Aesculap Flow 50 Instrucciones De Manejo página 139

times thoroughly (for at least 1 min) with water. Rinse all lumina of the prod-
ucts at least five times using a disposable syringe (minimum volume 100 ml).
4. Check the products (see Inspection and Maintenance).
Disinfecting procedure
1. Insert the cleaned and checked products into the disinfecting solution for the
prescribed contact time and make sure the products are sufficiently sub-
merged. Make sure the products do not touch one another. Rinse all lumina
of the products at least five times at the beginning or at the end of the con-
tact time using a disposable syringe (minimum volume 100 ml).
2. Remove the products from the disinfecting solution and rinse at least five
times thoroughly (at least 1 min) with water. Rinse all lumina of the products
at least five times using a disposable syringe (minimum volume 100 ml).
3. Dry the products by blowing off/blowing out with filtered compressed air.
4. Package the products as soon as possible after removal (see Packaging, pos-
sibly after additional drying in a clean location).
Documentation of the fundamental suitability of the reusable heating tube sys-
tem for an effective manual cleaning and disinfection was prepared by an inde-
pendent accredited and recognized (§15 (5) MPG) testing laboratory using the
pre-cleaning/cleaning agent neodisher Medizym and the disinfecting agent neo-
disher Septo 3000 (Dr. Weigert GmbH & Co. KG, Hamburg). This was done by tak-
ing into account the procedure described above.
Check the reusable tube system after cleaning or cleaning/disinfection for corro-
sion, damaged surfaces, chipping, soiling and discoloration and discard damaged
products. (See label of the product for the numerical restriction of reuse). In case
of damage (scratches, flaking) on the chrome-plated Luer-lock adapter, the prod-
ucts must be replaced immediately (no reuse permitted). Products still contami-
nated or dirty must be once again cleaned and disinfected.
Instrument oils or grease may not be used.
Please pack the tube systems into sterile disposable packaging (single or double
packaging) that comply with the following requirements (material/process):
• DIN EN ISO/ANSI AAMI ISO 11607
• Suitable for steam sterilization (temperature resistance up to min. 142 °C
(288 °F) with sufficient steam permeability)
• Sufficient protection of the products or sterilization packaging against me-
chanical damage
9.5.2 Sterilization of Reusable Tube Sets (NOT APPROVED FOR SALE IN
THE U.S.)
Sterilization must be carried out with only the following sterilization method list-
ed below; any other sterilization procedures are not permitted.
• Fractionated vacuum method
• Steam sterilizer according to DIN EN 13060/DIN EN 285 or ANSI AAMI ST79
• validated according to DIN EN ISO 17665 (valid IQ/OQ (picking) and product-
specific performance assessment (PQ))
• maximum sterilization temperature 138 °C (280 °F; plus tolerance according to
DIN EN ISO 17665)
• Sterilization time (exposure time at sterilization temperature) at least 5 min-
utes at 132 °C (270 °F) / 134 °C (273 °F)
2
at least three vacuum stages
3
Use of the less effective gravitation procedure is allowed only in case of non-avail-
ability of the fractionated vacuum procedure; requires significantly longer steriliza-
tion times and must be validated specifically for the products, devices, and
parameters in sole responsibility of the user.
2,3
(with sufficient product drying
Inspection
Maintenance
Packaging
4
) Steam sterilization
Care and Maintenance
EN
57