Additional Information - HAGER WERKEN Steri-Suc-Tube Anweisungen

If after the cleaning process, there is still contamination visible, the cleaning has to be repeated.
DISINfEctION: mANuAl
For the manual disinfection, please only use approved disinfectants with tested effectiveness (CE mark, VAH-/DGHM-listed).
Put the products/individual components into corresponding disinfection baths according to the disinfectant manufacturer's specifications.
Ensure that the products are sufficiently covered and do not contact each other. The instructions for use of the disinfectant manufacturer
must be strictly observed. Particularly the concentrations and contact times have to be observed.
Application with the following agents is recommended: - Dürr Dental ID 213 instrument disinfection
Description of the recommended disinfection process:
Completion of proper cleaning preparation and manual cleaning
Disinfection:
Insert the instrument into the strainer bowl. Hang the strainer bowl into the disinfection bath with disinfection solution;
remove contamination by means of cleaning brushes.
Disinfectant:
ID 213, company Dürr Dental, concentration: 2 %
cleaning tools: Mirasuc brush, REF 605 216/Chiru-Cleaner 23, REF 605 215
contact time:
5 min.
rinsing:
Rinse with water (at least drinking water quality) for 20 sec.
Drying:
Drying at room temperature
Make sure that the disinfectant is compatible with the products and cleaning agents that might be used. The pH of the disinfectant should lie
between 5.5 and 8.5. Do not use organic solvents (e.g. alcohols, ether, ketones, petrol), oxidizing agents (e.g. peroxides), halogens (chlorine,
iodine, bromine) or aromatic/halogen hydrocarbons. Please observe thermal restrictions that might apply considering the disinfectant man-
ufacturer's specifications.
Afterwards, rinsing of the products/individual components with water (at least drinking water quality) for at least 20 seconds. Before further
processing, the product must be free from any residues and dry.
DryINg
If you process the products manually, the products/individual components may be dried by blowing them off with filtered, oil-free com-
pressed air according to DIN ISO 8573-1 (medical cleanliness class) or at room temperature.
The drying in machine processing should be directly completed by the devices with hot air. With machine drying, the temperature of 100°C
should not be exceeded.
mAINtENANcE, cONtrOl AND chEck
The product does not make special requirements on maintenance. Re-assemble disassembled products/individual components. You must al-
ways carry out a visual inspection for contamination, damage, wear and deformation before and after the individual work steps.
Damaged or corroded products must no longer be used. If the product/individual component is not visibly clean, the entire processing has to
be repeated or the product/individual component has to be properly disposed of.
PAckAgINg
The product is to be packed in suitable and standardized transparent sterile packaging (sterilization bags) and sealed. Observe the instruc-
tions of the sterilization bag and sealing machine manufacturers as well as the current, normative requirements. Products/individual parts
that have not been sterilized in bags must be used immediately.
StErIlIZAtION
Only tested steam vacuum autoclaves may be used. Make sure that during the sterilization of several different products/individual compo-
nents, the autoclave is not overfilled and that the products/individual components do not contact each other. The following sterilization cy-
cles may be completed: Steam sterilization, 134 °C, hold time 5 minutes or steam sterilization, 121 °C, hold time 15 minutes. To dry the
products/individual components, the drying cycle of the autoclave should be set. Use the autoclave manufacturer's instructions for use.
StOrAgE
To maintain the sterility, the products should be stored in standardized sterilization bags at a dry, clean place until they are used. If the sterile
packaging is damaged, the products must be processed once again before their use.

ADDItIONAl INfOrmAtION

Mark the sterilized products according to the legal and national regulations. The recommended storage duration for sterile medical devices
is described in standard DIN 58953-8 and depends on external influences and effects during storage, transport and handling. The user must
ensure within the scope of their quality management system that specified processing cycles that might apply (see Limitations in the process-
ing) are not exceeded. The manufacturer and the competent authority of your member state shall be immediately notified all serious inci-
dents occurring in connection with the product. For the disposal of the products, there are regionally differing recommendations and
regulations. Ask your competent disposal company for the current regulations in your region.
cONtAct tO thE mANufActurEr
Phone: (+49) 203 / 99269 -0
Fax: (+49) 203 / 299283
Email: info@hagerwerken.de
The instructions specified above are validated by the medical device manufacturer as suitable for the preparation of a medical device for its re-
use. The processor is responsible to ensure that the actually completed processing with the equipment used, materials and personnel in the
preparation facility reaches the desired result. To this end, verification and/or validation and routine monitoring of the procedure are required.