free concentrate, 
pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

Phase

Step

T
[°C/°F]

t
[min]

Conc. 
[%]

Water 
quality

Chemical

I

Disinfec-
tant

                      

cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, 
and QUAT-free concentrate, 
pH ~ 9*

II

Rinsing

RT (cold)

1

-

D–W

-

Summary of Contents for Aesculap MACS T 011148

Page 1: ...chner MACS TL Gebruiksaanwijzing Technische beschrijving MACS TL Kirschner draad instrumentarium Bruksanvisning Teknisk beskrivning MACS TL Kirschnertr dinstrument MACS TL N vod k pou it Technick popi...

Page 2: ...gnment with the direction of the X ray as soon the metal shaft of the housing is projected as a point in the center of the X ray marking 8 A If the insertion instrument is not in proper alignment the...

Page 3: ...isible surfaces with an appropriate cleaning brush for at least 1 min Mobilize non rigid components such as set screws links etc during cleaning Thoroughly rinse through these components with the clea...

Page 4: ...erilization cycle and has the data on file The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products Other sterilization cycle...

Page 5: ...richtet wenn der Metallschaft des Geh uses als Punkt zentrisch zur R ntgenmarkierung 8 projiziert wird A Ist das Einsetzinstrument nicht richtig ausgerichtet wird der Metallschaft als Strich abgebilde...

Page 6: ...ntauchen Dabei darauf achten dass alle zug nglichen Oberfl chen benetzt sind Produkt mit einer geeigneten Reinigungsb rste in der L sung so lange reinigen bis auf der Oberfl che keine R ckst nde mehr...

Page 7: ...ntamination des Produkts w hrend der Lagerung verhindert Dampfsterilisation Hinweis Das Produkt darf nur im zerlegten Zustand sterilisiert werden Sicherstellen dass das Sterilisiermittel Zugang zu all...

Page 8: ...on parall lement au faisceau de rayons X sous contr le radiologique L instrument d insertion est orient parall lement au faisceau de rayons X lorsque la tige m tallique du bo tier se projette sous la...

Page 9: ...urfaces visibles Si n cessaire r p ter le processus de nettoyage d contamination Nettoyage manuel avec d contamination par immersion EP Eau potable ED m Eau d min ralis e au moins de qualit eau potabl...

Page 10: ...e que les ventuels tranchants soient prot g s Emballer les paniers perfor s de mani re adapt e au proc d de st rilisation p ex dans des containers de st rilisation Aesculap Veiller ce que l emballage...

Page 11: ...ente el aguja Kirschner con la mano en el empujador 6 Colocar el instrumento de inserci n paralelamente al rayo X controlando la operaci n mediante radiograf a Si el instrumento de inserci n est aline...

Page 12: ...mbiente Recomendaci n BBraun Stabimed Seguir las indicaciones sobre jeringas desechables y cepillos de limpieza m s adecuados ver Proceso homologado de limpieza y desinfecci n Fase I Sumergir todo el...

Page 13: ...mpedir una recontaminaci n del producto durante su almacena miento Esterilizaci n a vapor Nota El producto s lo puede esterilizarse desmontado Asegurarse de que el medio esterilizador tiene acceso a t...

Page 14: ...llo radiologico Lo strumento inseritore allineato parallelamente ai raggi X se il gambo metallico della custodia proiettato quale punto centrico sulla marchiatura radiologica 8 A Se lo strumento inser...

Page 15: ...nto di preparazione sterile e disinfezione validato Fase I Immergere completamente il prodotto nella soluzione disinfettante ad azione detergente attiva per almeno 15 min accertandosi che tutte le sup...

Page 16: ...stelli in maniera idonea per il procedimento di sterilizzazione ad es in Aesculap container per ste rilizzazione Accertarsi che l imballo impedisca eventuali ricontaminazioni del prodotto durante il m...

Page 17: ...nstrumento introdutor paralelamente aos raios X sob controlo radiosc pico O instrumento introdutor est posicionado em paralelo com o raio X quando o cabo de metal do corpo projec tado sob a forma de u...

Page 18: ...alidado Fase I Imergir totalmente o produto na solu o desinfectante de limpeza activa durante pelo menos 15 min Para tal assegurar que todas as superf cies acess veis ficam molhadas Limpar o produto c...

Page 19: ...uto s pode ser esterilizado se estiver desmontado Garantir que o produto de esteriliza o acede a todas as superf cies internas e externas Processo de esteriliza o validado Desmontar o produto Esterili...

Page 20: ...het inzetinstrument parallel aan de r ntgenstraal onder r ntgencontrole Het inzetinstrument staat parallel aan de r ntgenstraal als de metalen schacht van de behuizing als een punt wordt geprojecteerd...

Page 21: ...e reinigingsactieve desinfectieoplossing worden ondergedom peld Zorg ervoor dat alle bereikbare oppervlakken bevochtigd worden Reinig het product met een geschikte reinigingsborstel in de oplossing to...

Page 22: ...opslag verhindert Stoomsterilisatie Opmerking Het product mag uitsluitend in gedemonteerde toestand worden gesteriliseerd Zorg ervoor dat alle buiten en binnenvlakken met het sterilisatiemedium in co...

Page 23: ...at mot r ntgenstr len n r kapslingens metallskaft projiceras centriskt mot r ntgenmarkeringen 8 som punkt A Om ins ttningsintrumentet inte r korrekt injusterat avbildas metallskaftet som ett streck B...

Page 24: ...som t ex justerskruvar leder etc vid reng ringen Spola d refter igenom dessa st llen grundligt minst 5 g nger med den aktivt reng rande desinfektionsl sningen och en passande eng ngsspruta Fas II Sk l...

Page 25: ...iderad steriliseringsmetod Ta is r produkten ngsterilisering med fraktionerad vakuummetod ngsterilisator enligt DIN EN 285 och validerad enligt DIN EN ISO 17665 Sterilisering med den fraktionerade vak...

Page 26: ...MACS TL 3 4 5 6 7 8 9 10 Aesculap www extranet bbraun com MACS TL MACS TL MACS TL MACS TL MACS TL MACS TL FW343S 6 4 6 8 A B 7 5 7 20 6 6 MACS TL MACS TL 10 MACS TL 10 MACS TL 6 5 9 5 6 5 9 5 FW343S 2...

Page 27: ...tranet bbraun com Aesculap 6 45 C VAH FDA CE pH 8 www a k i org Rote Brosch re 6 H2O2 BBraun Stabimed I 15 1 5 II III 5 FW343S 60 C MACS TL 260 2 5 TE654202 20 260 2 5 TE654202 20 T C F t I 15 2 pH 9...

Page 28: ...665 134 C 5 B Braun Aesculap Aesculap Technischer Service Am Aesculap Platz 78532 Tuttlingen Germany Phone 49 7461 95 1602 Fax 49 7461 16 5621 E Mail ats aesculap de TA Nr 011148 07 14 V6 nd Nr 48392...

Page 29: ...ontrolou rovnob n s rentgenov m paprskem Zav d c n stroj je vyrovn n rovnob n s rentgenov mi paprsky kdy se kovov d k krytu jako bod prom t do st edu k rentgenov zna ce 8 A Pokud nen zav d c n stroj v...

Page 30: ...rouby klouby atd v pr b hu i t n pohybujte Z v rem tato m sta d kladn propl chn te pomoc vhodn st ka ky na jedno pou it dezinfek n m roztokem s ist c m inkem minim ln v ak 5 kr t F ze II V robek d kl...

Page 31: ...a validovan podle DIN EN ISO 17665 Sterilizace frak n vakuovou metodou p i teplot 134 C doba p soben 5 min P i sou asn sterilizaci v ce v robk v parn m steriliz toru zajist te aby nebylo p ekro eno ma...

Page 32: ...eli metalowy trzon obu dowy jest wy wietlany jako punkt wycentrowany wzgl dem oznaczenia rentgenowskiego 8 A Je eli instrument do wprowadzania nie jest prawid owo ustawiony metalowy trzon widoczny je...

Page 33: ...szczotek do czyszczenia i strzykawek jed norazowych patrz Walidowana procedura czyszczenia i dezynfekcji Faza I Produkt ca kowicie zanurzy w aktywnie czyszcz cym roztworze dezynfekcyjnym przynajmniej...

Page 34: ...ulap Zapobiec rekontaminacji produktu podczas jego przechowywania poprzez stosowanie odpowiedniego opakowa nia Sterylizacja parowa Notyfikacja Produkt mo e by sterylizowany wy cznie w stanie roz o ony...

Page 35: ...paralelne s r ntgenov m l om ke sa kovov n sada telesa projektuje ako bod vystredene k r ntgenov mu ozna eniu 8 A Ak osadzovac n stroj nie je spr vne vyrovnan zobraz sa kovov n sada ako iara B Zna ky...

Page 36: ...miesta d kladne prepl chnite istiacim dezinfek n m prostriedkom a vhodnou jednor zovou injek nou strieka kou najmenej 5 kr t F za II Cel n stroj v etky pr stupn povrchy opl chnite prepl chnite pod te...

Page 37: ...idovan pod a DIN EN ISO 17665 Steriliz cia mus prebieha vo frak nom v kuu pri 134 C po dobu 5 min Pri s asnej steriliz cii viacer ch v robkov v jednom parnom steriliz tore zabezpe te aby nebolo prekro...

Page 38: ...larak r ntgen i aretine 8 merkezli bir ekilde yans t l rsa yerle tirme aleti r nt gen n na paralel olarak hizalan r A Yerle tirme aleti do ru hizalanmad ysa metal aft izgi olarak g sterilir B aretli 7...

Page 39: ...entleri rn ayar vidalar eklemler vs temizlik s ras nda hareket ettiriniz Daha sonra bu yerleri temizleyici aktif sol syon ile tek kullan ml k bir enjekt r yard m yla 5 kereden az olmamak zere iyice du...

Page 40: ...si Fraksiyonlu vakum y nteminde buharl sterilizasyon DIN EN 285 standard na uygun ve DIN EN ISO 17665 standard na g re onaylanm buhar sterilizasyonu Fraksiyonlu vakum y ntemiyle 134 C 5 dakika i lem s...

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